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

NCT03394495 | Completed DMC

• 1 other identifier: 15600717
• Study Type: interventional
• Target: 184
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Fatigue

Keywords

Fatigue; Frailty; Cluster-RCT; Exercise; Behavioral change

Outcome Measures

Primary Outcomes (1)

• Participants' level of fatigue will be assessed using the 20-item Chinese Multidimensional Fatigue Inventory (CMFI-20)

  CMFI-20 consists of 20 items, each item is rated on a 5-point Likert scale from 1=strongly agree to 5 = strongly disagree, with all items summed to get the total score which ranges from 20-100, a higher score indicates more fatigue.

  To detect the change from baseline total fatigue score at mid-term programme (i.e. wk 8 after commences of the programme),and then 1 week, 6 month and 12 months months after completing the programme

Secondary Outcomes (8)

• Participants' lower-limb strength will be assessed using the 30-second chair stand test

  To detect the change from baseline lower-limb strength at mid-term programme (wk 8 after commences of the programme),and then 1 week, 6 month and 12 months months after completing the programme

• Participants' upper-limb strength will be assessed using a handheld Jamar Hydraulic Hand Dynamometer

  To detect the change from baseline upper-limb strength in kg at mid-term programme (wk 8 after commences of the programme),and then 1 week, 6 month and 12 months months after completing the programme

• Participants' functional mobility will be measured by the timed-up-and-go-test

  To detect the change from baseline time to complete the "timed-up-and-go-test" at mid-term programme (wk 8 after commences of the programme),and then 1 week, 6 month and 12 months months after completing the programme

• Participants' gait speed will be measured by the 6 meter walk test

  To detect the change from baseline gait speed at mid-term programme (wk 8 after commences of the programme),and then 1 week, 6 month and 12 months months after the completion of the programme

• Participants' exercise self-efficacy will be measured using Chinese Self-Efficacy for Exercise (CSEE) scale

  To detect the change from baseline total CSSE score at mid-term programme (wk 8 after commences of the programme),and then 1 week, 6 month and 12 months months after completing the programme

Study Arms (3)

BCE Combination group

EXPERIMENTAL

16-week BCE programme with exercise training. Six 1-hour sessions of BCE programme and a weekly 45-60 minute centre-based exercise programme from week 4 to week 16.

Other: BCE Combination group

Exercise group

NO INTERVENTION

16-week programme with health talks and exercise training. Six 1-hour sessions of health talks and a weekly 45-60 minutes centre-based exercise programme from week 4 to week 16.

Control group

NO INTERVENTION

Six sessions of centre-based health talks on the management of different health issues with the exception of fatigue.

Interventions

BCE Combination group OTHER

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

BCE Combination group

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• community-dwelling older people aged \> 70 years;
• able to communicate in Cantonese to ensure that they understand our instructions;
• able to walk with or without an assistive device and able to complete the Time Up and Go (TUG) test with no specific cutoff point to ensure that their mobility and balance is good enough to join the exercise training; and
• in a frail state with exhaustion as determined using the Fried Frailty Index (FFI), including: i) an unintentional loss of 10% of body weight in the past year; ii) exhaustion: by answering 'Yes' to either 'I felt that everything I did was an effort', or 'I could not get going in the last week'; iii) a slow walk time: with an average walking speed in the lowest quintile stratified by median body height; iv) reduced grip strength: with maximal grip strength in the lowest quintile stratified by body mass index quartile; and v) the Physical Activity Scale for the Elderly-Chinese (PASE-C) score in the lowest quintile (i.e., \< 30 for men and \< 27.7 for women). The presence of \> 3 items indicates frailty, and one criterion indicates that they suffer from exhaustion.

You may not qualify if:

• are suffering from any disease in which fatigue is a dominant symptom (such as neurodegenerative diseases, cancer, and end-stage renal failure cachexia cases;
• have been hospitalized for \> 5 days in the preceding 3 months, which may lead to muscle wasting due to recent bed rest or reduced activity levels during hospitalization;
• underwent major surgery (such as total joint replacement, major abdominal surgeries) during the last 6 months;
• are confined to bed or restricted by the permanent use of a wheelchair;
• report that they regularly perform moderately intense exercise (such as hiking, Tai Chi) for \> 3 hours per week;
• are terminally ill;
• have been diagnosed with major depression entailing frequent adjustments of their antidepressants to control unstable depressive moods. The criteria were chosen to avoid recruiting people with depression-induced fatigue. However, a consistent feeling of fatigue may manifest as a depressed mood. Thus, the participants' mood will be assessed using the Chinese-Geriatric Depression Scale (C-GDS).

Sponsors & Collaborators

• The Hong Kong Polytechnic University: lead

Study Sites (1)

Justina Liu

Hong Kong, Hong Kong

Location

Related Publications (63)

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• Liu JYW, Yin YH, Kor PPK, Kwan RYC, Lee PH, Chien WT, Siu PM, Hill KD. Effects of an individualised exercise programme plus Behavioural Change Enhancement (BCE) strategies for managing fatigue in frail older adults: a cluster randomised controlled trial. BMC Geriatr. 2023 Jun 16;23(1):370. doi: 10.1186/s12877-023-04080-0.

  PMID: 37328797 DERIVED

• Liu JYW, Kor PPK, Lee PL, Chien WT, Siu PM, Hill KD. 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. Phys Ther. 2019 Dec 16;99(12):1616-1627. doi: 10.1093/ptj/pzz130.

  PMID: 31508798 DERIVED

MeSH Terms

Conditions

Fatigue; Frailty; Motor Activity

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathologic Processes; Behavior

Study Officials

• Yat-wa Justina Liu

  The Hong Kong Polytechnic University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: An independent assessor who is blinded to the group allocations will assess the participants' outcomes.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: A three-arm parallel (single-blinded) cluster randomized controlled trial involves three groups of participants (the COMB, the EXER and the control group). Twelve community health centres that provide similar types of community care and social support services for community-dwelling older people, have been invited by a convenience method to work as collaborators in this study. Using computer-generated random numbers, a biostatistician not affiliated with this study will randomize the centres into either: control, EXER, or COMB group. So during the trial, participants in one group receive combination intervention "in parallel" to participants in the other two groups (the control group and the exercise group).

Study Record Dates

• First Submitted: December 15, 2017
• First Posted: January 9, 2018
• Study Start: February 26, 2018
• Primary Completion: April 30, 2020
• Study Completion: January 1, 2021
• Last Updated: February 28, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)