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

Overview

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.

Interventions

• Other Therapeutic exercise
  Therapeutic exercise focused on muscle strengthening, balance, and functional performance.
• Other Yoga therapeutic exercise
  Yoga is a mind-body practice that integrates physical postures, breathing techniques, and mindfulness with the aim of improving physical function, balance, strength, mobility, and psychological well-being. I

Primary outcome measures

• Functional disability [Time frame: Change from Baseline, after 4 weeks of intervention and 8 weeks after the end of the intervention.]

Secondary outcome measures (7)

• Numerical Pain Scale [Time frame: Change from Baseline, after 4 weeks of intervention and 8 weeks after the end of the intervention.]
• Functional self-perception [Time frame: Change from Baseline, after 4 weeks of intervention and 8 weeks after the end of the intervention.]
• Global Perception of Change scale [Time frame: Change from Baseline, after 4 weeks of intervention and 8 weeks after the end of the intervention.]
• Dynamic balance [Time frame: Change from Baseline, after 4 weeks of intervention and 8 weeks after the end of the intervention.]
• Maximum voluntary isometric contraction [Time frame: Change from Baseline, after 4 weeks of intervention and 8 weeks after the end of the intervention.]
• Stand Test [Time frame: Change from Baseline, after 4 weeks of intervention and 8 weeks after the end of the intervention.]
• functional balance [Time frame: Change from Baseline, after 4 weeks of intervention and 8 weeks after the end of the intervention.]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

Brazil · 1 center

• University of Nove de Julho — São Paulo

Identifiers

NCT: NCT07006883 · 85065624.0.0000.5511

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗