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| Name | Class |
|---|---|
| University of Leeds | OTHER |
| National Institute for Health Research, United Kingdom | OTHER_GOV |
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This study explores whether it is feasible to use a newly developed activity pacing framework to standardise how activity pacing is instructed by healthcare professionals in rehabilitation programmes for patients with chronic pain/fatigue.
Activity pacing is frequently advised in the management of chronic pain/fatigue, including chronic low back pain, chronic widespread pain/fibromyalgia and chronic fatigue syndrome/myalgic encephalomyelitis. However, there is no agreed definition of 'activity pacing' and it is instructed in various ways. For some, pacing involves adapting/limiting activities (for example, breaking down tasks/having rests); while for others, pacing involves having consistent activities/gradually increasing activities. Furthermore, pacing has been associated with both improved symptoms (decreased fatigue/anxiety/depression) and worsened symptoms (increased pain/disability).
Due to the high prevalence and cost (personal and financial) of chronic pain/fatigue, it is imperative that coping strategies such as pacing are clearly defined and evidence-based. This study involves Stage III in the development of an activity pacing framework to standardise how pacing is instructed by healthcare professionals. Stage I: Online Survey of pacing involved 92 healthcare professionals (doctors/nurses/physiotherapists/occupational therapists/clinical psychologists). The survey findings, together with existing research were used to develop the pacing framework. The framework was further developed in Stage II: Nominal Group Technique (consensus meeting), involving four patients and six healthcare professionals.
Stage III will test the feasibility of implementing the pacing framework clinically, by using it to underpin existing rehabilitation programmes for chronic pain/fatigue. Patients will attend rehabilitation programmes at the study sites as per usual practice. Patients' participation in this study involves their completion of a booklet of questionnaires. The aim of this feasibility study is to explore whether the activity pacing framework is usable in the clinical setting, to explore recruitment/retention rates, together with changes in symptoms between the start and end of treatment, and at 3-months follow-up. Stage III will also explore the acceptability of the framework by undertaking interviews with the patients and healthcare professionals involved in the rehabilitation programmes. Stage III is expected to last 22 months.
Future study will test the framework in a clinical trial to assess the effects of pacing on patients' symptoms. The pacing framework has the potential to improve treatments by providing guidance on the components of pacing found to have benefits for patients.
This study is funded by a Health Education England/National Institute for Health Research (HEE/NIHR) Integrated Clinical Academic (ICA) Clinical Lectureship.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Activity Pacing Framework | Adult patients attending rehabilitation programmes underpinned by the activity pacing framework. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Activity pacing framework | Behavioral | The activity pacing framework will be used to structure and standardise the instructions of pacing in existing rehabilitation programmes for adult patients with chronic pain/fatigue. The activity pacing framework has been developed in Stages I and II of this research. Stage I involved an online survey of activity pacing across healthcare professionals in England. The survey findings, together with existing research were used to develop the first draft of the framework. The framework was refined in Stage II: Nominal group technique (consensus method). The activity pacing framework describes the aims, facets and stages of pacing, together with how pacing relates to different behavioural typologies and other pain management strategies. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Activity Pacing Questionnaire (APQ-28) From Baseline to the End of the 6-week's Programme | The Activity Pacing Questionnaire (APQ) was developed to measure different themes of activity pacing. The APQ was initially validated among a sample of patients with chronic pain/fatigue and contained 26 items. Factor analysis identified five themes of pacing contained within the APQ-26: Activity adjustment, Activity consistency, Activity planning, Activity acceptance and Activity progression. The APQ-26 has been modified for the purpose of this study with the addition of two items to correspond to important aspects of pacing that were not included in the APQ-26. The APQ-28 reflects the content of the activity pacing framework. The APQ-28 will be used to assess the changes in activity pacing from baseline (pre-treatment: up to one week before the programme) to end of the programme (6-week's programme). Each of the five themes of pacing is calculated as a mean score (0-4), where higher scores indicated more implementation of pacing strategies. | Change in activity pacing from baseline (pre-treatment: up to one week before the programme) to the end of the 6-week's programme |
| Measure | Description | Time Frame |
|---|---|---|
| Activity Pacing at Baseline: Activity Pacing Questionnaire (APQ-28) | The Activity Pacing Questionnaire (APQ) was developed to measure different themes of activity pacing. The APQ was initially validated among a sample of patients with chronic pain/fatigue and contained 26 items. Factor analysis identified five themes of pacing contained within the APQ-26: Activity adjustment, Activity consistency, Activity planning, Activity acceptance and Activity progression. The APQ-26 has been modified for the purpose of this study with the addition of two items to correspond to important aspects of pacing that were not included in the APQ-26. The APQ-28 reflects the content of the activity pacing framework. The APQ-28 will be used to measure activity pacing at baseline (pre-treatment: up to one week before the programme). Each of the five themes of pacing is calculated as a mean score (0-4), where higher scores indicated more implementation of pacing strategies. |
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Feasibility Study Inclusion Criteria:
Exclusion Criteria:
Acceptability Study (qualitative interviews) Inclusion Criteria:
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The study population involves patients with conditions of chronic pain/fatigue, for example, chronic low back pain, chronic widespread pain, fibromyalgia and chronic fatigue syndrome/myalgic encephalomyelitis (CFS/ME). The study population includes those patients who are referred to the physiotherapy departments of The Pennine Acute Hospitals National Health Service (NHS) Trust and who attend a rehabilitation programme. The activity pacing framework will be used to structure and standardise the pacing component of the programme.
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| Name | Affiliation | Role |
|---|---|---|
| Deborah Antcliff, PhD, BSc | Pennine Acute Hospitals NHS Trust | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Pennine Acute Hospitals NHS Trust | Bury | Lancashire | BL9 7TD | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27322396 | Result | Antcliff D, Campbell M, Woby S, Keeley P. Activity Pacing is Associated With Better and Worse Symptoms for Patients With Long-term Conditions. Clin J Pain. 2017 Mar;33(3):205-214. doi: 10.1097/AJP.0000000000000401. | |
| 34880007 | Derived | Antcliff D, Keenan AM, Keeley P, Woby S, McGowan L. Testing a newly developed activity pacing framework for chronic pain/fatigue: a feasibility study. BMJ Open. 2021 Dec 8;11(12):e045398. doi: 10.1136/bmjopen-2020-045398. |
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This was a single-arm feasibility study. All patients received the same treatment, that is, they all attended the same rehabilitation programme that was underpinned by the activity pacing framework. Excluded from the study were those patients who did not meet the inclusion/exclusion criteria.
For the feasibility study, patient recruitment occurred between 21st May 2018 and 3rd September 2019. Patients were recruited from those referred to a rehabilitation programme within a physiotherapy-led, out-patient service in a National Health Service (NHS) Trust in Northern England.
The acceptability interviews involved patients (as above) and healthcare professionals (HCPs) delivering the programmes. HCP recruitment occurred between 18th September 2019 and 6th November 2019.
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| ID | Title | Description |
|---|---|---|
| FG000 | Activity Pacing Framework | Adult patients attending rehabilitation programmes underpinned by the activity pacing framework. Activity pacing framework: The activity pacing framework will be used to structure and standardise the instructions of pacing in existing rehabilitation programmes for adult patients with chronic pain/fatigue. The activity pacing framework has been developed in Stages I and II of this research. Stage I involved an online survey of activity pacing across healthcare professionals in England. The survey findings, together with existing research were used to develop the first draft of the framework. The framework was refined in Stage II: Nominal group technique (consensus method). The activity pacing framework describes the aims, facets and stages of pacing, together with how pacing relates to different behavioural typologies and other pain management strategies. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
All 107 participants were included in the baseline analyses. Some questions have fewer than 107 responses in instances of missing answers. For the question regarding participants' conditions, they were able to check more than one answer.
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| ID | Title | Description |
|---|---|---|
| BG000 | Activity Pacing Framework | Adult patients attending rehabilitation programmes underpinned by the activity pacing framework. Activity pacing framework: The activity pacing framework will be used to structure and standardise the instructions of pacing in existing rehabilitation programmes for adult patients with chronic pain/fatigue. The activity pacing framework has been developed in Stages I and II of this research. Stage I involved an online survey of activity pacing across healthcare professionals in England. The survey findings, together with existing research were used to develop the first draft of the framework. The framework was refined in Stage II: Nominal group technique (consensus method). The activity pacing framework describes the aims, facets and stages of pacing, together with how pacing relates to different behavioural typologies and other pain management strategies. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | One missing answer |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Activity Pacing Questionnaire (APQ-28) From Baseline to the End of the 6-week's Programme | The Activity Pacing Questionnaire (APQ) was developed to measure different themes of activity pacing. The APQ was initially validated among a sample of patients with chronic pain/fatigue and contained 26 items. Factor analysis identified five themes of pacing contained within the APQ-26: Activity adjustment, Activity consistency, Activity planning, Activity acceptance and Activity progression. The APQ-26 has been modified for the purpose of this study with the addition of two items to correspond to important aspects of pacing that were not included in the APQ-26. The APQ-28 reflects the content of the activity pacing framework. The APQ-28 will be used to assess the changes in activity pacing from baseline (pre-treatment: up to one week before the programme) to end of the programme (6-week's programme). Each of the five themes of pacing is calculated as a mean score (0-4), where higher scores indicated more implementation of pacing strategies. | Of the 107 participants who commenced the rehabilitation programme and provided baseline data (T1), 65 participants completed the data collection at the end of the 6-week rehabilitation programme. There were two missing answers for APQ-28 Activity adjustment. | Posted | Mean | 95% Confidence Interval | score on a scale | Change in activity pacing from baseline (pre-treatment: up to one week before the programme) to the end of the 6-week's programme |
There were no adverse events throughout the duration of the study, that is, between the start of recruitment in May 2018 and the end of the 3-months follow-up data collection in December 2019.
There were zero adverse events among a possible sample of 107 patients who commenced the rehabilitation programme; nor were there any adverse events during the interviews with the five healthcare professionals.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Activity Pacing Framework | Adult patients attending rehabilitation programmes underpinned by the activity pacing framework. Activity pacing framework: The activity pacing framework will be used to structure and standardise the instructions of pacing in existing rehabilitation programmes for adult patients with chronic pain/fatigue. The activity pacing framework has been developed in Stages I and II of this research. Stage I involved an online survey of activity pacing across healthcare professionals in England. The survey findings, together with existing research were used to develop the first draft of the framework. The framework was refined in Stage II: Nominal group technique (consensus method). The activity pacing framework describes the aims, facets and stages of pacing, together with how pacing relates to different behavioural typologies and other pain management strategies. |
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The target sample size of n=50 patients at 3-months follow-up (T3) for the feasibility study was attained (actual sample at T3: n=52). Despite recruiting to target for the feasibility study, this sample was not powered with a control arm to determine treatment effectiveness.
The generalisability of this study is limited to a sample of predominantly females, of white ethnic origin and recruited from only one Pain Service in Northern England, United Kingdom (UK).
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Deborah Antcliff | Pennine Acute NHS Trust | 0161 7242168 | Deborah.Antcliff@pat.nhs.uk |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 27, 2018 | May 14, 2018 | Prot_SAP_002.pdf |
| ICF | No | No | Yes | Informed Consent Form | Apr 27, 2018 | May 14, 2018 | ICF_003.pdf |
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| ID | Term |
|---|---|
| D059350 | Chronic Pain |
| D005356 | Fibromyalgia |
| D015673 | Fatigue Syndrome, Chronic |
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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|
| Baseline (pre-treatment: up to one week before the programme) |
| Activity Pacing at the End of Treatment: Activity Pacing Questionnaire (APQ-28) | The Activity Pacing Questionnaire (APQ) was developed to measure different themes of activity pacing. The APQ was initially validated among a sample of patients with chronic pain/fatigue and contained 26 items. Factor analysis identified five themes of pacing contained within the APQ-26: Activity adjustment, Activity consistency, Activity planning, Activity acceptance and Activity progression. The APQ-26 has been modified for the purpose of this study with the addition of two items to correspond to important aspects of pacing that were not included in the APQ-26. The APQ-28 reflects the content of the activity pacing framework. The APQ-28 will be used to measure activity pacing at the end of the 6-week's programme. Each of the five themes of pacing is calculated as a mean score (0-4), where higher scores indicated more implementation of pacing strategies. | 6-weeks (end of the programme) |
| Activity Pacing at 3-months Follow up: Activity Pacing Questionnaire (APQ-28) | The Activity Pacing Questionnaire (APQ) was developed to measure different themes of activity pacing. The APQ was initially validated among a sample of patients with chronic pain/fatigue and contained 26 items. Factor analysis identified five themes of pacing contained within the APQ-26: Activity adjustment, Activity consistency, Activity planning, Activity acceptance and Activity progression. The APQ-26 has been modified for the purpose of this study with the addition of two items to correspond to important aspects of pacing that were not included in the APQ-26. The APQ-28 reflects the content of the activity pacing framework. The APQ-28 will be used to measure activity pacing at 3-months follow up after the end of the 6-week's programme. Each of the five themes of pacing is calculated as a mean score (0-4), where higher scores indicated more implementation of pacing strategies. | 3-months follow-up (after the end of the 6-week's programme) |
| Pain at Baseline: 11-point Numerical Rating Scale (NRS) of Pain | Two 11-point Numerical Rating Scales (NRS) will assess current pain and usual pain, where 0='no pain' and 10='worst possible pain' at baseline (pre-treatment: up to one week before the programme) | Baseline (pre-treatment: up to one week before the programme) |
| Pain at the End of Treatment (6-weeks): 11-point Numerical Rating Scale (NRS) of Pain | Two 11-point Numerical Rating Scales (NRS) will assess current pain and usual pain, where 0='no pain' and 10='worst possible pain' at the end of the 6-week's programme. | 6-weeks (end of the programme) |
| Pain at 3-months Follow up: 11-point Numerical Rating Scale (NRS) of Pain | Two 11-point Numerical Rating Scales (NRS) will assess current pain and usual pain, where 0='no pain' and 10='worst possible pain' at 3-months follow up after the end of the 6-week's programme | 3-months follow-up (after the end of the 6-week's programme) |
| Depression at Baseline: Patient Health Questionnaire-9 (PHQ-9) | The Patient Health Questionnaire (PHQ-9) contains nine items that screen for and measure the severity of depression in the clinical setting. Items are developed based on the Diagnostic and Statistical Manual of Mental Disorders 4th Edition (DSM-IV). This will be measured at baseline (pre-treatment: up to one week before the programme). The total range of scores is 0-27, where 1-4=minimal depression, 5-9=mild depression, 10-14=moderate depression and ≥15=severe depression. | Baseline (pre-treatment: up to one week before the programme) |
| Depression at the End of Treatment (6-weeks): Patient Health Questionnaire-9 (PHQ-9) | The Patient Health Questionnaire (PHQ-9) contains nine items that screen for and measure the severity of depression in the clinical setting. Items are developed based on the Diagnostic and Statistical Manual of Mental Disorders 4th Edition (DSM-IV). This will be measured at the end of the 6-week's programme. The total range of scores is 0-27, where 1-4=minimal depression, 5-9=mild depression, 10-14=moderate depression and ≥15=severe depression. | 6-weeks (end of the programme) |
| Depression at 3-months Follow-up: Patient Health Questionnaire-9 | The Patient Health Questionnaire (PHQ-9) contains nine items that screen for and measure the severity of depression in the clinical setting. Items are developed based on the Diagnostic and Statistical Manual of Mental Disorders 4th Edition (DSM-IV). This will be measured at 3-months follow up after the end of the 6-week's programme. The total range of scores is 0-27, where 1-4=minimal depression, 5-9=mild depression, 10-14=moderate depression and ≥15=severe depression. | 3-months follow-up (after the end of the 6-week's programme) |
| Anxiety at Baseline: Generalised Anxiety Disorder Assessment (GAD-7) | The Generalised Anxiety Disorder Assessment (GAD-7) contains seven items that screen for and measure the severity of anxiety in the clinical setting. The items are based on the Diagnostic and Statistical Manual of Mental Disorders 4th Edition (DSM-IV). This will be measured at baseline (pre-treatment: up to one week before the programme). The total range of scores is 0-21, where 5-9=mild anxiety, 10-14=moderate anxiety and ≥15=severe anxiety. | Baseline (pre-treatment: up to one week before the programme) |
| Anxiety at the End of Treatment (6-weeks): Generalised Anxiety Disorder Assessment (GAD-7) | The Generalised Anxiety Disorder Assessment (GAD-7) contains seven items that screen for and measure the severity of anxiety in the clinical setting. The items are based on the Diagnostic and Statistical Manual of Mental Disorders 4th Edition (DSM-IV). This will be measured at the end of the 6-week's programme. The total range of scores is 0-21, where 5-9=mild anxiety, 10-14=moderate anxiety and ≥15=severe anxiety. | 6-weeks (end of the programme) |
| Anxiety at 3-months Follow up: Generalised Anxiety Disorder Assessment (GAD-7) | The Generalised Anxiety Disorder Assessment (GAD-7) contains seven items that screen for and measure the severity of anxiety in the clinical setting. The items are based on the Diagnostic and Statistical Manual of Mental Disorders 4th Edition (DSM-IV). This will be measured at 3-months follow up after the end of the 6-week's programme. The total range of scores is 0-21, where 5-9=mild anxiety, 10-14=moderate anxiety and ≥15=severe anxiety. | 3-months follow-up (after the end of the 6-week's programme) |
| Self-efficacy at Baseline: Pain Self Efficacy Questionnaire (PSEQ) | The Pain Self-Efficacy Questionnaire (PSEQ) contains 10 items that assess a persons' confidence in their ability to do things despite their pain. This will be measured at baseline (pre-treatment: up to one week before the programme). The range of total scores is 0-60 where PSEQ≥40 indicate those patients who are more likely to continue implementing coping strategies and PSEQ≤16 are considered low. | Baseline (pre-treatment: up to one week before the programme) |
| Self-efficacy at the End of Treatment: Pain Self Efficacy Questionnaire (PSEQ) | The Pain Self-Efficacy Questionnaire (PSEQ) contains 10 items that assess a persons' confidence in their ability to do things despite their pain. This will be measured at the end of the 6-week's programme. The range of total scores is 0-60 where PSEQ≥40 indicate those patients who are more likely to continue implementing coping strategies and PSEQ≤16 are considered low. | 6-weeks (end of the programme) |
| Self-efficacy at 3-months Follow up: Pain Self Efficacy Questionnaire (PSEQ) | The Pain Self-Efficacy Questionnaire (PSEQ) contains 10 items that assess a persons' confidence in their ability to do things despite their pain. This will be measured at 3-months follow up after the end of the 6-week's programme. The range of total scores is 0-60 where PSEQ≥40 indicate those patients who are more likely to continue implementing coping strategies and PSEQ≤16 are considered low. | 3-months follow-up (after the end of the 6-week's programme) |
| Fatigue at Baseline: Chalder Fatigue Questionnaire (CFQ) | The Chalder Fatigue Questionnaire (CFQ) contains two subscales: physical fatigue (seven items) and mental fatigue (four items). This will be measured at baseline (pre-treatment: up to one week before the programme). The total range for physical fatigue is 7-28 and the range for mental fatigue is 4-16, where higher scores indicated less fatigue. | Baseline (pre-treatment: up to one week before the programme) |
| Fatigue at the End of Treatment: Chalder Fatigue Questionnaire (CFQ) | The Chalder Fatigue Questionnaire (CFQ) contains two subscales: physical fatigue (seven items) and mental fatigue (four items). This will be measured at the end of the 6-week's programme. The total range for physical fatigue is 7-28 and the range for mental fatigue is 4-16, where higher scores indicated less fatigue. | 6-weeks (end of the programme) |
| Fatigue at 3-months Follow up: Chalder Fatigue Questionnaire (CFQ) | The Chalder Fatigue Questionnaire (CFQ) contains two subscales: physical fatigue (seven items) and mental fatigue (four items). This will be measured at 3-months follow up after the end of the 6-week's programme. The total range for physical fatigue is 7-28 and the range for mental fatigue is 4-16, where higher scores indicated less fatigue. | 3-months follow-up (after the end of the 6-week's programme) |
| Pain-related Anxiety, Fear and Avoidance at Baseline: Pain Anxiety Symptoms Scale-short Version (PASS-20) | The Pain Anxiety Symptoms Scale-short version (PASS-20) measures pain-related fear, anxiety and avoidance and it contains four subscales: cognitive anxiety, escape/avoidance, fearful thoughts and physiological anxiety. This will be measured at baseline (pre-treatment: up to one week before the programme). Only the Escape/avoidance subscale data were analysed to provide an measure of avoidance. The total score of this 5 item subscale ranges from 0-25 where higher scores indicated greater avoidance. | Baseline (pre-treatment: up to one week before the programme) |
| Pain-related Anxiety, Fear and Avoidance at the End of Treatment: Pain Anxiety Symptoms Scale-short Version (PASS-20) | The Pain Anxiety Symptoms Scale-short version (PASS-20) measures pain-related fear, anxiety and avoidance and it contains four subscales: cognitive anxiety, escape/avoidance, fearful thoughts and physiological anxiety. This will be measured at the end of the 6-week's programme. Only the Escape/avoidance subscale data were analysed to provide an measure of avoidance. The total score of this 5 item subscale ranges from 0-25 where higher scores indicated greater avoidance. | 6-weeks (end of the programme) |
| Pain-related Anxiety, Fear and Avoidance at 3-months Follow up: Pain Anxiety Symptoms Scale-short Version (PASS-20) | The Pain Anxiety Symptoms Scale-short version (PASS-20) measures pain-related fear, anxiety and avoidance and it contains four subscales: cognitive anxiety, escape/avoidance, fearful thoughts and physiological anxiety. This will be measured at 3-months follow up after the end of the 6-week's programme. Only the Escape/avoidance subscale data were analysed to provide an measure of avoidance. The total score of this 5 item subscale ranges from 0-25 where higher scores indicated greater avoidance. | 3-months follow-up (after the end of the 6-week's programme) |
| Physical and Mental Function at Baseline: 12-Item Short-Form Health Survey (SF-12) | The 12-Item Short-Form Health Survey (SF-12) is a generic health survey that assesses physical and mental function. This will be measured at baseline (pre-treatment: up to one week before the programme). The two subscale scores have a maximum score of 100, where higher scores indicated better function. | Baseline (pre-treatment: up to one week before the programme) |
| Physical and Mental Function at the End of Treatment: 12-Item Short-Form Health Survey (SF-12) | The 12-Item Short-Form Health Survey (SF-12) is a generic health survey that assesses physical and mental function. This will be measured at the end of the 6-week's programme. The two subscale scores have a maximum score of 100, where higher scores indicated better function. | 6-weeks (end of the programme) |
| Physical and Mental Function at 3-months Follow up: 12-Item Short-Form Health Survey (SF-12) | The 12-Item Short-Form Health Survey (SF-12) is a generic health survey that assesses physical and mental function. This will be measured at 3-months follow up after the end of the 6-week's programme. The two subscale scores have a maximum score of 100, where higher scores indicated better function. | 3-months follow-up (after the end of the 6-week's programme) |
| General Health Status and Quality of Life at Baseline: EuroQol (EQ-5D-5L) | The EuroQol (EQ-5D-5L) is a generic measure of health status that is widely used to assess both clinical and economic efficacy; and to compare health status across diseases. This will be measured at baseline (pre-treatment: up to one week before the programme). The EQ-5D-5L was calculated as an index score (0-1) where higher scores indicate better health-related quality of life. | Baseline (pre-treatment: up to one week before the programme) |
| General Health Status and Quality of Life at the End of Treatment: EuroQol (EQ-5D-5L) | The EuroQol (EQ-5D-5L) is a generic measure of health status that is widely used to assess both clinical and economic efficacy; and to compare health status across diseases. This will be measured at the end of the 6-week's programme. The EQ-5D-5L was calculated as an index score (0-1) where higher scores indicate better health-related quality of life. | 6-weeks (end of the programme) |
| General Health Status and Quality of Life at 3-months Follow up: EuroQol (EQ-5D-5L) | The EuroQol (EQ-5D-5L) is a generic measure of health status that is widely used to assess both clinical and economic efficacy; and to compare health status across diseases. This will be measured at 3-months follow up after the end of the 6-week's programme. The EQ-5D-5L was calculated as an index score (0-1) where higher scores indicate better health-related quality of life. | 3-months follow-up (after the end of the 6-week's programme) |
| Standard Deviation |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | One missing answer | Count of Participants | Participants |
|
| Conditions | Participants could check more than one condition in the tick box. | One participant gave a missing answer | Count of Participants | Participants |
|
| Number of conditions | Number of the above conditions (multiple co-morbidities) | One missing answer | Count of Participants | Participants |
|
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| Secondary | Activity Pacing at Baseline: Activity Pacing Questionnaire (APQ-28) | The Activity Pacing Questionnaire (APQ) was developed to measure different themes of activity pacing. The APQ was initially validated among a sample of patients with chronic pain/fatigue and contained 26 items. Factor analysis identified five themes of pacing contained within the APQ-26: Activity adjustment, Activity consistency, Activity planning, Activity acceptance and Activity progression. The APQ-26 has been modified for the purpose of this study with the addition of two items to correspond to important aspects of pacing that were not included in the APQ-26. The APQ-28 reflects the content of the activity pacing framework. The APQ-28 will be used to measure activity pacing at baseline (pre-treatment: up to one week before the programme). Each of the five themes of pacing is calculated as a mean score (0-4), where higher scores indicated more implementation of pacing strategies. | Included in these analyses are all 107 participants who provided data at baseline. There is one missing answer for APQ-28 Activity adjustment | Posted | Mean | Standard Deviation | score on a scale | Baseline (pre-treatment: up to one week before the programme) |
|
|
|
| Secondary | Activity Pacing at the End of Treatment: Activity Pacing Questionnaire (APQ-28) | The Activity Pacing Questionnaire (APQ) was developed to measure different themes of activity pacing. The APQ was initially validated among a sample of patients with chronic pain/fatigue and contained 26 items. Factor analysis identified five themes of pacing contained within the APQ-26: Activity adjustment, Activity consistency, Activity planning, Activity acceptance and Activity progression. The APQ-26 has been modified for the purpose of this study with the addition of two items to correspond to important aspects of pacing that were not included in the APQ-26. The APQ-28 reflects the content of the activity pacing framework. The APQ-28 will be used to measure activity pacing at the end of the 6-week's programme. Each of the five themes of pacing is calculated as a mean score (0-4), where higher scores indicated more implementation of pacing strategies. | Of the 107 participants who completed baseline data (T1), 65 completed data collection at the end of the 6-week rehabilitation programme (T2). There were two missing answers for APQ-28 Activity adjustment. | Posted | Mean | Standard Deviation | score on a scale | 6-weeks (end of the programme) |
|
|
|
| Secondary | Activity Pacing at 3-months Follow up: Activity Pacing Questionnaire (APQ-28) | The Activity Pacing Questionnaire (APQ) was developed to measure different themes of activity pacing. The APQ was initially validated among a sample of patients with chronic pain/fatigue and contained 26 items. Factor analysis identified five themes of pacing contained within the APQ-26: Activity adjustment, Activity consistency, Activity planning, Activity acceptance and Activity progression. The APQ-26 has been modified for the purpose of this study with the addition of two items to correspond to important aspects of pacing that were not included in the APQ-26. The APQ-28 reflects the content of the activity pacing framework. The APQ-28 will be used to measure activity pacing at 3-months follow up after the end of the 6-week's programme. Each of the five themes of pacing is calculated as a mean score (0-4), where higher scores indicated more implementation of pacing strategies. | Of the 107 participants who completed baseline data collection (T1) and those who completed the end of treatment (T2) data collection, 52 participants completed the 3-month follow-up data collection (T3). There were two missing answers for APQ Activity adjustment. | Posted | Mean | Standard Deviation | score on a scale | 3-months follow-up (after the end of the 6-week's programme) |
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| Secondary | Pain at Baseline: 11-point Numerical Rating Scale (NRS) of Pain | Two 11-point Numerical Rating Scales (NRS) will assess current pain and usual pain, where 0='no pain' and 10='worst possible pain' at baseline (pre-treatment: up to one week before the programme) | 107 participants completed the baseline questionnaire booklet. However, there was one missing answer for Current pain (n=106); and four missing answers for Usual pain (n=103). | Posted | Mean | Standard Deviation | score on a scale | Baseline (pre-treatment: up to one week before the programme) |
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| Secondary | Pain at the End of Treatment (6-weeks): 11-point Numerical Rating Scale (NRS) of Pain | Two 11-point Numerical Rating Scales (NRS) will assess current pain and usual pain, where 0='no pain' and 10='worst possible pain' at the end of the 6-week's programme. | All 65 participants completed the scales for current and usual pain in the 6-weeks (T2) questionnaire booklet. There were no missing answers | Posted | Mean | Standard Deviation | score on a scale | 6-weeks (end of the programme) |
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| Secondary | Pain at 3-months Follow up: 11-point Numerical Rating Scale (NRS) of Pain | Two 11-point Numerical Rating Scales (NRS) will assess current pain and usual pain, where 0='no pain' and 10='worst possible pain' at 3-months follow up after the end of the 6-week's programme | 52 participants completed the questionnaire booklets at 3-months follow-up. However, there were two missing answers for Usual pain. | Posted | Mean | Standard Deviation | score on a scale | 3-months follow-up (after the end of the 6-week's programme) |
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| Secondary | Depression at Baseline: Patient Health Questionnaire-9 (PHQ-9) | The Patient Health Questionnaire (PHQ-9) contains nine items that screen for and measure the severity of depression in the clinical setting. Items are developed based on the Diagnostic and Statistical Manual of Mental Disorders 4th Edition (DSM-IV). This will be measured at baseline (pre-treatment: up to one week before the programme). The total range of scores is 0-27, where 1-4=minimal depression, 5-9=mild depression, 10-14=moderate depression and ≥15=severe depression. | Three missing answers from the 107 participants at baseline (T1) | Posted | Mean | Standard Deviation | score on a scale | Baseline (pre-treatment: up to one week before the programme) |
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| Secondary | Depression at the End of Treatment (6-weeks): Patient Health Questionnaire-9 (PHQ-9) | The Patient Health Questionnaire (PHQ-9) contains nine items that screen for and measure the severity of depression in the clinical setting. Items are developed based on the Diagnostic and Statistical Manual of Mental Disorders 4th Edition (DSM-IV). This will be measured at the end of the 6-week's programme. The total range of scores is 0-27, where 1-4=minimal depression, 5-9=mild depression, 10-14=moderate depression and ≥15=severe depression. | Two missing answers from the 65 participants at T2 | Posted | Mean | Standard Deviation | score on a scale | 6-weeks (end of the programme) |
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| Secondary | Depression at 3-months Follow-up: Patient Health Questionnaire-9 | The Patient Health Questionnaire (PHQ-9) contains nine items that screen for and measure the severity of depression in the clinical setting. Items are developed based on the Diagnostic and Statistical Manual of Mental Disorders 4th Edition (DSM-IV). This will be measured at 3-months follow up after the end of the 6-week's programme. The total range of scores is 0-27, where 1-4=minimal depression, 5-9=mild depression, 10-14=moderate depression and ≥15=severe depression. | One missing answer from the 52 participants at T3. | Posted | Mean | Standard Deviation | score on a scale | 3-months follow-up (after the end of the 6-week's programme) |
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| Secondary | Anxiety at Baseline: Generalised Anxiety Disorder Assessment (GAD-7) | The Generalised Anxiety Disorder Assessment (GAD-7) contains seven items that screen for and measure the severity of anxiety in the clinical setting. The items are based on the Diagnostic and Statistical Manual of Mental Disorders 4th Edition (DSM-IV). This will be measured at baseline (pre-treatment: up to one week before the programme). The total range of scores is 0-21, where 5-9=mild anxiety, 10-14=moderate anxiety and ≥15=severe anxiety. | One missing answer from the 107 participants at baseline (T1) | Posted | Mean | Standard Deviation | score on a scale | Baseline (pre-treatment: up to one week before the programme) |
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| Secondary | Anxiety at the End of Treatment (6-weeks): Generalised Anxiety Disorder Assessment (GAD-7) | The Generalised Anxiety Disorder Assessment (GAD-7) contains seven items that screen for and measure the severity of anxiety in the clinical setting. The items are based on the Diagnostic and Statistical Manual of Mental Disorders 4th Edition (DSM-IV). This will be measured at the end of the 6-week's programme. The total range of scores is 0-21, where 5-9=mild anxiety, 10-14=moderate anxiety and ≥15=severe anxiety. | 65 participants at 6-weeks data collection (T2) | Posted | Mean | Standard Deviation | score on a scale | 6-weeks (end of the programme) |
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| Secondary | Anxiety at 3-months Follow up: Generalised Anxiety Disorder Assessment (GAD-7) | The Generalised Anxiety Disorder Assessment (GAD-7) contains seven items that screen for and measure the severity of anxiety in the clinical setting. The items are based on the Diagnostic and Statistical Manual of Mental Disorders 4th Edition (DSM-IV). This will be measured at 3-months follow up after the end of the 6-week's programme. The total range of scores is 0-21, where 5-9=mild anxiety, 10-14=moderate anxiety and ≥15=severe anxiety. | 52 participants provided data at 3-months (T3) | Posted | Mean | Standard Deviation | score on a scale | 3-months follow-up (after the end of the 6-week's programme) |
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| Secondary | Self-efficacy at Baseline: Pain Self Efficacy Questionnaire (PSEQ) | The Pain Self-Efficacy Questionnaire (PSEQ) contains 10 items that assess a persons' confidence in their ability to do things despite their pain. This will be measured at baseline (pre-treatment: up to one week before the programme). The range of total scores is 0-60 where PSEQ≥40 indicate those patients who are more likely to continue implementing coping strategies and PSEQ≤16 are considered low. | All 107 participants at T1 provided an answer | Posted | Mean | Standard Deviation | score on a scale | Baseline (pre-treatment: up to one week before the programme) |
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| Secondary | Self-efficacy at the End of Treatment: Pain Self Efficacy Questionnaire (PSEQ) | The Pain Self-Efficacy Questionnaire (PSEQ) contains 10 items that assess a persons' confidence in their ability to do things despite their pain. This will be measured at the end of the 6-week's programme. The range of total scores is 0-60 where PSEQ≥40 indicate those patients who are more likely to continue implementing coping strategies and PSEQ≤16 are considered low. | All 65 participants at T2 provided an answer | Posted | Mean | Standard Deviation | score on a scale | 6-weeks (end of the programme) |
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| Secondary | Self-efficacy at 3-months Follow up: Pain Self Efficacy Questionnaire (PSEQ) | The Pain Self-Efficacy Questionnaire (PSEQ) contains 10 items that assess a persons' confidence in their ability to do things despite their pain. This will be measured at 3-months follow up after the end of the 6-week's programme. The range of total scores is 0-60 where PSEQ≥40 indicate those patients who are more likely to continue implementing coping strategies and PSEQ≤16 are considered low. | All 52 participants at 3-months follow-up (T3) provided an answer | Posted | Mean | Standard Deviation | score on a scale | 3-months follow-up (after the end of the 6-week's programme) |
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| Secondary | Fatigue at Baseline: Chalder Fatigue Questionnaire (CFQ) | The Chalder Fatigue Questionnaire (CFQ) contains two subscales: physical fatigue (seven items) and mental fatigue (four items). This will be measured at baseline (pre-treatment: up to one week before the programme). The total range for physical fatigue is 7-28 and the range for mental fatigue is 4-16, where higher scores indicated less fatigue. | 107 participants completed the first questionnaire booklet (T1). However, there were four missing answers for physical fatigue (n=103) and one missing answer for mental fatigue (n-106) | Posted | Mean | Standard Deviation | score on a scale | Baseline (pre-treatment: up to one week before the programme) |
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| Secondary | Fatigue at the End of Treatment: Chalder Fatigue Questionnaire (CFQ) | The Chalder Fatigue Questionnaire (CFQ) contains two subscales: physical fatigue (seven items) and mental fatigue (four items). This will be measured at the end of the 6-week's programme. The total range for physical fatigue is 7-28 and the range for mental fatigue is 4-16, where higher scores indicated less fatigue. | 65 participants completed the 6-weeks questionnaire booklet (T2). However, there were three missing answers on the Physical fatigue subscale (n=62) and one missing answer on the Mental fatigue scale (n=64). | Posted | Mean | Standard Deviation | score on a scale | 6-weeks (end of the programme) |
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| Secondary | Fatigue at 3-months Follow up: Chalder Fatigue Questionnaire (CFQ) | The Chalder Fatigue Questionnaire (CFQ) contains two subscales: physical fatigue (seven items) and mental fatigue (four items). This will be measured at 3-months follow up after the end of the 6-week's programme. The total range for physical fatigue is 7-28 and the range for mental fatigue is 4-16, where higher scores indicated less fatigue. | Three missing answers for the Physical fatigue subscale; one missing answer for the Mental fatigue subscale | Posted | Mean | Standard Deviation | score on a scale | 3-months follow-up (after the end of the 6-week's programme) |
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| Secondary | Pain-related Anxiety, Fear and Avoidance at Baseline: Pain Anxiety Symptoms Scale-short Version (PASS-20) | The Pain Anxiety Symptoms Scale-short version (PASS-20) measures pain-related fear, anxiety and avoidance and it contains four subscales: cognitive anxiety, escape/avoidance, fearful thoughts and physiological anxiety. This will be measured at baseline (pre-treatment: up to one week before the programme). Only the Escape/avoidance subscale data were analysed to provide an measure of avoidance. The total score of this 5 item subscale ranges from 0-25 where higher scores indicated greater avoidance. | One missing answer | Posted | Mean | Standard Deviation | score on a scale | Baseline (pre-treatment: up to one week before the programme) |
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| Secondary | Pain-related Anxiety, Fear and Avoidance at the End of Treatment: Pain Anxiety Symptoms Scale-short Version (PASS-20) | The Pain Anxiety Symptoms Scale-short version (PASS-20) measures pain-related fear, anxiety and avoidance and it contains four subscales: cognitive anxiety, escape/avoidance, fearful thoughts and physiological anxiety. This will be measured at the end of the 6-week's programme. Only the Escape/avoidance subscale data were analysed to provide an measure of avoidance. The total score of this 5 item subscale ranges from 0-25 where higher scores indicated greater avoidance. | One missing answer | Posted | Mean | Standard Deviation | score on a scale | 6-weeks (end of the programme) |
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| Secondary | Pain-related Anxiety, Fear and Avoidance at 3-months Follow up: Pain Anxiety Symptoms Scale-short Version (PASS-20) | The Pain Anxiety Symptoms Scale-short version (PASS-20) measures pain-related fear, anxiety and avoidance and it contains four subscales: cognitive anxiety, escape/avoidance, fearful thoughts and physiological anxiety. This will be measured at 3-months follow up after the end of the 6-week's programme. Only the Escape/avoidance subscale data were analysed to provide an measure of avoidance. The total score of this 5 item subscale ranges from 0-25 where higher scores indicated greater avoidance. | All 52 participants at 3-months follow-up (T3) provided an answer for this subscale. | Posted | Mean | Standard Deviation | score on a scale | 3-months follow-up (after the end of the 6-week's programme) |
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| Secondary | Physical and Mental Function at Baseline: 12-Item Short-Form Health Survey (SF-12) | The 12-Item Short-Form Health Survey (SF-12) is a generic health survey that assesses physical and mental function. This will be measured at baseline (pre-treatment: up to one week before the programme). The two subscale scores have a maximum score of 100, where higher scores indicated better function. | Two missing answers for the physical and mental function subscales | Posted | Mean | Standard Deviation | score on a scale | Baseline (pre-treatment: up to one week before the programme) |
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| Secondary | Physical and Mental Function at the End of Treatment: 12-Item Short-Form Health Survey (SF-12) | The 12-Item Short-Form Health Survey (SF-12) is a generic health survey that assesses physical and mental function. This will be measured at the end of the 6-week's programme. The two subscale scores have a maximum score of 100, where higher scores indicated better function. | Two missing answers on the Physical and Mental function subscales | Posted | Mean | Standard Deviation | score on a scale | 6-weeks (end of the programme) |
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| Secondary | Physical and Mental Function at 3-months Follow up: 12-Item Short-Form Health Survey (SF-12) | The 12-Item Short-Form Health Survey (SF-12) is a generic health survey that assesses physical and mental function. This will be measured at 3-months follow up after the end of the 6-week's programme. The two subscale scores have a maximum score of 100, where higher scores indicated better function. | Five missing answers on the Physical and Mental function subscales | Posted | Mean | Standard Deviation | score on a scale | 3-months follow-up (after the end of the 6-week's programme) |
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| Secondary | General Health Status and Quality of Life at Baseline: EuroQol (EQ-5D-5L) | The EuroQol (EQ-5D-5L) is a generic measure of health status that is widely used to assess both clinical and economic efficacy; and to compare health status across diseases. This will be measured at baseline (pre-treatment: up to one week before the programme). The EQ-5D-5L was calculated as an index score (0-1) where higher scores indicate better health-related quality of life. | Seven missing answers from the 107 participants at baseline (T1). | Posted | Mean | Standard Deviation | score on a scale | Baseline (pre-treatment: up to one week before the programme) |
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| Secondary | General Health Status and Quality of Life at the End of Treatment: EuroQol (EQ-5D-5L) | The EuroQol (EQ-5D-5L) is a generic measure of health status that is widely used to assess both clinical and economic efficacy; and to compare health status across diseases. This will be measured at the end of the 6-week's programme. The EQ-5D-5L was calculated as an index score (0-1) where higher scores indicate better health-related quality of life. | Six missing answers from the 65 participants at 6-weeks (T2) data collection | Posted | Mean | Standard Deviation | score on a scale | 6-weeks (end of the programme) |
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| Secondary | General Health Status and Quality of Life at 3-months Follow up: EuroQol (EQ-5D-5L) | The EuroQol (EQ-5D-5L) is a generic measure of health status that is widely used to assess both clinical and economic efficacy; and to compare health status across diseases. This will be measured at 3-months follow up after the end of the 6-week's programme. The EQ-5D-5L was calculated as an index score (0-1) where higher scores indicate better health-related quality of life. | Seven missing answers from the 52 participants who responded to the 3-months follow-up (T3) | Posted | Mean | Standard Deviation | score on a scale | 3-months follow-up (after the end of the 6-week's programme) |
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| 0 |
| 107 |
| 0 |
| 107 |
| 0 |
| 107 |
Not provided
Not provided
Not provided
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D004679 | Encephalomyelitis |
| D000090862 | Neuroinflammatory Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
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| APQ-28 Activity consistency |
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| APQ-28 Activity acceptance |
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| APQ-28 Activity progression |
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| APQ-28 Activity consistency |
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| APQ-28 Activity acceptance |
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| APQ-28 Activity progression |
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| APQ-28 Activity consistency |
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| APQ-28 Activity acceptance |
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| APQ-28 Activity progression |
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