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Trial registered on ANZCTR


Registration number
ACTRN12619001183178
Ethics application status
Approved
Date submitted
5/08/2019
Date registered
22/08/2019
Date last updated
30/09/2019
Date data sharing statement initially provided
22/08/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Preventing falls in older age with yoga-based exercise: effectiveness, cost-effectiveness and implementation
Scientific title
What is the effect of a group-based yoga exercise program compared to a yoga relaxation program on falls among community-dwelling people aged 60 years and over?
Secondary ID [1] 298827 0
APP1163067
Universal Trial Number (UTN)
Trial acronym
Successful AGEing (SAGE) yoga trial
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Falls
313782 0
Condition category
Condition code
Injuries and Accidents 312184 312184 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Arm 1: Group-based yoga exercise program.
Participants allocated to the group-based yoga exercise program will be offered attendance at yoga classes in trial-specific groups of 15-25 people at established yoga studios with experienced yoga teachers. Participants will aim to attend 80, one-hour duration classes in total on a twice-weekly basis, over the 12-month period. Participants will be also asked to complete a home-based yoga program for at least two 20-minute sessions each week.
The yoga classes will be provided free of charge to participants. Class content will emphasise standing yoga postures that challenge balance and build leg strength. The program will be tailored to participant ability and progression of difficulty for each posture will occur as skills and confidence increase. The program is based on the Iyengar style of yoga which was chosen as it involves holding static postures rather than flowing movements, which is likely to be simpler to learn and has been used successfully with older adults. Iyengar yoga also uses aids (“props” e.g. blocks, straps) to modify the postures and to enable people with a range of functional abilities to participate, making it the ideal style for older people. Intervention adherence will be recorded by yoga teachers who will keep class attendance records and participants who will keep home yoga practise diaries.
Intervention code [1] 315093 0
Treatment: Other
Intervention code [2] 315094 0
Prevention
Comparator / control treatment
Arm 2: Yoga relaxation program group
Participants allocated to the yoga relaxation program group will attend two one-hour workshops with groups of 15-25 people to learn a relaxation yoga program. Participants will be encouraged to practice this regularly. The workshops will be held at approximately 2 weeks and 6 weeks after randomisation. The frequency of practice of the yoga relaxation program will be at the discretion of the participants. The yoga relaxation program differs from the intervention in that it will include seated or lying postures that do not impact on balance or leg strength but emphasise breathing and relaxation.
Control group
Active

Outcomes
Primary outcome [1] 320817 0
Number of falls in the 12 months after randomisation, assessed using monthly falls calendars.
Timepoint [1] 320817 0
12 month period after randomisation.
Secondary outcome [1] 372941 0
Mental wellbeing assessed using the Warwick-Edinburgh Mental Well-being Scale.
Timepoint [1] 372941 0
Baseline and 12 months after randomisation
Secondary outcome [2] 372942 0
Self-reported overall physical activity, planned activity and home exercise assessed with the Incidental and Planned Exercise Questionnaire.
Timepoint [2] 372942 0
Baseline and 12 months after randomisation
Secondary outcome [3] 372943 0
Quality of life assessed using the EQ-5D-5L.
Timepoint [3] 372943 0
Baseline and 12 months after randomisation
Secondary outcome [4] 372944 0
Balance self-confidence assessed with the Activity-specific Balance Confidence Scale- Simplified
Timepoint [4] 372944 0
Baseline and 12 months after randomisation
Secondary outcome [5] 372945 0
Physical function assessed with the lower limb function subscale of the Late Life Function and Disability Instrument.
Timepoint [5] 372945 0
Baseline and 12 months after randomisation
Secondary outcome [6] 372946 0
Pain assessed with specific study developed questions
Timepoint [6] 372946 0
Baseline and 12 months after randomisation
Secondary outcome [7] 372947 0
Goal attainment measured with the Goal Attainment Scale.
Timepoint [7] 372947 0
12 months after randomisation
Secondary outcome [8] 372948 0
Sleep quality and disturbances measured using Pittsburg Sleep Quality Index.
Timepoint [8] 372948 0
Baseline and 12 months after randomisation
Secondary outcome [9] 373945 0
Cost-effectiveness of delivering the intervention, fall-related and total costs of health and community service utilisation. Health-system and community-service contact will be collected on a monthly basis along with the falls calendars. Participants will be asked to mark on the monthly postal questionnaire each time they use a health and community service (e.g. GP, physiotherapist, nurse).
Timepoint [9] 373945 0
12-month period after randomisation.
Secondary outcome [10] 373946 0
Process evaluation using semi-structured interviews with yoga instructors and participants.
Timepoint [10] 373946 0
12 and 18 months after randomisation.

Eligibility
Key inclusion criteria
Eligible participants will:
a) Be aged 60 years and over;
b) Live independently at home;
c) Not currently participate in yoga;
d) Be able to travel to an intervention location.
Minimum age
60 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
People will be excluded if they:
a) Are “house-bound” (have not been outside independently in past month);
b) Have a cognitive impairment (scoring 4 or less on the 8-point Memory Impairment Screen);
c) Have insufficient English language skills to fully participate;
d) Have self-assessed inability to walk 10 metres unassisted; have a progressive neurological disease (e.g. Parkinson‘s disease);
e) Have a medical condition precluding exercise (e.g. unstable cardiac disease).

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)
Group allocation will be determined using REDCap (Research Electronic Data Capture), a centralised web-based randomisation system within The University of Sydney. This will ensure concealment of allocation to groups and an auditable process. Randomisation will occur after participants have completed all baseline measures to avoid recruitment bias.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomisation schedule will be created by a researcher not involved in recruitment/eligibility assessment using Stata software (StataCorp) and embedded in the study REDCap database. The group allocation system will use stratification to ensure balance by yoga studio location.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
The number of falls per person-year will be analysed using negative binomial regression models to estimate between-group difference in fall rates after one year (primary outcome). Generalised linear models will assess the effect of group allocation on continuously-scored secondary outcomes (mental wellbeing, physical activity, quality of life, balance confidence, physical function, pain, goal attainment, sleep), adjusting for baseline scores. Analyses will follow a pre-specified Statistical Analysis Plan, will be conducted while masked to group allocation and will use an intention-to-treat approach. Analyses will utilise Stata software and will be overseen by an experienced biostatistician.
The economic evaluation will take a health and community care funder perspective, and will include benefits related to falls prevented and Quality Adjusted Life Years (QALY) gained. Using mean costs and mean health outcomes in each trial arm, the incremental cost/ QALY of the intervention group compared with control group will be calculated and plotted on a cost-effectiveness plane. Bootstrapping will be used to estimate a distribution around costs and health outcomes, and to calculate the confidence intervals around the incremental cost-effectiveness ratios. One-way sensitivity analysis will be conducted around key variables, and a probabilistic sensitivity analysis will be conducted to estimate the joint uncertainty in all parameters; a cost-effectiveness acceptability curve (CEAC) will be plotted to measure the probability that an intervention is cost-effective, given a decision maker’s willingness to pay for each additional QALY gained. We will collect intervention cost data (staff costs, consumables, capital costs), health and community service contact, fall rates and utility-based quality of life.

Recruitment
Recruitment status
Recruiting
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] 303378 0
Government body
Name [1] 303378 0
NHMRC Project Grant
Address [1] 303378 0
Level 1
16 Marcus Clarke Street
Canberra ACT 2601
Country [1] 303378 0
Australia
Primary sponsor type
University
Name
The University of Sydney
Address
PO BOX M179
Missenden Road, Camperdown
NSW 2050
Country
Australia
Secondary sponsor category [1] 303411 0
None
Name [1] 303411 0
Address [1] 303411 0
Country [1] 303411 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303910 0
The University of Sydney Human Research Ethics Committee
Ethics committee address [1] 303910 0
Human Ethics Office
Margaret Telfer Building (K07)
University of Sydney NSW 2006
Ethics committee country [1] 303910 0
Australia
Date submitted for ethics approval [1] 303910 0
04/07/2019
Approval date [1] 303910 0
22/08/2019
Ethics approval number [1] 303910 0

Summary
Brief summary
This study aims to compare the effect on falls and other measures of health and wellbeing of:
a) a group-based yoga exercise program over 12 months, and
b) a seated home-based yoga relaxation program over 12 months. Participants allocated to the group-based yoga exercise program will attend yoga classes at established yoga studios with experienced yoga teachers for one hour, twice weekly for 40 weeks. Participants allocated to the yoga relaxation program group will attend two one-hour workshops to learn a relaxation yoga program. We hypothesise that greater effects on the rate of falls will be evident from the group-based yoga exercise program compared to the yoga relaxation program.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 95214 0
A/Prof Anne Tiedemann
Address 95214 0
Institute for Musculoskeletal Health, School of Public Health, The University of Sydney, PO Box M179 Missenden Rd NSW 2050
Country 95214 0
Australia
Phone 95214 0
+61 2 86276233
Fax 95214 0
+61 2 96570301
Email 95214 0
anne.tiedemann@sydney.edu.au
Contact person for public queries
Name 95215 0
A/Prof Anne Tiedemann
Address 95215 0
Institute for Musculoskeletal Health, School of Public Health, The University of Sydney, PO Box M179 Missenden Rd NSW 2050
Country 95215 0
Australia
Phone 95215 0
+61 2 86276233
Fax 95215 0
+61 2 96570301
Email 95215 0
anne.tiedemann@sydney.edu.au
Contact person for scientific queries
Name 95216 0
A/Prof Anne Tiedemann
Address 95216 0
Institute for Musculoskeletal Health, School of Public Health, The University of Sydney, PO Box M179 Missenden Rd NSW 2050
Country 95216 0
Australia
Phone 95216 0
+61 2 86276233
Fax 95216 0
+61 2 96570301
Email 95216 0
anne.tiedemann@sydney.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Individual participant data underlying published results
When will data be available (start and end dates)?
Beginning 3 months and ending 5 years following main results publication.
Available to whom?
Data will be available on a case-by-case basis at the discretion of the Principal Chief Investigator.
Available for what types of analyses?
For meta-analysis.
How or where can data be obtained?
Access subject to approvals by Principal Chief Investigator (anne.tiedemann@sydney.edu.au)
What supporting documents are/will be available?
Study protocol
Statistical analysis plan
Informed consent form
Ethical approval
How or where can supporting documents be obtained?
Type [1] 3434 0
Study protocol
Citation [1] 3434 0
Link [1] 3434 0
Email [1] 3434 0
anne.tiedemann@sydney.edu.au
Other [1] 3434 0
Attachment [1] 3434 0
Type [2] 3435 0
Statistical analysis plan
Citation [2] 3435 0
Link [2] 3435 0
Email [2] 3435 0
anne.tiedemann@sydney.edu.au
Other [2] 3435 0
Attachment [2] 3435 0
Type [3] 3436 0
Informed consent form
Citation [3] 3436 0
Link [3] 3436 0
Email [3] 3436 0
anne.tiedemann@sydney.edu.au
Other [3] 3436 0
Attachment [3] 3436 0
Type [4] 3437 0
Ethical approval
Citation [4] 3437 0
Link [4] 3437 0
Email [4] 3437 0
anne.tiedemann@sydney.edu.au
Other [4] 3437 0
Attachment [4] 3437 0
Summary results
No Results