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

Study Overview
=================
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.

Official Title
-----------------
The Effect of Exercise on Physical Function in Older Women With Osteoporosis and a History of Vertebral Fracture: A Randomized Controlled Trial

Conditions
-----------------
Osteoporosis, Vertebral Fractures

Intervention / Treatment
-----------------
* Other: Exercise


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 65 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Intervention consists of strength and balance exercise in group sessions, twice a week for 12 weeks | Other: Exercise<br>* Strength and balance exercise in Groups, focusing on lower limb strength, back strength and static and dynamic balance<br>|
| No Intervention: Control<br>Participants allocated in the control group are instructed to live as usual | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 10 meter habitual walking speed |  | Up to 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life of participants assessed by the questionnaire Qualeffo 41 |  | Up to 18 months | 
| Senior Fitness test |  | Up to 18 months | 
| Functional reach |  | Up to 18 months | 
| Four Square Step Test |  | Up to 18 months | 
| Grip Strength |  | 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 |