The Effects of Home Exercise in Older Women With Vertebral Fractures: A Pilot Randomized Controlled Trial.
Aged
Exercise Therapy
/ methods
Feasibility Studies
Female
Fractures, Spontaneous
/ etiology
Humans
Intention to Treat Analysis
Leg
Muscle Strength
Osteoporosis
/ complications
Pain Measurement
Patient Compliance
/ statistics & numerical data
Patient Reported Outcome Measures
Patient Selection
Physical Functional Performance
Pilot Projects
Posture
Quality of Life
Single-Blind Method
Spinal Fractures
/ etiology
Exercise
Mobility
Osteoporosis
Quality of Life
Rehabilitation
Spinal Fractures
Journal
Physical therapy
ISSN: 1538-6724
Titre abrégé: Phys Ther
Pays: United States
ID NLM: 0022623
Informations de publication
Date de publication:
17 04 2020
17 04 2020
Historique:
received:
03
01
2020
revised:
29
04
2019
accepted:
21
08
2019
pubmed:
4
1
2020
medline:
4
7
2020
entrez:
4
1
2020
Statut:
ppublish
Résumé
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. This pilot study will explore the effect of home exercise versus control on functional performance, posture, and patient-reported outcome measures. This study was a parallel 2-arm pilot feasibility trial with 1:1 randomization to exercise or attentional control groups. This study took place in 5 Canadian and 2 Australian academic or community hospitals/centers. This study included 141 women ≥65 years of age with radiographically confirmed vertebral fractures. 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. 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. 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. Treatment effects on variables may have been underestimated due to multiple comparisons and underpowered analyses. 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.
Sections du résumé
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.
Identifiants
pubmed: 31899499
pii: 5695650
doi: 10.1093/ptj/pzz188
pmc: PMC7439228
doi:
Banques de données
ClinicalTrials.gov
['NCT01761084']
Types de publication
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
662-676Subventions
Organisme : CIHR
ID : MOP 123445
Pays : Canada
Informations de copyright
© 2020 American Physical Therapy Association.
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