ABSTRACT
Background: Despite the great individual and societal burden associated with multimorbidity, little is known about how to effectively manage it. Objective: The aim of this multicenter randomized controlled trial (RCT) is to investigate the 12-month effects of a personalized exercise therapy and self-management support program in addition to usual care in people with multimorbidity. Design: This is a protocol for a pragmatic, parallel-group (1:1 ratio), superiority RCT conducted at five intervention sites (two hospitals, a private practice physiotherapy clinic and two municipal rehabilitation centers) in Region Zealand, Denmark. A total of 228 persons with multimorbidity aged 18 years or older, will be randomly allocated to one of two groups. Both groups will receive usual care, defined as routine care for multimorbidity at the discretion of the treating doctor, while the intervention group will also participate in a 12-week exercise therapy and self-management support program tailored to people with multimorbidity at one of the intervention sites. The primary outcome will be the between-group difference in change in EQ-5D-5L from baseline to the follow-up at 12 months. Secondary outcomes include objectively-measured physical function and physical activity, inflammatory markers, disease and treatment burden, anxiety, depression, stress, sleep, pain and other self-reported parameters. In parallel with the RCT, an observational cohort will follow persons aged ≥18 years with multimorbidity not adhering to all eligibility criteria, as well as people fulfilling all eligibility criteria, but unwilling to participate in the RCT. This study was approved by the Regional Committee on Health Research Ethics for Region Zealand (SJ-857) and results will be communicated in scientific papers, at relevant conferences and to a broader audience. Discussion: Exercise therapy and self-management support is safe and effective in people with single conditions. However, it is still unclear whether this holds true for individuals with multimorbidity. This pragmatic, multicenter RCT will provide high-quality evidence on the benefits and harms of exercise therapy and self-management support and, if the results support it, lead to the development of a plan for implementation in clinical practice.
ABSTRACT
BACKGROUND: Recovery of function and regaining muscle strength are challenging after hip fracture. We compared the effectiveness of a 12- versus 6-week outpatient physical therapy program with progressive resistive training (PRT) to increase strength and physical performance. METHODS: This parallel, superiority, 2-group randomized controlled trial was conducted in 4 clinics that enrolled community-dwelling, cognitively intact older adults (+60 years) with a surgical repair of a hip fracture and no major medical conditions. Participants received 12 or 6 weeks of PRT and standardized physical therapy, twice weekly. Pain was monitored throughout. Primary outcome was the change in the 6-minute walk test (6MWT) from baseline to 12-week follow-up. Randomization via a computer-generated allocation sequence was implemented using sealed, sequentially numbered opaque envelopes and assessors were blinded to group assignment. RESULTS: Participants (81% women) with a mean (SD) age of 77 (8.1) years were enrolled at an average of 18 days after hip fracture surgery and randomized into a 12-week group (n = 50) or a 6-week group (n = 50). Mean (SD) change scores in the 6MWT were 143.8 (81.1) and 161.5 (84.1) m in the 12- and 6-week groups, respectively (both exceeding the minimal clinically important difference of 55 m). The mean between-group difference was -17.7 m (95% CI -50.1, 14.8). Pain during training did not exceed moderate levels nor increase as training intensity increased. CONCLUSION: Twelve weeks of physical therapy with PRT was not superior to 6 weeks in improving walking distance. Hip fracture-related pain was relatively low and indicated strength testing and training was well tolerated. Clinical Trials Registration Number: NCT01174589.
