Improving Balance in Frail Elderly

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Nancy Mayo, McGill University

ClinicalTrials.gov Identifier:

NCT00785746

First received: November 4, 2008

Last updated: February 1, 2013

Last verified: March 2010

History of Changes

Purpose

The objective of this pilot study is to estimate, for a frail elderly population, the extent to which balance improves following a Core-Strength training program in comparison to a Stretch & Strength program. A secondary objective is to explore the impact of core strength training on urinary incontinence.

Condition	Intervention	Phase
Elderly Frail	Other: Core	Phase 0

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor)
Official Title:	Improving Balance in Frail Elderly: A Randomized Clinical Trial of Two Methods to Enhance Strength (Stretch and Strength Versus Core Strength)

Resource links provided by NLM:

MedlinePlus related topics: Urinary Incontinence

U.S. FDA Resources

Further study details as provided by McGill University:

Primary Outcome Measures:

Berg balance scale [ Time Frame: baseline, 6 weeks, discharge ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Functional walking capacity 6 minute walk test [ Time Frame: baseline, 6 weeks, discharge ] [ Designated as safety issue: No ]
Gait speed [ Time Frame: baseline, 6 weeks, discharge ] [ Designated as safety issue: No ]
Bridge Test [ Time Frame: Baseline, 6 weeks, discharge ] [ Designated as safety issue: No ]
Activities-Specific Balance Confidence Scale (ABC Scale) [ Time Frame: Baseline, 6 weeks, Discharge ] [ Designated as safety issue: No ]
International Consultation on Urinary Incontinence Questionnaire- Urinary Incontinence Short Form (ICIQ-UI) [ Time Frame: Baseline, 6 weeks, discharge ] [ Designated as safety issue: No ]

Enrollment:	60
Study Start Date:	August 2006
Study Completion Date:	December 2009
Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: core strength training of the core muscles.	Other: Core We have devised a series of core strength training exercises that can be easily and safely performed under the supervision of trained staff. The exercises will be individualized depending on the participants' ability and health conditions. The majority, but not all, of exercises will be performed on or with exercise balls of different sizes and shapes, round for more advanced persons and oval for more frail persons.
No Intervention: stretch and strength This program consists of general stretching exercises and peripheral muscle strengthening exercises with a special emphasis on strengthening the upper extremity muscles because of their importance for ADL but not necessarily balance.

Arms

Assigned Interventions

Experimental: core

strength training of the core muscles.

Other: Core

We have devised a series of core strength training exercises that can be easily and safely performed under the supervision of trained staff. The exercises will be individualized depending on the participants' ability and health conditions. The majority, but not all, of exercises will be performed on or with exercise balls of different sizes and shapes, round for more advanced persons and oval for more frail persons.

No Intervention: stretch and strength

This program consists of general stretching exercises and peripheral muscle strengthening exercises with a special emphasis on strengthening the upper extremity muscles because of their importance for ADL but not necessarily balance.

Detailed Description:

Participants will be randomized to one of the two exercise groups, Core-Strength training group or the Stretch & Strength group. The exercises will consist of 15-20 minute session for every day they attend the GDH. Measures will be made at admission, after 6 weeks of the program and at discharge if more than past 6 weeks.

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

elderly persons attending the geriatric day hospital at the royal victoria hospital

Exclusion Criteria:

persons who are not medically fit to participate in the Geriatric day hospital physiotherapy component.
the individuals at high risk for falls

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00785746

Locations

Canada, Quebec
McGill University-Royal Victoria Hospital Site
Montreal, Quebec, Canada, H3A-1A1

Sponsors and Collaborators

McGill University

Investigators

Principal Investigator:

Nancy E Mayo, PhD

McGill University, Division of Clinical Epidemiology

More Information

No publications provided

Responsible Party:	Nancy Mayo, BSc(PT), MSc, PhD, McGill University
ClinicalTrials.gov Identifier:	NCT00785746 History of Changes
Other Study ID Numbers:	SDR-06--010
Study First Received:	November 4, 2008
Last Updated:	February 1, 2013
Health Authority:	Canada: Ethics Review Committee

Keywords provided by McGill University:

elderly, balance, core, strength

ClinicalTrials.gov processed this record on June 18, 2013

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