NCT02781974

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
149

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

May 18, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 25, 2016

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 12, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 12, 2018

Completed
Last Updated

March 8, 2019

Status Verified

March 1, 2019

Enrollment Period

2.8 years

First QC Date

May 18, 2016

Last Update Submit

March 6, 2019

Conditions

OsteoporosisVertebral Fractures

Outcome Measures

Primary Outcomes (1)

  • 10 meter habitual walking speed

    Up to 18 months

Secondary Outcomes (9)

  • 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

  • +4 more secondary outcomes

Study Arms (2)

Intervention

EXPERIMENTAL

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

Other: Exercise

Control

NO INTERVENTION

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

Interventions

ExerciseOTHER

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

Intervention

Eligibility Criteria

Age65 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

OsloMet - Oslo Metropolitan University

Oslo, 0130, Norway

Location

Related Publications (4)

  • 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.

    PMID: 32682416DERIVED

  • 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.

    PMID: 31925473DERIVED

  • 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.

    PMID: 31684886DERIVED

  • 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.

    PMID: 29615028DERIVED

MeSH Terms

Conditions

OsteoporosisSpinal Fractures

Interventions

Exercise

Condition Hierarchy (Ancestors)

Bone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic DiseasesSpinal InjuriesBack InjuriesWounds and InjuriesFractures, Bone

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

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
PRINCIPAL INVESTIGATOR
PI Title
phd-student

Study Record Dates

First Submitted

May 18, 2016

First Posted

May 25, 2016

Study Start

January 1, 2016

Primary Completion

October 12, 2018

Study Completion

October 12, 2018

Last Updated

March 8, 2019

Record last verified: 2019-03

Locations

NO(1)