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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02218411
Other study ID # CEU UCH
Secondary ID
Status Completed
Phase Phase 1
First received July 14, 2014
Last updated August 14, 2014
Start date September 2012
Est. completion date January 2013

Study information

Verified date August 2014
Source Cardenal Herrera University
Contact n/a
Is FDA regulated No
Health authority Spain: Ethics Committee
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 55
Est. completion date January 2013
Est. primary completion date September 2012
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 65 Years and older
Eligibility 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 Design

Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Other:
Exercise training
Exercises routine based on the Otago exercise programme

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Cardenal Herrera University

Outcome

Type Measure Description Time frame Safety issue
Primary Change in the Timed Up and Go test General mobility measurement Pre intervention and after 4-month intervention No
Secondary Change in the Berg Balance Scale Functional Balance measurement Pre intervention and after 4-month intervention No
Secondary Change in the 6.min Walk Test Aerobic Endurance Measurement Pre intervention and after 4-month intervention No
Secondary Change in the One-Leg Stand One-leg Balance Measurement Pre intervention and after 4-month intervention No
Secondary Change in the Short Physical Performance Battery Lower Limb Functional Measurement Pre intervention and after 4-month intervention No
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