- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05439252
Exercise Snacking to Improve Strength and STability: ESISST Pilot Study (ESSIST)
The Acceptability of Exercise Snacking to Improve Leg Strength in Memory Clinic Outpatients: a Pilot Study
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Avon
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Bath, Avon, United Kingdom, BA2 7AY
- University of Bath
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Aged >65 years
- Have attended the Memory Clinic at the RICE Centre in Bath
- Mini-mental state examination (MMSE) score of ≥20
- Short Physical Performance Battery (SPPB) score 3-8 and not scoring 0 on any component of the test
- Capability to safely perform the exercise snacking movements, assessed by a researcher during screening, and be able to have someone present in the home who could call for help if required during all exercise snacks.
- Not regularly engaging in recreational sports or structured exercise (once a week or more).
- Have a foreseeable clear period of 28 consecutive days in which to perform the exercise snacking protocol (i.e. no planned holidays or hospitalisation)
Exclusion Criteria:
- Co-morbidity preventing participation (e.g. severe breathlessness, pain, psychosis, Parkinson's, Dementia with Lewy Bodies, or other severe neurological disease)
- Individuals with a history of bone, joint or neuromuscular problems or a current musculoskeletal injury ascertained through preliminary screening that would prevent exercise snacking or be made worse by performing exercise snacking.
- Individuals with contraindications to exercise including chest pain, dizziness, or loss of consciousness, or who have been instructed by their doctor to only do physical activity recommended by them.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 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
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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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Acceptability of the Intervention
Time Frame: 28-days (post 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)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Attitudes to Exercise
Time Frame: 28-days (pre-to-post intervention)
|
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
Time Frame: 28-days (pre-to-post intervention)
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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
Time Frame: 28-days (pre-to-post intervention)
|
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
Time Frame: 28-days (pre-to-post intervention)
|
Patient Health Questionnaire Score on a scale of 0-27, with lower scores indicating less depression
|
28-days (pre-to-post intervention)
|
|
Patient Anxiety
Time Frame: 28-days (pre-to-post intervention)
|
Generalised Anxiety Disorder Assessment Score on a scale of 0-21, with lower scores indicating lower anxiety
|
28-days (pre-to-post intervention)
|
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General Health
Time Frame: 28-days (pre-to-post intervention)
|
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
Time Frame: 28-days (pre-to-post intervention)
|
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
Time Frame: 28-days (pre-to-post intervention)
|
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
Time Frame: 28-days (pre-to-post intervention)
|
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
Time Frame: 28-days (pre-to-post intervention)
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Montreal Cognitive Assessment Score on a scale of 0-30, with lower scores indicating greater cognitive impairment
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28-days (pre-to-post intervention)
|
|
Cognitive Assessment
Time Frame: 28-days (pre-to-post intervention)
|
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
Time Frame: 28-days (pre-to-post intervention)
|
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
Time Frame: 28-days (pre-to-post intervention)
|
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
Time Frame: 28-days (pre-to-post intervention)
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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
Time Frame: 28-days (pre-to-post intervention)
|
Standing balance test scores Maximum time for single leg balance holds, capped at 60 seconds on each leg
|
28-days (pre-to-post intervention)
|
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Physical Function Assessments
Time Frame: 28-days (pre-to-post intervention)
|
Timed-up-and-go Time in seconds to complete a functional movement task
|
28-days (pre-to-post intervention)
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Acceptability of the Intervention
Time Frame: 28-days (post intervention)
|
OPTIONAL qualitative exit interview
|
28-days (post intervention)
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Tomas Welsh, MD, PhD, RICE
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- UoB-ESS-02
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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