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

Abstract

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 area frail and have general fatigue can 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 1 of 3 groups. The combined group will receive a 16-week combined intervention consisting of individualized exercise training and the BCE program plus 2 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.