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A randomised comparative effectiveness trial of YOGa and strengthening exercise for knee osteoArthritis (YOGA Trial)

A randomised comparative effectiveness trial of yoga and strengthening exercise for knee osteoarthritis.

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12621000066886
Acronym
YOGA Trial
Enrollment
126
Registered
2021-01-27
Start date
2021-02-01
Completion date
Unknown
Last updated
2021-02-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Osteoarthritis is a common joint disorder for which there is no cure. Knee osteoarthritis is the most common form of osteoarthritis. Exercise is a core treatment for knee osteoarthritis. Muscle strengthening exercise has been shown to improve pain and function and is recommended by clinical guidelines. Yoga is a mind-body exercise intervention that can provide increased flexibility, muscle strength, physical balancing, improved fitness, and has demonstrated pain-relieving properties. Yoga, with its potential for improving musculoskeletal function, nervous system, and sympathetic activity, may therefore have greater benefits than commonly used strengthening exercise. Previous studies of yoga in knee osteoarthritis patients have been of low-quality with a high risk of bias and did not perform subgroup analyses to identify patients who may specifically benefit from yoga. This randomised controlled trial aims to compare the effectiveness of the 24-week yoga program vs strengthening exercise (12 weeks (2x/week of group-based + 1x/week of home-based) + 12 weeks of (3x/week) home-based) on knee pain in knee osteoarthritis patients with a priori subgroup analysis of knee osteoarthritis patients with neuropathic pain compared to strengthening exercise. If successful, yoga can be easily implemented as a complementary treatment along with conventional treatment to improve the management of knee osteoarthritis.

Interventions

63 eligible participants will be randomly allocated to a 24-week yoga program with three 1-hour sessions per week (two 1 hour group-based sessions and one 1 hour home-based session) for the first 12 weeks and then three 1-hour per week home-based yoga sessions for the remaining 12 weeks. The group-based yoga sessions will be led by yoga teachers and participants will be instructed to continue their 1-hour yoga program at home (1 day per week for the first 12 weeks and 3days/week for another 12 w

63 eligible participants will be randomly allocated to a 24-week yoga program with three 1-hour sessions per week (two 1 hour group-based sessions and one 1 hour home-based session) for the first 12 weeks and then three 1-hour per week home-based yoga sessions for the remaining 12 weeks. The group-based yoga sessions will be led by yoga teachers and participants will be instructed to continue their 1-hour yoga program at home (1 day per week for the first 12 weeks and 3days/week for another 12 weeks. The participants will be given a detailed information sheet on their yoga sessions which they were doing in the group-based sessions. We will give them a recorded video of the individual sessions for reference. Self-reported adherence to the intervention and comparator program from baseline to 12 and 12 to 24 weeks will be assessed using an online logbook (includes checklist). Yoga sessions will include low to moderate intensity asanas such as, Low intensity: Breathing practices, mental practices, warm-up and stretches Moderate intensity: Sun salutations, standing, balancing, and stabilizing poses. We will use a modified Borg Scale questionnaire to describe the intensity of the yoga. We will ask the participants to work at 5-7 on the modified Borg Scale, which would be deemed as a moderate-intensity yoga.

Sponsors

University of Tasmania
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
40 Years to No maximum
Healthy volunteers
No

Inclusion criteria

1. Aged >/=40 years 2. Knee pain on most days for at least six months 3. VAS knee pain intensity of >/=40 mm in the last month. 4. Meet American College of Rheumatology (ACR) clinical criteria for the diagnosis of knee OA 5. Be willing to participate in a group yoga program or group strengthening exercise program three times per week for 12-weeks and can attend on the days/times of the week that scheduled classes are running. A painDETECT score of more than 12 will be used to identify neuropathic pain.

Exclusion criteria

1. Patients currently or in the past three months engaged in strengthening exercise or yoga program 2. Other forms of inflammatory arthritis (especially rheumatoid arthritis and gout). 3. A significant knee injury that required treatment within the last six months. 4. Arthroscopy or open surgery in the index knee in the last six months or planned in the next 6-8 months. 5. Injections of corticosteroids (last three months) or hyaluronic acid (last six months) in the index knee. 6. Pregnancy or breastfeeding. 7. Currently participating in any other drug/device/exercise clinical trial related to OA. 8. Presence of any serious medical illness or condition that may preclude a 24-week follow up. 9. Any condition that precludes safe participation in exercise (i.e. fails the safety for exercise clearance). 10. Unable to walk without a gait aid. 11. Inability to provide informed consent in English. 12. Plan to start an exercise or another new treatment for knee OA in the next six months. 13. Planned absences (e.g. trips away) of >2 weeks maximum during the 12-week period.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026