Condition category
Injury, Occupational Diseases, Poisoning
Date applied
26/09/2005
Date assigned
26/09/2005
Last edited
25/02/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Michel Y. Tousignant

ORCID ID

Contact details

Centre de recherche sur le vieillissement
I.U.G.S. - Pavillon D'Youville
1036
rue Belvédère Sud
Sherbrooke
J1H 4C4
Canada
+1 819-821-1170 (2351)
Michel.Tousignant@USherbrooke.ca

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

MCT-58344

Study information

Scientific title

Cost-efficacy analysis of balance training based on Tai Chi to prevent falls in frail older adults: a randomised controlled trial

Acronym

Study hypothesis

At the end of the intervention:
1. Falls incidence rate will be inferior in the Tai Chi intervention as compared to conventional balance intervention
2. Total number of falls will be inferior in the Tai Chi intervention as compared to conventional balance intervention
3. Tai Chi intervention will be cost-effective as compared to conventional balance intervention

Ethics approval

Comité d'éthique de la recherche, Institut universitaire de gériatrie de Sherbrooke, Sherbrooke, Québec approved on the 11th November 2003

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Any diagnosis causing the loss of autonomy; falls in elderly adults

Intervention

Experimental group: Tai Chi intervention includes two sessions of one hour per day for 15 weeks. The intervention is based on movement using body alignment and specific weight transfers in different directions. 10 movements compose the sequence of Tai Chi. Moreover, the subjects are trained to relaxation and breathing exercises. The intervention is given in groups of 4 to 6 subjects. Since subjects present specific disabilities, the intervention is adapted in order to be at the limit of the capacities for each individual in a secure way. Feedback is given at each session.

Control group:
Conventional physiotherapy balance training is given to subjects of the control group for two sessions of one hour per day for 15 weeks

Trial details received: 12 Sept 2005

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Incidence rate on fall in one year of follow-up

Secondary outcome measures

1. Time interval between end of the intervention and the first fall
2. Total number of falls by subjects
3. Balance
4. Walking
5. Fear of Falling
6. Social participation

Overall trial start date

01/10/2002

Overall trial end date

30/06/2007

Reason abandoned

Eligibility

Participant inclusion criteria

1. To be a risk of falling (at least one fall in the six last months)
2. Aged greater than or equal to 65 years old, either sex
3. Scoring less than 49/56 at the Berg test
4. Showing good mental capacities (scoring greater than 65 at the 3MS test)

Participant type

Patient

Age group

Senior

Gender

Both

Target number of participants

122

Participant exclusion criteria

To be unable to make physical exercises based on medical assessment

Recruitment start date

01/10/2002

Recruitment end date

30/06/2007

Locations

Countries of recruitment

Canada

Trial participating centre

Centre de recherche sur le vieillissement
Sherbrooke
J1H 4C4
Canada

Sponsor information

Organisation

University of Sherbrooke (Canada)

Sponsor details

2500
Boulevard Université
Sherbrooke
J1K 2R1
Canada

Sponsor type

University/education

Website

http://www.usherbrooke.ca/

Funders

Funder type

Research organisation

Funder name

Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MCT-58344)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes