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

NCT ID: NCT02781974

Last Updated: 2019-03-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

149 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-31

Study Completion Date

2018-10-12

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Osteoporosis Vertebral Fractures

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Intervention

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

Group Type EXPERIMENTAL

Exercise

Intervention Type OTHER

Strength and balance exercise in Groups, focusing on lower limb strength, back strength and static and dynamic balance

Control

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Exercise

Strength and balance exercise in Groups, focusing on lower limb strength, back strength and static and dynamic balance

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Oslo Metropolitan University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Brita Stanghelle

phd-student

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

OsloMet - Oslo Metropolitan University

Oslo, , Norway

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Norway

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 32682416 (View on PubMed)

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.

Reference Type DERIVED
PMID: 31925473 (View on PubMed)

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.

Reference Type DERIVED
PMID: 31684886 (View on PubMed)

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.

Reference Type DERIVED
PMID: 29615028 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2014/2050

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.