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Exercise Snacking to Improve Strength and STability: ESISST Pilot Study

The Acceptability of Exercise Snacking to Improve Leg Strength in Memory Clinic Outpatients: a Pilot Study

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05439252
Acronym
ESSIST
Enrollment
21
Registered
2022-06-30
Start date
2022-08-01
Completion date
2023-01-20
Last updated
2024-10-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acceptability of an Exercise Intervention

Keywords

Exercise Snacking, Elderly, Homebased exercise, Outpatient

Brief 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. 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.

Interventions

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.

Sponsors

University of Bath
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Intervention model description

Single group, pre-test-post-test pilot study of acceptability

Eligibility

Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Acceptability of the Intervention28-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).

Secondary

MeasureTime frameDescription
Cognitive Assessment28-days (pre-to-post intervention)Montreal Cognitive Assessment Score on a scale of 0-30, with lower scores indicating greater cognitive impairment
Attitudes to Exercise28-days (pre-to-post intervention)Outcome Expectancy for Exercise Questionnaire Score on a scale of 0-5, with higher scores indicating higher outcome expectancy
Self-confidence for Exercise28-days (pre-to-post intervention)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.
Psychological Need Satisfaction for Exercise28-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
Current Mental Health28-days (pre-to-post intervention)Patient Health Questionnaire Score on a scale of 0-27, with lower scores indicating less depression
General Health28-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.
Patient Vitality28-days (pre-to-post intervention)Subjective Vitality Index Score on a scale of 0-49, with higher scores indicating greater vitality
Patient Life Satisfaction28-days (pre-to-post intervention)Life Satisfaction Scale Score on a scale of 0-35, with higher scores indicating greater satisfaction with life
Patient Quality of Life28-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
Physical Function Assessments28-days (pre-to-post intervention)Short Physical Performance Battery Score on a scale of 0-12, with higher scores indicating greater physical function
Patient Anxiety28-days (pre-to-post intervention)Generalised Anxiety Disorder Assessment Score on a scale of 0-21, with lower scores indicating lower anxiety

Other

MeasureTime frameDescription
Acceptability of the Intervention28-days (post intervention)OPTIONAL qualitative exit interview

Countries

United Kingdom

Participant flow

Recruitment details

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.

Pre-assignment details

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.

Participants by arm

ArmCount
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.
21
Total21

Baseline characteristics

CharacteristicExercise Snacking Group
Age, Continuous78 years
STANDARD_DEVIATION 8
Race/Ethnicity, Customized
Asian British
1 Participants
Race/Ethnicity, Customized
White British
20 Participants
Region of Enrollment
United Kingdom
21 Participants
Sex: Female, Male
Female
4 Participants
Sex: Female, Male
Male
17 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
1 / 21
other
Total, other adverse events
0 / 21
serious
Total, serious adverse events
0 / 21

Outcome results

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).

Time frame: 28-days (post intervention)

Population: Outpatients aged \>65 years who had attended an NHS commissioned memory clinic at the Research Institute for Care of Older Adults in Bath, UK

ArmMeasureValue (MEAN)Dispersion
Exercise Snacking GroupAcceptability of the Intervention4.6 score on a scaleStandard Deviation 0.6
Secondary

Attitudes to Exercise

Outcome Expectancy for Exercise Questionnaire Score on a scale of 0-5, with higher scores indicating higher outcome expectancy

Time frame: 28-days (pre-to-post intervention)

Population: Outpatients aged \>65 years who had attended an NHS commissioned memory clinic at the Research Institute for Care of Older Adults in Bath, UK

ArmMeasureGroupValue (MEAN)Dispersion
Exercise Snacking GroupAttitudes to ExerciseBaseline4.0 score on a scaleStandard Deviation 0.6
Exercise Snacking GroupAttitudes to ExercisePost-intervention4.3 score on a scaleStandard Deviation 0.5
Secondary

Cognitive Assessment

Groningen Frailty Index Score on a scale of 0-15, with higher scores being more frail

Time frame: 28-days (pre-to-post intervention)

Population: Outpatients aged \>65 years who had attended an NHS commissioned memory clinic at the Research Institute for Care of Older Adults in Bath, UK

ArmMeasureGroupValue (MEAN)Dispersion
Exercise Snacking GroupCognitive AssessmentBaseline3.9 score on a scaleStandard Deviation 2.1
Exercise Snacking GroupCognitive AssessmentPost-intervention3.6 score on a scaleStandard Deviation 1.9
Secondary

Cognitive Assessment

Montreal Cognitive Assessment Score on a scale of 0-30, with lower scores indicating greater cognitive impairment

Time frame: 28-days (pre-to-post intervention)

Population: Outpatients aged \>65 years who had attended an NHS commissioned memory clinic at the Research Institute for Care of Older Adults in Bath, UK

ArmMeasureGroupValue (MEAN)Dispersion
Exercise Snacking GroupCognitive AssessmentBaseline23.3 score on a scaleStandard Deviation 4
Exercise Snacking GroupCognitive AssessmentPost-intervention24.3 score on a scaleStandard Deviation 4
Secondary

Current Mental Health

Patient Health Questionnaire Score on a scale of 0-27, with lower scores indicating less depression

Time frame: 28-days (pre-to-post intervention)

Population: Outpatients aged \>65 years who had attended an NHS commissioned memory clinic at the Research Institute for Care of Older Adults in Bath, UK

ArmMeasureGroupValue (MEAN)Dispersion
Exercise Snacking GroupCurrent Mental HealthBaseline3.5 score on a scaleStandard Deviation 3.5
Exercise Snacking GroupCurrent Mental HealthPost-intervention3.7 score on a scaleStandard Deviation 3.7
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.

Time frame: 28-days (pre-to-post intervention)

Population: Outpatients aged \>65 years who had attended an NHS commissioned memory clinic at the Research Institute for Care of Older Adults in Bath, UK

ArmMeasureGroupValue (MEAN)Dispersion
Exercise Snacking GroupGeneral HealthPhysical Domain: Baseline48.5 score on a scaleStandard Deviation 8
Exercise Snacking GroupGeneral HealthPhysical Domain: Post-Intervention46.1 score on a scaleStandard Deviation 6.8
Exercise Snacking GroupGeneral HealthMental Domain: Baseline47.5 score on a scaleStandard Deviation 11.9
Exercise Snacking GroupGeneral HealthMental Domain: Post-intervention51.3 score on a scaleStandard Deviation 12.8
Secondary

Patient Anxiety

Generalised Anxiety Disorder Assessment Score on a scale of 0-21, with lower scores indicating lower anxiety

Time frame: 28-days (pre-to-post intervention)

Population: Outpatients aged \>65 years who had attended an NHS commissioned memory clinic at the Research Institute for Care of Older Adults in Bath, UK

ArmMeasureGroupValue (MEAN)Dispersion
Exercise Snacking GroupPatient AnxietyBaseline2 score on a scaleStandard Deviation 2
Exercise Snacking GroupPatient AnxietyPoat-intervention1.6 score on a scaleStandard Deviation 2.1
Secondary

Patient Life Satisfaction

Life Satisfaction Scale Score on a scale of 0-35, with higher scores indicating greater satisfaction with life

Time frame: 28-days (pre-to-post intervention)

Population: Outpatients aged \>65 years who had attended an NHS commissioned memory clinic at the Research Institute for Care of Older Adults in Bath, UK

ArmMeasureGroupValue (MEAN)Dispersion
Exercise Snacking GroupPatient Life SatisfactionBaseline29 score on a scaleStandard Deviation 4.1
Exercise Snacking GroupPatient Life SatisfactionPost-intervention27.7 score on a scaleStandard Deviation 5.5
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

Time frame: 28-days (pre-to-post intervention)

Population: Outpatients aged \>65 years who had attended an NHS commissioned memory clinic at the Research Institute for Care of Older Adults in Bath, UK

ArmMeasureGroupValue (MEAN)Dispersion
Exercise Snacking GroupPatient Quality of LifePost-intervention79.4 score on a scaleStandard Deviation 8.2
Exercise Snacking GroupPatient Quality of LifeBaseline82.5 score on a scaleStandard Deviation 11.1
Secondary

Patient Vitality

Subjective Vitality Index Score on a scale of 0-49, with higher scores indicating greater vitality

Time frame: 28-days (pre-to-post intervention)

Population: Outpatients aged \>65 years who had attended an NHS commissioned memory clinic at the Research Institute for Care of Older Adults in Bath, UK

ArmMeasureGroupValue (MEAN)Dispersion
Exercise Snacking GroupPatient VitalityBaseline30.8 score on a scaleStandard Deviation 8.7
Exercise Snacking GroupPatient VitalityPost-intervention32.4 score on a scaleStandard Deviation 6.1
Secondary

Physical Function Assessments

60 second sit-to-stand test The number of sit-to-stands completed in 60 seconds

Time frame: 28-days (pre-to-post intervention)

Population: Outpatients aged \>65 years who had attended an NHS commissioned memory clinic at the Research Institute for Care of Older Adults in Bath, UK

ArmMeasureGroupValue (MEAN)Dispersion
Exercise Snacking GroupPhysical Function AssessmentsBaseline17.2 repetitions completedStandard Deviation 4.9
Exercise Snacking GroupPhysical Function AssessmentsPost-intervention22.7 repetitions completedStandard Deviation 7.4
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

Time frame: 28-days (pre-to-post intervention)

Population: Outpatients aged \>65 years who had attended an NHS commissioned memory clinic at the Research Institute for Care of Older Adults in Bath, UK

ArmMeasureGroupValue (MEAN)Dispersion
Exercise Snacking GroupPhysical Function AssessmentsBaseline10.8 score on a scaleStandard Deviation 2.1
Exercise Snacking GroupPhysical Function AssessmentsPost-intervention11.6 score on a scaleStandard Deviation 2
Secondary

Physical Function Assessments

Standing balance test scores Maximum time for single leg balance holds, capped at 60 seconds on each leg

Time frame: 28-days (pre-to-post intervention)

Population: Outpatients aged \>65 years who had attended an NHS commissioned memory clinic at the Research Institute for Care of Older Adults in Bath, UK

ArmMeasureGroupValue (MEAN)Dispersion
Exercise Snacking GroupPhysical Function AssessmentsRight leg; Baseline27.3 secondsStandard Deviation 24.5
Exercise Snacking GroupPhysical Function AssessmentsRight leg; Post-intervention26.9 secondsStandard Deviation 21.9
Exercise Snacking GroupPhysical Function AssessmentsLeft leg; Baseline22.1 secondsStandard Deviation 21.2
Exercise Snacking GroupPhysical Function AssessmentsLeft leg; Post-intervention28.8 secondsStandard Deviation 22.4
Secondary

Physical Function Assessments

Timed-up-and-go Time in seconds to complete a functional movement task

Time frame: 28-days (pre-to-post intervention)

Population: Outpatients aged \>65 years who had attended an NHS commissioned memory clinic at the Research Institute for Care of Older Adults in Bath, UK

ArmMeasureGroupValue (MEAN)Dispersion
Exercise Snacking GroupPhysical Function AssessmentsBaseline12.6 time in secondsStandard Deviation 5
Exercise Snacking GroupPhysical Function AssessmentsPost-intervention10.8 time in secondsStandard Deviation 5.1
Secondary

Physical Function Assessments

Short Physical Performance Battery Score on a scale of 0-12, with higher scores indicating greater physical function

Time frame: 28-days (pre-to-post intervention)

Population: Outpatients aged \>65 years who had attended an NHS commissioned memory clinic at the Research Institute for Care of Older Adults in Bath, UK

ArmMeasureGroupValue (MEAN)Dispersion
Exercise Snacking GroupPhysical Function AssessmentsBaseline7 score on a scaleStandard Deviation 1.5
Exercise Snacking GroupPhysical Function AssessmentsPost-intervention8.8 score on a scaleStandard Deviation 2.3
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

Time frame: 28-days (pre-to-post intervention)

Population: Outpatients aged \>65 years who had attended an NHS commissioned memory clinic at the Research Institute for Care of Older Adults in Bath, UK

ArmMeasureGroupValue (MEAN)Dispersion
Exercise Snacking GroupPsychological Need Satisfaction for ExerciseBaseline5 score on a scaleStandard Deviation 0.7
Exercise Snacking GroupPsychological Need Satisfaction for ExercisePost-intervention5 score on a scaleStandard Deviation 0.7
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.

Time frame: 28-days (pre-to-post intervention)

Population: Outpatients aged \>65 years who had attended an NHS commissioned memory clinic at the Research Institute for Care of Older Adults in Bath, UK

ArmMeasureGroupValue (MEAN)Dispersion
Exercise Snacking GroupSelf-confidence for ExerciseBaseline70.1 score on a scaleStandard Deviation 26.2
Exercise Snacking GroupSelf-confidence for ExercisePost-intervention66.3 score on a scaleStandard Deviation 16.3
Other Pre-specified

Acceptability of the Intervention

OPTIONAL qualitative exit interview

Time frame: 28-days (post intervention)

Source: ClinicalTrials.gov · Data processed: Feb 8, 2026