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

Osteoporosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02781974
• Other study ID #: 2014/2050
• Status: Completed
• Phase: N/A
• Start date: January 2016
• Est. completion date: October 12, 2018

Study information

• Verified date: March 2019
• Source: Oslo and Akershus University College of Applied Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 149
• Est. completion date: October 12, 2018
• Est. primary completion date: October 12, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fractures, Bone
• Osteoporosis
• Spinal Fractures
• Vertebral Fractures

Intervention

Other:
• Exercise
Strength and balance exercise in Groups, focusing on lower limb strength, back strength and static and dynamic balance

Locations

Country	Name	City	State
Norway	OsloMet - Oslo Metropolitan University	Oslo

Sponsors (1)

Lead Sponsor	Collaborator
Oslo and Akershus University College of Applied Sciences

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	10 meter habitual walking speed		Up to 18 months
Secondary	Quality of life of participants assessed by the questionnaire Qualeffo 41		Up to 18 months
Secondary	Senior Fitness test		Up to 18 months
Secondary	Functional reach		Up to 18 months
Secondary	Four Square Step Test		Up to 18 months
Secondary	Grip Strength		Up to 18 months
Secondary	Short Form -36		Up to 18 months
Secondary	FES-1		Up to 18 months
Secondary	IPAQ-SF		Up to 18 months
Secondary	Patient Specific Function Scale		Up to 18 months