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The effects of home exercise in older women with vertebral fractures: a pilot randomized controlled trial
Gibbs JC, McArthur C, Wark JD, Thabane L, Scherer SC, Prasad S, Papaioannou A, Mittmann N, Laprade J, Kim S, Khan A, Kendler DL, Hill KD, Cheung AM, Bleakney R, Ashe MC, Adachi JD, Giangregorio LM
Physical Therapy 2020 Apr;100(4):662-676
clinical trial
8/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: Yes; Baseline comparability: Yes; Blind subjects: No; Blind therapists: No; Blind assessors: Yes; Adequate follow-up: Yes; Intention-to-treat analysis: Yes; Between-group comparisons: Yes; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed*

BACKGROUND: Regular exercise is advocated in osteoporosis guidelines to prevent fractures. Few studies have evaluated the effect of exercise on functional performance, posture, and other outcomes that are important to patients after vertebral fractures. OBJECTIVE: This pilot study will explore the effect of home exercise versus control on functional performance, posture, and patient-reported outcome measures. DESIGN: This study was a parallel 2-arm pilot feasibility trial with 1:1 randomization to exercise or attentional control groups. SETTING: This study took place in 5 Canadian and 2 Australian academic or community hospitals/centers. PARTICIPANTS: This study included 141 women >= 65 years of age with radiographically confirmed vertebral fractures. INTERVENTION: A physical therapist delivered exercise and behavioral counseling in 6 home visits over 8 months and monthly calls. Participants were to exercise >= 3 times weekly. Controls received equal attention. MEASUREMENTS: Functional performance, posture, quality of life, pain, and behavior-change outcomes were assessed at baseline and after 6 (questionnaires only) and 12 months. Adherence to exercise was assessed by calendar diary. All t tests examined between-group mean differences (MD) in change from baseline in intention-to-treat and per-protocol analyses. RESULTS: There was a small effect of exercise on 5 times sit-to-stand test versus control (MD -1.58 (95% CI -3.09 to -0.07), intention-to-treat; MD -1.49 (95% CI -3.12 to 0.16), per-protocol). There were no other major or statistically significant MDs for any other measured outcomes after follow-up. Adherence declined over time. LIMITATIONS: Treatment effects on variables may have been underestimated due to multiple comparisons and underpowered analyses. CONCLUSIONS: Our exploratory estimate of the effect of exercise on functional leg muscle strength was consistent in direction and magnitude with other trials in individuals with vertebral fractures. Declining adherence to home exercise suggests that strategies to enhance long-term adherence might be important in future confirmatory trials.

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