Jenna C Gibbs1, Caitlin McArthur2, John D Wark3, Lehana Thabane4, Samuel C Scherer5, Sadhana Prasad6, Alexandra Papaioannou7, Nicole Mittmann8, Judi Laprade9, Sandra Kim10, Aliya Khan6, David L Kendler11, Keith D Hill12, Angela M Cheung13, Robert Bleakney14, Maureen C Ashe15, Jonathan D Adachi6, Lora M Giangregorio16. 1. Department of Kinesiology and Physical Education, McGill University, Montreal, Quebec, Canada. 2. Department of Medicine, McMaster University, Hamilton, Ontario, Canada; and GERAS Centre for Aging Research, Hamilton Health Sciences, Hamilton, Ontario, Canada. 3. Department of Medicine, University of Melbourne, Parkville, Victoria, Australia; and Bone and Mineral Medicine, Royal Melbourne Hospital, Parkville, Victoria, Australia. 4. Department of Health Research Methods, Evidence, and Impact, McMaster University. 5. Department of Medicine, University of Melbourne; Royal Melbourne Hospital; and Broadmeadows Health Services, Northern Health, Melbourne, Australia. 6. Department of Medicine, McMaster University. 7. Department of Medicine, McMaster University; GERAS Centre for Aging Research, Hamilton Health Sciences; and Department of Health Research Methods, Evidence, and Impact, McMaster University. 8. Sunnybrook Research Institute, Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada. 9. Department of Surgery, University of Toronto, Toronto, Ontario, Canada; and Ontario Osteoporosis Strategy, Osteoporosis Canada, Toronto, Ontario, Canada. 10. Department of Medicine, University of Toronto; and Centre for Osteoporosis and Bone Health, Women's College Hospital, Toronto, Ontario, Canada. 11. Department of Medicine, University of British Columbia, Vancouver, British Columbia, Canada. 12. Grad Dip Physio, BAppSc (Physio), School of Primary and Allied Health Care, Peninsula Campus, Monash University, Frankston, Australia. 13. Department of Medicine, University of Toronto; and Osteoporosis Program and Centre of Excellence in Skeletal Health Assessment, University Health Network and Sinai Health System, Toronto, Ontario, Canada. 14. Department of Medical Imaging, University of Toronto; and Centre of Excellence in Skeletal Health Assessment, University Health Network and Sinai Health System. 15. Department of Family Practice, University of British Columbia; and Centre for Hip Health and Mobility, Vancouver, British Columbia, Canada. 16. Department of Kinesiology, University of Waterloo; and Schlegel-University of Waterloo Research Institute for Aging, Waterloo, Ontario, Canada; and KITE, Toronto Rehab-University Health Network, Toronto, Ontario, Canada.
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.
RCT Entities:
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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