Trial Outcomes & Findings for Build Better Bones With Exercise (NCT NCT01761084)
NCT ID: NCT01761084
Last Updated: 2019-11-14
Results Overview
Number of participants recruited and retained. Criteria for success = 20 recruited per site and at least 75% retained.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
141 participants
Primary outcome timeframe
Monthly records up to 12 months.
Results posted on
2019-11-14
Participant Flow
Participant milestones
| Measure |
Exercise and Behaviour Change Strategies
The exercise program will include strength training, balance training and cardiovascular exercise that is individually tailored to the participants' abilities. The physical therapist will also implement strategies to assist with behaviour change, such as documenting progress in a log, participating in action planning and coping planning, and using techniques in the spirit of motivational interviewing.
Exercise and behaviour change strategies: a)cardiovascular exercise (e.g., marching, walking) for ≥10 minutes per day b)postural retraining and balance exercises ≥3 days a week (will be encouraged to do these daily) c)perform muscle strengthening and balance training exercises ≥ 3 days a week d)the exercise intervention was developed using the Bone Fit program as a framework (http://www.bonefit.ca/). The physical therapist will tailor exercises and work with participant to integrate them into their day.
|
General Health or Social Discussion
Participants in the control group will receive equal attention, but will not be prescribed exercise, or participate in counselling about exercise. The physical therapist will discuss topics related to general health.
|
|---|---|---|
|
Overall Study
STARTED
|
71
|
70
|
|
Overall Study
COMPLETED
|
66
|
64
|
|
Overall Study
NOT COMPLETED
|
5
|
6
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Build Better Bones With Exercise
Baseline characteristics by cohort
| Measure |
Exercise and Behaviour Change Strategies
n=71 Participants
The exercise program will include strength training, balance training and cardiovascular exercise that is individually tailored to the participants' abilities. The physical therapist will also implement strategies to assist with behaviour change, such as documenting progress in a log, participating in action planning and coping planning, and using techniques in the spirit of motivational interviewing.
Exercise and behaviour change strategies: a)cardiovascular exercise (e.g., marching, walking) for ≥10 minutes per day b)postural retraining and balance exercises ≥3 days a week (will be encouraged to do these daily) c)perform muscle strengthening and balance training exercises ≥ 3 days a week d)the exercise intervention was developed using the Bone Fit program as a framework (http://www.bonefit.ca/). The physical therapist will tailor exercises and work with participant to integrate them into their day.
|
General Health or Social Discussion
n=70 Participants
Participants in the control group will receive equal attention, but will not be prescribed exercise, or participate in counselling about exercise. The physical therapist will discuss topics related to general health.
|
Total
n=141 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
76 years
STANDARD_DEVIATION 6.4 • n=93 Participants
|
77 years
STANDARD_DEVIATION 7.28 • n=4 Participants
|
76 years
STANDARD_DEVIATION 6.85 • n=27 Participants
|
|
Sex: Female, Male
Female
|
71 Participants
n=93 Participants
|
70 Participants
n=4 Participants
|
141 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Monthly records up to 12 months.Number of participants recruited and retained. Criteria for success = 20 recruited per site and at least 75% retained.
Outcome measures
| Measure |
Exercise and Behaviour Change Strategies
n=71 Participants
The exercise program will include strength training, balance training and cardiovascular exercise that is individually tailored to the participants' abilities. The physical therapist will also implement strategies to assist with behaviour change, such as documenting progress in a log, participating in action planning and coping planning, and using techniques in the spirit of motivational interviewing.
Exercise and behaviour change strategies: a)cardiovascular exercise (e.g., marching, walking) for ≥10 minutes per day b)postural retraining and balance exercises ≥3 days a week (will be encouraged to do these daily) c)perform muscle strengthening and balance training exercises ≥ 3 days a week d)the exercise intervention was developed using the Bone Fit program as a framework (http://www.bonefit.ca/). The physical therapist will tailor exercises and work with participant to integrate them into their day.
|
General Health or Social Discussion
n=70 Participants
Participants in the control group will receive equal attention, but will not be prescribed exercise, or participate in counselling about exercise. The physical therapist will discuss topics related to general health.
|
|---|---|---|
|
Feasibility of Recruitment and Retention
|
66 Participants
|
64 Participants
|
PRIMARY outcome
Timeframe: Monthly records over 12 monthsPopulation: Only the Exercise Group received the exercise program.
Number of exercise sessions completed relative to prescribed. We will use a diary for participants to self-report adherence.
Outcome measures
| Measure |
Exercise and Behaviour Change Strategies
n=71 Participants
The exercise program will include strength training, balance training and cardiovascular exercise that is individually tailored to the participants' abilities. The physical therapist will also implement strategies to assist with behaviour change, such as documenting progress in a log, participating in action planning and coping planning, and using techniques in the spirit of motivational interviewing.
Exercise and behaviour change strategies: a)cardiovascular exercise (e.g., marching, walking) for ≥10 minutes per day b)postural retraining and balance exercises ≥3 days a week (will be encouraged to do these daily) c)perform muscle strengthening and balance training exercises ≥ 3 days a week d)the exercise intervention was developed using the Bone Fit program as a framework (http://www.bonefit.ca/). The physical therapist will tailor exercises and work with participant to integrate them into their day.
|
General Health or Social Discussion
Participants in the control group will receive equal attention, but will not be prescribed exercise, or participate in counselling about exercise. The physical therapist will discuss topics related to general health.
|
|---|---|---|
|
Adherence
|
66 % of weeks meeting adherence threshold
Interval 17.0 to 86.0
|
—
|
SECONDARY outcome
Timeframe: Baseline, one year and at report of fracture (monitored monthly for reports).Incident fracture will be a composite outcome of a vertebral fracture or fragility fracture (excluding fractures due to trauma or cancer). A fracture questionnaire will be used to ascertain the occurrence of fractures, the approximate timing and the cause with fracture occurrence, location and severity verified through health record data. Lateral thoracic and lumbar spine x-rays will be performed on participants at baseline (to confirm prevalent vertebral fractures) and follow-up (to identify new fractures). Vertebral fractures will be defined as radiographic presence of ≥25% reduction in anterior, middle or posterior height of a vertebra using the Genant visual semi-quantitative method.
Outcome measures
| Measure |
Exercise and Behaviour Change Strategies
n=71 Participants
The exercise program will include strength training, balance training and cardiovascular exercise that is individually tailored to the participants' abilities. The physical therapist will also implement strategies to assist with behaviour change, such as documenting progress in a log, participating in action planning and coping planning, and using techniques in the spirit of motivational interviewing.
Exercise and behaviour change strategies: a)cardiovascular exercise (e.g., marching, walking) for ≥10 minutes per day b)postural retraining and balance exercises ≥3 days a week (will be encouraged to do these daily) c)perform muscle strengthening and balance training exercises ≥ 3 days a week d)the exercise intervention was developed using the Bone Fit program as a framework (http://www.bonefit.ca/). The physical therapist will tailor exercises and work with participant to integrate them into their day.
|
General Health or Social Discussion
n=70 Participants
Participants in the control group will receive equal attention, but will not be prescribed exercise, or participate in counselling about exercise. The physical therapist will discuss topics related to general health.
|
|---|---|---|
|
Number of Fractures.
Baseline
|
168 Fractures
|
163 Fractures
|
|
Number of Fractures.
12 Month Follow-up
|
183 Fractures
|
178 Fractures
|
SECONDARY outcome
Timeframe: Monthly up to one year.Diary for participants to self-report falls.
Outcome measures
| Measure |
Exercise and Behaviour Change Strategies
n=71 Participants
The exercise program will include strength training, balance training and cardiovascular exercise that is individually tailored to the participants' abilities. The physical therapist will also implement strategies to assist with behaviour change, such as documenting progress in a log, participating in action planning and coping planning, and using techniques in the spirit of motivational interviewing.
Exercise and behaviour change strategies: a)cardiovascular exercise (e.g., marching, walking) for ≥10 minutes per day b)postural retraining and balance exercises ≥3 days a week (will be encouraged to do these daily) c)perform muscle strengthening and balance training exercises ≥ 3 days a week d)the exercise intervention was developed using the Bone Fit program as a framework (http://www.bonefit.ca/). The physical therapist will tailor exercises and work with participant to integrate them into their day.
|
General Health or Social Discussion
n=70 Participants
Participants in the control group will receive equal attention, but will not be prescribed exercise, or participate in counselling about exercise. The physical therapist will discuss topics related to general health.
|
|---|---|---|
|
Number of Fallers
|
48 Participants
|
36 Participants
|
SECONDARY outcome
Timeframe: Baseline and one year.Outcome measures
| Measure |
Exercise and Behaviour Change Strategies
n=71 Participants
The exercise program will include strength training, balance training and cardiovascular exercise that is individually tailored to the participants' abilities. The physical therapist will also implement strategies to assist with behaviour change, such as documenting progress in a log, participating in action planning and coping planning, and using techniques in the spirit of motivational interviewing.
Exercise and behaviour change strategies: a)cardiovascular exercise (e.g., marching, walking) for ≥10 minutes per day b)postural retraining and balance exercises ≥3 days a week (will be encouraged to do these daily) c)perform muscle strengthening and balance training exercises ≥ 3 days a week d)the exercise intervention was developed using the Bone Fit program as a framework (http://www.bonefit.ca/). The physical therapist will tailor exercises and work with participant to integrate them into their day.
|
General Health or Social Discussion
n=70 Participants
Participants in the control group will receive equal attention, but will not be prescribed exercise, or participate in counselling about exercise. The physical therapist will discuss topics related to general health.
|
|---|---|---|
|
Occiput to Wall Distance
Baseline
|
5.3 centimetres
Standard Deviation 4.0
|
6.2 centimetres
Standard Deviation 4.7
|
|
Occiput to Wall Distance
Month 12
|
5.3 centimetres
Standard Deviation 4.4
|
6.1 centimetres
Standard Deviation 3.9
|
SECONDARY outcome
Timeframe: Baseline and one year.The SPPB consists of balance tests (side-by-side, semi-tandem, and tandem standing), gait speed during 4-meter walk test, and the average time taken to rise from a chair with arms folded across chest and sit back down (Five-Times-Sit-to-Stand test), sub-scores of which are added to determine a composite score (0-12), with higher scores indicative of better performance.
Outcome measures
| Measure |
Exercise and Behaviour Change Strategies
n=71 Participants
The exercise program will include strength training, balance training and cardiovascular exercise that is individually tailored to the participants' abilities. The physical therapist will also implement strategies to assist with behaviour change, such as documenting progress in a log, participating in action planning and coping planning, and using techniques in the spirit of motivational interviewing.
Exercise and behaviour change strategies: a)cardiovascular exercise (e.g., marching, walking) for ≥10 minutes per day b)postural retraining and balance exercises ≥3 days a week (will be encouraged to do these daily) c)perform muscle strengthening and balance training exercises ≥ 3 days a week d)the exercise intervention was developed using the Bone Fit program as a framework (http://www.bonefit.ca/). The physical therapist will tailor exercises and work with participant to integrate them into their day.
|
General Health or Social Discussion
n=70 Participants
Participants in the control group will receive equal attention, but will not be prescribed exercise, or participate in counselling about exercise. The physical therapist will discuss topics related to general health.
|
|---|---|---|
|
Scores on the Short Physical Performance Battery (SPPB)
Baseline
|
9.6 score on a scale
Standard Deviation 2.2
|
8.8 score on a scale
Standard Deviation 2.3
|
|
Scores on the Short Physical Performance Battery (SPPB)
12 months
|
9.7 score on a scale
Standard Deviation 2.5
|
9.0 score on a scale
Standard Deviation 2.3
|
SECONDARY outcome
Timeframe: Baseline and one year.Balance Outcome Measure for Elder Rehabilitation (BOOMER) includes the step test, the Timed Up and Go, the Functional Reach test and the timed static stance feet together eyes closed test. The sub-scores of which are added to create a composite score (0-16), with higher scores indicating better performance.
Outcome measures
| Measure |
Exercise and Behaviour Change Strategies
n=71 Participants
The exercise program will include strength training, balance training and cardiovascular exercise that is individually tailored to the participants' abilities. The physical therapist will also implement strategies to assist with behaviour change, such as documenting progress in a log, participating in action planning and coping planning, and using techniques in the spirit of motivational interviewing.
Exercise and behaviour change strategies: a)cardiovascular exercise (e.g., marching, walking) for ≥10 minutes per day b)postural retraining and balance exercises ≥3 days a week (will be encouraged to do these daily) c)perform muscle strengthening and balance training exercises ≥ 3 days a week d)the exercise intervention was developed using the Bone Fit program as a framework (http://www.bonefit.ca/). The physical therapist will tailor exercises and work with participant to integrate them into their day.
|
General Health or Social Discussion
n=70 Participants
Participants in the control group will receive equal attention, but will not be prescribed exercise, or participate in counselling about exercise. The physical therapist will discuss topics related to general health.
|
|---|---|---|
|
Scores on Balance Outcome Measure for Elder Rehabilitation (BOOMER).
Baseline
|
13.5 score on a scale
Standard Deviation 2.2
|
13.2 score on a scale
Standard Deviation 2.0
|
|
Scores on Balance Outcome Measure for Elder Rehabilitation (BOOMER).
Month 12
|
13.6 score on a scale
Standard Deviation 2.6
|
13.2 score on a scale
Standard Deviation 2.3
|
SECONDARY outcome
Timeframe: Baseline, 6 months and one year.Population: Withdrawals at 6 months - intervention group (n=4) and control group (n=5). Withdrawals at 12 months - intervention group (n=5) and control group (n=6).
OQLQ scores range 1-7, with higher scores indicate greater quality of life. EQ5D5L VAS scores range 0-100, with higher scores indicating better overall health. VAS pain scores range 0-10, with lower scores indicating less pain.
Outcome measures
| Measure |
Exercise and Behaviour Change Strategies
n=71 Participants
The exercise program will include strength training, balance training and cardiovascular exercise that is individually tailored to the participants' abilities. The physical therapist will also implement strategies to assist with behaviour change, such as documenting progress in a log, participating in action planning and coping planning, and using techniques in the spirit of motivational interviewing.
Exercise and behaviour change strategies: a)cardiovascular exercise (e.g., marching, walking) for ≥10 minutes per day b)postural retraining and balance exercises ≥3 days a week (will be encouraged to do these daily) c)perform muscle strengthening and balance training exercises ≥ 3 days a week d)the exercise intervention was developed using the Bone Fit program as a framework (http://www.bonefit.ca/). The physical therapist will tailor exercises and work with participant to integrate them into their day.
|
General Health or Social Discussion
n=70 Participants
Participants in the control group will receive equal attention, but will not be prescribed exercise, or participate in counselling about exercise. The physical therapist will discuss topics related to general health.
|
|---|---|---|
|
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).
EQ5D-VAS - Baseline
|
74.1 score on a scale
Standard Deviation 19.1
|
75.7 score on a scale
Standard Deviation 20.0
|
|
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).
EQ5D-VAS - Month 6
|
75.5 score on a scale
Standard Deviation 17.6
|
75.7 score on a scale
Standard Deviation 18.8
|
|
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).
EQ5D-VAS - Month 12
|
74.6 score on a scale
Standard Deviation 19.1
|
75.7 score on a scale
Standard Deviation 15.4
|
|
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).
OQLQ - Average - Baseline
|
5.1 score on a scale
Standard Deviation 1.3
|
5.2 score on a scale
Standard Deviation 1.2
|
|
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).
OQLQ - Average - Month 6
|
5.4 score on a scale
Standard Deviation 1.2
|
5.6 score on a scale
Standard Deviation 1.2
|
|
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).
OQLQ - Average - Month 12
|
5.4 score on a scale
Standard Deviation 1.4
|
5.4 score on a scale
Standard Deviation 1.3
|
|
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).
Pain VAS at Rest - Baseline
|
2.7 score on a scale
Standard Deviation 2.7
|
2.4 score on a scale
Standard Deviation 2.1
|
|
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).
Pain VAS at Rest - Month 6
|
2.3 score on a scale
Standard Deviation 2.4
|
2.1 score on a scale
Standard Deviation 2.1
|
|
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).
Pain VAS at Rest - Month 12
|
1.9 score on a scale
Standard Deviation 2.2
|
2.1 score on a scale
Standard Deviation 2.2
|
|
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).
Pain VAS Movement - Baseline
|
3.8 score on a scale
Standard Deviation 2.9
|
4.2 score on a scale
Standard Deviation 2.6
|
|
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).
Pain VAS Movement - Month 6
|
3.0 score on a scale
Standard Deviation 2.4
|
3.5 score on a scale
Standard Deviation 2.5
|
|
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).
Pain VAS Movement - Month 12
|
3.6 score on a scale
Standard Deviation 2.7
|
3.9 score on a scale
Standard Deviation 2.5
|
SECONDARY outcome
Timeframe: Baseline, 6 months and one year.Population: Withdrawals at 6 months - intervention group (n=4) and control group (n=5). Withdrawals at 12 months - intervention group (n=5) and control group (n=6)
To assess self-efficacy related to engaging in exercise, participants will be asked "Over the next 3 months, how confident are you that you can perform exercise on most days of the week?" and "Over the next 3 months, how confident are you that you can perform exercise on 3 days of the week?." To assess implementation intentions, participants are asked "Do you already have concrete plans regarding exercise?". Patients will rate their answers on a scale from 1-5. Higher scores indicate greater exercise self-efficacy.
Outcome measures
| Measure |
Exercise and Behaviour Change Strategies
n=71 Participants
The exercise program will include strength training, balance training and cardiovascular exercise that is individually tailored to the participants' abilities. The physical therapist will also implement strategies to assist with behaviour change, such as documenting progress in a log, participating in action planning and coping planning, and using techniques in the spirit of motivational interviewing.
Exercise and behaviour change strategies: a)cardiovascular exercise (e.g., marching, walking) for ≥10 minutes per day b)postural retraining and balance exercises ≥3 days a week (will be encouraged to do these daily) c)perform muscle strengthening and balance training exercises ≥ 3 days a week d)the exercise intervention was developed using the Bone Fit program as a framework (http://www.bonefit.ca/). The physical therapist will tailor exercises and work with participant to integrate them into their day.
|
General Health or Social Discussion
n=70 Participants
Participants in the control group will receive equal attention, but will not be prescribed exercise, or participate in counselling about exercise. The physical therapist will discuss topics related to general health.
|
|---|---|---|
|
Scores on Exercise Self-efficacy Scales.
Baseline
|
4.4 units on a scale
Standard Deviation 0.7
|
4.4 units on a scale
Standard Deviation 0.6
|
|
Scores on Exercise Self-efficacy Scales.
Month 6
|
4.2 units on a scale
Standard Deviation 0.7
|
4.0 units on a scale
Standard Deviation 0.8
|
|
Scores on Exercise Self-efficacy Scales.
Month 12
|
4.0 units on a scale
Standard Deviation 0.8
|
4.0 units on a scale
Standard Deviation 0.7
|
SECONDARY outcome
Timeframe: Baseline, 6 months and one year.Population: Withdrawals at 6 months - intervention group (n=4) and control group (n=5). Withdrawals at 12 months - intervention group (n=5) and control group (n=6).
Questionnaire about how concerned the participant is about the possibility of falling during common daily activities. Scores range from 7 (no concern about falling) to 28 (severe concern about falling.
Outcome measures
| Measure |
Exercise and Behaviour Change Strategies
n=71 Participants
The exercise program will include strength training, balance training and cardiovascular exercise that is individually tailored to the participants' abilities. The physical therapist will also implement strategies to assist with behaviour change, such as documenting progress in a log, participating in action planning and coping planning, and using techniques in the spirit of motivational interviewing.
Exercise and behaviour change strategies: a)cardiovascular exercise (e.g., marching, walking) for ≥10 minutes per day b)postural retraining and balance exercises ≥3 days a week (will be encouraged to do these daily) c)perform muscle strengthening and balance training exercises ≥ 3 days a week d)the exercise intervention was developed using the Bone Fit program as a framework (http://www.bonefit.ca/). The physical therapist will tailor exercises and work with participant to integrate them into their day.
|
General Health or Social Discussion
n=70 Participants
Participants in the control group will receive equal attention, but will not be prescribed exercise, or participate in counselling about exercise. The physical therapist will discuss topics related to general health.
|
|---|---|---|
|
Score on Short-form Falls Efficacy Scale International (FES-I).
Baseline
|
12.1 score on a scale
Standard Deviation 4.8
|
12.9 score on a scale
Standard Deviation 5.6
|
|
Score on Short-form Falls Efficacy Scale International (FES-I).
Month 6
|
11.4 score on a scale
Standard Deviation 4.0
|
11.5 score on a scale
Standard Deviation 4.7
|
|
Score on Short-form Falls Efficacy Scale International (FES-I).
Month 12
|
11.5 score on a scale
Standard Deviation 4.7
|
12.3 score on a scale
Standard Deviation 5.0
|
SECONDARY outcome
Timeframe: Monthly up to one year.Population: Only participants who reported working and/or volunteering were asked this question.
Questionnaire regarding much did the participant's spine fracture(s) or osteoporosis affect their productivity while working? The scale is 0-10, with higher numbers indicating more effect on their work.
Outcome measures
| Measure |
Exercise and Behaviour Change Strategies
n=71 Participants
The exercise program will include strength training, balance training and cardiovascular exercise that is individually tailored to the participants' abilities. The physical therapist will also implement strategies to assist with behaviour change, such as documenting progress in a log, participating in action planning and coping planning, and using techniques in the spirit of motivational interviewing.
Exercise and behaviour change strategies: a)cardiovascular exercise (e.g., marching, walking) for ≥10 minutes per day b)postural retraining and balance exercises ≥3 days a week (will be encouraged to do these daily) c)perform muscle strengthening and balance training exercises ≥ 3 days a week d)the exercise intervention was developed using the Bone Fit program as a framework (http://www.bonefit.ca/). The physical therapist will tailor exercises and work with participant to integrate them into their day.
|
General Health or Social Discussion
n=70 Participants
Participants in the control group will receive equal attention, but will not be prescribed exercise, or participate in counselling about exercise. The physical therapist will discuss topics related to general health.
|
|---|---|---|
|
Productivity
Baseline
|
1.89 units on a scale
Standard Deviation 2.536
|
1.85 units on a scale
Standard Deviation 1.927
|
|
Productivity
Month 1
|
1.60 units on a scale
Standard Deviation 2.257
|
1.76 units on a scale
Standard Deviation 1.985
|
|
Productivity
Month 2
|
1.32 units on a scale
Standard Deviation 2.212
|
2.12 units on a scale
Standard Deviation 1.965
|
|
Productivity
Month 3
|
1.21 units on a scale
Standard Deviation 2.149
|
2.94 units on a scale
Standard Deviation 2.947
|
|
Productivity
Month 4
|
1.00 units on a scale
Standard Deviation 1.910
|
2.50 units on a scale
Standard Deviation 2.307
|
|
Productivity
Month 5
|
0.11 units on a scale
Standard Deviation .471
|
1.57 units on a scale
Standard Deviation 1.910
|
|
Productivity
Month 6
|
0.69 units on a scale
Standard Deviation 1.778
|
1.88 units on a scale
Standard Deviation 2.261
|
|
Productivity
Month 7
|
.80 units on a scale
Standard Deviation 1.781
|
2.07 units on a scale
Standard Deviation 2.556
|
|
Productivity
Month 8
|
0.93 units on a scale
Standard Deviation 2.056
|
2.00 units on a scale
Standard Deviation 2.191
|
|
Productivity
Month 9
|
1.07 units on a scale
Standard Deviation 2.556
|
1.76 units on a scale
Standard Deviation 2.333
|
|
Productivity
Month 10
|
0.95 units on a scale
Standard Deviation 2.089
|
1.24 units on a scale
Standard Deviation 1.855
|
|
Productivity
Month 11
|
0.88 units on a scale
Standard Deviation 2.029
|
1.83 units on a scale
Standard Deviation 2.503
|
|
Productivity
Month 12
|
0.76 units on a scale
Standard Deviation 2.022
|
2.16 units on a scale
Standard Deviation 2.115
|
SECONDARY outcome
Timeframe: Baseline, 6 months, 12 monthsPopulation: Withdrawals at 6 months - intervention group (n=4) and control group (n=5) Withdrawals at 12 months - intervention group (n=5) and control group (n=6)
A modified version of the Short-Form International Physical Activity Questionnaire (IPAQ) will be completed. A subset of participants at the University of Waterloo (St. Mary's General Hospital) will wear an accelerometer for 7 days.
Outcome measures
| Measure |
Exercise and Behaviour Change Strategies
n=71 Participants
The exercise program will include strength training, balance training and cardiovascular exercise that is individually tailored to the participants' abilities. The physical therapist will also implement strategies to assist with behaviour change, such as documenting progress in a log, participating in action planning and coping planning, and using techniques in the spirit of motivational interviewing.
Exercise and behaviour change strategies: a)cardiovascular exercise (e.g., marching, walking) for ≥10 minutes per day b)postural retraining and balance exercises ≥3 days a week (will be encouraged to do these daily) c)perform muscle strengthening and balance training exercises ≥ 3 days a week d)the exercise intervention was developed using the Bone Fit program as a framework (http://www.bonefit.ca/). The physical therapist will tailor exercises and work with participant to integrate them into their day.
|
General Health or Social Discussion
n=70 Participants
Participants in the control group will receive equal attention, but will not be prescribed exercise, or participate in counselling about exercise. The physical therapist will discuss topics related to general health.
|
|---|---|---|
|
Physical Activity
Baseline Strength/Balance physical activity
|
6.7 Minutes per week
Standard Deviation 17.0
|
6.4 Minutes per week
Standard Deviation 16.8
|
|
Physical Activity
Baseline Moderate-Vigorous physical activity
|
43.2 Minutes per week
Standard Deviation 138.5
|
48.8 Minutes per week
Standard Deviation 156.1
|
|
Physical Activity
Baseline Walking
|
168.8 Minutes per week
Standard Deviation 366.0
|
194.9 Minutes per week
Standard Deviation 278.3
|
|
Physical Activity
Month 6 Strength/Balance physical activity
|
80.8 Minutes per week
Standard Deviation 85.8
|
15.7 Minutes per week
Standard Deviation 36.4
|
|
Physical Activity
Month 6 Moderate-Vigorous physical activity
|
76.1 Minutes per week
Standard Deviation 143.9
|
147.3 Minutes per week
Standard Deviation 346.0
|
|
Physical Activity
Month 6 Walking
|
165.4 Minutes per week
Standard Deviation 120.6
|
154.0 Minutes per week
Standard Deviation 161.6
|
|
Physical Activity
Month 12 Strength/Balance physical activity
|
68.4 Minutes per week
Standard Deviation 68.3
|
21.1 Minutes per week
Standard Deviation 44.9
|
|
Physical Activity
Month 12 Moderate-Vigorous physical activity
|
93.9 Minutes per week
Standard Deviation 225.9
|
128.9 Minutes per week
Standard Deviation 352.3
|
|
Physical Activity
Month 12 Walking
|
161.2 Minutes per week
Standard Deviation 140.7
|
268.0 Minutes per week
Standard Deviation 342.3
|
SECONDARY outcome
Timeframe: Monthly up to one year.Defined as death or event that is life-threatening, requires hospitalization or results in disability.
Outcome measures
| Measure |
Exercise and Behaviour Change Strategies
n=71 Participants
The exercise program will include strength training, balance training and cardiovascular exercise that is individually tailored to the participants' abilities. The physical therapist will also implement strategies to assist with behaviour change, such as documenting progress in a log, participating in action planning and coping planning, and using techniques in the spirit of motivational interviewing.
Exercise and behaviour change strategies: a)cardiovascular exercise (e.g., marching, walking) for ≥10 minutes per day b)postural retraining and balance exercises ≥3 days a week (will be encouraged to do these daily) c)perform muscle strengthening and balance training exercises ≥ 3 days a week d)the exercise intervention was developed using the Bone Fit program as a framework (http://www.bonefit.ca/). The physical therapist will tailor exercises and work with participant to integrate them into their day.
|
General Health or Social Discussion
n=70 Participants
Participants in the control group will receive equal attention, but will not be prescribed exercise, or participate in counselling about exercise. The physical therapist will discuss topics related to general health.
|
|---|---|---|
|
Number of Serious Adverse Events.
|
18 events
|
12 events
|
SECONDARY outcome
Timeframe: over the course of the study (2.29 years)Number of participants randomized out of all participants screened
Outcome measures
| Measure |
Exercise and Behaviour Change Strategies
n=2822 Participants
The exercise program will include strength training, balance training and cardiovascular exercise that is individually tailored to the participants' abilities. The physical therapist will also implement strategies to assist with behaviour change, such as documenting progress in a log, participating in action planning and coping planning, and using techniques in the spirit of motivational interviewing.
Exercise and behaviour change strategies: a)cardiovascular exercise (e.g., marching, walking) for ≥10 minutes per day b)postural retraining and balance exercises ≥3 days a week (will be encouraged to do these daily) c)perform muscle strengthening and balance training exercises ≥ 3 days a week d)the exercise intervention was developed using the Bone Fit program as a framework (http://www.bonefit.ca/). The physical therapist will tailor exercises and work with participant to integrate them into their day.
|
General Health or Social Discussion
Participants in the control group will receive equal attention, but will not be prescribed exercise, or participate in counselling about exercise. The physical therapist will discuss topics related to general health.
|
|---|---|---|
|
Number of Individuals Screened and Eligible Per Collection Site.
|
141 Participants
|
—
|
SECONDARY outcome
Timeframe: over recruitment periodPopulation: Total people screened for inclusion
Outcome measures
| Measure |
Exercise and Behaviour Change Strategies
n=2254 Participants
The exercise program will include strength training, balance training and cardiovascular exercise that is individually tailored to the participants' abilities. The physical therapist will also implement strategies to assist with behaviour change, such as documenting progress in a log, participating in action planning and coping planning, and using techniques in the spirit of motivational interviewing.
Exercise and behaviour change strategies: a)cardiovascular exercise (e.g., marching, walking) for ≥10 minutes per day b)postural retraining and balance exercises ≥3 days a week (will be encouraged to do these daily) c)perform muscle strengthening and balance training exercises ≥ 3 days a week d)the exercise intervention was developed using the Bone Fit program as a framework (http://www.bonefit.ca/). The physical therapist will tailor exercises and work with participant to integrate them into their day.
|
General Health or Social Discussion
Participants in the control group will receive equal attention, but will not be prescribed exercise, or participate in counselling about exercise. The physical therapist will discuss topics related to general health.
|
|---|---|---|
|
Number of Potentially Eligible Males
|
308 Participants
|
—
|
SECONDARY outcome
Timeframe: Monthly up to 12 months.Outcome measures
| Measure |
Exercise and Behaviour Change Strategies
n=71 Participants
The exercise program will include strength training, balance training and cardiovascular exercise that is individually tailored to the participants' abilities. The physical therapist will also implement strategies to assist with behaviour change, such as documenting progress in a log, participating in action planning and coping planning, and using techniques in the spirit of motivational interviewing.
Exercise and behaviour change strategies: a)cardiovascular exercise (e.g., marching, walking) for ≥10 minutes per day b)postural retraining and balance exercises ≥3 days a week (will be encouraged to do these daily) c)perform muscle strengthening and balance training exercises ≥ 3 days a week d)the exercise intervention was developed using the Bone Fit program as a framework (http://www.bonefit.ca/). The physical therapist will tailor exercises and work with participant to integrate them into their day.
|
General Health or Social Discussion
n=70 Participants
Participants in the control group will receive equal attention, but will not be prescribed exercise, or participate in counselling about exercise. The physical therapist will discuss topics related to general health.
|
|---|---|---|
|
Number of Participants With Multiple Falls
|
31 Participants
|
22 Participants
|
SECONDARY outcome
Timeframe: Monthly up to 12 months.Outcome measures
| Measure |
Exercise and Behaviour Change Strategies
n=71 Participants
The exercise program will include strength training, balance training and cardiovascular exercise that is individually tailored to the participants' abilities. The physical therapist will also implement strategies to assist with behaviour change, such as documenting progress in a log, participating in action planning and coping planning, and using techniques in the spirit of motivational interviewing.
Exercise and behaviour change strategies: a)cardiovascular exercise (e.g., marching, walking) for ≥10 minutes per day b)postural retraining and balance exercises ≥3 days a week (will be encouraged to do these daily) c)perform muscle strengthening and balance training exercises ≥ 3 days a week d)the exercise intervention was developed using the Bone Fit program as a framework (http://www.bonefit.ca/). The physical therapist will tailor exercises and work with participant to integrate them into their day.
|
General Health or Social Discussion
n=70 Participants
Participants in the control group will receive equal attention, but will not be prescribed exercise, or participate in counselling about exercise. The physical therapist will discuss topics related to general health.
|
|---|---|---|
|
Total Number of Falls
|
130 Falls
|
127 Falls
|
SECONDARY outcome
Timeframe: Accrued costs over 12 monthsPopulation: For each resource cost, only participants utilizing the resource are included.
Outcome measures
| Measure |
Exercise and Behaviour Change Strategies
n=71 Participants
The exercise program will include strength training, balance training and cardiovascular exercise that is individually tailored to the participants' abilities. The physical therapist will also implement strategies to assist with behaviour change, such as documenting progress in a log, participating in action planning and coping planning, and using techniques in the spirit of motivational interviewing.
Exercise and behaviour change strategies: a)cardiovascular exercise (e.g., marching, walking) for ≥10 minutes per day b)postural retraining and balance exercises ≥3 days a week (will be encouraged to do these daily) c)perform muscle strengthening and balance training exercises ≥ 3 days a week d)the exercise intervention was developed using the Bone Fit program as a framework (http://www.bonefit.ca/). The physical therapist will tailor exercises and work with participant to integrate them into their day.
|
General Health or Social Discussion
n=70 Participants
Participants in the control group will receive equal attention, but will not be prescribed exercise, or participate in counselling about exercise. The physical therapist will discuss topics related to general health.
|
|---|---|---|
|
Value of Direct Medical Resources Per Participant.
Medications
|
2127 Dollars (Canadian)
Standard Deviation 3579
|
1823 Dollars (Canadian)
Standard Deviation 3063
|
|
Value of Direct Medical Resources Per Participant.
Medical costs related to adverse events
|
1680 Dollars (Canadian)
Standard Deviation 3600
|
3130 Dollars (Canadian)
Standard Deviation 3180
|
|
Value of Direct Medical Resources Per Participant.
Physician visits and tests/ procedures
|
829 Dollars (Canadian)
Standard Deviation 1033
|
848 Dollars (Canadian)
Standard Deviation 863
|
|
Value of Direct Medical Resources Per Participant.
Allied health professional visits
|
301 Dollars (Canadian)
Standard Deviation 331
|
95 Dollars (Canadian)
Standard Deviation 51
|
SECONDARY outcome
Timeframe: Accrued costs over 12 monthsPopulation: For each resource cost, only participants utilizing the resource are included.
Outcome measures
| Measure |
Exercise and Behaviour Change Strategies
n=71 Participants
The exercise program will include strength training, balance training and cardiovascular exercise that is individually tailored to the participants' abilities. The physical therapist will also implement strategies to assist with behaviour change, such as documenting progress in a log, participating in action planning and coping planning, and using techniques in the spirit of motivational interviewing.
Exercise and behaviour change strategies: a)cardiovascular exercise (e.g., marching, walking) for ≥10 minutes per day b)postural retraining and balance exercises ≥3 days a week (will be encouraged to do these daily) c)perform muscle strengthening and balance training exercises ≥ 3 days a week d)the exercise intervention was developed using the Bone Fit program as a framework (http://www.bonefit.ca/). The physical therapist will tailor exercises and work with participant to integrate them into their day.
|
General Health or Social Discussion
n=70 Participants
Participants in the control group will receive equal attention, but will not be prescribed exercise, or participate in counselling about exercise. The physical therapist will discuss topics related to general health.
|
|---|---|---|
|
Value of Non-direct Medical Resources Per Participant.
Unpaid caregiver time
|
5005 Dollars (Canadian)
Standard Deviation 9220
|
4631 Dollars (Canadian)
Standard Deviation 8091
|
|
Value of Non-direct Medical Resources Per Participant.
Lost productivity
|
998 Dollars (Canadian)
Standard Deviation 1642
|
917 Dollars (Canadian)
Standard Deviation 1322
|
|
Value of Non-direct Medical Resources Per Participant.
Out of pocket costs
|
1007 Dollars (Canadian)
Standard Deviation 1453
|
872 Dollars (Canadian)
Standard Deviation 1250
|
SECONDARY outcome
Timeframe: Baseline and one yearPopulation: Withdrawals at 12 months - intervention group (n=5) and control group (n=6). The remainder (5 intervention, 2 control) did not attend the follow-up visit.
Outcome measures
| Measure |
Exercise and Behaviour Change Strategies
n=71 Participants
The exercise program will include strength training, balance training and cardiovascular exercise that is individually tailored to the participants' abilities. The physical therapist will also implement strategies to assist with behaviour change, such as documenting progress in a log, participating in action planning and coping planning, and using techniques in the spirit of motivational interviewing.
Exercise and behaviour change strategies: a)cardiovascular exercise (e.g., marching, walking) for ≥10 minutes per day b)postural retraining and balance exercises ≥3 days a week (will be encouraged to do these daily) c)perform muscle strengthening and balance training exercises ≥ 3 days a week d)the exercise intervention was developed using the Bone Fit program as a framework (http://www.bonefit.ca/). The physical therapist will tailor exercises and work with participant to integrate them into their day.
|
General Health or Social Discussion
n=70 Participants
Participants in the control group will receive equal attention, but will not be prescribed exercise, or participate in counselling about exercise. The physical therapist will discuss topics related to general health.
|
|---|---|---|
|
Participant Height
Baseline
|
156.5 centimetres
Standard Deviation 6.4
|
156.1 centimetres
Standard Deviation 7.2
|
|
Participant Height
Month 12
|
156.4 centimetres
Standard Deviation 6.6
|
155.9 centimetres
Standard Deviation 7.2
|
SECONDARY outcome
Timeframe: Monthly up to one yearPopulation: Subsequent number of participants drops after baseline due to withdrawals or monthly follow-up not being completed.
0-10 scale about ability to do activities of daily living. Higher scores indicate more difficulty.
Outcome measures
| Measure |
Exercise and Behaviour Change Strategies
n=71 Participants
The exercise program will include strength training, balance training and cardiovascular exercise that is individually tailored to the participants' abilities. The physical therapist will also implement strategies to assist with behaviour change, such as documenting progress in a log, participating in action planning and coping planning, and using techniques in the spirit of motivational interviewing.
Exercise and behaviour change strategies: a)cardiovascular exercise (e.g., marching, walking) for ≥10 minutes per day b)postural retraining and balance exercises ≥3 days a week (will be encouraged to do these daily) c)perform muscle strengthening and balance training exercises ≥ 3 days a week d)the exercise intervention was developed using the Bone Fit program as a framework (http://www.bonefit.ca/). The physical therapist will tailor exercises and work with participant to integrate them into their day.
|
General Health or Social Discussion
n=70 Participants
Participants in the control group will receive equal attention, but will not be prescribed exercise, or participate in counselling about exercise. The physical therapist will discuss topics related to general health.
|
|---|---|---|
|
Activities of Daily Living
Baseline
|
3.17 units on a scale
Standard Deviation 3.005
|
3.46 units on a scale
Standard Deviation 2.406
|
|
Activities of Daily Living
Month 1
|
2.79 units on a scale
Standard Deviation 2.696
|
2.75 units on a scale
Standard Deviation 2.397
|
|
Activities of Daily Living
Month 2
|
2.99 units on a scale
Standard Deviation 2.841
|
3.05 units on a scale
Standard Deviation 2.446
|
|
Activities of Daily Living
Month 3
|
2.96 units on a scale
Standard Deviation 2.946
|
3.12 units on a scale
Standard Deviation 2.362
|
|
Activities of Daily Living
Month 4
|
3.14 units on a scale
Standard Deviation 2.762
|
3.34 units on a scale
Standard Deviation 2.639
|
|
Activities of Daily Living
Month 5
|
3.45 units on a scale
Standard Deviation 2.922
|
3.39 units on a scale
Standard Deviation 2.741
|
|
Activities of Daily Living
Month 6
|
2.74 units on a scale
Standard Deviation 2.613
|
2.95 units on a scale
Standard Deviation 2.673
|
|
Activities of Daily Living
Month 7
|
2.95 units on a scale
Standard Deviation 2.772
|
3.33 units on a scale
Standard Deviation 2.691
|
|
Activities of Daily Living
Month 8
|
2.98 units on a scale
Standard Deviation 2.723
|
3.07 units on a scale
Standard Deviation 2.389
|
|
Activities of Daily Living
Month 9
|
2.98 units on a scale
Standard Deviation 2.831
|
3.28 units on a scale
Standard Deviation 2.821
|
|
Activities of Daily Living
Month 11
|
2.90 units on a scale
Standard Deviation 2.537
|
3.32 units on a scale
Standard Deviation 2.381
|
|
Activities of Daily Living
Month 12
|
2.52 units on a scale
Standard Deviation 2.599
|
2.58 units on a scale
Standard Deviation 2.342
|
|
Activities of Daily Living
Month 10
|
2.97 units on a scale
Standard Deviation 2.414
|
3.14 units on a scale
Standard Deviation 2.599
|
SECONDARY outcome
Timeframe: Baseline and one yearPopulation: Only participants from the University of Waterloo and the University of Toronto sites assessed.
A physical performance measure of combined trunk and arm endurance.
Outcome measures
| Measure |
Exercise and Behaviour Change Strategies
n=17 Participants
The exercise program will include strength training, balance training and cardiovascular exercise that is individually tailored to the participants' abilities. The physical therapist will also implement strategies to assist with behaviour change, such as documenting progress in a log, participating in action planning and coping planning, and using techniques in the spirit of motivational interviewing.
Exercise and behaviour change strategies: a)cardiovascular exercise (e.g., marching, walking) for ≥10 minutes per day b)postural retraining and balance exercises ≥3 days a week (will be encouraged to do these daily) c)perform muscle strengthening and balance training exercises ≥ 3 days a week d)the exercise intervention was developed using the Bone Fit program as a framework (http://www.bonefit.ca/). The physical therapist will tailor exercises and work with participant to integrate them into their day.
|
General Health or Social Discussion
n=13 Participants
Participants in the control group will receive equal attention, but will not be prescribed exercise, or participate in counselling about exercise. The physical therapist will discuss topics related to general health.
|
|---|---|---|
|
Timed Loaded Standing Test
Baseline
|
101.9 Seconds
Standard Deviation 39.8
|
107.5 Seconds
Standard Deviation 34.6
|
|
Timed Loaded Standing Test
Month 12
|
120 Seconds
Standard Deviation 39.9
|
106 Seconds
Standard Deviation 37.6
|
SECONDARY outcome
Timeframe: Baseline and Month 12Population: Withdrawals at 12 months - intervention group (n=5) and control group (n=6). The remainder (9 intervention, 8 control) did not have a second x-ray.
Any vertebral fracture (Genant Grade 1 or higher) found on x-ray, divided into location groupings of T1-T3, T4-T8, T9-L1, and L2-L5.
Outcome measures
| Measure |
Exercise and Behaviour Change Strategies
n=71 Participants
The exercise program will include strength training, balance training and cardiovascular exercise that is individually tailored to the participants' abilities. The physical therapist will also implement strategies to assist with behaviour change, such as documenting progress in a log, participating in action planning and coping planning, and using techniques in the spirit of motivational interviewing.
Exercise and behaviour change strategies: a)cardiovascular exercise (e.g., marching, walking) for ≥10 minutes per day b)postural retraining and balance exercises ≥3 days a week (will be encouraged to do these daily) c)perform muscle strengthening and balance training exercises ≥ 3 days a week d)the exercise intervention was developed using the Bone Fit program as a framework (http://www.bonefit.ca/). The physical therapist will tailor exercises and work with participant to integrate them into their day.
|
General Health or Social Discussion
n=70 Participants
Participants in the control group will receive equal attention, but will not be prescribed exercise, or participate in counselling about exercise. The physical therapist will discuss topics related to general health.
|
|---|---|---|
|
Location of Vertebral Fractures
Baseline T1-T3
|
3 Fractures
|
1 Fractures
|
|
Location of Vertebral Fractures
Baseline T4-T8
|
54 Fractures
|
42 Fractures
|
|
Location of Vertebral Fractures
Baseline T9-L1
|
74 Fractures
|
88 Fractures
|
|
Location of Vertebral Fractures
Baseline L2-L5
|
38 Fractures
|
36 Fractures
|
|
Location of Vertebral Fractures
Month 12 T1-T3
|
3 Fractures
|
2 Fractures
|
|
Location of Vertebral Fractures
Month 12 T4-T8
|
43 Fractures
|
39 Fractures
|
|
Location of Vertebral Fractures
Month 12 T9-L1
|
66 Fractures
|
76 Fractures
|
|
Location of Vertebral Fractures
Month 12 L2-L5
|
34 Fractures
|
28 Fractures
|
SECONDARY outcome
Timeframe: Baseline and Month 12Population: Withdrawals at 12 months - intervention group (n=5) and control group (n=6). The remainder (7 intervention, 2 control) either did not attend the follow-up visit or did not have access to a scale at the visit.
Outcome measures
| Measure |
Exercise and Behaviour Change Strategies
n=71 Participants
The exercise program will include strength training, balance training and cardiovascular exercise that is individually tailored to the participants' abilities. The physical therapist will also implement strategies to assist with behaviour change, such as documenting progress in a log, participating in action planning and coping planning, and using techniques in the spirit of motivational interviewing.
Exercise and behaviour change strategies: a)cardiovascular exercise (e.g., marching, walking) for ≥10 minutes per day b)postural retraining and balance exercises ≥3 days a week (will be encouraged to do these daily) c)perform muscle strengthening and balance training exercises ≥ 3 days a week d)the exercise intervention was developed using the Bone Fit program as a framework (http://www.bonefit.ca/). The physical therapist will tailor exercises and work with participant to integrate them into their day.
|
General Health or Social Discussion
n=70 Participants
Participants in the control group will receive equal attention, but will not be prescribed exercise, or participate in counselling about exercise. The physical therapist will discuss topics related to general health.
|
|---|---|---|
|
Participant Weight
Baseline
|
65.1 kilograms
Standard Deviation 12.8
|
66.5 kilograms
Standard Deviation 15.4
|
|
Participant Weight
Month 12
|
66.1 kilograms
Standard Deviation 13.3
|
66.6 kilograms
Standard Deviation 15.4
|
Adverse Events
Exercise and Behaviour Change Strategies
Serious events: 17 serious events
Other events: 43 other events
Deaths: 0 deaths
General Health or Social Discussion
Serious events: 12 serious events
Other events: 34 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Exercise and Behaviour Change Strategies
n=71 participants at risk
The exercise program will include strength training, balance training and cardiovascular exercise that is individually tailored to the participants' abilities. The physical therapist will also implement strategies to assist with behaviour change, such as documenting progress in a log, participating in action planning and coping planning, and using techniques in the spirit of motivational interviewing.
Exercise and behaviour change strategies: a)cardiovascular exercise (e.g., marching, walking) for ≥10 minutes per day b)postural retraining and balance exercises ≥3 days a week (will be encouraged to do these daily) c)perform muscle strengthening and balance training exercises ≥ 3 days a week d)the exercise intervention was developed using the Bone Fit program as a framework (http://www.bonefit.ca/). The physical therapist will tailor exercises and work with participant to integrate them into their day.
|
General Health or Social Discussion
n=70 participants at risk
Participants in the control group will receive equal attention, but will not be prescribed exercise, or participate in counselling about exercise. The physical therapist will discuss topics related to general health.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
1.4%
1/71 • Number of events 1
|
0.00%
0/70
|
|
Cardiac disorders
Heart failure
|
1.4%
1/71 • Number of events 2
|
0.00%
0/70
|
|
Infections and infestations
Pneumonia
|
1.4%
1/71 • Number of events 1
|
2.9%
2/70 • Number of events 2
|
|
General disorders
Idiopathic severe left foot pain
|
1.4%
1/71 • Number of events 1
|
0.00%
0/70
|
|
Injury, poisoning and procedural complications
Fracture
|
5.6%
4/71 • Number of events 4
|
1.4%
1/70 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
1.4%
1/71 • Number of events 1
|
1.4%
1/70 • Number of events 1
|
|
Product Issues
Adverse reaction to Forteo
|
0.00%
0/71
|
1.4%
1/70 • Number of events 1
|
|
Vascular disorders
Stroke
|
0.00%
0/71
|
2.9%
2/70 • Number of events 2
|
|
Cardiac disorders
Atrial fibrillation
|
1.4%
1/71 • Number of events 1
|
0.00%
0/70
|
|
Cardiac disorders
Dizziness
|
1.4%
1/71 • Number of events 1
|
0.00%
0/70
|
|
Cardiac disorders
Chest pain
|
1.4%
1/71 • Number of events 1
|
0.00%
0/70
|
|
Cardiac disorders
Elevated blood pressure
|
0.00%
0/71
|
1.4%
1/70 • Number of events 1
|
|
General disorders
Severe vertigo
|
0.00%
0/71
|
1.4%
1/70 • Number of events 1
|
|
Infections and infestations
Influenza
|
1.4%
1/71 • Number of events 1
|
0.00%
0/70
|
|
Infections and infestations
Stomach infection
|
1.4%
1/71 • Number of events 1
|
0.00%
0/70
|
|
Injury, poisoning and procedural complications
Wound infection
|
1.4%
1/71 • Number of events 1
|
0.00%
0/70
|
|
Injury, poisoning and procedural complications
Vertebral pain
|
1.4%
1/71 • Number of events 1
|
0.00%
0/70
|
|
Injury, poisoning and procedural complications
Extreme knee pain
|
0.00%
0/71
|
1.4%
1/70 • Number of events 1
|
|
Vascular disorders
Aneurysm
|
0.00%
0/71
|
1.4%
1/70 • Number of events 1
|
|
Vascular disorders
Hematoma
|
0.00%
0/71
|
1.4%
1/70 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Shoulder dislocation
|
1.4%
1/71 • Number of events 1
|
0.00%
0/70
|
Other adverse events
| Measure |
Exercise and Behaviour Change Strategies
n=71 participants at risk
The exercise program will include strength training, balance training and cardiovascular exercise that is individually tailored to the participants' abilities. The physical therapist will also implement strategies to assist with behaviour change, such as documenting progress in a log, participating in action planning and coping planning, and using techniques in the spirit of motivational interviewing.
Exercise and behaviour change strategies: a)cardiovascular exercise (e.g., marching, walking) for ≥10 minutes per day b)postural retraining and balance exercises ≥3 days a week (will be encouraged to do these daily) c)perform muscle strengthening and balance training exercises ≥ 3 days a week d)the exercise intervention was developed using the Bone Fit program as a framework (http://www.bonefit.ca/). The physical therapist will tailor exercises and work with participant to integrate them into their day.
|
General Health or Social Discussion
n=70 participants at risk
Participants in the control group will receive equal attention, but will not be prescribed exercise, or participate in counselling about exercise. The physical therapist will discuss topics related to general health.
|
|---|---|---|
|
Cardiac disorders
Irregular heart beat
|
0.00%
0/71
|
2.9%
2/70 • Number of events 2
|
|
Ear and labyrinth disorders
Hearing loss
|
0.00%
0/71
|
2.9%
2/70 • Number of events 2
|
|
Eye disorders
Cataracts
|
1.4%
1/71 • Number of events 2
|
0.00%
0/70
|
|
General disorders
Increased pain
|
21.1%
15/71 • Number of events 20
|
7.1%
5/70 • Number of events 9
|
|
Hepatobiliary disorders
Enlarged bile duct
|
0.00%
0/71
|
1.4%
1/70 • Number of events 1
|
|
Immune system disorders
Rash
|
1.4%
1/71 • Number of events 1
|
0.00%
0/70
|
|
Infections and infestations
Bronchitis
|
0.00%
0/71
|
1.4%
1/70 • Number of events 1
|
|
Injury, poisoning and procedural complications
Fracture
|
4.2%
3/71 • Number of events 3
|
4.3%
3/70 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
arthritis-related pains
|
5.6%
4/71 • Number of events 5
|
0.00%
0/70
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cyst
|
1.4%
1/71 • Number of events 1
|
0.00%
0/70
|
|
Reproductive system and breast disorders
Vaginal tenderness
|
0.00%
0/71
|
1.4%
1/70 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Obstructive sleep apnea
|
1.4%
1/71 • Number of events 1
|
0.00%
0/70
|
|
Skin and subcutaneous tissue disorders
Itchy scalp
|
1.4%
1/71 • Number of events 1
|
0.00%
0/70
|
|
Surgical and medical procedures
Skin basal cell carcinoma removed
|
1.4%
1/71 • Number of events 1
|
0.00%
0/70
|
|
Eye disorders
Macular degeneration
|
0.00%
0/71
|
1.4%
1/70 • Number of events 1
|
|
General disorders
Dizziness/loss of balance
|
4.2%
3/71 • Number of events 3
|
0.00%
0/70
|
|
General disorders
Numbness/tingling in mouth
|
2.8%
2/71 • Number of events 2
|
0.00%
0/70
|
|
General disorders
foot edema
|
1.4%
1/71 • Number of events 1
|
0.00%
0/70
|
|
Infections and infestations
corn infected on foot
|
0.00%
0/71
|
1.4%
1/70 • Number of events 1
|
|
Infections and infestations
Influenza
|
2.8%
2/71 • Number of events 2
|
1.4%
1/70 • Number of events 1
|
|
Infections and infestations
Fungal infection
|
1.4%
1/71 • Number of events 1
|
0.00%
0/70
|
|
Infections and infestations
Gastroenteritis
|
2.8%
2/71 • Number of events 2
|
1.4%
1/70 • Number of events 1
|
|
Infections and infestations
Infected finger
|
0.00%
0/71
|
1.4%
1/70 • Number of events 1
|
|
Infections and infestations
Lyme Disease
|
1.4%
1/71 • Number of events 1
|
0.00%
0/70
|
|
Infections and infestations
Meniere's Disease
|
1.4%
1/71 • Number of events 1
|
0.00%
0/70
|
|
Infections and infestations
Pancreatitis
|
1.4%
1/71 • Number of events 2
|
0.00%
0/70
|
|
Infections and infestations
Respiratory infection
|
5.6%
4/71 • Number of events 5
|
0.00%
0/70
|
|
Infections and infestations
Shingles
|
4.2%
3/71 • Number of events 3
|
0.00%
0/70
|
|
Infections and infestations
Sinus infection
|
1.4%
1/71 • Number of events 1
|
0.00%
0/70
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/71
|
2.9%
2/70 • Number of events 4
|
|
Injury, poisoning and procedural complications
Fall/trip
|
36.6%
26/71 • Number of events 29
|
17.1%
12/70 • Number of events 19
|
|
Injury, poisoning and procedural complications
Soft tissue injury
|
5.6%
4/71 • Number of events 5
|
12.9%
9/70 • Number of events 11
|
|
Injury, poisoning and procedural complications
Domestic violence incident
|
0.00%
0/71
|
1.4%
1/70 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Idiopathic breathing difficulties
|
1.4%
1/71 • Number of events 1
|
0.00%
0/70
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/71
|
1.4%
1/70 • Number of events 1
|
|
Surgical and medical procedures
Gallbladder Surgery
|
1.4%
1/71 • Number of events 1
|
0.00%
0/70
|
|
Surgical and medical procedures
Bladder cyst surgery
|
1.4%
1/71 • Number of events 1
|
0.00%
0/70
|
|
Surgical and medical procedures
Glass splinter removed from finger
|
1.4%
1/71 • Number of events 2
|
0.00%
0/70
|
|
Surgical and medical procedures
Endoscopy
|
0.00%
0/71
|
2.9%
2/70 • Number of events 2
|
|
Surgical and medical procedures
Facial growth removal
|
0.00%
0/71
|
1.4%
1/70 • Number of events 1
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place