NCT05439252

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 21, 2022

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 30, 2022

Completed
1 month until next milestone

Study Start

First participant enrolled

August 1, 2022

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 20, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 20, 2023

Completed
1.7 years until next milestone

Results Posted

Study results publicly available

October 4, 2024

Completed
Last Updated

October 4, 2024

Status Verified

July 1, 2024

Enrollment Period

6 months

First QC Date

June 21, 2022

Results QC Date

April 14, 2023

Last Update Submit

July 8, 2024

Conditions

Keywords

Exercise SnackingElderlyHomebased exerciseOutpatient

Outcome Measures

Primary Outcomes (1)

  • 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).

    28-days (post intervention)

Secondary Outcomes (16)

  • Attitudes to Exercise

    28-days (pre-to-post intervention)

  • Self-confidence for Exercise

    28-days (pre-to-post intervention)

  • Psychological Need Satisfaction for Exercise

    28-days (pre-to-post intervention)

  • Current Mental Health

    28-days (pre-to-post intervention)

  • Patient Anxiety

    28-days (pre-to-post intervention)

  • +11 more secondary outcomes

Other Outcomes (1)

  • Acceptability of the Intervention

    28-days (post intervention)

Study Arms (1)

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

Behavioral: Exercise Snacking

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.

Exercise Snacking Group

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Bath

Bath, Avon, BA2 7AY, United Kingdom

Location

Related Publications (1)

  • 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.

Results Point of Contact

Title
Dr Oliver Perkin
Organization
University of Bath

Study Officials

  • Tomas Welsh, MD, PhD

    RICE

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Model Details: Single group, pre-test-post-test pilot study of acceptability
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle Investigator

Study Record Dates

First Submitted

June 21, 2022

First Posted

June 30, 2022

Study Start

August 1, 2022

Primary Completion

January 20, 2023

Study Completion

January 20, 2023

Last Updated

October 4, 2024

Results First Posted

October 4, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Individual participant data will not be shared with other researchers

Locations