Effect of a Multicomponent Home-Based Physical Therapy Intervention on Ambulation After Hip Fracture in Older Adults: The CAP Randomized Clinical Trial.

Importance: Disability persists after hip fracture in older persons. Current rehabilitation may not be sufficient to restore ability to walk in the community. Objective: To compare a multicomponent home-based physical therapy intervention (training) with an active control on ability to walk in the community. Design, Setting, and Participants: Parallel, 2-group randomized clinical trial conducted at 3 US clinical centers (Arcadia University, University of Connecticut Health Center, and University of Maryland, Baltimore). Randomization began on September 16, 2013, and ended on June 20, 2017; follow-up ended on October 17, 2017. Patients aged 60 years and older were enrolled after nonpathologic, minimal trauma hip fracture, if they were living in the community and walking without human assistance before the fracture, were assessed within 26 weeks of hospitalization, and were not able to walk during daily activities at the time of enrollment. A total of 210 participants were randomized and reassessed 16 and 40 weeks later. Interventions: The training intervention (active treatment) (n = 105) included aerobic, strength, balance, and functional training. The active control group (n = 105) received transcutaneous electrical nerve stimulation and active range-of-motion exercises. Both groups received 2 to 3 home visits from a physical therapist weekly for 16 weeks; nutritional counseling; and daily vitamin D (2000 IU), calcium (600 mg), and multivitamins. Main Outcomes and Measures: The primary outcome (community ambulation) was defined as walking 300 m or more in 6 minutes at 16 weeks after randomization. The study was designed to test a 1-sided hypothesis of superiority of training compared with active control. Results: Among 210 randomized participants (mean age, 80.8 years; 161 women [76.7%]), 197 (93.8%) completed the trial (187 [89.0%] by completing the 6-minute walk test at 16 weeks and 10 [4.8%] by adjudication of the primary outcome). Among these, 22 of 96 training participants (22.9%) and 18 of 101 active control participants (17.8%) (difference, 5.1% [1-sided 97.5% CI, -∞ to 16.3%]; 1-sided P = .19) became community ambulators. Seventeen training participants (16.2%) and 15 control participants (14.3%) had 1 or more reportable adverse events during the intervention period. The most common reportable adverse events reported were falls (training: 6 [5.7%], control: 4 [3.8%]), femur/hip fracture (2 in each group), pneumonia (training: 2, control: 0), urinary tract infection (training: 2, control: 0), dehydration (training: 0, control: 2), and dyspnea (training: 0, control: 2). Conclusions and Relevance: Among older adults with a hip fracture, a multicomponent home-based physical therapy intervention compared with an active control that included transcutaneous electrical nerve stimulation and active range-of-motion exercises did not result in a statistically significant improvement in the ability to walk 300 m or more in 6 minutes after 16 weeks. Trial Registration: ClinicalTrials.gov Identifier: NCT01783704.

Home-based leg-strengthening exercise improves function 1 year after hip fracture: a randomized controlled study.

OBJECTIVES: To compare the effectiveness of a short-term leg-strengthening exercise program with that of attentional control on improving strength, walking abilities, and function 1 year after hip fracture. DESIGN: Randomized controlled pilot study. SETTING: Patients' homes. PARTICIPANTS: Community-dwelling older adults (n=26) 6 months after hip fracture at baseline. INTERVENTION: Exercise and control participants received interventions from physical therapists twice a week for 10 weeks. The exercise group received high-intensity leg-strengthening exercises. The control group received transcutaneous electrical nerve stimulation and mental imagery. MEASUREMENTS: Isometric force production of lower extremity muscles, usual and fast gait speed, 6-minute walk (6-MW) distance, modified Physical Performance Test (mPPT), and Medical Outcomes Study 36-item Short Form Survey (SF-36) physical function. RESULTS: The primary endpoint was 1 year after fracture. Isometric force production (P=.006), usual (P=.02) and fast (P=.03) gait speed, 6-MW distance (P=.005), and mPPT score (P<.001) were improved 1 year after fracture with exercise. Effect sizes were 0.79 for strength, 0.81 for mPPT score, 0.56 for gait speed, 0.49 for 6-MW, and 0.30 for SF-36 score. More patients in the exercise group made meaningful changes in gait speed and 6-MW distance than control patients (chi-square P=.004). CONCLUSION: A 10-week home-based progressive resistance exercise program was sufficient to achieve moderate to large effects on physical performance and quality of life and may offer an alternative intervention mode for patients with hip fracture who are unable to leave home by 6 months after the fracture. The effects were maintained at 3 months after completion of the training program.