Detailed Search Results
| Author/Association: | Magaziner J, Mangione KK, Orwig D, Baumgarten M, Magder L, Terrin M, Fortinsky RH, Gruber-Baldini AL, Beamer BA, Tosteson ANA, Kenny AM, Shardell M, Binder EF, Koval K, Resnick B, Miller R, Forman S, McBride R, Craik RL |
| Title: | Effect of a multicomponent home-based physical therapy intervention on ambulation after hip fracture in older adults: the CAP randomized clinical trial [with consumer summary] |
| Source: | JAMA 2019 Sep 10;322(10):946-956 |
| Method: | clinical trial |
| Method Score: | 5/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: No; Baseline comparability: Yes; Blind subjects: No; Blind therapists: No; Blind assessors: No; Adequate follow-up: Yes; Intention-to-treat analysis: No; Between-group comparisons: Yes; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed* |
| Consumer Summary: | KEY POINTS: QUESTION: What is the effect of a multicomponent home-based physical therapy intervention on the ability of older persons recovering from hip fracture to walk at a speed enabling them to carry out daily activities in the community? FINDINGS: In a randomized trial including 210 older adults who had experienced a hip fracture, receiving the intervention compared with an active control resulted in an ability to walk 300 m more in 6 minutes after 16 weeks in 22.9% versus 17.8% of participants, respectively, a difference that was not statistically significant. MEANING: This multicomponent intervention did not significantly improve community ambulation compared with an active control intervention. |
| 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 (2,000 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 -infinity to 16.3%); 1-sided p = 0.19) 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. Full text (sometimes free) may be available at these link(s):  help |
