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

Gibbs JC1McArthur C2Wark JD3Thabane L4Scherer SC5Prasad S6Papaioannou A7Mittmann N8Laprade J9Kim S10Khan A6Kendler DL11Hill KD12Cheung AM13Bleakney R14Ashe MC15Adachi JD16Giangregorio LM17.

Phys Ther. 2020 Jan 3. pii: pzz188. doi: 10.1093/ptj/pzz188. [Epub ahead of print]

 

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 two-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 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 and 12 months. Adherence to exercise was assessed by calendar diary. T-tests examined between-group mean differences (MD) in change from baseline in intention-to-treat (ITT) and per-protocol analyses.

RESULTS:

There was a small effect of exercise on five times sit-to-stand test versus control (MD: -1.58 [95% CI: -3.09, -0.07], ITT; MD: -1.49 [95% CI: -3.12, 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.