N/A
N=141
Build Better Bones With Exercise
Osteoporotic Fractures · Spinal Fractures
Bottom Line
View on ClinicalTrials.gov: NCT01761084 ↗Enrolled (actual)
141
Serious AEs
20.6%
Results posted
Nov 2019
Primary outcome: Primary: Feasibility of Recruitment and Retention — 66; 64 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Exercise and behaviour change strategies (Behavioral)
- Age
- Older Adult · 65+ yrs
- Sex
- Female
- Sponsor
- University of Waterloo
- Primary completion
- Dec 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Feasibility of Recruitment and Retention |
66; 64 | — |
| PRIMARY Adherence |
66 | — |
| SECONDARY Number of Fractures. |
168; 163; 183; 178 | — |
| SECONDARY Number of Fallers |
48; 36 | — |
| SECONDARY Occiput to Wall Distance |
5.3; 6.2; 5.3; 6.1 | 0.811 |
| SECONDARY Scores on the Short Physical Performance Battery (SPPB) |
9.6; 8.8; 9.7; 9.0 | 0.796 |
| SECONDARY Scores on Balance Outcome Measure for Elder Rehabilitation (BOOMER). |
13.5; 13.2; 13.6; 13.2 | 0.719 |
| SECONDARY Quality of Life (QoL) and Pain Scores Measured Through the EuroQOL Instrument (EQ5D5L) and the Osteoporosis Quality of Life Questionnaire (OQLQ) and a Visual Analog Scale (VAS). |
74.1; 75.7; 75.5; 75.7; 74.6; 75.7 | 0.854 |
| SECONDARY Scores on Exercise Self-efficacy Scales. |
4.4; 4.4; 4.2; 4.0; 4.0; 4.0 | — |
| SECONDARY Score on Short-form Falls Efficacy Scale International (FES-I). |
12.1; 12.9; 11.4; 11.5; 11.5; 12.3 | — |
| SECONDARY Productivity |
1.89; 1.85; 1.60; 1.76; 1.32; 2.12 | .951 |
| SECONDARY Physical Activity |
6.7; 6.4; 43.2; 48.8; 168.8; 194.9 | <0.05 sig |
| SECONDARY Number of Serious Adverse Events. |
18; 12 | — |
| SECONDARY Number of Individuals Screened and Eligible Per Collection Site. |
141 | — |
| SECONDARY Number of Potentially Eligible Males |
308 | — |
| SECONDARY Number of Participants With Multiple Falls |
31; 22 | — |
| SECONDARY Total Number of Falls |
130; 127 | — |
| SECONDARY Value of Direct Medical Resources Per Participant. |
2127; 1823; 1680; 3130; 829; 848 | — |
| SECONDARY Value of Non-direct Medical Resources Per Participant. |
5005; 4631; 998; 917; 1007; 872 | — |
| SECONDARY Participant Height |
156.5; 156.1; 156.4; 155.9 | 0.536 |
| SECONDARY Activities of Daily Living |
3.17; 3.46; 2.79; 2.75; 2.99; 3.05 | .900 |
| SECONDARY Timed Loaded Standing Test |
101.9; 107.5; 120; 106 | .712 |
| SECONDARY Location of Vertebral Fractures |
3; 1; 54; 42; 74; 88 | — |
| SECONDARY Participant Weight |
65.1; 66.5; 66.1; 66.6 | 0.461 |
Summary
The long-term goal of our research team is to conduct a large multicentre study to evaluate whether tailored home exercise can prevent fractures in high-risk individuals. The proposed project will address the feasibility of such a trial, but will also evaluate the effect of exercise on quality of life, posture and many other outcomes important to individuals with vertebral fractures. Physiotherapists will conduct 6 home visits with participants to deliver the intervention (or social visit for controls) using a similar model to previous work by our team and others. The purpose of this pilot study is determining the feasibility of recruitment, retention and adherence of an international multicentre randomized controlled study evaluating the efficacy of thrice-weekly home exercise for one year among women with vertebral fracture. As secondary objectives, the investigators will examine the effects of exercise on function, balance, quality of life, pain, falls and fractures. The primary hypothesis is that the investigators will successfully recruit and retain the target sample, and achieve an adherence rate of 60%.
Eligibility Criteria
Inclusion Criteria
- Has a) a known or suspected vertebral fracture of non-traumatic etiology OR b) one of the following:
- documented height loss of ≥2cm
- historical height loss of ≥6cm
- visible hyperkyphosis
- age greater than or equal to 65 years of age
- able to understand instructions in english
- able to give informed consent (no cognitive impairment)
Exclusion Criteria
- Current or prior cancer
- On dialysis, known liver, kidney or malabsorption disease
- Progressive neurological disorder, unable to stand or walk for 10 metres, with/without gait aid or progressive disorder likely to prevent study completion, palliative care.
- Current participation in muscle strengthening or similar exercise program ≥ 3 times per week
- Uncontrolled hypertension or other contraindications to exercise
Data sourced from ClinicalTrials.gov (NCT01761084). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.