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Trial registered on ANZCTR


Registration number
ACTRN12612000103864
Ethics application status
Approved
Date submitted
18/01/2012
Date registered
20/01/2012
Date last updated
21/05/2013
Type of registration
Retrospectively registered

Titles & IDs
Public title
Preventing falls in older people in residential care settings: improving balance through Tai Chi and Yoga - a randomised controlled study.
Scientific title
In residents of aged care facilities, can Tai Chi and/ or Yoga compared with usual care improve balance and prevent falls?
Secondary ID [1] 279690 0
Nil
Universal Trial Number (UTN)
U1111-1126-9617
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Falls in older people in residential care 285619 0
Improving balance through Tai Chi and Yoga 285639 0
Condition category
Condition code
Public Health 285808 285808 0 0
Epidemiology
Alternative and Complementary Medicine 285825 285825 0 0
Other alternative and complementary medicine
Physical Medicine / Rehabilitation 285826 285826 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Exercise intervention. Professional Yoga and Tai Chi trainers delivered modified Yoga and Tai Chi to participating residents of an aged care facility in half hour sessions, twice a week for fourteen weeks. There were two parallel intervention groups: a Yoga group and a Tai Chi group.

The yoga program included limbering movements, asanas, breathing practices and a type of relaxation meditation called 'yoga nidra'.

The tai chi program comprised slow, controlled and circular movements that used functional patterns and engaged the mind.

Both Yoga and Tai Chi were modified to suit the individual participant.
Intervention code [1] 283984 0
Rehabilitation
Intervention code [2] 284089 0
Prevention
Intervention code [3] 284090 0
Lifestyle
Comparator / control treatment
Usual activities offered in residential care facility. The facility offered all residents a ' Staying Active' program that included:
1. weekly half hour seated exercise sessions called Physical culture.
2. gym with bikes, pulleys and massage by a trained staff
3. Games and group activities ( eg. Bingo, group reading, story telling)
Control group
Active

Outcomes
Primary outcome [1] 286324 0
Berg Balance Score
Timepoint [1] 286324 0
At week one and week fourteen of intervention period
Secondary outcome [1] 295428 0
Pain measured by verbal descriptor pain scale
Timepoint [1] 295428 0
At Week One, Week Seven and Week Fourteen of intervention period
Secondary outcome [2] 295429 0
Quality of life measured by Dementia Quality of Life (DEMQOL) Questionnaire
Timepoint [2] 295429 0
At Week One, Week Seven and Week Fourteen of intervention period
Secondary outcome [3] 295613 0
number of falls from the resident medical/nursing records maintained by the facility
Timepoint [3] 295613 0
6 months before intervention, during intervention and 6 months after intervention

Eligibility
Key inclusion criteria
Resident of aged care facility, ability to stand with hand support, ability to understand English, ability to understand and follow simple instructions and demonstrations
Minimum age
60 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Severe debilitating illness, severe cognitive impairment, inability to see, inability to hear, medically unfit for exercise, inability to understand and or to speak English.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participants were recruited by informed consent, baseline assessment; randomisation by a researcher not involved in recruitment and allocation concealed in sealed opaque envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 284472 0
University
Name [1] 284472 0
Research Training Scheme Allowance for Research Higher Degree Students- University of Newcastle
Address [1] 284472 0
School of Nursing and Midwifery, Faculty of Health, University of Newcastle, Callaghan, NSW 2308
Country [1] 284472 0
Australia
Primary sponsor type
University
Name
University of Newcastle
Address
School of Nursing and Midwifery, Faculty of Health, University of Newcastle, Callaghan, NSW 2308
Country
Australia
Secondary sponsor category [1] 283398 0
None
Name [1] 283398 0
Address [1] 283398 0
Country [1] 283398 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286457 0
Human Research Ethics Committee
Ethics committee address [1] 286457 0
Human Research Ethics Committee, University of Newcastle, Callaghan, NSW 2308
Ethics committee country [1] 286457 0
Australia
Date submitted for ethics approval [1] 286457 0
Approval date [1] 286457 0
09/12/2010
Ethics approval number [1] 286457 0
H-2010-1164

Summary
Brief summary
The main aims of the study are to:
1. Determine the feasibility of conducting a 14- week Tai Chi or Yoga program in a residential care setting.
2. Observe and record the modified Tai Chi and Yoga approaches used for older people with different levels of balance ability
3. Determine the feasibility of detecting changes in balance, pain experience, quality of life and incidence of falls in older residents who follow the Yoga/ Tai Chi programs compared to those who receive usual care.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33605 0
Prof Isabel Higgins
Address 33605 0
Professor of Older person Nursing,
School of nursing and midwifery, Faculty of Health, University Drive, University of Newcastle, Callaghan, NSW 2308
Country 33605 0
Australia
Phone 33605 0
+61249216144
Fax 33605 0
Email 33605 0
Isabel.Higgins@newcastle.edu.au
Contact person for public queries
Name 16852 0
Mrs Padmapriya Saravanakumar
Address 16852 0
Candidate for PhD, School of Nursing and Midwifery, Faculty of Health, University of Newcastle, Callaghan, NSW 2308.
Country 16852 0
Australia
Phone 16852 0
+61 425181973
Fax 16852 0
Email 16852 0
Padmapriya.Saravanakumar@uon.edu.au
Contact person for scientific queries
Name 7780 0
Prof Prof. Isabel Higgins
Address 7780 0
Professor of Older Person Nursing, School of Nursing and Midwifery, Faculty of Health, University of Newcastle, Callaghan, NSW 2308.
Country 7780 0
Australia
Phone 7780 0
+61 2 49216144
Fax 7780 0
Email 7780 0
Isabel.Higgins@newcastle.edu.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary