Clinical trial NCT05439252: Exercise Snacking to Improve Strength and STability: ESISST Pilot Study
Official title: The Acceptability of Exercise Snacking to Improve Leg Strength in Memory Clinic Outpatients: a Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acceptability of an Exercise Intervention
Keywords: Exercise Snacking
Elderly
Homebased exercise
Outpatient
Lead sponsor: University of Bath
Sponsor class: OTHER
First posted: 2022-06-30
Enrollment: 21
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single group, pre-test-post-test pilot study of acceptability
Primary purpose: OTHER

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Acceptability of the Intervention
timeFrame: 28-days (post intervention)
Secondary outcomes:
measure: Attitudes to Exercise
timeFrame: 28-days (pre-to-post intervention)
measure: Self-confidence for Exercise
timeFrame: 28-days (pre-to-post intervention)
measure: Psychological Need Satisfaction for Exercise
timeFrame: 28-days (pre-to-post intervention)
measure: Current Mental Health
timeFrame: 28-days (pre-to-post intervention)
measure: Patient Anxiety
timeFrame: 28-days (pre-to-post intervention)
measure: General Health
timeFrame: 28-days (pre-to-post intervention)
measure: Patient Vitality
timeFrame: 28-days (pre-to-post intervention)
measure: Patient Life Satisfaction
timeFrame: 28-days (pre-to-post intervention)
measure: Patient Quality of Life
timeFrame: 28-days (pre-to-post intervention)
measure: Cognitive Assessment
timeFrame: 28-days (pre-to-post intervention)
measure: Cognitive Assessment
timeFrame: 28-days (pre-to-post intervention)
measure: Physical Function Assessments
timeFrame: 28-days (pre-to-post intervention)
measure: Physical Function Assessments
timeFrame: 28-days (pre-to-post intervention)
measure: Physical Function Assessments
timeFrame: 28-days (pre-to-post intervention)
measure: Physical Function Assessments
timeFrame: 28-days (pre-to-post intervention)
measure: Physical Function Assessments
timeFrame: 28-days (pre-to-post intervention)
Other outcomes:
measure: Acceptability of the Intervention
timeFrame: 28-days (post intervention)
Locations:
city: Bath
country: United Kingdom
facility: University of Bath
state: Avon
Study officials:
affiliation: RICE
name: Tomas Welsh, MD, PhD
role: STUDY_DIRECTOR
References: