Study of Effect of Exercise With Osteoporosis and Vertebral Fracture

NCT01120197 | Completed Results DMC

• 1 other identifier: 301.0
• Study Type: interventional
• Target: 89
• Locations: 1 country
• Sites: 1

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".

Conditions

Osteoporosis; Vertebral Fracture

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (5)

• Timed Up & Go Test (TUG)

  At baseline, 3 and 12 months after the baseline.

• Functional Reach

  At baseline, 3 and 12 months after the baseline

• QUALEFFO 41

  At baseline, 3 and 12 months after the baseline

• General Health Questionnaire 20 (GHQ20).

  At baseline, 3 and 12 months after baseline

• Falls-Efficacy Scale-International

  Baseline, 3 months follow-up, 12 months follow up

Study Arms (2)

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).

Other: Exercise group

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.

Other: Control Group

Interventions

Exercise group OTHER

Weekly exercises

Exercise group

Control Group OTHER

No Intervention, control group only

Control Group

Eligibility Criteria

• Age: 60 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• recent vertebral fractures
• unable to complete the questionnaires
• major cognitive impairment (MMSE) ( MMS \< 23 )

Sponsors & Collaborators

• Ostfold Hospital Trust: lead
• Norwegian Fund for Postgraduate Training in Physiotherapy: collaborator

Study Sites (1)

Ostfold Hospital Trust

Sarpsborg, 1703, Norway

Location

MeSH Terms

Conditions

Osteoporosis; Spinal Fractures

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Spinal Injuries; Back Injuries; Wounds and Injuries; Fractures, Bone

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Limitations and Caveats

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.

Results Point of Contact

• Title: Professor, Ph. D, Researcher. Astrid Bergland.
• Organization: Faculty of Health Sciences, Oslo University College, Oslo, Norway

astrid.bergland@hf.hio.no

+4722452507

Study Officials

• Astrid Bergland, Professor

  Faculty of Health Science, University of Oslo, Norway

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 6, 2010
• First Posted: May 10, 2010
• Study Start: May 1, 2005
• Primary Completion: January 1, 2009
• Study Completion: November 1, 2009
• Last Updated: October 28, 2016
• Results First Posted: May 30, 2014

Record last verified: 2016-09

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)