Clinical trial NCT07006883: Effects of a Yoga Program on the Functionality of Individuals
Official title: Effects of a Yoga Program on the Functionality of Individuals With Knee Osteoarthritis
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Knee Osteoarthritis
Lead sponsor: University of Nove de Julho
Sponsor class: OTHER
First posted: 2025-06-05
Enrollment: 90
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Primary outcomes:
measure: Functional disability
timeFrame: Change from Baseline, after 4 weeks of intervention and 8 weeks after the end of the intervention.
Secondary outcomes:
measure: Numerical Pain Scale
timeFrame: Change from Baseline, after 4 weeks of intervention and 8 weeks after the end of the intervention.
measure: Functional self-perception
timeFrame: Change from Baseline, after 4 weeks of intervention and 8 weeks after the end of the intervention.
measure: Global Perception of Change scale
timeFrame: Change from Baseline, after 4 weeks of intervention and 8 weeks after the end of the intervention.
measure: Dynamic balance
timeFrame: Change from Baseline, after 4 weeks of intervention and 8 weeks after the end of the intervention.
measure: Maximum voluntary isometric contraction
timeFrame: Change from Baseline, after 4 weeks of intervention and 8 weeks after the end of the intervention.
measure: Stand Test
timeFrame: Change from Baseline, after 4 weeks of intervention and 8 weeks after the end of the intervention.
measure: functional balance
timeFrame: Change from Baseline, after 4 weeks of intervention and 8 weeks after the end of the intervention.
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: University of Nove de Julho
Study officials:
References: