Effects of a Yoga Program on the Functionality of Individuals

University of Nove de Julho

Status: Enrolling

Conditions: Knee Osteoarthritis

Treatments: Other: Therapeutic exercise; Other: Yoga therapeutic exercise

Study type: Interventional

Funder types: Other

Identifiers

NCT07006883

85065624.0.0000.5511

Details and patient eligibility

About

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.

Enrollment: 90 estimated patients

Sex: All

Ages: 40 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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90 participants in 2 patient groups

Therapeutic exercise group

Active Comparator group

Description:

The program consists of warm-up, strengthening, and mobility exercises, based on functional movements that are typically challenging for individuals with knee osteoarthritis (KOA), in addition to balance exercises previously defined in a prior clinical trial. The program will be delivered in three phases: Phase 1 (weeks 0-2), Phase 2 (weeks 2-4), and Phase 3 (weeks 4-8). Every two weeks, participants will be reassessed to allow for potential adjustments aimed at promoting the progressive progression of the exercises.

Treatment:

Other: Therapeutic exercise

Yoga therapeutic exercise

Experimental group

Description:

The program was developed based on previous studies and considering the functional demands of each established position, as detailed in Tables 4, 5, and 6. The intervention will be structured into three phases: Phase 1 (weeks 0-2), Phase 2 (weeks 2-4), and Phase 3 (weeks 4-8). Every two weeks, participants will be reassessed to allow for potential adjustments, aiming to ensure the progressive progression of the exercises.

Treatment:

Other: Yoga therapeutic exercise