Trial Outcomes & Findings for Exercise Snacking to Improve Strength and STability: ESISST Pilot Study (NCT NCT05439252)

NCT ID: NCT05439252

Last Updated: 2024-10-04

Results Overview

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).

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 21 participants
• Primary outcome timeframe: 28-days (post intervention)
• Results posted on: 2024-10-04

Participant Flow

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.

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.

Participant milestones

Measure	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.
Overall Study STARTED	21
Overall Study COMPLETED	18
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Exercise Snacking to Improve Strength and STability: ESISST Pilot Study

Baseline characteristics by cohort

Measure	Exercise Snacking Group n=21 Participants 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.
Age, Continuous	78 years STANDARD_DEVIATION 8 • n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants
Sex: Female, Male Male	17 Participants n=5 Participants
Race/Ethnicity, Customized White British	20 Participants n=5 Participants
Race/Ethnicity, Customized Asian British	1 Participants n=5 Participants
Region of Enrollment United Kingdom	21 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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

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).

Outcome measures

Measure

Exercise Snacking Group n=18 Participants 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.

Acceptability of the Intervention

4.6 score on a scale Standard Deviation 0.6

SECONDARY outcome

Timeframe: 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

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

Outcome measures

Measure	Exercise Snacking Group n=18 Participants 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.
Attitudes to Exercise Baseline	4.0 score on a scale Standard Deviation 0.6
Attitudes to Exercise Post-intervention	4.3 score on a scale Standard Deviation 0.5

SECONDARY outcome

Timeframe: 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

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.

Outcome measures

Measure	Exercise Snacking Group n=18 Participants 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.
Self-confidence for Exercise Baseline	70.1 score on a scale Standard Deviation 26.2
Self-confidence for Exercise Post-intervention	66.3 score on a scale Standard Deviation 16.3

SECONDARY outcome

Timeframe: 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

Psychological need satisfaction for exercise questionnaire Score on a scale of 0-6, with higher scores indicating a greater satisfaction of basic psychological needs

Outcome measures

Measure	Exercise Snacking Group n=18 Participants 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.
Psychological Need Satisfaction for Exercise Baseline	5 score on a scale Standard Deviation 0.7
Psychological Need Satisfaction for Exercise Post-intervention	5 score on a scale Standard Deviation .7

SECONDARY outcome

Timeframe: 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

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

Outcome measures

Measure	Exercise Snacking Group n=18 Participants 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.
Current Mental Health Baseline	3.5 score on a scale Standard Deviation 3.5
Current Mental Health Post-intervention	3.7 score on a scale Standard Deviation 3.7

SECONDARY outcome

Timeframe: 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

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

Outcome measures

Measure	Exercise Snacking Group n=18 Participants 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.
Patient Anxiety Baseline	2 score on a scale Standard Deviation 2
Patient Anxiety Poat-intervention	1.6 score on a scale Standard Deviation 2.1

SECONDARY outcome

Timeframe: 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

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.

Outcome measures

Measure	Exercise Snacking Group n=18 Participants 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.
General Health Physical Domain: Baseline	48.5 score on a scale Standard Deviation 8.0
General Health Physical Domain: Post-Intervention	46.1 score on a scale Standard Deviation 6.8
General Health Mental Domain: Baseline	47.5 score on a scale Standard Deviation 11.9
General Health Mental Domain: Post-intervention	51.3 score on a scale Standard Deviation 12.8

SECONDARY outcome

Timeframe: 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

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

Outcome measures

Measure	Exercise Snacking Group n=18 Participants 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.
Patient Vitality Baseline	30.8 score on a scale Standard Deviation 8.7
Patient Vitality Post-intervention	32.4 score on a scale Standard Deviation 6.1

SECONDARY outcome

Timeframe: 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

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

Outcome measures

Measure	Exercise Snacking Group n=18 Participants 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.
Patient Life Satisfaction Baseline	29 score on a scale Standard Deviation 4.1
Patient Life Satisfaction Post-intervention	27.7 score on a scale Standard Deviation 5.5

SECONDARY outcome

Timeframe: 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

Overall quality of life scale Score on a scale of 0-100, with higher scores indicating better quality of life

Outcome measures

Measure	Exercise Snacking Group n=18 Participants 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.
Patient Quality of Life Baseline	82.5 score on a scale Standard Deviation 11.1
Patient Quality of Life Post-intervention	79.4 score on a scale Standard Deviation 8.2

SECONDARY outcome

Timeframe: 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

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

Outcome measures

Measure	Exercise Snacking Group n=18 Participants 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.
Cognitive Assessment Post-intervention	24.3 score on a scale Standard Deviation 4.0
Cognitive Assessment Baseline	23.3 score on a scale Standard Deviation 4.0

SECONDARY outcome

Timeframe: 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

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

Outcome measures

Measure	Exercise Snacking Group n=18 Participants 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.
Cognitive Assessment Baseline	3.9 score on a scale Standard Deviation 2.1
Cognitive Assessment Post-intervention	3.6 score on a scale Standard Deviation 1.9

SECONDARY outcome

Timeframe: 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

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

Outcome measures

Measure	Exercise Snacking Group n=18 Participants 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.
Physical Function Assessments Baseline	7 score on a scale Standard Deviation 1.5
Physical Function Assessments Post-intervention	8.8 score on a scale Standard Deviation 2.3

SECONDARY outcome

Timeframe: 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

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

Outcome measures

Measure	Exercise Snacking Group n=18 Participants 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.
Physical Function Assessments Baseline	17.2 repetitions completed Standard Deviation 4.9
Physical Function Assessments Post-intervention	22.7 repetitions completed Standard Deviation 7.4

SECONDARY outcome

Timeframe: 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

60 second sit-to-stand rating of perceived exertion Borg scale from 6-20, with higher scores indicating greater perceived exertion

Outcome measures

Measure	Exercise Snacking Group n=18 Participants 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.
Physical Function Assessments Baseline	10.8 score on a scale Standard Deviation 2.1
Physical Function Assessments Post-intervention	11.6 score on a scale Standard Deviation 2.0

SECONDARY outcome

Timeframe: 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

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

Outcome measures

Measure	Exercise Snacking Group n=18 Participants 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.
Physical Function Assessments Left leg; Post-intervention	28.8 seconds Standard Deviation 22.4
Physical Function Assessments Right leg; Baseline	27.3 seconds Standard Deviation 24.5
Physical Function Assessments Right leg; Post-intervention	26.9 seconds Standard Deviation 21.9
Physical Function Assessments Left leg; Baseline	22.1 seconds Standard Deviation 21.2

SECONDARY outcome

Timeframe: 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

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

Outcome measures

Measure	Exercise Snacking Group n=18 Participants 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.
Physical Function Assessments Baseline	12.6 time in seconds Standard Deviation 5.0
Physical Function Assessments Post-intervention	10.8 time in seconds Standard Deviation 5.1

OTHER_PRE_SPECIFIED outcome

Timeframe: 28-days (post intervention)

OPTIONAL qualitative exit interview

Outcome measures

Outcome data not reported

Adverse Events

Exercise Snacking Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 1 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr Oliver Perkin

University of Bath

Phone: 01225384356

Email: o.j.perkin@bath.ac.uk

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place