Clinical trial NCT01120197: Study of Effect of Exercise With Osteoporosis and Vertebral Fracture
Official title: Study of Effect of Exercise on Health-related Quality of Life, Mobility and Balance in Osteoporotic Women With a History of Vertebral Fracture.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoporosis
Vertebral Fracture
Keywords: randomized controlled trial
osteoporosis
moderate-intensity circuit exercises
balance
health-related quality of life
Lead sponsor: Ostfold Hospital Trust
Sponsor class: OTHER
Collaborators: name: Norwegian Fund for Postgraduate Training in Physiotherapy
First posted: 2010-05-10
Enrollment: 89
Sex: FEMALE
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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).

Eligibility criteria: 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 )

Primary outcomes:
measure: Time Used to Walk 20 m at Maximal Speed.
timeFrame: At baseline, 3 and 12 months after the baseline
Secondary outcomes:
measure: Timed Up & Go Test (TUG)
timeFrame: At baseline, 3 and 12 months after the baseline.
measure: Functional Reach
timeFrame: At baseline, 3 and 12 months after the baseline
measure: QUALEFFO 41
timeFrame: At baseline, 3 and 12 months after the baseline
measure: General Health Questionnaire 20 (GHQ20).
timeFrame: At baseline, 3 and 12 months after baseline
measure: Falls-Efficacy Scale-International
timeFrame: Baseline, 3 months follow-up, 12 months follow up
Other outcomes:
Locations:
city: Sarpsborg
country: Norway
facility: Ostfold Hospital Trust
Study officials:
affiliation: Faculty of Health Science, University of Oslo, Norway
name: Astrid Bergland, Professor
role: STUDY_DIRECTOR
References: