NCT07006883 Effects of a Yoga Program on the Functionality of Individuals
| NCT ID | NCT07006883 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Nove de Julho |
| Condition | Knee Osteoarthritis |
| Study Type | INTERVENTIONAL |
| Enrollment | 90 participants |
| Start Date | 2025-08-01 |
| Primary Completion | 2029-01-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 90 participants in total. It began in 2025-08-01 with a primary completion date of 2029-01-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
There is a notable and emerging use of structured exercise programs incorporating Yoga for chronic musculoskeletal pain. However, regarding knee osteoarthritis (KOA), the effectiveness of Yoga remains uncertain to justify its inclusion in therapeutic exercise programs in routine clinical practice. Therefore, the aim of this project is to evaluate the effects of Yoga on functionality in individuals with KOA. For this purpose, participants with KOA, including individuals of both sexes, aged 45 years or older, with a clinical diagnosis of KOA, will be randomly allocated using a random sequence generated by software, organized in six blocks of 24 codes, with an allocation ratio of 1:1, numbered sequentially from 1 to 126. Allocation will be concealed and performed after pre-intervention assessment and confirmation of eligibility criteria. Participants will be distributed into two groups: (1) Experimental group - Yoga (n = 45) and (2) Control group - therapeutic exercise (n = 45). The intervention will last 8 weeks, with assessments conducted at baseline, after 4 weeks, and after 8 weeks of the intervention programs. The following outcome measures will be used: Knee Injury and Osteoarthritis Outcome Score (KOOS), Berg Balance Scale (BBS), Numeric Pain Rating Scale (NPRS), Pain Self-Efficacy Questionnaire (PSEQ), Global Perceived Effect Scale (GPE), 30-Second Sit-to-Stand Test (30s-STS), Timed Up and Go Test (TUG), and Maximal Voluntary Isometric Contraction (MVIC). Data analysis will include a normality test to verify the distribution of the data, followed by the appropriate statistical tests for intra- and intergroup comparisons. The comparisons will consider two factors: time and group. A significance level of 5% (p \< 0.05) will be adopted for all analyses.
Eligibility Criteria
Inclusion Criteria: * A clinical diagnosis of knee osteoarthritis (knee pain for \> 3 months) * Morning stiffness \<30 minutes * Crepitus * Bone tenderness, and absence of palpable heat and/or diagnosis established radiographically (determined by Kellgren and Lawrence grade 1 to 3 on a scale 1 up to 4) Exclusion Criteria: * Bilateral hip or KOA * Severe osteoporosis * Fibromyalgia * Clinical history of tumors or cancer * Active inflammatory joint diseases (rheumatoid arthritis, gout), undergoing any joint replacement of the lower extremity * Neurological diseases (Parkinson's disease, Stroke, Multiple Sclerosis, muscular dystrophies, neuromotor disease, Alzheimer's disease) * Infected wounds or osteomyelitis in the knee region * Deep vein thrombosis or thrombophlebitis, sensory changes in the lower limbs * A cognitive and cardiopulmonary impairment that may prevent or limit the performance of exercises * Use of a walking assistance device, history of recent trauma to the knee * Be performing or having prior any form of treatment involving physiotherapy, intra-articular corticosteroids, anti-inflammatories, opioid medication, or chondroprotective in the six months before the start of interventions
Frequently Asked Questions
Who can join the NCT07006883 clinical trial?
This trial is open to participants of all sexes, aged 40 Years or older, up to 80 Years, studying Knee Osteoarthritis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07006883 currently recruiting?
Yes, NCT07006883 is actively recruiting participants. Visit ClinicalTrials.gov or contact University of Nove de Julho to inquire about joining.
Where is the NCT07006883 trial being conducted?
This trial is being conducted at São Paulo, Brazil.
Who is sponsoring the NCT07006883 clinical trial?
NCT07006883 is sponsored by University of Nove de Julho. The trial plans to enroll 90 participants.