Effects of an individualised exercise programme plus Behavioural Change Enhancement (BCE) strategies for managing fatigue in frail older adults: a cluster randomised controlled trial.

BACKGROUND: To the best of our knowledge, although ageing-induced fatigue could cause adverse outcomes such as frailty, there is currently no intervention for it. This study evaluated the effects of an individualised exercise programme with/without BCE strategies on reducing fatigue in older adults. METHODS: A three-armed cluster-randomised controlled trial (RCT) was conducted with 184 participants (mean age: 79.1 ± 6.4; mean frailty score: 2.8 + 0.8) from 21 community centres (ClinicalTrials.gov: NCT03394495). They were randomised into either: the COMB group (n = 64), receiving 16 weeks of exercise training plus the BCE programme; the EXER group (n = 65), receiving exercise training and health talks; or the control group (n = 55), receiving only health talks. Fatigue was assessed using the Multi-dimensional Fatigue Inventory (range: 20 to 100, with higher scores indicating higher fatigue levels) at baseline, and immediately, 6 months, and 12 months post-intervention. RESULTS: The GEE analyses showed significant interaction (time x group) between the COMB and control groups immediately (p < 0.001), 6 months (p < 0.001), and 12 months (p < 0.001) post-intervention. Comparing the COMB and EXER groups, there was a significant interaction immediately (p = 0.013) and at 12 months post-intervention (p = 0.007). However, no significant difference was seen between the EXER group and control group at any time point. CONCLUSIONS: The COMB intervention showed better immediate and sustainable effects (i.e., 12 months after the intervention) on reducing fatigue in frail older adults than exercise training or health education alone. TRIAL REGISTRATION: ClinicalTrials.gov (NCT03394495), registered on 09/01/2018.

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.

BACKGROUND: Although the evidence suggests that general fatigue is a strong indicator of rapid aging, frailty, and disability, general fatigue is undertreated in gerontological care. OBJECTIVE: The aim of this study is to investigate whether an individualized exercise program with and without behavioral change enhancement (BCE) strategies for older people who are frail and have general fatigue will reduce their fatigue and symptoms of frailty. DESIGN: A 3-arm, single-blind, cluster randomized controlled trial registered with ClinicalTrials.gov (NCT03394495) will be conducted. SETTING: The study will be conducted in a community setting. PARTICIPANTS: Two hundred eighty-five community-dwelling older people with general fatigue will be recruited from 12 district community health centers. INTERVENTION: People from each center will be randomized to one of three groups. The combined group will receive a 16-week combined intervention consisting of individualized exercise training and the BCE program, plus two booster sessions at 2 and 6 months after the program. The exercise group will receive exercise training and health talks only. The control group will receive health talks only. MEASUREMENTS: Outcome measures will be collected at baseline, at the midpoint (week 8) of the program, and then at 1 week, 6 months, and 12 months after the end of the program. The primary outcome---level of fatigue---will be measured using the Multidimensional Fatigue Inventory. Secondary outcomes will include the participants' frailty status, strength, mobility, exercise self-efficacy, and habitual physical activity. LIMITATIONS: A self-reported level of fatigue will be used. CONCLUSIONS: The effect of exercise and BCE strategies on general fatigue among older people who are frail is not known. This study will be a pioneering interventional study on how general fatigue among older people who are frail can be managed and how fatigue-related frailty can be prevented or minimized.