Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612001019897
Ethics application status
Approved
Date submitted
20/09/2012
Date registered
20/09/2012
Date last updated
6/11/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
Yoga for rheumatoid arthritis – A pilot randomised controlled trial
Scientific title
The effect of yoga on pain and sleep disturbance in rheumatoid arthritis patients – a pilot randomised controlled trial.
Secondary ID [1] 281277 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Rheumatoid arthritis 287474 0
Condition category
Condition code
Inflammatory and Immune System 287808 287808 0 0
Rheumatoid arthritis
Alternative and Complementary Medicine 287809 287809 0 0
Other alternative and complementary medicine

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants in the intervention/yoga group will continue to receive their usual medical care under their Consultant Rheumatologist and General Practitioner, and prescribed concomitant medication for their rheumatoid arthritis. Additionally, they will receive an 8-week yoga programme of group and home practice, tailored for people with rheumatoid arthritis. Group practice will consist of a weekly 75- minute instructor-led yoga class, consisting of gentle yoga postures, breathing and relaxation techniques, with a focus on physical and mental relaxation. Home practice will consist of following a 20-minute audio relaxation practice, to be completed 3 times per week, at a time and day of the participant’s choice.
Intervention code [1] 285746 0
Behaviour
Intervention code [2] 285747 0
Lifestyle
Comparator / control treatment
Participants in the usual care/control group will continue to receive their usual medical care under their Consultant Rheumatologist and General Practitioner, with prescribed concomitant medication for their rheumatoid arthritis. At the completion of the study, participants in the usual care group will be offered a weekend yoga workshop, consisting of the group and home yoga practices received by the intervention group.
Control group
Active

Outcomes
Primary outcome [1] 288031 0
Primary Outcome 1: Pain associated with rheumatoid arthritis in the past week, measured on a 10cm Visual Analogue Scale.
Timepoint [1] 288031 0
Timepoint: Weeks 0, 9 (1-week post-intervention), 12 (4 weeks post-intervention).
Primary outcome [2] 288032 0
Primary Outcome 2: Sleep quality, measured with the Insomnia Severity Index
Timepoint [2] 288032 0
Timepoint: Weeks 0, 9 (1-week post-intervention), 12 (4 weeks post-intervention).
Secondary outcome [1] 299307 0
Secondary outcome 1: Functional disability will be assessed with the Health Assessment Questionnaire Disability Index (HAQ).
Timepoint [1] 299307 0
Timepoint: Weeks 0, 9 (1-week post-intervention), 12 (4 weeks post-intervention).
Secondary outcome [2] 299308 0
Secondary outcome 2: Disease activity will be assessed using the Clinical Disease Activity Index (CDAI)
Timepoint [2] 299308 0
Timepoint: Weeks 0, 9 (1-week post-intervention), 12 (4 weeks post-intervention).
Secondary outcome [3] 299309 0
Secondary outcome 3: Quality of life will be assessed with the generic Euroqol EQ-5D (EQ-5D).
Timepoint [3] 299309 0
Timepoint: Weeks 0, 9 (1-week post-intervention), 12 (4 weeks post-intervention).
Secondary outcome [4] 299310 0
Secondary outcome 4: Mental health will be measured with the Hospital Anxiety and Depression Scale (HADS).
Timepoint [4] 299310 0
Timepoint: Weeks 0, 9 (1-week post-intervention), 12 (4 weeks post-intervention).
Secondary outcome [5] 299311 0
Secondary outcome 5: Fatigue will be measured by the Bristol Rheumatoid Arthritis Fatigue Numerical Rating Scales (BRAF-NRS).
Timepoint [5] 299311 0
Timepoint: Weeks 0, 9 (1-week post-intervention), 12 (4 weeks post-intervention).

Eligibility
Key inclusion criteria
Participants need to have a clinical diagnosis of rheumatoid arthritis, according to the American College of Rheumatology classification criteria; be aged 18 years or older; be able to understand written and spoken English; have baseline pain equal to or greater than 3 on a 10-point numeric rating scale; have baseline sleep disturbance equivalent to greater than 30 minutes to fall asleep or greater than 30 minutes awakened during the night; have had a stable medication regime for the previous 8 weeks; be able to self-mobilize in and out of a chair; agree to refrain from receiving or commencing other complementary and alternative medicine treatments or exercise programmes for the duration of the intervention; agree to notify researchers of any change in usual medications during the intervention, especially analgesics; and provide written informed consent.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Potential participants will be excluded if they already practice or have regularly practiced yoga in the previous 6 months; have recently had or expect to have surgery within 6 months of screening; have a medical condition, physical, or mental health impairment apart from RA that precludes their safe participation in exercise; are unable to commit to availability for the full course of the intervention; or have had or expect to have intra-articular steroid injections within 4 weeks of screening.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Potential participants will be identified from an existing list of rheumatoid arthritis patients at the Rheumatology Department, Dunedin Public Hospital (DPH). Additional participants may be approached through rheumatology and orthopedic outpatient clinics at DPH and invited to take part in the study.

Potential participants will be posted a letter of invitation to the study, which will include an Information Sheet explaining the proposed yoga intervention. Those showing interest in the study will be telephoned by the main investigator, and a preliminary screening conducted to determine eligibility for the trial.

Eligible potential participants will attend individual appointments at the School of Physiotherapy. Written informed consent will be obtained, a final screening for eligibility carried out, and baseline measures taken. Following the collection of baseline data participants will be assigned a participant identification number, and randomized into one of two groups.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A randomization schedule will be generated using the R statistical software package (R 2.14.2), by a research member not involved in the assessment of participants. Randomization will be by random permuted blocks, to ensure minimum and maximum class sizes. The generated numbers will be consecutively sealed in identical opaque envelopes, and kept in a locked cabinet. Envelopes will be allocated in sequence to participants, by an independent researcher not involved in the assessment of participants.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



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
1/11/2012
Actual
4/11/2012
Date of last participant enrolment
Anticipated
Actual
31/01/2013
Date of last data collection
Anticipated
Actual
Sample size
Target
28
Accrual to date
Final
26
Recruitment outside Australia
Country [1] 4566 0
New Zealand
State/province [1] 4566 0
Otago

Funding & Sponsors
Funding source category [1] 286041 0
University
Name [1] 286041 0
University of Otago
Country [1] 286041 0
New Zealand
Primary sponsor type
Individual
Name
Dr Simon Stebbings
Address
Department of Medicine,
Dunedin School of Medicine,
PO Box 913,
Dunedin 9054
Country
New Zealand
Secondary sponsor category [1] 284855 0
None
Name [1] 284855 0
Address [1] 284855 0
Country [1] 284855 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288088 0
Health and Disability Ethics Committee
Ethics committee address [1] 288088 0
Ethics committee country [1] 288088 0
New Zealand
Date submitted for ethics approval [1] 288088 0
08/10/2012
Approval date [1] 288088 0
19/10/2012
Ethics approval number [1] 288088 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34743 0
Dr Simon Stebbings
Address 34743 0
Department of Medicine
Dunedin School of Medicine
PO Box 56
Dunedin 9054
Country 34743 0
New Zealand
Phone 34743 0
+6434740999 extn 9217
Fax 34743 0
Email 34743 0
[email protected]
Contact person for public queries
Name 17990 0
Lesley Ward
Address 17990 0
Post-Doctoral Research Assistant
Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences (NDORMS)
University of Oxford
Windmill Road
Headington
Oxfordshire
OX3 7HE
UK
Country 17990 0
United Kingdom
Phone 17990 0
+44 1865 226410
Fax 17990 0
+44 1865 227966
Email 17990 0
[email protected]
Contact person for scientific queries
Name 8918 0
Lesley Ward
Address 8918 0
Post-Doctoral Research Assistant
Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences (NDORMS)
University of Oxford
Windmill Road
Headington
Oxfordshire
OX3 7HE
UK
Country 8918 0
United Kingdom
Phone 8918 0
+44 1865 226410
Fax 8918 0
+44 1865 227966
Email 8918 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.