Study of Effect of Exercise With Osteoporosis and Vertebral Fracture

This study has been completed.
Sponsor:
Collaborator:
Norwegian Fund for Postgraduate Training in Physiotherapy
Information provided by (Responsible Party):
Ostfold Hospital Trust
ClinicalTrials.gov Identifier:
NCT01120197
First received: May 6, 2010
Last updated: May 5, 2014
Last verified: May 2014
  Purpose

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".


Condition Intervention
Osteoporosis
Vertebral Fracture
Other: Exercise group
Other: Control Group

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
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.

Resource links provided by NLM:


Further study details as provided by Ostfold Hospital Trust:

Primary Outcome Measures:
  • Time Used to Walk 20 m at Maximal Speed. [ Time Frame: At baseline, 3 and 12 months after the baseline ] [ Designated as safety issue: No ]
    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


Secondary Outcome Measures:
  • Timed Up & Go Test (TUG) [ Time Frame: At baseline, 3 and 12 months after the baseline. ] [ Designated as safety issue: No ]
    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.

  • Functional Reach [ Time Frame: At baseline, 3 and 12 months after the baseline ] [ Designated as safety issue: No ]

    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.


  • QUALEFFO 41 [ Time Frame: At baseline, 3 and 12 months after the baseline ] [ Designated as safety issue: No ]

    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.


  • General Health Questionnaire 20 (GHQ20). [ Time Frame: At baseline, 3 and 12 months after baseline ] [ Designated as safety issue: No ]
    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.

  • Falls-Efficacy Scale-International [ Time Frame: Baseline, 3 months follow-up, 12 months follow up ] [ Designated as safety issue: No ]
    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.


Enrollment: 89
Study Start Date: May 2005
Study Completion Date: November 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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).

Other: Exercise group
Weekly exercises
Other Name: Exercise group
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.

Other: Control Group
No Intervention, control group only
Other Name: Control Group

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

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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 )
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01120197

Locations
Norway
Ostfold Hospital Trust
Sarpsborg, Norway, 1703
Sponsors and Collaborators
Ostfold Hospital Trust
Norwegian Fund for Postgraduate Training in Physiotherapy
Investigators
Study Director: Astrid Bergland, Professor Faculty of Health Science, University of Oslo, Norway
  More Information

No publications provided

Responsible Party: Ostfold Hospital Trust
ClinicalTrials.gov Identifier: NCT01120197     History of Changes
Other Study ID Numbers: 301.0
Study First Received: May 6, 2010
Results First Received: May 23, 2012
Last Updated: May 5, 2014
Health Authority: Norway: Norwegian Social Science Data Services

Keywords provided by Ostfold Hospital Trust:
randomized controlled trial
osteoporosis
moderate-intensity circuit exercises
balance
health-related quality of life

Additional relevant MeSH terms:
Fractures, Bone
Osteoporosis
Spinal Fractures
Back Injuries
Bone Diseases
Bone Diseases, Metabolic
Musculoskeletal Diseases
Spinal Injuries
Wounds and Injuries

ClinicalTrials.gov processed this record on October 22, 2014