The Effect of Exercise on Physical Function in Older Women With Osteoporosis and a History of Vertebral Fracture

Not Applicable

Completed

• Conditions: Vertebral Fractures; Osteoporosis
• Interventions: Other: Exercise

• Registration Number: NCT02781974
• Lead Sponsor: Oslo Metropolitan University

Brief Summary

The study is a parallel-group single blinded randomized controlled trial, examining the effect of exercise on physical function in older women with osteoporosis and a history of vertebral fracture. The participants will randomly be assigned in a 1:1 ratio to the intervention group and the control group. The intervention will follow newly developed exercise recommendations for people with osteoporosis and vertebral fractures, which states the balance- and strength exercises should be performed at least twice a week. The intervention is a group exercise session circuit program lasting for 12 weeks. The participants will be tested at baseline, and followed up at 3 months and 6 months.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-01
• Study First Submitted: 2016-05-18
• Study First Submitted QC: 2016-05-24
• Study First Posted: 2016-05-25
• Primary Completion: 2018-10-12
• Study Completion: 2018-10-12
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-06
• Last Update Posted: 2019-03-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 149

Inclusion Criteria

• Women over 65 years, living at home, able to walk with or without walking aids
• having osteoporosis verified by DXA scan (-2,5)
• at least one vertebral fracture, verified by X-ray

Exclusion Criteria

• Health conditions that make it unsafe to exercise
• not able to understand and speak Norwegian adequately to participate in the intervention

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	Exercise	Intervention consists of strength and balance exercise in group sessions, twice a week for 12 weeks

Primary Outcome Measures

Name	Time	Method
10 meter habitual walking speed	Up to 18 months

Secondary Outcome Measures

Name	Time	Method
Senior Fitness test	Up to 18 months
Functional reach	Up to 18 months
Grip Strength	Up to 18 months
Quality of life of participants assessed by the questionnaire Qualeffo 41	Up to 18 months
Four Square Step Test	Up to 18 months
Short Form -36	Up to 18 months
FES-1	Up to 18 months
IPAQ-SF	Up to 18 months
Patient Specific Function Scale	Up to 18 months

Trial Locations

Locations (1)

OsloMet - Oslo Metropolitan University; 🇳🇴 Oslo, Norway