NCT05758727

Brief Summary

Engaging in muscle strength and balance (S\&B) exercises and has numerous health benefits for older adults, promoting greater mobility, reducing risk of falling, and overall improved health and wellbeing. Given the rising age of global populations, reducing the burden associated with lost physical function is essential to minimise health and social care costs. Unfortunately, very few older adults engage in sufficient S\&B exercise to reap these benefits, with a lack of time, self-efficacy and access to leisure facilities cited as the key barriers. Finding innovative ways promote an acceptable and engaging format of S\&B exercise is consequently a public health priority. One novel way that aims to address typical barriers to participation in older adults is through the promotion of exercise 'snacks', as opposed to a more traditional, lengthy structured exercise session at a leisure centre. Exercise snacking describes short bursts of exercise that are designed to be undertaken over a short period in the home environment and without the need for any specialised exercise clothing or equipment. In the initial laboratory and cross-sectional and pilot intervention research, the investigators have been testing two formats of 5-minute, twice-daily, strength exercise- and tai-chi-snacking, which has been shown to be acceptable and feasible to implement in older adults. This protocol presents initial efficacy for evoking improved physical function in people aged 65 years or more. The investigators' remote study demonstrated that remote assessment and delivery of 4-week exercise and tai-chi snacking interventions were acceptable and feasible. However, qualitative feedback indicated that exercise programmes may be more acceptable and interesting with simpler tai-chi movements and exercise snacking programme with upper body movements. Nevertheless, the investigators only recruited healthy older adults, doing short-term interventions in previous studies. This study aims to test the effectiveness of progressive S\&B interventions over a sustained period in pre-frail older adults.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2022

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 20, 2022

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

February 15, 2023

Completed
20 days until next milestone

First Posted

Study publicly available on registry

March 7, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 23, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2023

Completed
Last Updated

August 8, 2023

Status Verified

August 1, 2023

Enrollment Period

1.1 years

First QC Date

February 15, 2023

Last Update Submit

August 5, 2023

Conditions

Keywords

Exercise snackingTai-chi snackingOlder adultsHomebased exercise

Outcome Measures

Primary Outcomes (1)

  • Changes of Short Physical Performance Battery (SPPB) between every 4 weeks

    Participants will be asked to do the SPPB test which includes balance test, gait speed test, and chair stand test.

    12-weeks (week 0, week 4, week 8, week 12)

Secondary Outcomes (18)

  • 1RM of leg press

    12-weeks (week 0, week 4, week 8, week 12)

  • Balance function

    12-weeks (week 0, week 4, week 8, week 12)

  • Strength function

    12-weeks (week 0, week 4, week 8, week 12)

  • Agility function

    12-weeks (week 0, week 4, week 8, week 12)

  • Flexibility

    12-weeks (week 0, week 4, week 8, week 12)

  • +13 more secondary outcomes

Study Arms (2)

Home-based exercise group

EXPERIMENTAL

This group will be asked to practise the 'exercise snacking and Tai-chi snacking' exercises once each and record the exercise bouts in a log book.

Other: Exercise intervention

Control group

NO INTERVENTION

Usual care control group

Interventions

The exercise programme is progressive and has three levels. Each bout of exercise and Tai-chi snacking consists of 5 exercises. Each exercise is performed for one minute with one minute rest in between. For exercise snacking movements (including leg exercise, shoulder exercise, single leg exercise, arm exercise, and ankle exercise), participants are encouraged to complete as many repetitions as possible of that exercise in that minute. For Tai-chi snacking movements (including single leg squat, trunk rotation, single leg stand, hip and knee exercise, and ankle mobility exercise), participants are encouraged to complete repetitions of each exercise at a self-selected pace that is comfortable for them to maintain for the full minute, with the aim being to complete the movements as accurately and smoothly as possible (based on correct posture and proper alignment).

Home-based exercise group

Eligibility Criteria

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

You may qualify if:

  • People aged 65 or greater and are able to perform daily physical activity independently.
  • Not regularly engaging in recreational sports or structured exercise (once a week or more).
  • Citizen of UK or Taiwan.
  • Individuals who are able to do the 5 reps sit-to-stand in less than 60s and the feet side-by-side stand for at least 10s, following the initial safety screening.

You may not qualify if:

  • Individuals with current ongoing medication or treatment for injuries or illness that would impact on any of the study outcomes.
  • Individuals with a current musculoskeletal injury that would preclude participation in exercise ascertained through preliminary screening.
  • 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.
  • Individuals who have been diagnosed with dementia.
  • Individuals who are unable to consent for themselves or complete the familiarisation / baseline screening by themselves.
  • Individuals who score more than 8 on the Short Physical Performance Battery, score more than 6 between strength and balance sections, or score zero on any component of the test.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department for Health, University of Bath

Bath, Bath And North East Somerset, United Kingdom

Location

Study Officials

  • Max Western

    Department for Health, University of Bath

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctoral student

Study Record Dates

First Submitted

February 15, 2023

First Posted

March 7, 2023

Study Start

May 20, 2022

Primary Completion

June 23, 2023

Study Completion

July 31, 2023

Last Updated

August 8, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

Locations