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

Primary Purpose

Osteoporosis, Vertebral Fractures

Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Exercise
Sponsored by
Oslo Metropolitan University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoporosis

Eligibility Criteria

65 Years - undefined (Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • OsloMet - Oslo Metropolitan University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention

Control

Arm Description

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

Participants allocated in the control group are instructed to "live as usual"

Outcomes

Primary Outcome Measures

10 meter habitual walking speed

Secondary Outcome Measures

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

Full Information

First Posted
May 18, 2016
Last Updated
March 6, 2019
Sponsor
Oslo Metropolitan University
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1. Study Identification

Unique Protocol Identification Number
NCT02781974
Brief Title
The Effect of Exercise on Physical Function in Older Women With Osteoporosis and a History of Vertebral Fracture
Official Title
The Effect of Exercise on Physical Function in Older Women With Osteoporosis and a History of Vertebral Fracture: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
January 2016 (undefined)
Primary Completion Date
October 12, 2018 (Actual)
Study Completion Date
October 12, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oslo Metropolitan University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoporosis, Vertebral Fractures

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
149 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
Intervention consists of strength and balance exercise in group sessions, twice a week for 12 weeks
Arm Title
Control
Arm Type
No Intervention
Arm Description
Participants allocated in the control group are instructed to "live as usual"
Intervention Type
Other
Intervention Name(s)
Exercise
Intervention Description
Strength and balance exercise in Groups, focusing on lower limb strength, back strength and static and dynamic balance
Primary Outcome Measure Information:
Title
10 meter habitual walking speed
Time Frame
Up to 18 months
Secondary Outcome Measure Information:
Title
Quality of life of participants assessed by the questionnaire Qualeffo 41
Time Frame
Up to 18 months
Title
Senior Fitness test
Time Frame
Up to 18 months
Title
Functional reach
Time Frame
Up to 18 months
Title
Four Square Step Test
Time Frame
Up to 18 months
Title
Grip Strength
Time Frame
Up to 18 months
Title
Short Form -36
Time Frame
Up to 18 months
Title
FES-1
Time Frame
Up to 18 months
Title
IPAQ-SF
Time Frame
Up to 18 months
Title
Patient Specific Function Scale
Time Frame
Up to 18 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
OsloMet - Oslo Metropolitan University
City
Oslo
ZIP/Postal Code
0130
Country
Norway

12. IPD Sharing Statement

Citations:
PubMed Identifier
32682416
Citation
Stanghelle B, Bentzen H, Giangregorio L, Pripp AH, Skelton DA, Bergland A. Physical fitness in older women with osteoporosis and vertebral fracture after a resistance and balance exercise programme: 3-month post-intervention follow-up of a randomised controlled trial. BMC Musculoskelet Disord. 2020 Jul 18;21(1):471. doi: 10.1186/s12891-020-03495-9.
Results Reference
derived
PubMed Identifier
31925473
Citation
Stanghelle B, Bentzen H, Giangregorio L, Pripp AH, Skelton DA, Bergland A. Effects of a resistance and balance exercise programme on physical fitness, health-related quality of life and fear of falling in older women with osteoporosis and vertebral fracture: a randomized controlled trial. Osteoporos Int. 2020 Jun;31(6):1069-1078. doi: 10.1007/s00198-019-05256-4. Epub 2020 Jan 10. Erratum In: Osteoporos Int. 2020 Apr 27;:
Results Reference
derived
PubMed Identifier
31684886
Citation
Stanghelle B, Bentzen H, Giangregorio L, Pripp AH, Bergland A. Associations between health-related quality of life, physical function and pain in older women with osteoporosis and vertebral fracture. BMC Geriatr. 2019 Nov 4;19(1):298. doi: 10.1186/s12877-019-1268-y.
Results Reference
derived
PubMed Identifier
29615028
Citation
Stanghelle B, Bentzen H, Giangregorio L, Pripp AH, Bergland A. Effect of a resistance and balance exercise programme for women with osteoporosis and vertebral fracture: study protocol for a randomized controlled trial. BMC Musculoskelet Disord. 2018 Apr 3;19(1):100. doi: 10.1186/s12891-018-2021-y.
Results Reference
derived

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

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