NCT03394495

Individualized Exercise Program Plus Behavioral Change Enhancement Strategies for Managing Fatigue in Frail Older People

Completed NA Last updated 28 February 2024

What this trial tests

NA trial testing BCE Combination group in Fatigue in 184 participants. Completed in 1 January 2021.

Timeline

26 February 2018

Primary endpoint
30 April 2020

1 January 2021

Quick facts

Lead sponsor	The Hong Kong Polytechnic University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	184
Start date	26 February 2018
Primary completion	30 April 2020
Estimated completion	1 January 2021
Sites	1 location across Hong Kong

Drugs / interventions tested

• BCE Combination group

Conditions studied

• Fatigue — all drugs for Fatigue →

Sponsor

The Hong Kong Polytechnic University

Who can join

70 and older, any sex, with Fatigue. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This project aims to investigate the effects of an individualized exercise programme with and without BCE strategies for community-dwelling frail older people with general fatigue, so as to reduce their fatigue and improve their physical endurance, exercise self-efficacy, and habitual physical activity, while reducing their symptoms of frailty.

Twelve district community health centres will be randomized to one of the three study groups: the combined (COMB) group, receiving the 16-week combined intervention consisting of individualized exercise training and Behavioural Change Enhancement programmes plus two booster sessions at 2 and 6 months after the programme; the exercise (EXER) group, receiving exercise training and health talks only; or the control group, receiving health talks only. Participants from each centre will be placed in their centre's corresponding group.

It is hypothesized that the COMB group will achieve a significantly greater reduction in fatigue and a greater improvement in their physical endurance, exercise self-efficacy, and habitual physical activity, and a significantly greater reduction in their frailty symptoms, when compared with the EXER and control groups at 1 week and 6 and 12 months after completing the interventions.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Effects of an individualised exercise programme plus Behavioural Change Enhancement (BCE) strategies for managing fatigue in frail older adults: a cluster randomised controlled trial.
   Liu JYW, Yin YH, Kor PPK, Kwan RYC, et al · · 2023 · cited 12× · PMID 37328797 · DOI 10.1186/s12877-023-04080-0
2. Effects of an Individualized Exercise Program Plus Behavioral Change Enhancement Strategies for Managing Fatigue in Older People Who Are Frail: Protocol for a Cluster Randomized Controlled Trial.
   Liu JYW, Kor PPK, Lee PL, Chien WT, et al · · 2019 · cited 5× · PMID 31508798 · DOI 10.1093/ptj/pzz130
3. Editorial: Post Acute Care for Frail Older Persons: Time for a Standardized Model of Care.
   Calcaterra L, Cesari M. · · 2022 · cited 2× · PMID 35122083 · DOI 10.14283/jfa.2021.52