Effectiveness of a physical exercise intervention program in improving functional mobility in older adults after hip fracture in later stage rehabilitation: protocol of a randomized clinical trial (REATIVE Study)

Abstract

Background: Hip fractures resulting from falls increase substantially with advancing age and less than half of older hip fracture survivors regain their former levels of mobility. There is increasing evidence that rehabilitation interventions with exercises that goes beyond the sub-acute phase or even in a later stage of care have a positive impact on various functional abilities. The purpose of this study is to determine if exercise program training for people who have suffered a fall-related hip fracture will improve functional mobility when compared with usual care.

Methods: A randomized controlled trial with blinded assessors and intention-to-treat analysis will be undertaken. We will recruit 82 older adults, 60 years or over who have suffered a hip fracture due to a fall in the previous 6 to 24 months. Participants randomized to the Intervention Group (IG) will undertake a physical exercise program involving progressive and challenging balance training and neuromuscular and functional training of the lower limbs, conducted at home by physiotherapists, once a week, lasting about one hour, in the first, second and third month after randomization and will be taught to perform exercises at home, twice a week, using a booklet. Visits to monitor and progress the home exercise program will be conducted once a month, from the fourth to the sixth month and each 2 months until the end of the follow up at the 12^th month, i.e., a total of 18 sessions. Participants will receive monthly phone calls to encourage exercise adherence. The control group will receive usual care. The primary outcome will be mobility-related disability and participants will be assessed at baseline, and at 3 months, 6 and 12 months. Participants will receive monthly phone calls to ask about falls and exercise adherence. Adverse effects will be monitored.

Discussion: This study proposes a home-based exercise program, which may in part overcome some barriers for rehabilitation, such as difficulties with public transportation and lack of a caregiver to accompany older patients to sessions. If a positive effect is observed this program has the potential to be incorporated into the public health system and contribute to building a pathway of care for older people with hip fracture.

Trial registration: Clinicaltrials.gov Identifier: NCT02295527 .

Keywords: Accidental falls; Aging health; Clinical trial; Exercise program; Hip fracture; Rehabilitation.