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Study of Effect of Exercise With Osteoporosis and Vertebral Fracture

NCT ID: NCT01120197

Last Updated: 2016-10-28

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

89 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-05-31

Study Completion Date

2009-11-30

Brief Summary

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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".

Detailed Description

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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).

Conditions

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Osteoporosis Vertebral Fracture

Keywords

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randomized controlled trial osteoporosis moderate-intensity circuit exercises balance health-related quality of life

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Exercise group

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).

Group Type EXPERIMENTAL

Exercise group

Intervention Type OTHER

Weekly exercises

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. The control group is followed for the same duration as the intervention group.

Group Type OTHER

Control Group

Intervention Type OTHER

No Intervention, control group only

Interventions

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Exercise group

Weekly exercises

Intervention Type OTHER

Control Group

No Intervention, control group only

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* women
* living at home
* ambulatory
* aged 60 or more
* clinical diagnosis of osteoporosis
* a history of vertebral fracture

Exclusion Criteria

* recent vertebral fractures
* unable to complete the questionnaires
* major cognitive impairment (MMSE) ( MMS \< 23 )
Minimum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Norwegian Fund for Postgraduate Training in Physiotherapy

OTHER

Sponsor Role collaborator

Ostfold Hospital Trust

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Astrid Bergland, Professor

Role: STUDY_DIRECTOR

Faculty of Health Science, University of Oslo, Norway

Locations

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Ostfold Hospital Trust

Sarpsborg, , Norway

Site Status

Countries

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Norway

Other Identifiers

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301.0

Identifier Type: -

Identifier Source: org_study_id