- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02218411
Video-supported Group-based Otago Exercise Programme on Physical Performance in Older Adults.
August 14, 2014 updated by: Eva Segura Ortí, Cardenal Herrera University
Effectiveness of a Video-supported Group-based Otago Exercise Programme on Physical Performance in Community-dwelling Older Adults: a Pilot Randomized Controlled Trial
The purpose of this study was to evaluate the effects of a video-supported group-based Otago exercise programme intervention on balance, mobility, physical performance and aerobic endurance in community-dwelling older adults 65+ years old.
Study Overview
Study Type
Interventional
Enrollment (Actual)
55
Phase
- Phase 1
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
65 years and older (Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Aged 65 years and older.
- Living in the community (Valencia, Spain).
- Able to ambulate independently without a walking aid.
- Have no severe medical contraindication for physical activity.
- Able to communicate.
- Have self-reported visual and auditory capacities to follow commands.
- Provide signed informed consent.
Exclusion Criteria:
- Unable to ambulate independently.
- Mini-mental state examination score of <24.
- Barthel Index score of <80.
- Severe visual and auditory disabilities.
- Unstable cardiovascular disease.
- Neurological disorder that could compromise them from exercising.
- Upper or lower extremity fracture in the past year.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Exercise
Exercises routine based on the Otago exercise programme
|
Exercises routine based on the Otago exercise programme
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in the Timed Up and Go test
Time Frame: Pre intervention and after 4-month intervention
|
General mobility measurement
|
Pre intervention and after 4-month intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in the Berg Balance Scale
Time Frame: Pre intervention and after 4-month intervention
|
Functional Balance measurement
|
Pre intervention and after 4-month intervention
|
Change in the 6.min Walk Test
Time Frame: Pre intervention and after 4-month intervention
|
Aerobic Endurance Measurement
|
Pre intervention and after 4-month intervention
|
Change in the One-Leg Stand
Time Frame: Pre intervention and after 4-month intervention
|
One-leg Balance Measurement
|
Pre intervention and after 4-month intervention
|
Change in the Short Physical Performance Battery
Time Frame: Pre intervention and after 4-month intervention
|
Lower Limb Functional Measurement
|
Pre intervention and after 4-month intervention
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Vicent Benavent-Caballer, PT, MS, CEU UCH
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2012
Primary Completion (Actual)
September 1, 2012
Study Completion (Actual)
January 1, 2013
Study Registration Dates
First Submitted
July 14, 2014
First Submitted That Met QC Criteria
August 14, 2014
First Posted (Estimate)
August 18, 2014
Study Record Updates
Last Update Posted (Estimate)
August 18, 2014
Last Update Submitted That Met QC Criteria
August 14, 2014
Last Verified
August 1, 2014
More Information
Terms related to this study
Other Study ID Numbers
- CEU UCH
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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