Trial Outcomes & Findings for Study of Effect of Exercise With Osteoporosis and Vertebral Fracture (NCT NCT01120197)
NCT ID: NCT01120197
Last Updated: 2016-10-28
Results Overview
Times (measured in seconds) used walking at maximum speed for 20m indoors. No acceleration or deceleration phase used. The type of walking aids used during the test will be recorded. The participants walk as fast as possible wearing their ordinary shoes. The test perform once, the time measured with a stopwatch and the time used on 20 m will be recorded
COMPLETED
NA
89 participants
At baseline, 3 and 12 months after the baseline
2016-10-28
Participant Flow
Participant milestones
| Measure |
Exercise Group
Exercise Group: Subjects in the intervention group must participate in a training course consisted of 24 sessions over 3 months. The exercises include aerobic, stretching, balance and functional training, i.e. circuit exercises focus been on: the prevention of falls and fractures, improving balance and coordination, improving posture, and informing subjects about risk factors for falls and for osteoporosis and fractures. A 3-hour session of information and supervision will be hold for the intervention group by the same physiotherapist who leads the training sessions. The focus is on body awareness and ergonomic advice in specific, daily-life situations (e.g. lifting/carrying, resting positions).
The intervention is in accordance with Rehabilitation treatment guidelines in postmenupausal and senile osteoporosis ( Bonaiuti et al. 2005).
|
Control Group
Control group with no intervention
Subjects in the control group are asked to maintain their current lifestyle. No restrictions are placed on their exercise activities
|
|---|---|---|
|
Overall Study
STARTED
|
47
|
42
|
|
Overall Study
COMPLETED
|
38
|
32
|
|
Overall Study
NOT COMPLETED
|
9
|
10
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study of Effect of Exercise With Osteoporosis and Vertebral Fracture
Baseline characteristics by cohort
| Measure |
Exercise Group
n=47 Participants
: Subjects in the intervention group must participate in a training course consisted of 24 sessions over 3 months. The exercises include aerobic, stretching, balance and functional training, i.e. circuit exercises focus been on: the prevention of falls and fractures, improving balance and coordination, improving posture, and informing subjects about risk factors for falls and for osteoporosis and fractures. A 3-hour session of information and supervision will be hold for the intervention group by the same physiotherapist who leads the training sessions. The focus is on body awareness and ergonomic advice in specific, daily-life situations (e.g. lifting/carrying, resting positions).
|
Control Group
n=42 Participants
Control group with no intervention
Subjects in the control group are asked to maintain their current lifestyle. No restrictions are placed on their exercise activities
|
Total
n=89 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
47 Participants
n=5 Participants
|
42 Participants
n=7 Participants
|
89 Participants
n=5 Participants
|
|
Age, Continuous
|
70.8 years
STANDARD_DEVIATION 5.9 • n=5 Participants
|
72 years
STANDARD_DEVIATION 5.8 • n=7 Participants
|
71.4 years
STANDARD_DEVIATION 5.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
47 Participants
n=5 Participants
|
42 Participants
n=7 Participants
|
89 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Norway
|
47 participants
n=5 Participants
|
42 participants
n=7 Participants
|
89 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: At baseline, 3 and 12 months after the baselineTimes (measured in seconds) used walking at maximum speed for 20m indoors. No acceleration or deceleration phase used. The type of walking aids used during the test will be recorded. The participants walk as fast as possible wearing their ordinary shoes. The test perform once, the time measured with a stopwatch and the time used on 20 m will be recorded
Outcome measures
| Measure |
Exercise Group
n=47 Participants
Subjects in the intervention group must participate in a training course consisted of 24 sessions over 3 months. The exercises include aerobic, stretching, balance and functional training, i.e. circuit exercises focus been on: the prevention of falls and fractures, improving balance and coordination, improving posture, and informing subjects about risk factors for falls and for osteoporosis and fractures. A 3-hour session of information and supervision will be hold for the intervention group by the same physiotherapist who leads the training sessions. The focus is on body awareness and ergonomic advice in specific, daily-life situations (e.g. lifting/carrying, resting positions).
|
Control Group
n=42 Participants
Control group with no intervention
Subjects in the control group are asked to maintain their current lifestyle. No restrictions are placed on their exercise activities. \[We recommend specifying length of time they are followed\]
|
|---|---|---|
|
Time Used to Walk 20 m at Maximal Speed.
Baseline
|
14.9 Seconds
Standard Deviation 4.3
|
14.7 Seconds
Standard Deviation 3.5
|
|
Time Used to Walk 20 m at Maximal Speed.
3 months
|
13.4 Seconds
Standard Deviation 4.1
|
15.2 Seconds
Standard Deviation 4.3
|
|
Time Used to Walk 20 m at Maximal Speed.
12 months
|
13.8 Seconds
Standard Deviation 4.7
|
15.3 Seconds
Standard Deviation 4.7
|
SECONDARY outcome
Timeframe: At baseline, 3 and 12 months after the baseline.The subject will be instructed to rise from a chair with a seat height of 43 cm, walk 3 m, turn around, return and sit down again, wearing ordinary footwear and use customary walking aids if necessary.
Outcome measures
| Measure |
Exercise Group
n=47 Participants
Subjects in the intervention group must participate in a training course consisted of 24 sessions over 3 months. The exercises include aerobic, stretching, balance and functional training, i.e. circuit exercises focus been on: the prevention of falls and fractures, improving balance and coordination, improving posture, and informing subjects about risk factors for falls and for osteoporosis and fractures. A 3-hour session of information and supervision will be hold for the intervention group by the same physiotherapist who leads the training sessions. The focus is on body awareness and ergonomic advice in specific, daily-life situations (e.g. lifting/carrying, resting positions).
|
Control Group
n=42 Participants
Control group with no intervention
Subjects in the control group are asked to maintain their current lifestyle. No restrictions are placed on their exercise activities. \[We recommend specifying length of time they are followed\]
|
|---|---|---|
|
Timed Up & Go Test (TUG)
Baseline
|
7.9 Seconds
Standard Deviation 2.6
|
8.3 Seconds
Standard Deviation 2.4
|
|
Timed Up & Go Test (TUG)
3 months
|
7.5 Seconds
Standard Deviation 2.1
|
8.7 Seconds
Standard Deviation 2.8
|
|
Timed Up & Go Test (TUG)
12 months
|
7.3 Seconds
Standard Deviation 2.1
|
8.5 Seconds
Standard Deviation 2.5
|
SECONDARY outcome
Timeframe: At baseline, 3 and 12 months after the baselineThe maximum distance in centimetres that can be reached forward in a standing position while maintaining a fixed base of support. Subjects will be instructed to stand sideways against a wall in a natural position and stretch one arm forward level with the shoulder. The position of the third metacarpophalangeal (MCP) joint was taken as the zero point. With the body tilted forward as far as possible, the subjects continued to stretch the arm parallel to the ground. Amount of cm indicate better balance.
Outcome measures
| Measure |
Exercise Group
n=47 Participants
Subjects in the intervention group must participate in a training course consisted of 24 sessions over 3 months. The exercises include aerobic, stretching, balance and functional training, i.e. circuit exercises focus been on: the prevention of falls and fractures, improving balance and coordination, improving posture, and informing subjects about risk factors for falls and for osteoporosis and fractures. A 3-hour session of information and supervision will be hold for the intervention group by the same physiotherapist who leads the training sessions. The focus is on body awareness and ergonomic advice in specific, daily-life situations (e.g. lifting/carrying, resting positions).
|
Control Group
n=42 Participants
Control group with no intervention
Subjects in the control group are asked to maintain their current lifestyle. No restrictions are placed on their exercise activities. \[We recommend specifying length of time they are followed\]
|
|---|---|---|
|
Functional Reach
Baseline
|
26.1 Centimetres
Standard Deviation 6.7
|
27.4 Centimetres
Standard Deviation 6.3
|
|
Functional Reach
3 months
|
27.7 Centimetres
Standard Deviation 6.5
|
25.2 Centimetres
Standard Deviation 7.5
|
|
Functional Reach
12 months
|
27.1 Centimetres
Standard Deviation 6.5
|
27.7 Centimetres
Standard Deviation 5.4
|
SECONDARY outcome
Timeframe: At baseline, 3 and 12 months after the baselineQuality of Life Questionnaire issued by the European Foundation for Osteoporosis (QUALEFFO-41), is a disease-specific questionnaire to be used by patients with vertebral fractures attributed to osteoporosis. QUALEFFO-41 is self-administered and contains questions in five domains: pain, ability to perform physical functions, social functioning, general health perception and mental performance. These five domains can be evaluated individually or be represented in a total score. All scores in all the domains are expressed in values ranging from 0-100, where 0 represents the best and 100 the worst. The total QALEFFO score is calculated as a sum of all answers to items and then linearly transformed on the scale 0-100. High scores indicate poor quality of life.
Outcome measures
| Measure |
Exercise Group
n=47 Participants
Subjects in the intervention group must participate in a training course consisted of 24 sessions over 3 months. The exercises include aerobic, stretching, balance and functional training, i.e. circuit exercises focus been on: the prevention of falls and fractures, improving balance and coordination, improving posture, and informing subjects about risk factors for falls and for osteoporosis and fractures. A 3-hour session of information and supervision will be hold for the intervention group by the same physiotherapist who leads the training sessions. The focus is on body awareness and ergonomic advice in specific, daily-life situations (e.g. lifting/carrying, resting positions).
|
Control Group
n=42 Participants
Control group with no intervention
Subjects in the control group are asked to maintain their current lifestyle. No restrictions are placed on their exercise activities. \[We recommend specifying length of time they are followed\]
|
|---|---|---|
|
QUALEFFO 41
Baseline
|
31.8 units on a scale
Standard Deviation 14.4
|
31.3 units on a scale
Standard Deviation 13.3
|
|
QUALEFFO 41
3 months
|
29.8 units on a scale
Standard Deviation 14.3
|
31.5 units on a scale
Standard Deviation 14.9
|
|
QUALEFFO 41
12 months
|
28.7 units on a scale
Standard Deviation 13.5
|
31.7 units on a scale
Standard Deviation 14.8
|
SECONDARY outcome
Timeframe: At baseline, 3 and 12 months after baselineGHQ-20 is a generic instrument and registers distress and psychopathology. GHQ-20 is self-administered and the answers to each item may be treated as a "Likert Scale" and have weights assigned to each position (0-1-2-3) where 0 is no distress, and 3 is severe distress. This gives a possible range for the total GHQ-20 score of 0-60. Higher scores indicating poor qol.
Outcome measures
| Measure |
Exercise Group
n=47 Participants
Subjects in the intervention group must participate in a training course consisted of 24 sessions over 3 months. The exercises include aerobic, stretching, balance and functional training, i.e. circuit exercises focus been on: the prevention of falls and fractures, improving balance and coordination, improving posture, and informing subjects about risk factors for falls and for osteoporosis and fractures. A 3-hour session of information and supervision will be hold for the intervention group by the same physiotherapist who leads the training sessions. The focus is on body awareness and ergonomic advice in specific, daily-life situations (e.g. lifting/carrying, resting positions).
|
Control Group
n=42 Participants
Control group with no intervention
Subjects in the control group are asked to maintain their current lifestyle. No restrictions are placed on their exercise activities. \[We recommend specifying length of time they are followed\]
|
|---|---|---|
|
General Health Questionnaire 20 (GHQ20).
Baseline
|
18.7 units on a scale
Standard Deviation 8.8
|
20 units on a scale
Standard Deviation 6.9
|
|
General Health Questionnaire 20 (GHQ20).
3 months
|
15.1 units on a scale
Standard Deviation 7
|
19.8 units on a scale
Standard Deviation 7.4
|
|
General Health Questionnaire 20 (GHQ20).
12 months
|
16.1 units on a scale
Standard Deviation 7.1
|
19 units on a scale
Standard Deviation 6.1
|
SECONDARY outcome
Timeframe: Baseline, 3 months follow-up, 12 months follow upA 16- item self report or interview- based questionnaire assessing the fear of falling during basic and more demanding activities of daily living (Yardley et al. 2005). Each item is scored on a four point scale. Minimun score indicating low concern about falling is 16. The maximun score indication high concern about falling is 64.
Outcome measures
Outcome data not reported
Adverse Events
Exercise Group
Control Group
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Professor, Ph. D, Researcher. Astrid Bergland.
Faculty of Health Sciences, Oslo University College, Oslo, Norway
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place