Effects of a Yoga Program on the Functionality of Individuals

NCT ID: NCT07006883

Last Updated: 2025-12-18

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-08-01
• Study Completion Date: 2029-01-30

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.

Conditions

Knee Osteoarthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Therapeutic exercise group

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.

Group Type: ACTIVE_COMPARATOR

Therapeutic exercise

Intervention Type: OTHER

Therapeutic exercise focused on muscle strengthening, balance, and functional performance.

Yoga therapeutic exercise

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.

Group Type: EXPERIMENTAL

Yoga therapeutic exercise

Intervention Type: OTHER

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

Interventions

Therapeutic exercise

Therapeutic exercise focused on muscle strengthening, balance, and functional performance.

Intervention Type: 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

Intervention Type: OTHER

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Nove de Julho

OTHER

Sponsor Role: lead

Responsible Party

Cid André Fidelis de Paula Gomes

Professor Phd

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of Nove de Julho

São Paulo, , Brazil

Site Status: RECRUITING

Countries

Brazil

Facility Contacts

Cid A Gomes, Master of Science

Role: primary

Other Identifiers

85065624.0.0000.5511

Identifier Type: -

Identifier Source: org_study_id