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

Abstract

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.

Conflict of interest statement

Conflict of Interest Disclosures: Dr Magaziner reported receiving grants from the National Institutes of Health (NIH) and personal fees from Ammonett, Novartis, Pluristem, UCB, and Viking. Dr Mangione reported receiving grants from the National Institute on Aging (NIA) and NIH, and personal fees from Puristem and the University of Maryland. Dr Orwig reported receiving grants from the Eunice Kennedy Shriver National Institute of Child Health and Human Development and the NIA. Drs Baumgarten, Magder, and Tosteson reported receiving grants from the NIH. Dr Terrin reported receiving grants from the National Heart, Lung, and Blood Institute and NIH. Drs Gruber-Baldini and Shardell reported receiving grants from the NIA. Dr Beamer reported receiving grants from the NIA/NIH and Veterans Affairs. Dr Binder reported receiving grants from Astellas Pharma and an interview stipend from Pfizer. Dr Miller reported being a full-time employee of Novartis Institutes for Biomedical Research. Ms McBride reported receiving grants from the University of Maryland School of Medicine. Dr Craik reported receiving grants from the NIH and personal fees from the University of Maryland School of Medicine, as well as serving on the external advisory board of the Pepper Center at the University of Maryland School of Medicine. No other disclosures were reported.

Figures

Figure.. Enrollment, Randomization, and Follow-up of Participants

SMWT indicates 6-minute walk test. aA physical therapist was considered to be part of a given site if the therapist was assigned to at least 50% of the expected visits for at least 1 participant at that site. bA given participant was considered to have been treated by a given physical therapist if the therapist was assigned to at least 50% of expected visits for that participant. If no single therapist was assigned to at least 50% of the participant’s expected intervention visits, the therapist who had been assigned to the largest number of visits was considered to have treated the participant. cAn additional participant in the active control group died after the 16-week assessment window.