ANZCTR - Registration

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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]

Nil

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Rheumatoid arthritis

Condition category

Condition code

Inflammatory and Immune System

Rheumatoid arthritis

Alternative and Complementary Medicine

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]

Behaviour

Intervention code [2]

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]

Primary Outcome 1: Pain associated with rheumatoid arthritis in the past week, measured on a 10cm Visual Analogue Scale.

Timepoint [1]

Timepoint: Weeks 0, 9 (1-week post-intervention), 12 (4 weeks post-intervention).

Primary outcome [2]

Primary Outcome 2: Sleep quality, measured with the Insomnia Severity Index

Timepoint [2]

Timepoint: Weeks 0, 9 (1-week post-intervention), 12 (4 weeks post-intervention).

Secondary outcome [1]

Secondary outcome 1: Functional disability will be assessed with the Health Assessment Questionnaire Disability Index (HAQ).

Timepoint [1]

Timepoint: Weeks 0, 9 (1-week post-intervention), 12 (4 weeks post-intervention).

Secondary outcome [2]

Secondary outcome 2: Disease activity will be assessed using the Clinical Disease Activity Index (CDAI)

Timepoint [2]

Timepoint: Weeks 0, 9 (1-week post-intervention), 12 (4 weeks post-intervention).

Secondary outcome [3]

Secondary outcome 3: Quality of life will be assessed with the generic Euroqol EQ-5D (EQ-5D).

Timepoint [3]

Timepoint: Weeks 0, 9 (1-week post-intervention), 12 (4 weeks post-intervention).

Secondary outcome [4]

Secondary outcome 4: Mental health will be measured with the Hospital Anxiety and Depression Scale (HADS).

Timepoint [4]

Timepoint: Weeks 0, 9 (1-week post-intervention), 12 (4 weeks post-intervention).

Secondary outcome [5]

Secondary outcome 5: Fatigue will be measured by the Bristol Rheumatoid Arthritis Fatigue Numerical Rating Scales (BRAF-NRS).

Timepoint [5]

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]

New Zealand

State/province [1]

Otago

Funding & Sponsors

Funding source category [1]

University

Name [1]

University of Otago

Address [1]

PO Box 56,
Dunedin 9054

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Health and Disability Ethics Committee

Ethics committee address [1]

Ministry of Health, 
No 1 The Terrace, 
PO Box 5013, 
Wellington 6011

Ethics committee country [1]

New Zealand

Date submitted for ethics approval [1]

08/10/2012

Approval date [1]

19/10/2012

Ethics approval number [1]

Summary

Brief summary

Rheumatoid arthritis (RA) is an inflammatory musculoskeletal disease, with an estimated prevalence of 0.8–3.2% in the New Zealand population. Current medical management of RA is predominantly pharmaceutical. However, exercise is also recommended as a non-pharmaceutical form of symptom management, targeting both mental and physical health. 

People with musculoskeletal conditions are the highest users of complementary and alternative medicine (CAM), and an increasingly popular form of CAM among people with RA is yoga. In our previous research focus group research, people with RA perceived yoga as a form of exercise adaptable to the variable symptoms of their RA; and identified pain, sleep, and stress as symptoms of their RA they believe may be particularly amenable to a yoga practice. We have conducted a systematic review, which suggests yoga is a safe and acceptable form of physical exercise for individuals across a range of musculoskeletal conditions, with potentially clinically relevant improvements in physical and mental health. Additionally, we have completed a Delphi survey of leading yoga researchers and identified parameters of yoga interventions appropriate for people with a musculoskeletal condition. 

The present study will look at the effect of a yoga practice specifically tailored for people with RA on a participant’s mental and social health. The 8-week study design is guided by the results of our Delphi survey. The study’s aims are: 1) To assess the feasibility and acceptability of a yoga intervention for rheumatoid arthritis, operationalized as time and rate of recruitment, protocol adherence, participant retention, safety, and acceptability of the intervention; and 2) To estimate the effect of yoga on primary outcomes of RA-related pain and sleep quality.

Trial website

Trial related presentations / publications

Ward, L. J., Stebbings, S., Athens, J., Cherkin, D., & Baxter, D. (2014). Yoga for pain and sleep quality in rheumatoid arthritis: Study protocol for a pilot randomized controlled trial. Physical Therapy Reviews, 19(4), 266-276. doi:10.1179/1743288X14Y.0000000139

Public notes

Contacts

Principal investigator

Name

Dr Simon Stebbings

Address

Department of Medicine
Dunedin School of Medicine
PO Box 56
Dunedin 9054

Country

New Zealand

Phone

+6434740999 extn 9217

Fax

Email

simon.stebbings@otago.ac.nz

Contact person for public queries

Name

Lesley Ward

Address

Post-Doctoral Research Assistant
Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences (NDORMS)
University of Oxford
Windmill Road
Headington
Oxfordshire
OX3 7HE
UK

Country

United Kingdom

Phone

+44 1865 226410

Fax

+44 1865 227966

Email

lesley.ward@ndorms.ox.ac.uk

Contact person for scientific queries

Name

Lesley Ward

Address

Post-Doctoral Research Assistant
Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences (NDORMS)
University of Oxford
Windmill Road
Headington
Oxfordshire
OX3 7HE
UK

Country

United Kingdom

Phone

+44 1865 226410

Fax

+44 1865 227966

Email

lesley.ward@ndorms.ox.ac.uk

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.