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As we age, muscles can become progressively weaker to the point that tasks of daily living cannot be carried out safely. However, regular resistance exercise training has been shown to maintain and even increase muscle strength in older adults. Previous research has identified a homebased, non-loaded, lower limb only, 'exercise snacking' model that does not require exercise equipment or supervision as a viable alternative exercise strategy to traditional resistance exercise, with potential to improve leg muscle strength in healthy older adults. This approach has been shown to be feasible and acceptable to general healthy older adult population, however this approach to exercise focussed on improving strength has not been considered in a clinical population.
This research seeks to investigate the acceptability of 28 days of homebased exercise snacking in outpatients with attending the memory clinic at the Research Institute for Care of the Elderly (RICE) Centre in Bath, UK, with diagnosis limited to mild cognitive impairment only. This study will improve understanding of how zero-cost exercise strategies to potentially improve muscle function and delay frailty could be incorporated in daily routines of older adults.
Potential participants will be identified by clinicians during memory clinic outpatient appointments at the Research Institute for Care of the Elderly (RICE) in Bath. Clinicians will provide a brief overview of the study, and the Participant Information sheet to those individuals interested in participating.
Potential participants will then be contacted by the researcher at RICE to arrange a screening meeting. This will be a face-to-face meeting, taking place at RICE. Potential participants are invited to bring carers to this meeting.
At the screening meeting, a verbal overview of the study will be provided by the researcher and written informed consent must be provided by the potential participant after they have had chance to ask questions about the study.
A health screen questionnaire will be completed, and basic cognitive and physical function tests will be undertaken to assess participant eligibility. Participants passing these tests will be invited to participate.
Eligible participants will be asked to complete questionnaires and undertake further tests of physical function, including a thorough practice of the exercise intervention. The baseline assessment will take place during the same visit as the screening meeting. If the researcher believes that performance in these baseline physical function tests indicates that it would not be safe for the participant to continue in the study, then then will be withdrawn at that point.
All participants will be asked to undertake 28 consecutive days of exercise snacking. This involves two bouts of exercise per day, one in the morning and one in the afternoon/evening. Each bout will consist of five exercises, with each exercise performed for 60 seconds only, followed by 60 seconds of rest, before performing the next exercise. The exercises require no specialist equipment or clothing but must only be performed when there is someone else in the house that would be capable of calling for help in the event of an emergency.
Participants will be provided with a logbook to record information about each exercise bout, and an appendix document with detailed instruction on how to perform exercise snacking. Participants will also be asked to wear a physical activity monitor for the first seven days of exercise snacking, and to return this in a pre-paid and addressed envelope after this period of wear.
Participants will be invited to the RICE centre within five days completing the exercise snacking intervention to complete the same questionnaires and physical function tests that were undertaken at the baseline assessment. A further questionnaire exploring the acceptability of the exercise snacking intervention will be completed. Participants will also be invited to undertake a qualitative interview with the researcher to gain further insight into the participant's experience of the intervention.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Exercise Snacking Group | Experimental | For 28 days, this group will be asked to perform two 'exercise snacks' a day; once in the morning and once in the evening, and record exercise snacking compliance data in a log book |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exercise Snacking | Behavioral | Each bout of exercise snacking consists of 5 exercise. Each exercise is performed for one minute, with aim of completing as many repetitions as possible of that exercise in that minute. One minute of rest is observed between each exercise of the exercise snack. The five exercises are sit-to-stand from a chair, seated overhead arm raises, march on the spot, seated arm raises and shoulder touches, and seated calf raises. The sit-to-stand exercise is always performed first, with the number of repetitions achieved recorded, and subsequent exercises performed in any order without recording of repetitions. |
| Measure | Description | Time Frame |
|---|---|---|
| Acceptability of the Intervention | Participants will be asked to complete a Theoretical Framework of Acceptability questionnaire on their experiences of the exercise snacking questionnaire. The scale scores range from 0 to 5 with high scores indicating greater acceptability, and the total score representing the mean average of 7 individual domains of acceptability (each also rated 0-5). | 28-days (post intervention) |
| Measure | Description | Time Frame |
|---|---|---|
| Attitudes to Exercise | Outcome Expectancy for Exercise Questionnaire Score on a scale of 0-5, with higher scores indicating higher outcome expectancy | 28-days (pre-to-post intervention) |
| Self-confidence for Exercise |
| Measure | Description | Time Frame |
|---|---|---|
| Acceptability of the Intervention | OPTIONAL qualitative exit interview | 28-days (post intervention) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tomas Welsh, MD, PhD | RICE | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Bath | Bath | Avon | BA2 7AY | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37542234 | Derived | Western MJ, Welsh T, Keen K, Bishop V, Perkin OJ. Exercise snacking to improve physical function in pre-frail older adult memory clinic patients: a 28-day pilot study. BMC Geriatr. 2023 Aug 4;23(1):471. doi: 10.1186/s12877-023-04169-6. |
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Individual participant data will not be shared with other researchers
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The baseline assessment took place during the same visit as the screening, provided that potential participants met all eligibility criteria and enrolled in the study, and there was no group assignment as this was a single group study design.
This pilot study aimed to collect primary outcome measure from 20 participants in a single group study design. Participants were all outpatients who had attended an NHS commissioned memory clinic in Bath, UK. All data collection took place during a three-month testing window, with a rolling recruitment strategy capped at up to 10 replacement participants who could complete the 28-day intervention and associated assessments within the three-month testing phase.
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| ID | Title | Description |
|---|---|---|
| FG000 | Exercise Snacking Group | For 28 days, this group will be asked to perform two 'exercise snacks' a day; once in the morning and once in the evening, and record exercise snacking compliance data in a log book Exercise Snacking: Each bout of exercise snacking consists of 5 exercise. Each exercise is performed for one minute, with aim of completing as many repetitions as possible of that exercise in that minute. One minute of rest is observed between each exercise of the exercise snack. The five exercises are sit-to-stand from a chair, seated overhead arm raises, march on the spot, seated arm raises and shoulder touches, and seated calf raises. The sit-to-stand exercise is always performed first, with the number of repetitions achieved recorded, and subsequent exercises performed in any order without recording of repetitions. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Outpatients aged >65 years who had attended an NHS commissioned memory clinic at the Research Institute for Care of Older Adults in Bath, UK
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| ID | Title | Description |
|---|---|---|
| BG000 | Exercise Snacking Group | For 28 days, this group will be asked to perform two 'exercise snacks' a day; once in the morning and once in the evening, and record exercise snacking compliance data in a log book Exercise Snacking: Each bout of exercise snacking consists of 5 exercise. Each exercise is performed for one minute, with aim of completing as many repetitions as possible of that exercise in that minute. One minute of rest is observed between each exercise of the exercise snack. The five exercises are sit-to-stand from a chair, seated overhead arm raises, march on the spot, seated arm raises and shoulder touches, and seated calf raises. The sit-to-stand exercise is always performed first, with the number of repetitions achieved recorded, and subsequent exercises performed in any order without recording of repetitions. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Acceptability of the Intervention | Participants will be asked to complete a Theoretical Framework of Acceptability questionnaire on their experiences of the exercise snacking questionnaire. The scale scores range from 0 to 5 with high scores indicating greater acceptability, and the total score representing the mean average of 7 individual domains of acceptability (each also rated 0-5). | Outpatients aged >65 years who had attended an NHS commissioned memory clinic at the Research Institute for Care of Older Adults in Bath, UK | Posted | Mean | Standard Deviation | score on a scale | 28-days (post intervention) |
|
Adverse event data were collected from the beginning of screening to the end of the final assessment, with final assessment scheduled within two weeks of completing the 28-day intervention which began at the screening session. Thus the time period for adverse event collect was 4-6 weeks.
Adverse events were as per the definitions from clinicaltrials.gov
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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 | Exercise Snacking Group | For 28 days, this group will be asked to perform two 'exercise snacks' a day; once in the morning and once in the evening, and record exercise snacking compliance data in a log book Exercise Snacking: Each bout of exercise snacking consists of 5 exercise. Each exercise is performed for one minute, with aim of completing as many repetitions as possible of that exercise in that minute. One minute of rest is observed between each exercise of the exercise snack. The five exercises are sit-to-stand from a chair, seated overhead arm raises, march on the spot, seated arm raises and shoulder touches, and seated calf raises. The sit-to-stand exercise is always performed first, with the number of repetitions achieved recorded, and subsequent exercises performed in any order without recording of repetitions. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Oliver Perkin | University of Bath | 01225384356 | o.j.perkin@bath.ac.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 | Mar 22, 2022 | Apr 14, 2023 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jun 21, 2022 | Apr 14, 2023 | ICF_001.pdf |
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Single group, pre-test-post-test pilot study of acceptability
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The 'Barriers Self-Efficacy Scale', (BARSE), to assess participants perceived capabilities to exercise. The scale ranges from 0-100, with a higher score indicating higher self-efficacy.
| 28-days (pre-to-post intervention) |
| Psychological Need Satisfaction for Exercise | Psychological need satisfaction for exercise questionnaire Score on a scale of 0-6, with higher scores indicating a greater satisfaction of basic psychological needs | 28-days (pre-to-post intervention) |
| Current Mental Health | Patient Health Questionnaire Score on a scale of 0-27, with lower scores indicating less depression | 28-days (pre-to-post intervention) |
| Patient Anxiety | Generalised Anxiety Disorder Assessment Score on a scale of 0-21, with lower scores indicating lower anxiety | 28-days (pre-to-post intervention) |
| General Health | Short Form Health Survey (SF-36) Separate scales from 0 to 100 for each of the two domains (physical and mental), with higher scores meaning better health status in both. The two domains are reported separately but not combined. | 28-days (pre-to-post intervention) |
| Patient Vitality | Subjective Vitality Index Score on a scale of 0-49, with higher scores indicating greater vitality | 28-days (pre-to-post intervention) |
| Patient Life Satisfaction | Life Satisfaction Scale Score on a scale of 0-35, with higher scores indicating greater satisfaction with life | 28-days (pre-to-post intervention) |
| Patient Quality of Life | Overall quality of life scale Score on a scale of 0-100, with higher scores indicating better quality of life | 28-days (pre-to-post intervention) |
| Cognitive Assessment | Montreal Cognitive Assessment Score on a scale of 0-30, with lower scores indicating greater cognitive impairment | 28-days (pre-to-post intervention) |
| Cognitive Assessment | Groningen Frailty Index Score on a scale of 0-15, with higher scores being more frail | 28-days (pre-to-post intervention) |
| Physical Function Assessments | Short Physical Performance Battery Score on a scale of 0-12, with higher scores indicating greater physical function | 28-days (pre-to-post intervention) |
| Physical Function Assessments | 60 second sit-to-stand test The number of sit-to-stands completed in 60 seconds | 28-days (pre-to-post intervention) |
| Physical Function Assessments | 60 second sit-to-stand rating of perceived exertion Borg scale from 6-20, with higher scores indicating greater perceived exertion | 28-days (pre-to-post intervention) |
| Physical Function Assessments | Standing balance test scores Maximum time for single leg balance holds, capped at 60 seconds on each leg | 28-days (pre-to-post intervention) |
| Physical Function Assessments | Timed-up-and-go Time in seconds to complete a functional movement task | 28-days (pre-to-post intervention) |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Secondary | Attitudes to Exercise | Outcome Expectancy for Exercise Questionnaire Score on a scale of 0-5, with higher scores indicating higher outcome expectancy | Outpatients aged >65 years who had attended an NHS commissioned memory clinic at the Research Institute for Care of Older Adults in Bath, UK | Posted | Mean | Standard Deviation | score on a scale | 28-days (pre-to-post intervention) |
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| Secondary | Self-confidence for Exercise | The 'Barriers Self-Efficacy Scale', (BARSE), to assess participants perceived capabilities to exercise. The scale ranges from 0-100, with a higher score indicating higher self-efficacy. | Outpatients aged >65 years who had attended an NHS commissioned memory clinic at the Research Institute for Care of Older Adults in Bath, UK | Posted | Mean | Standard Deviation | score on a scale | 28-days (pre-to-post intervention) |
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| Secondary | Psychological Need Satisfaction for Exercise | Psychological need satisfaction for exercise questionnaire Score on a scale of 0-6, with higher scores indicating a greater satisfaction of basic psychological needs | Outpatients aged >65 years who had attended an NHS commissioned memory clinic at the Research Institute for Care of Older Adults in Bath, UK | Posted | Mean | Standard Deviation | score on a scale | 28-days (pre-to-post intervention) |
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| Secondary | Current Mental Health | Patient Health Questionnaire Score on a scale of 0-27, with lower scores indicating less depression | Outpatients aged >65 years who had attended an NHS commissioned memory clinic at the Research Institute for Care of Older Adults in Bath, UK | Posted | Mean | Standard Deviation | score on a scale | 28-days (pre-to-post intervention) |
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| Secondary | Patient Anxiety | Generalised Anxiety Disorder Assessment Score on a scale of 0-21, with lower scores indicating lower anxiety | Outpatients aged >65 years who had attended an NHS commissioned memory clinic at the Research Institute for Care of Older Adults in Bath, UK | Posted | Mean | Standard Deviation | score on a scale | 28-days (pre-to-post intervention) |
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| Secondary | General Health | Short Form Health Survey (SF-36) Separate scales from 0 to 100 for each of the two domains (physical and mental), with higher scores meaning better health status in both. The two domains are reported separately but not combined. | Outpatients aged >65 years who had attended an NHS commissioned memory clinic at the Research Institute for Care of Older Adults in Bath, UK | Posted | Mean | Standard Deviation | score on a scale | 28-days (pre-to-post intervention) |
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| Secondary | Patient Vitality | Subjective Vitality Index Score on a scale of 0-49, with higher scores indicating greater vitality | Outpatients aged >65 years who had attended an NHS commissioned memory clinic at the Research Institute for Care of Older Adults in Bath, UK | Posted | Mean | Standard Deviation | score on a scale | 28-days (pre-to-post intervention) |
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| Secondary | Patient Life Satisfaction | Life Satisfaction Scale Score on a scale of 0-35, with higher scores indicating greater satisfaction with life | Outpatients aged >65 years who had attended an NHS commissioned memory clinic at the Research Institute for Care of Older Adults in Bath, UK | Posted | Mean | Standard Deviation | score on a scale | 28-days (pre-to-post intervention) |
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| Secondary | Patient Quality of Life | Overall quality of life scale Score on a scale of 0-100, with higher scores indicating better quality of life | Outpatients aged >65 years who had attended an NHS commissioned memory clinic at the Research Institute for Care of Older Adults in Bath, UK | Posted | Mean | Standard Deviation | score on a scale | 28-days (pre-to-post intervention) |
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| Secondary | Cognitive Assessment | Montreal Cognitive Assessment Score on a scale of 0-30, with lower scores indicating greater cognitive impairment | Outpatients aged >65 years who had attended an NHS commissioned memory clinic at the Research Institute for Care of Older Adults in Bath, UK | Posted | Mean | Standard Deviation | score on a scale | 28-days (pre-to-post intervention) |
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| Secondary | Cognitive Assessment | Groningen Frailty Index Score on a scale of 0-15, with higher scores being more frail | Outpatients aged >65 years who had attended an NHS commissioned memory clinic at the Research Institute for Care of Older Adults in Bath, UK | Posted | Mean | Standard Deviation | score on a scale | 28-days (pre-to-post intervention) |
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| Secondary | Physical Function Assessments | Short Physical Performance Battery Score on a scale of 0-12, with higher scores indicating greater physical function | Outpatients aged >65 years who had attended an NHS commissioned memory clinic at the Research Institute for Care of Older Adults in Bath, UK | Posted | Mean | Standard Deviation | score on a scale | 28-days (pre-to-post intervention) |
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| Secondary | Physical Function Assessments | 60 second sit-to-stand test The number of sit-to-stands completed in 60 seconds | Outpatients aged >65 years who had attended an NHS commissioned memory clinic at the Research Institute for Care of Older Adults in Bath, UK | Posted | Mean | Standard Deviation | repetitions completed | 28-days (pre-to-post intervention) |
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| Secondary | Physical Function Assessments | 60 second sit-to-stand rating of perceived exertion Borg scale from 6-20, with higher scores indicating greater perceived exertion | Outpatients aged >65 years who had attended an NHS commissioned memory clinic at the Research Institute for Care of Older Adults in Bath, UK | Posted | Mean | Standard Deviation | score on a scale | 28-days (pre-to-post intervention) |
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| Secondary | Physical Function Assessments | Standing balance test scores Maximum time for single leg balance holds, capped at 60 seconds on each leg | Outpatients aged >65 years who had attended an NHS commissioned memory clinic at the Research Institute for Care of Older Adults in Bath, UK | Posted | Mean | Standard Deviation | seconds | 28-days (pre-to-post intervention) |
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| Secondary | Physical Function Assessments | Timed-up-and-go Time in seconds to complete a functional movement task | Outpatients aged >65 years who had attended an NHS commissioned memory clinic at the Research Institute for Care of Older Adults in Bath, UK | Posted | Mean | Standard Deviation | time in seconds | 28-days (pre-to-post intervention) |
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| Other Pre-specified | Acceptability of the Intervention | OPTIONAL qualitative exit interview | Not Posted | 28-days (post intervention) | Participants |
| 1 |
| 21 |
| 0 |
| 21 |
| 0 |
| 21 |
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| Title | Measurements |
|---|---|
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| Mental Domain: Post-intervention |
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| Title | Measurements |
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| Left leg; Post-intervention |
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