Video-supported Group-based Otago Exercise Programme on P... | NCT02218411

Studies
Video-supported Group-based Otago Exercise Programme on Physical Performance in Older Adults.

NCT02218411

Sponsor

Cardenal Herrera University

Status

Completed

Last Update Posted

Aug 18, 2014Estimated

Enrollment

55Actual

Phase

Phase 1

Conditions

Healthy Aging

Interventions

Exercise training

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2012

Primary Completion Date

Sep 2012Actual

Completion Date

Jan 2013Actual

First Submitted Date

Jul 14, 2014

First Submission Date that Met QC Criteria

Aug 14, 2014

First Posted Date

Aug 18, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 14, 2014

Last Update Posted Date

Aug 18, 2014Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Eva Segura Ortí, Effectiveness of a video-supported group-based Otago exercise programme on physical performance in community-dwelling older adults: a pilot randomized controlled trial, Cardenal Herrera UniversityPrincipal Investigator

Lead Sponsor

Cardenal Herrera UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

55Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Exercise	Experimental	Exercises routine based on the Otago exercise programme	Other: Exercise training

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Exercise training	Other	Exercises routine based on the Otago exercise programme	Exercise

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in the Timed Up and Go test	General mobility measurement	Pre intervention and after 4-month intervention

Secondary Outcomes

Measure	Description	Time Frame
Change in the Berg Balance Scale	Functional Balance measurement	Pre intervention and after 4-month intervention
Change in the 6.min Walk Test	Aerobic Endurance Measurement

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

65 Years

Maximum Age

Not provided

Standard Ages

Older Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Vicent Benavent-Caballer, PT, MS	CEU UCH	Principal Investigator

Locations

Not provided

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
26395209	Derived	Benavent-Caballer V, Rosado-Calatayud P, Segura-Orti E, Amer-Cuenca JJ, Lison JF. The effectiveness of a video-supported group-based Otago exercise programme on physical performance in community-dwelling older adults: a preliminary study. Physiotherapy. 2016 Sep;102(3):280-6. doi: 10.1016/j.physio.2015.08.002. Epub 2015 Sep 1.

ID	Term
D009043	Motor Activity
D009068	Movement
D009142	Musculoskeletal Physiological Phenomena
D055687	Musculoskeletal and Neural Physiological Phenomena