The Effects of Home Exercise in Older Women With Vertebral Fractures: A Pilot Randomized Controlled Trial

Abstract

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.

Trial registration: ClinicalTrials.gov NCT01761084.

Keywords: Exercise; Mobility; Osteoporosis; Quality of Life; Rehabilitation; Spinal Fractures.

© 2020 American Physical Therapy Association.

Figures

Figure 1

CONSORT study flow diagram.

Figure 2

Mean change in functional performance outcomes: 5 times sit-to-stand (5 T-STS) test time (seconds), Timed Up and Go (TUG) test time (seconds), functional reach test distance (cm), and step test (average no. of steps) after 12 months in the exercise and control groups. A between-group difference for change in 5 T-STS test time was observed in favor of exercise compared with control (mean difference [MD] = −1.58, 95% confidence interval [CI] = −3.09, −0.07, intention to treat [ITT]; MD = −1.48, 95% CI = −3.13 to 0.16, per-protocol) (2A). No statistically significant between-group differences were found for TUG (2B), functional reach (2C), and step tests (2D). All data are expressed as mean change (standard error mean).