- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00785746
Improving Balance in Frail Elderly
February 1, 2013 updated by: Nancy Mayo, McGill University
Improving Balance in Frail Elderly: A Randomized Clinical Trial of Two Methods to Enhance Strength (Stretch and Strength Versus Core Strength)
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.
Study Overview
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.
Study Type
Interventional
Enrollment (Actual)
60
Phase
- Early Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Quebec
-
Montreal, Quebec, Canada, H3A-1A1
- McGill University-Royal Victoria Hospital Site
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-
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
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
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
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: core
strength training of the core muscles.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Berg balance scale
Time Frame: baseline, 6 weeks, discharge
|
baseline, 6 weeks, discharge
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Functional walking capacity 6 minute walk test
Time Frame: baseline, 6 weeks, discharge
|
baseline, 6 weeks, discharge
|
|
Gait speed
Time Frame: baseline, 6 weeks, discharge
|
baseline, 6 weeks, discharge
|
|
Bridge Test
Time Frame: Baseline, 6 weeks, discharge
|
Baseline, 6 weeks, discharge
|
|
Activities-Specific Balance Confidence Scale (ABC Scale)
Time Frame: Baseline, 6 weeks, Discharge
|
Baseline, 6 weeks, Discharge
|
|
International Consultation on Urinary Incontinence Questionnaire- Urinary Incontinence Short Form (ICIQ-UI)
Time Frame: Baseline, 6 weeks, discharge
|
Baseline, 6 weeks, discharge
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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
August 1, 2006
Primary Completion (Actual)
December 1, 2009
Study Completion (Actual)
December 1, 2009
Study Registration Dates
First Submitted
November 4, 2008
First Submitted That Met QC Criteria
November 4, 2008
First Posted (Estimate)
November 5, 2008
Study Record Updates
Last Update Posted (Estimate)
February 4, 2013
Last Update Submitted That Met QC Criteria
February 1, 2013
Last Verified
March 1, 2010
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- SDR-06--010
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.