CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 184 enrolled
Drug / intervention
BCE Combination groupother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03394495
NCT03394495N/ACompleted

Evaluation of an Individualized Exercise Programme Plus Behavioural Change Enhancement Strategies for Managing General Fatigue in Community-dwelling Frail Older People: A Cluster-randomized Controlled Trial.

The Hong Kong Polytechnic University·interventional·Posted Jan 9, 2018·Updated Feb 28, 2024

In Brief

A clinical study evaluating BCE Combination group for Fatigue. Completed, enrolled 184 participants across 1 site.

Detailed Summary

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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsFatigue
CountriesHong Kong
Collaborators--

Timeline

N/ACompletedFinished
201820192020202120222023202420252026
First PostedJan 9, 2018
Enrollment StartFeb 26, 2018
Primary CompletionApr 30, 2020
Study CompletionJan 1, 2021
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 8.5 years ago

Interventions

BCE Combination groupother

The combination intervention programme consists of a weekly exercise training sessions and 6 sessions of Behavioral Change Enhancement (BCE) programme.