Effects of a Yoga Program on the Functionality of Individuals

NCT07006883 | Recruiting DMC

• 1 other identifier: 85065624.0.0000.5511
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Functional disability

  Knee Injury and Osteoarthritis Outcome Score (KOOS). It aims to evaluate the domains of pain, symptoms, activities of daily living, function related to recreation and sports, and quality of life related to the knee. Totaling 42 items, each item must be answered using a Likert scale that ranges from 0 (best score) to 4 (worst score), and the score for each subscale ranges from 0 (worst score) to 100 (best score).

  Change from Baseline, after 4 weeks of intervention and 8 weeks after the end of the intervention.

Secondary Outcomes (7)

• Numerical Pain Scale

  Change from Baseline, after 4 weeks of intervention and 8 weeks after the end of the intervention.

• Functional self-perception

  Change from Baseline, after 4 weeks of intervention and 8 weeks after the end of the intervention.

• Global Perception of Change scale

  Change from Baseline, after 4 weeks of intervention and 8 weeks after the end of the intervention.

• Dynamic balance

  Change from Baseline, after 4 weeks of intervention and 8 weeks after the end of the intervention.

• Maximum voluntary isometric contraction

  Change from Baseline, after 4 weeks of intervention and 8 weeks after the end of the intervention.

Study Arms (2)

Therapeutic exercise group

ACTIVE COMPARATOR

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.

Other: Therapeutic exercise

Yoga therapeutic exercise

EXPERIMENTAL

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.

Other: Yoga therapeutic exercise

Interventions

Therapeutic exercise OTHER

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

Therapeutic exercise group

Yoga therapeutic exercise 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

Yoga therapeutic exercise

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Nove de Julho: lead

Study Sites (1)

University of Nove de Julho

São Paulo, 01504-001, Brazil

RECRUITING

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Exercise Therapy

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Phd

Study Record Dates

• First Submitted: May 28, 2025
• First Posted: June 5, 2025
• Study Start: August 1, 2025
• Primary Completion (Estimated): January 30, 2029
• Study Completion (Estimated): January 30, 2029
• Last Updated: December 18, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)