Fall prevention in the elderly - A randomized clinical trial on the effectiveness of Tai Chi Chuan

ISRCTN	ISRCTN98840266
DOI	https://doi.org/10.1186/ISRCTN98840266
ClinicalTrials.gov (NCT)	Nil known
Clinical Trials Information System (CTIS)	Nil known
Protocol serial number	22000131
Sponsor	Netherlands Organisation for Health Research and Development (ZonMw)
Funder	Netherlands Organisation for Health Research and Development (ZonMw) - 22000131.

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Dr Petra EM Zeeuwe
Scientific

PO Box 1738
Rotterdam
3000 DR
Netherlands

Phone	+31 (0)10 4632119
Email	p.zeeuwe@erasmusmc.nl

Primary study design	Interventional
Study design	Randomized controlled trial
Secondary study design	Randomised controlled trial
Scientific title	Fall prevention in the elderly - A randomized clinical trial on the effectiveness of Tai Chi Chuan
Study objectives	Tai Chi Chuan can reduce fall incidents in the elderly living at home who are at risk of falling.
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Fall prevention
Intervention	Tai Chi Chuan lessons for a period of 13 weeks, twice a week for 1 hour Control: no intervention
Intervention type	Other
Primary outcome measure(s)	New fall incidents
Key secondary outcome measure(s)	1. Balance 2. Fear of falling 3. Blood pressure 4. Heart frequency 5. Some lung parameters 6. Physical activity 7. Self-efficacy 8. Quality of life 9. Mental health 10. Severity of fall incidents and consequent injuries 11. Medical consumption 12. Compliance to intervention
Completion date	01/03/2005

Participant type(s)	Patient
Age group	Senior
Sex	All
Target sample size at registration	270
Key inclusion criteria	1. Experienced a fall in the preceding year, or 2. Suffer from two of the following risk factors: a. Disturbed balance b. Mobility problems c. Dizziness d. The use of benzodiazepines or diuretics
Key exclusion criteria	1. Progressive disorders 2. Unable to undergo the intervention 3. Unable to fill in a Dutch questionnaire 4. Miss 80% of the lessons 5. Tai Chi Chuan performed in the preceding year 6. Not available during the next 4 months
Date of first enrolment	01/09/2003
Date of final enrolment	01/03/2005

PO Box 1738

Rotterdam
3000 DR
Netherlands

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Protocol article	Study protocol	30/03/2006		Yes	No

06/11/2019: Internal review.