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CompletedNCT00785746Updated Feb 4, 2013

Improving Balance in Frail Elderly

An Early Phase 1 interventional study of Core in Elderly and Frail, sponsored by McGill University. Completed at 1 site in Canada. Per ClinicalTrials.gov, last updated 2013-02-04.

Sponsored by McGill University · Early Phase 1 and Interventional

Phase
Early Phase 1
Study type
Interventional
Enrollment
60
Allocation
Randomized
Sex
All
01

Study summary

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.

Read the 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.

02

Conditions studied

  • Elderly
  • Frail

Keywords

  • elderly, balance, core, strength
03

In context

Lead sponsor

McGill University is the lead sponsor of 244 studies on the registry; 49 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • persons who are not medically fit to participate in the Geriatric day hospital physiotherapy component.
  • the individuals at high risk for falls
05

Study design

Phase
Early Phase 1
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
60 participants (actual)

Study arms

  • Experimental
    core

    strength training of the core muscles.

    Other: Core

  • 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.

Interventions

  • OtherCore

    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.

06

What researchers measure

Primary outcomes

  1. Berg balance scale

    Time frame: baseline, 6 weeks, discharge

Secondary outcomes

  1. Functional walking capacity 6 minute walk test

    Time frame: baseline, 6 weeks, discharge

  2. Gait speed

    Time frame: baseline, 6 weeks, discharge

  3. Bridge Test

    Time frame: Baseline, 6 weeks, discharge

  4. Activities-Specific Balance Confidence Scale (ABC Scale)

    Time frame: Baseline, 6 weeks, Discharge

  5. International Consultation on Urinary Incontinence Questionnaire- Urinary Incontinence Short Form (ICIQ-UI)

    Time frame: Baseline, 6 weeks, discharge

07

Study locations

1 site
  • McGill University-Royal Victoria Hospital Site
    Montreal, Quebec H3A-1A1, Canada
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 4, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00785746
Lead sponsor
McGill University
Responsible party
Nancy Mayo (BSc(PT), MSc, PhD, McGill University) — Principal investigator
First posted
Nov 5, 2008
Start date
Aug 2006
Primary completion
Dec 2009
Completion
Dec 2009
Last update
Feb 4, 2013

Study contacts

Nancy E Mayo, PhD
principal investigator · McGill University, Division of Clinical Epidemiology

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2010. You cannot join it, but the record below documents what was studied.

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