Acceptability of an Exercise InterventionESSISTNCT05439252
Exercise Snacking to Improve Strength and STability: ESISST Pilot Study
A study testing Exercise Snacking in people with Acceptability of an Exercise Intervention, run by University of Bath at 1 site in United Kingdom.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Acceptability of an Exercise Intervention
- What is being tested?
- Exercise Snacking
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Aug 2022to 20 Jan 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 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)
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Being tested
- Exercise Snacking
- Keywords
- Exercise Snacking, Elderly, Homebased exercise, Outpatient
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise SnackingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Behavioral: Exercise Snacking |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 28-days (post intervention)
Secondary outcomes (16)
Attitudes to Exercise
Outcome Expectancy for Exercise Questionnaire Score on a scale of 0-5, with higher scores indicating higher outcome expectancy
Measured: 28-days (pre-to-post intervention)
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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 28-days (pre-to-post intervention)
Patient Vitality
Subjective Vitality Index Score on a scale of 0-49, with higher scores indicating greater vitality
Measured: 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
Measured: 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
Measured: 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
Measured: 28-days (pre-to-post intervention)
Cognitive Assessment
Groningen Frailty Index Score on a scale of 0-15, with higher scores being more frail
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 28-days (pre-to-post intervention)
Physical Function Assessments
Timed-up-and-go Time in seconds to complete a functional movement task
Measured: 28-days (pre-to-post intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2022
- Study start1 Aug 2022
- Primary completion20 Jan 2023
- Study completion20 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acceptability of an Exercise InterventionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single group, pre-test-post-test pilot study of acceptability
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Bath
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Oliver Perkin, University of Bath
- Investigators
- Tomas Welsh, MD, PhD, Study director, RICE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05439252
- Sponsor's protocol ID
- UoB-ESS-02
- Acronym
- ESSIST
- Status last verified
- Jul 2024
- First submitted
- 21 Jun 2022
- Last updated
- 4 Oct 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared with other researchers
Publications
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.
PubMed 37542234
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Acceptability of Exercise Snacking to Improve Leg Strength in Memory Clinic Outpatients: a Pilot Study
- ClinicalTrials.gov ID
- NCT05439252
- Acronym / sponsor ID
- ESSIST / UoB-ESS-02
- Keywords
- Exercise Snacking, Elderly, Homebased exercise, Outpatient
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- University of BathUniversity, hospital or other
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 20 Jan 2023 (actual)
- Study completion
- 20 Jan 2023 (actual)
- First posted
- 30 Jun 2022 (actual)
- Results
- Posted 4 Oct 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single group, pre-test-post-test pilot study of acceptability
| Arm | Type | Receives |
|---|---|---|
| Exercise Snacking Group | Experimental | Behavioral: Exercise SnackingFor 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 |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise SnackingEach 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. | Behavioural | Exercise Snacking Group |
Primary outcome
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).
16 secondary outcomes
Attitudes to Exercise
Time frame: 28-days (pre-to-post intervention)
Self-confidence for Exercise
Time frame: 28-days (pre-to-post intervention)
Psychological Need Satisfaction for Exercise
Time frame: 28-days (pre-to-post intervention)
Current Mental Health
Time frame: 28-days (pre-to-post intervention)
Patient Anxiety
Time frame: 28-days (pre-to-post intervention)
General Health
Time frame: 28-days (pre-to-post intervention)
Patient Vitality
Time frame: 28-days (pre-to-post intervention)
Patient Life Satisfaction
Time frame: 28-days (pre-to-post intervention)
Patient Quality of Life
Time frame: 28-days (pre-to-post intervention)
Cognitive Assessment
Time frame: 28-days (pre-to-post intervention)
Cognitive Assessment
Time frame: 28-days (pre-to-post intervention)
Physical Function Assessments
Time frame: 28-days (pre-to-post intervention)
Physical Function Assessments
Time frame: 28-days (pre-to-post intervention)
Physical Function Assessments
Time frame: 28-days (pre-to-post intervention)
Physical Function Assessments
Time frame: 28-days (pre-to-post intervention)
Physical Function Assessments
Time frame: 28-days (pre-to-post intervention)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37542234Western 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.
- Individual participant dataSharing planned: No. Individual participant data will not be shared with other researchers
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tomas Welsh, MD, PhD study director
RICE
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise Snacking in people with Acceptability of an Exercise Intervention, run by University of Bath at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Oct 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acceptability of the Intervention (time frame: 28-days (post intervention)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05439252, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Oct 2024.