NCT00785746

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P75+ for early_phase_1

Timeline
Completed

Started Aug 2006

Typical duration for early_phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2006

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

November 4, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 5, 2008

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

February 4, 2013

Status Verified

March 1, 2010

Enrollment Period

3.3 years

First QC Date

November 4, 2008

Last Update Submit

February 1, 2013

Conditions

Keywords

elderly, balance, core, strength

Outcome Measures

Primary Outcomes (1)

  • Berg balance scale

    baseline, 6 weeks, discharge

Secondary Outcomes (5)

  • Functional walking capacity 6 minute walk test

    baseline, 6 weeks, discharge

  • Gait speed

    baseline, 6 weeks, discharge

  • Bridge Test

    Baseline, 6 weeks, discharge

  • Activities-Specific Balance Confidence Scale (ABC Scale)

    Baseline, 6 weeks, Discharge

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

    Baseline, 6 weeks, discharge

Study Arms (2)

core

EXPERIMENTAL

strength training of the core muscles.

Other: Core

stretch and strength

NO INTERVENTION

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

CoreOTHER

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.

core

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

McGill University-Royal Victoria Hospital Site

Montreal, Quebec, H3A-1A1, Canada

Location

Study Officials

  • Nancy E Mayo, PhD

    McGill University, Division of Clinical Epidemiology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
BSc(PT), MSc, PhD

Study Record Dates

First Submitted

November 4, 2008

First Posted

November 5, 2008

Study Start

August 1, 2006

Primary Completion

December 1, 2009

Study Completion

December 1, 2009

Last Updated

February 4, 2013

Record last verified: 2010-03

Locations