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| Name | Class |
|---|---|
| Norwegian Fund for Postgraduate Training in Physiotherapy | OTHER |
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The aim of this randomized controlled trial is to evaluate the effectiveness for health-related quality of life (HRQOL) of a 3-month course of exercises for a group of postmenopausal women with osteoporosis who has at least one vertebral fracture versus a control group (undertaking their usual activities). The course of exercises is devised in accordance with methods recommended in "Rehabilitation treatment guidelines in postmenopausal and senile osteoporosis".
Public health policies in most European countries are concerned with how to keep older people living independently with a qualitatively good life in the community as long as possible. Apart from its personal and human cost, osteoporosis is a major public health problem, which has an enormous social and economic impact. Osteoporosis(OP) is a common condition among older people,and a non-fatal condition that leads more to changes in the quality of life than to change in the length of life. Osteoporosis is a skeletal disorder characterized by decreased bone mass. The World Health Organization (WHO) Study Group on Osteoporosis has defined osteoporosis as "a hip BMD level of more than 2.5 SDs below the mean BMD for young, white, adult women". Using the WHO definition, approximately 30% of postmenopausal women have osteoporosis.
The most common consequences of osteoporosis are fractures. Furthermore the most common conditions associated with osteoporosis are back pain, limitations in physical functioning, and psychosocial impairment. Thus, the purpose of this study is to record the effect of the programme on mobility, balance, the disease-specific and generic health-related quality of life for women with osteoporosis and a history of vertebral fractures. The programme consist of a three-hour educational session and a three-month course of exercises in accordance with guidelines for women with an increased risk of falls and postmenopausal osteoporotic women with a history of fractures.
Our hypothesis that a three-month course of exercises and a three-hour lesson on how to cope with osteoporosis will have a significantly positive effect on the generic and disease-specific quality of life, as well as the balance and mobility, of elderly (≥60 years) women with postmenopausal osteoporosis and a history of vertebral fractures, both 3 months after the intervention and after one year.
The sample would be recruited from the Osteoporosis Outpatient clinic at the Ostfold Hospital, Norway and they their body mineral density (BMD) has been measured using Dual-Energy X-Ray Absorptiometry (DXA). The design of the study is a randomized controlled trial and the sample would be randomized to an intervention group or a control group.
Subjects in the control group are asked to maintain their current lifestyle. No restrictions are placed on their exercise activities. 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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Exercise group | Experimental | Exercise group with intervention 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 | Other | 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. The control group is followed for the same duration as the intervention group. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exercise group | Other | Weekly exercises |
| |
| Control Group |
| Measure | Description | Time Frame |
|---|---|---|
| Time Used to Walk 20 m at Maximal Speed. | 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 | At baseline, 3 and 12 months after the baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Timed Up & Go Test (TUG) | 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. | At baseline, 3 and 12 months after the baseline. |
| Functional Reach |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Astrid Bergland, Professor | Faculty of Health Science, University of Oslo, Norway | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ostfold Hospital Trust | Sarpsborg | 1703 | Norway |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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). |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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). |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Time Used to Walk 20 m at Maximal Speed. | 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 | Posted | Mean | Standard Deviation | Seconds | At baseline, 3 and 12 months after the baseline |
|
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Adverse events were systematically reported in the way that participants held log diaries after each exercise session (any adverse events: yes/no). Any adverse event would have been further investigated by the researchers.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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). |
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The numbers in our study were relatively small, and some caution is required in interpretation. Additionally, it cannot be ruled out that participants have become aware of the treatment allocation, and this could potentially have biased the results.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Professor, Ph. D, Researcher. Astrid Bergland. | Faculty of Health Sciences, Oslo University College, Oslo, Norway | +4722452507 | astrid.bergland@hf.hio.no |
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| ID | Term |
|---|---|
| D010024 | Osteoporosis |
| D016103 | Spinal Fractures |
| ID | Term |
|---|---|
| D001851 | Bone Diseases, Metabolic |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D008659 | Metabolic Diseases |
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| ID | Term |
|---|---|
| D035061 | Control Groups |
| ID | Term |
|---|---|
| D015340 | Epidemiologic Research Design |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D012107 | Research Design |
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| Other |
No Intervention, control group only |
|
The 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. |
| At baseline, 3 and 12 months after the baseline |
| QUALEFFO 41 | Quality 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. | At baseline, 3 and 12 months after the baseline |
| General Health Questionnaire 20 (GHQ20). | GHQ-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. | At baseline, 3 and 12 months after baseline |
| Falls-Efficacy Scale-International | A 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. | Baseline, 3 months follow-up, 12 months follow up |
| BG001 | 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 |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | 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. [We recommend specifying length of time they are followed] |
|
|
| Secondary | Timed Up & Go Test (TUG) | 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. | Posted | Mean | Standard Deviation | Seconds | At baseline, 3 and 12 months after the baseline. |
|
|
|
| Secondary | Functional Reach | The 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. | Posted | Mean | Standard Deviation | Centimetres | At baseline, 3 and 12 months after the baseline |
|
|
|
| Secondary | QUALEFFO 41 | Quality 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. | Posted | Mean | Standard Deviation | units on a scale | At baseline, 3 and 12 months after the baseline |
|
|
|
| Secondary | General Health Questionnaire 20 (GHQ20). | GHQ-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. | Posted | Mean | Standard Deviation | units on a scale | At baseline, 3 and 12 months after baseline |
|
|
|
| Secondary | Falls-Efficacy Scale-International | A 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. | Not Posted | Baseline, 3 months follow-up, 12 months follow up |
| 0 |
| 47 |
| 0 |
| 47 |
| EG001 | 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. | 0 | 42 | 0 | 42 |
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| D009750 |
| Nutritional and Metabolic Diseases |
| D013124 | Spinal Injuries |
| D019567 | Back Injuries |
| D014947 | Wounds and Injuries |
| D050723 | Fractures, Bone |
| D008722 | Methods |
| 12 months |
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| 12 months |
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| 12 months |
|
| 12 months |
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