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| Name | Class |
|---|---|
| University of Hull | OTHER |
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This INITIATE study evaluates the use of high-intensity interval training as a treatment modality for patients with intermittent claudication - an ambulatory leg pain caused by narrowed arteries that supply the lower limbs.
It is an observational cohort study considering high-intensity interval training (HIIT) as a treatment for intermittent claudication, consisting of two workstreams. Workstream 1: an initial observational cohort study to consider the feasibility of the intervention and exclusion criteria. Workstream 2: a proof of concept study utilising the altered intervention and exclusion criteria following recommendations highlighted during workstream 1.
Patients with peripheral vascular disease (PVD) may develop a reproducible pain in their legs when they walk, which usually subsides with rest. This is known as intermittent claudication (IC) and is caused by a reduced blood supply to the legs as a result of narrowed or hardened arteries that supply the lower limbs. This ambulatory pain impedes on activities of daily living, functional capacity and quality of life.
National Institute for Health and Care Excellence (NICE) clinical guidance recommends a 12-week supervised exercise programme as first-line treatment for IC, whereby patients are encouraged to walk to the point of maximal pain. Robust clinical trials have demonstrated that supervised exercise programmes are efficacious for improving both pain-free and maximal walking distances, whilst also potentially improving quality of life.
Despite this, supervised exercise programmes are vastly under-utilised and not always available to consultant vascular surgeons. This means that further programmes need to be developed in order to provide a range of options to patients to improve uptake and adherence rates. One such programme is a 6-week high-intensity interval training programme.
An initial observational cohort study of the 6 week HIIT programme will be conducted to determine to determine the feasibility of the intervention and inclusion criteria. The results from this will be used to make any necessary changes to the HIIT intervention before moving into a proof of concept study, considering the utility, safety, acceptability and potential clinical efficacy of this programme.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High-Intensity interval training (workstream 1) | Experimental | High-intensity interval training performed for 20 minutes, 3 times weekly for a period of 6 weeks at 85-100% of maximal heart rate. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High-intensity interval training | Other | a high-intensity interval training programme completed 3 times a week for 6 weeks using a stationary Wattbike. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Tolerability Test - Related Withdrawals | Defined by examining the number of withdrawals related to the intervention or study procedures (i.e. patients unable to tolerate). | From the first to last exercise session, i.e. from week 0 to week 6. |
| Feasibility Test | Feasibility measures included the number of patients screened vs. the number eligible, the number of patients eligible vs. the number recruited and the number recruited vs. the number completed. | From study opening to completion/withdrawal of the last patient |
| Tolerability Test - Achieving the Required Intensity | Considers the patients ability to achieve and maintain exercise at the appropriate intensity for the duration of each session | From the first to last exercise session, i.e. from week 0 to week 6. |
| Tolerability Test - Number of Sessions Completed | Considers the number of sessions completed compared to the theoretical number. | From the first to last exercise session, i.e. from week 0 to week 6. |
| Tolerability Test - Number of HIIT Intervals Completed | Considers the number of HIIT intervals completed compared to the theoretical number. | From the first to last exercise session, i.e. from week 0 to week 6. |
| Measure | Description | Time Frame |
|---|---|---|
| Safety Events Recorded | Defined as the occurrence of any adverse or serious adverse events related to the intervention. | From enrolment to completion of 12-week follow-up |
| Acceptability Testing |
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Workstream 1
Inclusion criteria:
Exclusion criteria:
Additional exclusion criteria:
Following baseline cardiopulmonary exercise test (CPET), patients will be withdrawn and prevented from continuing their involvement in the study if there is any evidence of:
Workstream 2:
Inclusion criteria:
Exclusion criteria:
Additional exclusion criteria:
Following baseline CPET, patients will be withdrawn and prevented from continuing their involvement in the study if there is any evidence of:
● Exercise-induced myocardial ischaemia or significant haemodynamic compromise (manifesting as anginal symptoms, significant ECG changes or an abnormal blood pressure response).
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| Name | Affiliation | Role |
|---|---|---|
| Sean Pymer, MSc | Academic Vascular Surgical Unit, Hull York Medical School | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Academic Vascular Surgical Unit, Vascular Dept. 1st Floor Tower Block | Hull | HU3 2JZ | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38301846 | Result | Pymer S, Harwood AE, Ibeggazene S, McGregor G, Huang C, Nicholls AR, Ingle L, Long J, Rooms M, Chetter IC, Twiddy M. High INtensity Interval Training in pATiEnts with Intermittent Claudication: A Qualitative Acceptability Study. Ann Vasc Surg. 2024 May;102:17-24. doi: 10.1016/j.avsg.2023.11.043. Epub 2024 Jan 30. | |
| 37330704 | Result |
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| ID | Title | Description |
|---|---|---|
| FG000 | High-Intensity Interval Training | High-intensity interval training performed for 20 minutes, 3 times weekly for a period of 6 weeks at 85-100% of maximal heart rate. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Baseline characteristics broken down by workstream
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| ID | Title | Description |
|---|---|---|
| BG000 | High-Intensity Interval Training (Workstream 1) | High-intensity interval training performed for 20 minutes, 3 times weekly for a period of 6 weeks at 85-100% of maximal heart rate. |
| BG001 | High-Intensity Interval Training (Workstream 2) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Workstream 1, n=30 Workstream 2, n=40 |
| 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 | Tolerability Test - Related Withdrawals | Defined by examining the number of withdrawals related to the intervention or study procedures (i.e. patients unable to tolerate). | Workstream 1 = 30 participants Workstream 2 = 40 participants | Posted | Count of Participants | Participants | From the first to last exercise session, i.e. from week 0 to week 6. |
|
|
From enrollment to 18 weeks later for each patient.
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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 | High-Intensity Interval Training | High-intensity interval training performed for 20 minutes, 3 times weekly for a period of 6 weeks at 85-100% of maximal heart rate. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Thrombosed popliteal aneurysm | Vascular disorders | Non-systematic Assessment | The SAE was a thrombosed popliteal aneurysm that occurred in the period between two exercise sessions. The patient was admitted for surgery and underwent a lower limb bypass procedure. Symptoms occurred 2 days after exercise so unlikely related. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Post-exercise dizzines | General disorders | Non-systematic Assessment | There were 7 occurrences of dizziness that occurred after exercise sessions or CPET |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Sean Pymer | Hull University Teaching Hospitals NHS Trust | 01482 674643 | s.pymer@nhs.net |
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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 | Feb 25, 2021 | Mar 19, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D058729 | Peripheral Arterial Disease |
| D007383 | Intermittent Claudication |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D050197 | Atherosclerosis |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D000072696 | High-Intensity Interval Training |
| ID | Term |
|---|---|
| D064797 | Physical Conditioning, Human |
| D015444 | Exercise |
| D009043 | Motor Activity |
| D009068 | Movement |
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Workstream 1: An initial single group cohort of 30 patients will be recruited and analysed to refine/alter the intervention and exclusion criteria based on its feasibility.
Workstream 2: This altered intervention and inclusion criteria will be considered in a further proof of concept study which will be multi-centre aiming to recruit a further x40 patients.
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An evaluation of the acceptability of the exercise intervention assessed by patient feedback, using semi-structured interviews.
| post-intervention follow-up, i.e. week 6. |
| Maximum Walking Distance | assessment of the distance that the patient can currently walk before having to stop due to claudication pain. | Baseline, post-intervention (week 6), then 4 weeks (week 10) and 12 weeks (week 18) post-intervention. |
| Peak Oxygen Uptake | Peak oxygen uptake assessed via cardiopulmonary exercise testing | Baseline, post-intervention (week 6), then 4 weeks (week 10) and 12 weeks (week 18) post-intervention. |
| Quality of Life Questionnaire Short-form-36 (SF-36) | Patient reported quality of life using the SF-36 SF-36 is a 36-Item Short Form Health Survey questionnaire. It consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability. | Baseline and post-intervention (week 6) |
| Vascular Quality of Life Questionnaire - (VascuQol) | VascuQoL includes 25 items subdivided into 5 domains and a sum score is also calculated by dividing the total score by 25. Each domain and the total score range from 1 to 7 with 1 representing the worst score and 7 the best. | Baseline and post-intervention (week 6) follow-up |
| Ankle-Brachial Pressure Index | The index or ratio of the pressure in the ankle compared with the arm. | Baseline, post-intervention (week 6), then 4 weeks (week 10) and 12 weeks (week 18) post-intervention. |
| Peak Power Output | Peak power output assessed via CPET | Baseline, post-intervention (week 6), then 4 weeks (week 10) and 12 weeks (week 18) post-intervention. |
| Pain-free Walking Distance | assessment of the distance that the patient can currently walk before experiencing claudication pain. | Baseline, post-intervention (week 6), then 4 weeks (week 10) and 12 weeks (week 18) post-intervention. |
| Ventilatory Anaerobic Threshold (VAT) | Ventilatory anaerobic threshold assessed via cardiopulmonary exercise testing | Baseline, post-intervention (week 6), then 4 weeks (week 10) and 12 weeks (week 18) post-intervention. |
| Quality of Life Questionnaire Short-form-36 (SF-36) | Patient reported quality of life using the SF-36 SF-36 is a 36-Item Short Form Health Survey questionnaire. It consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability. | 4 weeks (week 10) and 12 weeks (week 18) post-intervention |
| Vascular Quality of Life Questionnaire - (VascuQol) | VascuQoL includes 25 items subdivided into 5 domains and a sum score is also calculated by dividing the total score by 25. Each domain and the total score range from 1 to 7 with 1 representing the worst score and 7 the best. | 4 weeks (week 10) and 12 weeks (week 18) post-intervention. |
| Pymer S, Harwood AE, Prosser J, Waddell A, Rhavindhran B, Ibeggazene S, McGregor G, Huang C, Twiddy M, Nicholls AR, Ingle L, Carroll S, He H, Long J, Rooms M, Chetter IC. High-intensity interval training in patients with intermittent claudication. J Vasc Surg. 2023 Oct;78(4):1048-1056.e4. doi: 10.1016/j.jvs.2023.05.045. Epub 2023 Jun 16. |
| 33186201 | Derived | Pymer S, Ibeggazene S, Palmer J, Smith GE, Harwood AE, Carroll S, Ingle L, Chetter IC. Considering the Feasibility, Tolerability, and Safety of High-Intensity Interval Training as a Novel Treatment for Patients With Intermittent Claudication. J Cardiopulm Rehabil Prev. 2021 May 1;41(3):188-193. doi: 10.1097/HCR.0000000000000551. |
| 32636290 | Derived | Pymer S, Harwood A, Ibeggazene S, McGregor G, Huang C, Twiddy M, Nicholls AR, Ingle L, Carroll S, Long J, Rooms M, Chetter IC; INITIATE investigator group. High INtensity Interval Training In pATiEnts with intermittent claudication (INITIATE): protocol for a multicentre, proof-of-concept, prospective interventional study. BMJ Open. 2020 Jul 6;10(7):e038825. doi: 10.1136/bmjopen-2020-038825. |
| Adverse Event |
|
| No longer meeting inclusion criteria |
|
| No reason given |
|
| Withdrawal by Subject |
|
High-intensity interval training performed for 20 minutes, 3 times weekly for a period of 6 weeks at 85-100% of maximal heart rate |
| BG002 | Total | Total of all reporting groups |
Workstream 1, n=30 Workstream 2, n=40
| Mean |
| Standard Deviation |
| years |
|
| Sex: Female, Male | Workstream 1, n=30 Workstream 2, n=40 | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Height | Workstream 1, n=30 Workstream 2, n=40 | Mean | Standard Deviation | cm |
|
| Weight | Workstream 1, n=30 Workstream 2, n=40 | Mean | Standard Deviation | kg |
|
| body mass index (BMI) | Workstream 1, n=30 Workstream 2, n=40 | Mean | Standard Deviation | kg/m^2 |
|
| Systolic blood pressure | Workstream 1, n=30 Workstream 2, n=40 | Mean | Standard Deviation | mmHg |
|
| Diastolic blood pressure | Workstream 1, n=30 Workstream 2, n=40 | Mean | Standard Deviation | mmHg |
|
| Ankle-brachial pressure index (ABPI) (worst leg) | ABPI involves measuring the systolic blood pressure in the brachial, dorsalis pedis and posterial tibial arteries bilaterally using an appropriately sized sphygmomanometer, placed on the arms and above the ankles. The ABPI is calculated by dividing the highest systolic pressure of the dorsalis pedis and posterior tibial arteries of each ankle by the highest systolic brachial pressure of both arms. | Workstream 1, n=30 Workstream 2, n=40 | Mean | Standard Deviation | Index |
|
| Intermittent claudication distance (ICD) | Workstream 1, n=30 Workstream 2, n=40 | Mean | Standard Deviation | metres |
|
| Maximum Walking Distance (MWD) | Workstream 1, n=30 Workstream 2, n=40 | Mean | Standard Deviation | metres |
|
| Smoking status | Workstream 1, n=30 Workstream 2, n=40 | Count of Participants | Participants |
|
| Best medical therapy (BMT) | Best medical therapy comprised being prescribed an antiplatelet or anticoagulant and a statin. | Workstream 1, n=30 Workstream 2, n=40 | Count of Participants | Participants |
|
|
|
| Primary | Feasibility Test | Feasibility measures included the number of patients screened vs. the number eligible, the number of patients eligible vs. the number recruited and the number recruited vs. the number completed. | The overall number of participants analysed in the number of patients screened. Each row then represents the number of patients eligible vs. screened, the number recruited vs. eligible and the number completed vs. recruited. | Posted | Number | participants | From study opening to completion/withdrawal of the last patient |
|
|
|
| Primary | Tolerability Test - Achieving the Required Intensity | Considers the patients ability to achieve and maintain exercise at the appropriate intensity for the duration of each session | Includes all participants that completed the programme and the type of units is the number of HIIT intervals completed. The number analysed is the total amount of intervals completed per workstream. The count of units is the number of intervals where the required intensity was achieved. | Posted | Count of Units | Number of HIIT intervals | From the first to last exercise session, i.e. from week 0 to week 6. | Number of HIIT intervals | Number of HIIT intervals |
|
|
|
| Primary | Tolerability Test - Number of Sessions Completed | Considers the number of sessions completed compared to the theoretical number. | Includes all participants that completed the programme and the type of units is the number of HIIT sessions completed. The number analysed is the total amount of planned sessions per workstream. The count of units is the number of sessions that were actually attended. | Posted | Count of Units | Number of HIIT sessions | From the first to last exercise session, i.e. from week 0 to week 6. | Number of HIIT sessions | Number of HIIT sessions |
|
|
|
| Primary | Tolerability Test - Number of HIIT Intervals Completed | Considers the number of HIIT intervals completed compared to the theoretical number. | Includes all participants that completed the programme and the type of units is the number of HIIT intervals completed. The number analysed is the total amount of planned HIIT intervals. The count of units is the number of intervals that were actually completed. | Posted | Count of Units | Number of HIIT intervals | From the first to last exercise session, i.e. from week 0 to week 6. | Number of HIIT intervals | Number of HIIT intervals |
|
|
|
| Secondary | Safety Events Recorded | Defined as the occurrence of any adverse or serious adverse events related to the intervention. | The analysed population is all patients who were recruited to the programme. Adverse events were considered at each visit and exercise session. | Posted | Number | Events | From enrolment to completion of 12-week follow-up |
|
|
|
| Secondary | Acceptability Testing | An evaluation of the acceptability of the exercise intervention assessed by patient feedback, using semi-structured interviews. | Posted | Count of Participants | Participants | post-intervention follow-up, i.e. week 6. |
|
|
|
| Secondary | Maximum Walking Distance | assessment of the distance that the patient can currently walk before having to stop due to claudication pain. | Only patients completing the programme and providing baseline and follow-up data are included. This comprises: Post-intervention follow-up Workstream 1; n = 15/30 Workstream 2; n = 29/40 Total = 44/70. 4-week post-intervention follow-up Workstream 1; n = 12/30 Workstream 2; n = 16/40 Total = 28/70. 12-week post-intervention follow-up Workstream 1; n =11/30 Workstream 2; n = 24/40 Total = 35/70. | Posted | Mean | Standard Deviation | metres | Baseline, post-intervention (week 6), then 4 weeks (week 10) and 12 weeks (week 18) post-intervention. |
|
|
|
| Secondary | Peak Oxygen Uptake | Peak oxygen uptake assessed via cardiopulmonary exercise testing | Only patients completing the programme and providing baseline and follow-up data are included. This comprises: End of programme follow-up: Workstream 1; n = 13/30 Workstream 2; n = 29/40 Total = 42/70. 4-week follow-up: Workstream 1; n = 10/30 Workstream 2; n = 16/40 Total = 26/70. 12-week follow-up: Workstream 1; n = 9/30 Workstream 2; n = 20/40 Total = 29/70. | Posted | Mean | Standard Deviation | ml/kg/min | Baseline, post-intervention (week 6), then 4 weeks (week 10) and 12 weeks (week 18) post-intervention. |
|
|
|
| Secondary | Quality of Life Questionnaire Short-form-36 (SF-36) | Patient reported quality of life using the SF-36 SF-36 is a 36-Item Short Form Health Survey questionnaire. It consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability. | Only patients completing the programme and providing baseline and follow-up data are included. This comprises: Workstream 1; n = 15/30 Workstream 2; n = 30/40 Total = 45/70. | Posted | Mean | Standard Deviation | units on a scale | Baseline and post-intervention (week 6) |
|
|
|
| Secondary | Vascular Quality of Life Questionnaire - (VascuQol) | VascuQoL includes 25 items subdivided into 5 domains and a sum score is also calculated by dividing the total score by 25. Each domain and the total score range from 1 to 7 with 1 representing the worst score and 7 the best. | Only patients completing the programme and providing baseline and follow-up data are included. This comprises: Workstream 1; n = 15/30 Workstream 2; n = 30/40 Total = 45/70. | Posted | Mean | Standard Deviation | units on a scale | Baseline and post-intervention (week 6) follow-up |
|
|
|
| Secondary | Ankle-Brachial Pressure Index | The index or ratio of the pressure in the ankle compared with the arm. | Only patients completing the programme and providing baseline and follow-up data are included. This comprises: Post-intervention follow-up Workstream 1; n = 15/30 Workstream 2; n = 30/40 Total = 44/70. 4-week post-intervention follow-up Workstream 1; n = 12/30 Workstream 2; n = 16/40 Total = 28/70. 12-week post-intervention follow-up Workstream 1; n =11/30 Workstream 2; n = 24/40 Total = 35/70. | Posted | Mean | Standard Deviation | Index | Baseline, post-intervention (week 6), then 4 weeks (week 10) and 12 weeks (week 18) post-intervention. |
|
|
|
| Secondary | Peak Power Output | Peak power output assessed via CPET | Only patients completing the programme and providing baseline and follow-up data are included. This comprises: End of programme follow-up: Workstream 1; n = 13/30 Workstream 2; n = 29/40 Total = 42/70. 4-week follow-up: Workstream 1; n = 10/30 Workstream 2; n = 16/40 Total = 26/70. 12-week follow-up: Workstream 1; n = 9/30 Workstream 2; n = 20/40 Total = 29/70. | Posted | Mean | Standard Deviation | Watts | Baseline, post-intervention (week 6), then 4 weeks (week 10) and 12 weeks (week 18) post-intervention. |
|
|
|
| Secondary | Pain-free Walking Distance | assessment of the distance that the patient can currently walk before experiencing claudication pain. | Only patients completing the programme and providing baseline and follow-up data are included. This comprises: Post-intervention follow-up Workstream 1; n = 15/30 Workstream 2; n = 30/40 Total = 45/70. 4-week post-intervention follow-up Workstream 1; n = 12/30 Workstream 2; n = 16/40 Total = 28/70. 12-week post-intervention follow-up Workstream 1; n =11/30 Workstream 2; n = 24/40 Total = 35/70. | Posted | Mean | Standard Deviation | metres | Baseline, post-intervention (week 6), then 4 weeks (week 10) and 12 weeks (week 18) post-intervention. |
|
|
|
| Secondary | Ventilatory Anaerobic Threshold (VAT) | Ventilatory anaerobic threshold assessed via cardiopulmonary exercise testing | Only patients completing the programme and providing baseline and follow-up data are included. This comprises: End of programme follow-up: Workstream 1; n = 13/30 Workstream 2; n = 29/40 Total = 42/70. 4-week follow-up: Workstream 1; n = 10/30 Workstream 2; n = 16/40 Total = 26/70. 12-week follow-up: Workstream 1; n = 9/30 Workstream 2; n = 20/40 Total = 29/70. | Posted | Mean | Standard Deviation | ml/kg/min | Baseline, post-intervention (week 6), then 4 weeks (week 10) and 12 weeks (week 18) post-intervention. |
|
|
|
| Secondary | Quality of Life Questionnaire Short-form-36 (SF-36) | Patient reported quality of life using the SF-36 SF-36 is a 36-Item Short Form Health Survey questionnaire. It consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability. | Only patients completing the programme and providing baseline and follow-up data are included. This comprises: 4-week follow-up: Workstream 1; n = 13/30 Workstream 2; n = 16/40 Total = 29/70. 12-week follow-up: Workstream 1; n = 11/30 Workstream 2; n = 24/40 Total = 35/70. | Posted | Mean | Standard Deviation | units on a scale | 4 weeks (week 10) and 12 weeks (week 18) post-intervention |
|
|
|
| Secondary | Vascular Quality of Life Questionnaire - (VascuQol) | VascuQoL includes 25 items subdivided into 5 domains and a sum score is also calculated by dividing the total score by 25. Each domain and the total score range from 1 to 7 with 1 representing the worst score and 7 the best. | Only patients completing the programme and providing follow-up data are included. This comprises: 4-week follow-up: Workstream 1; n = 13/30 Workstream 2; n = 16/40 Total = 29/70. 12-week follow-up: Workstream 1; n = 10/30 Workstream 2; n = 24/40 Total = 34/70. | Posted | Mean | Standard Deviation | units on a scale | 4 weeks (week 10) and 12 weeks (week 18) post-intervention. |
|
|
|
| 0 |
| 70 |
| 1 |
| 70 |
| 10 |
| 70 |
|
|
| Dull chest ache | Cardiac disorders | Non-systematic Assessment | an isolated episode of a 'dull chest ache' that occurred in the period between two exercise sessions. Following referral to cardiology a diagnosis of probable angina was made but not confirmed as a diagnostic angiogram was refused. |
|
| Back spasm | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | The occurrence of a back spasm after an exercise session. |
|
| Headache | General disorders | Non-systematic Assessment | One occurrence of a headache after exercise |
|
| Hypertensive CPET response | Cardiac disorders | Non-systematic Assessment | One occurrence of a hypertensive CPET response |
|
Not provided
Not provided
Not provided
| D002318 |
| Cardiovascular Diseases |
| D016491 | Peripheral Vascular Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001519 | Behavior |
| D009142 |
| Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
| Non-smoker |
|
|
| Workstream 1 - recruited |
|
|
| Workstream 1 - completed |
|
|
| Workstream 2 - screened |
|
|
| Workstream 2 - eligible |
|
|
| Workstream 2 - recruited |
|
|
| Workstream 2 - completed |
|
|
| Workstream 2 - intervals at the required intensity |
|
|
| Workstream 2 - HIIT sessions completed |
|
|
| Workstream 2 - HIIT intervals completed |
|
|
|
|
| Workstream 1 - 4-week post intervention follow-up |
|
|
| Workstream 1 - 12-week post intervention follow-up |
|
|
| Workstream 2 baseline |
|
|
| Workstream 2 Post-intervention follow-up |
|
|
| Workstream 2 - 4-week post intervention follow-up |
|
|
| Workstream 2 - 12-week post intervention follow-up |
|
|
|
| Workstream 1 - 4-week post-intervention follow-up VO2Peak |
|
|
| Workstream 1 - 12-week post-intervention follow-up VO2Peak |
|
|
| Workstream 2 - baseline VO2Peak |
|
|
| Workstream 2 - post-intervention follow-up VO2Peak |
|
|
| Workstream 2 - 4-week post-intervention follow-up VO2Peak |
|
|
| Workstream 2 - 12-week post-intervention follow-up VO2Peak |
|
|
|
| Workstream 1 baseline role physical |
|
|
| Workstream 1 follow-up role physical |
|
|
| Workstream 1 baseline pain |
|
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| Workstream 1 follow-up pain |
|
|
| Workstream 1 baseline general health |
|
|
| Workstream 1 follow-up general health |
|
|
| Workstream 1 baseline vitality |
|
|
| Workstream 1 follow-up vitality |
|
|
| Workstream 1 baseline social functioning |
|
|
| Workstream 1 follow-up social functioning |
|
|
| Workstream 1 baseline role emotional |
|
|
| Workstream 1 follow-up role emotional |
|
|
| Workstream 1 baseline mental health |
|
|
| Workstream 1 follow-up mental health |
|
|
| Workstream 1 baseline PCS |
|
|
| Workstream 1 follow-up PCS |
|
|
| Workstream 1 baseline MCS |
|
|
| Workstream 1 follow-up MCS |
|
|
| Workstream 2 baseline physical functioning |
|
|
| Workstream 2 follow-up physical functioning |
|
|
| Workstream 2 baseline role physical |
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|
| Workstream 2 follow-up role physical |
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| Workstream 2 baseline pain |
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| Workstream 2 follow-up pain |
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| Workstream 2 baseline general health |
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| Workstream 2 follow-up general health |
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| Workstream 2 baseline vitality |
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| Workstream 2 follow-up vitality |
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| Workstream 2 baseline social functioning |
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| Workstream 2 follow-up social functioning |
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| Workstream 2 baseline role emotional |
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| Workstream 2 follow-up role emotional |
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| Workstream 2 baseline mental health |
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| Workstream 2 follow-up mental health |
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| Workstream 2 baseline PCS |
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| Workstream 2 follow-up PCS |
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| Workstream 2 baseline MCS |
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| Workstream 2 follow-up MCS |
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| Workstream 1 baseline social score |
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| Workstream 1 follow-up social score |
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| Workstream 1 baseline activities score |
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| Workstream 1 follow-up activities score |
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| Workstream 1 baseline symptom score |
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|
| Workstream 1 follow-up symptom score |
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| Workstream 1 baseline emotional score |
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| Workstream 1 follow-up emotional score |
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|
| Workstream 1 baseline total score |
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|
| Workstream 1 follow-up total score |
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|
| Workstream 2 baseline pain score |
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|
| Workstream 2 follow-up pain score |
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|
| Workstream 2 baseline social score |
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|
| Workstream 2 follow-up social score |
|
|
| Workstream 2 baseline activities score |
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|
| Workstream 2 follow-up activities score |
|
|
| Workstream 2 baseline symptom score |
|
|
| Workstream 2 follow-up symptom score |
|
|
| Workstream 2 baseline emotional score |
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|
| Workstream 2 follow-up emotional score |
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|
| Workstream 2 baseline total score |
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|
| Workstream 2 follow-up total score |
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|
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| Workstream 1 - 4-week post-intervention follow-up |
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| Workstream 1 - 12-week post-intervention follow-up |
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|
| Workstream 2 baseline |
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| Workstream 2 post-intervention follow-up |
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|
| Workstream 2 - 4-week post-intervention follow-up |
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|
| Workstream 2 - 12-week post-intervention follow-up |
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|
|
| Workstream 1 - 4-weeks post-intervention follow-up peak power output |
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|
| Workstream 1 - 12-week post-intervention follow-up peak power output |
|
|
| Workstream 2 - baseline peak power output |
|
|
| Workstream 2 - post-intervention follow-up peak power output |
|
|
| Workstream 2 - 4-weeks post-intervention follow-up peak power output |
|
|
| Workstream 2 - 12-weeks post-intervention follow-up peak power output |
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|
|
| Workstream 1 - 4-week post intervention follow-up |
|
|
| Workstream 1 - 12-week post intervention follow-up |
|
|
| Workstream 2 baseline |
|
|
| Workstream 2 Post-intervention follow-up |
|
|
| Workstream 2 - 4-week post intervention follow-up |
|
|
| Workstream 2 - 12-week post intervention follow-up |
|
|
|
| Workstream 1 - 4-week post-intervention follow-up VAT |
|
|
| Workstream 1 - 12-week post-intervention follow-up VAT |
|
|
| Workstream 2 - baseline VAT |
|
|
| Workstream 2 - post-intervention follow-up VAT |
|
|
| Workstream 2 - 4-week post-intervention follow-up VAT |
|
|
| Workstream 2 - 12-week post-intervention follow-up VAT |
|
|
|
| Workstream 1 - 4-week follow-up role physical |
|
|
| Workstream 1 - 12-week follow-up follow-up role physical |
|
|
| Workstream 1 - 4-week follow-up pain |
|
|
| Workstream 1 - 12-week follow-up pain |
|
|
| Workstream 1 - 4-week follow-up general health |
|
|
| Workstream 1 - 12-week follow-up general health |
|
|
| Workstream 1 - 4-week follow-up vitality |
|
|
| Workstream 1 - 12-week follow-up vitality |
|
|
| Workstream 1 - 4-week follow-up social functioning |
|
|
| Workstream 1 - 12-week follow-up social functioning |
|
|
| Workstream 1 - 4-week follow-up role emotional |
|
|
| Workstream 1 - 12-week follow-up role emotional |
|
|
| Workstream 1 - 4-week follow-up mental health |
|
|
| Workstream 1 - 12-week follow-up mental health |
|
|
| Workstream 1 - 4-week follow-up PCS |
|
|
| Workstream 1 - 12-week follow-up PCS |
|
|
| Workstream 1 - 4 week follow-up MCS |
|
|
| Workstream 1 - 12-week follow-up MCS |
|
|
| Workstream 2 - 4-week follow-up physical functioning |
|
|
| Workstream 2 - 12-week follow-up physical functioning |
|
|
| Workstream 2 - 4-week follow-up role physical |
|
|
| Workstream 2 - 12-week follow-up role physical |
|
|
| Workstream 2 - 4-week pain |
|
|
| Workstream 2 - 12-week follow-up pain |
|
|
| Workstream 2 - 4-week follow-up general health |
|
|
| Workstream 2 - 12-week follow-up general health |
|
|
| Workstream 2 - 4-week follow-up vitality |
|
|
| Workstream 2 - 12 -week follow-up vitality |
|
|
| Workstream 2 - 4-week follow-up social functioning |
|
|
| Workstream 2 - 12-week follow-up social functioning |
|
|
| Workstream 2 4-week follow-up role emotional |
|
|
| Workstream 2 - 12-week follow-up role emotional |
|
|
| Workstream 2 4-week follow-up mental health |
|
|
| Workstream 2 - 12-week follow-up mental health |
|
|
| Workstream 2 - 4-week follow-up PCS |
|
|
| Workstream 2 - 12-week follow-up PCS |
|
|
| Workstream 2 - 4-week follow-up MCS |
|
|
| Workstream 2 - 12-week follow-up MCS |
|
|
|
| Workstream 1 - 4-week follow-up social score |
|
|
| Workstream 1 - 12-week follow-up social score |
|
|
| Workstream 1 - 4-week follow-up activities score |
|
|
| Workstream 1 - 12-week follow-up activities score |
|
|
| Workstream 1 - 4-week follow-up symptom score |
|
|
| Workstream 1 - 12-week follow-up symptom score |
|
|
| Workstream 1 4-week follow-up emotional score |
|
|
| Workstream 1 - 12-week follow-up emotional score |
|
|
| Workstream 1 - 4-week total score |
|
|
| Workstream 1 - 12-week follow-up total score |
|
|
| Workstream 2 4-week follow-up pain score |
|
|
| Workstream 2 - 12-week follow-up pain score |
|
|
| Workstream 2 - 4-week follow-up social score |
|
|
| Workstream 2 - 12-week follow-up social score |
|
|
| Workstream 2 4-week follow-up activities score |
|
|
| Workstream 2 - 12-week follow-up activities score |
|
|
| Workstream 2 4-week follow-up symptom score |
|
|
| Workstream 2 - 12-week follow-up symptom score |
|
|
| Workstream 2 4-week follow-up emotional score |
|
|
| Workstream 2 - 12-week follow-up emotional score |
|
|
| Workstream 2 - 4-week follow-up total score |
|
|
| Workstream 2 - 12-week follow-up total score |
|
|