Knee OsteoarthritisNCT07006883
Effects of a Yoga Program on the Functionality of Individuals
A study testing Therapeutic exercise and Yoga therapeutic exercise in people with Knee Osteoarthritis, run by University of Nove de Julho at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Therapeutic exercise and Yoga therapeutic exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Aug 2025to 30 Jan 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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)
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- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Brazil1 site, 1 recruiting
- Recruiting
University of Nove de Julho
São Paulo, 01504-001
Cid A Gomes, Master of Science, +5511970941936, cid.andre@gmail.com
Cid A Gomes, master of science
About this study
Official title: Effects of a Yoga Program on the Functionality of Individuals With Knee Osteoarthritis
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).
Read more
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
- Being tested
- Therapeutic exercise, Yoga therapeutic exercise
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Therapeutic exerciseOther
Therapeutic exercise focused on muscle strengthening, balance, and functional performance.
Yoga therapeutic exerciseOther
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Yoga therapeutic exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Change from Baseline, after 4 weeks of intervention and 8 weeks after the end of the intervention.
Secondary outcomes (7)
Numerical Pain Scale
The Numerical rating pain scale, a simple, easily administered scale evaluates the perceived intensity of pain, using an 11-point scale from 0, representing 'no pain', to 10, which is the 'worst possible pain'.
Measured: Change from Baseline, after 4 weeks of intervention and 8 weeks after the end of the intervention.
Functional self-perception
Pain self-efficacy questionnaire, structured into 10 items where each item is evaluated by selecting a number on a 7-point numerical scale (scores from 0 to 6), where 0 means "not at all confident" and 6 means "completely confident". The items cover different functions, from work, social activities, domestic tasks and coping with pain without medication. A total score is calculated from the sum of the scores for each of the 10 items, producing a total score that ranges from 0 to 60. Higher scores reflect stronger self-efficacy beliefs.
Measured: Change from Baseline, after 4 weeks of intervention and 8 weeks after the end of the intervention.
Global Perception of Change scale
The perception of the global effect of the treatment by the research participant will be evaluated by the Global Perception of Change scale. The Global Perception of Change scale is a direct scale on the patient's self-perception when the intervention is performed. This scale consists of 11 points, ranging from -5 (worsening compared to the start of treatment), 0 (neutral) and +5 (improvement compared to the start of treatment), using the Portuguese version.
Measured: Change from Baseline, after 4 weeks of intervention and 8 weeks after the end of the intervention.
Dynamic balance
Iimed up and go test, research participants will be instructed to get up from a chair, walk 3 meters comfortably and safely, come back and sit down in the chair. The time taken to complete this task will be measured using a stopwatch that will be started after the verbal command 'go' and stopped when the participant returns to the initial sitting position. A first attempt will be made to familiarize the participant with the procedure. Two assessments will then be carried out. The average of the two assessments will be recorded for later data analysis.
Measured: Change from Baseline, after 4 weeks of intervention and 8 weeks after the end of the intervention.
Maximum voluntary isometric contraction
manual dynamometer portable (Lafayette Manual Muscle System, Modelo 01165, Lafayette Instrument Company, Lafayette, IN). Four 5-second readings will be taken during maximal voluntary isometric contraction (MVIC) with a 30-second rest period between contractions. The first CIVM will familiarize the volunteer with carrying out the task. A new set of readings will be taken if a volunteer can perform three contractions with at least 10% variability. Strong and constant verbal stimuli will be used throughout the test. Always with the research participants' hands positioned crossed on the chest. Thus, bilateral assessments of the muscles, quadriceps, and gluteus medius will be carried out. The order of CIVM readings will be randomized to avoid collection bias. The research participant will remain in lateral decubitus with a pillow positioned between the legs, with the limb to be tested superiorly in a neutral position.
Measured: Change from Baseline, after 4 weeks of intervention and 8 weeks after the end of the intervention.
Stand Test
The 30-Second Chair Stand Test (30s-CST) assesses physical function and is recommended by OARSI for individuals with knee osteoarthritis (KOA). The participant performs as many sit-to-stand repetitions as possible in 30 seconds, using a 43 cm-high, straight-backed chair without armrests, placed against a wall. The starting position is seated, feet flat, hip-width apart, and arms crossed over the chest. Two to three practice repetitions are recommended. If unable to stand independently, participants may use hand support or a mobility aid, with score adjustments. The same chair must be used for all assessments.
Measured: Change from Baseline, after 4 weeks of intervention and 8 weeks after the end of the intervention.
functional balance
The Berg Balance Scale (BBS) is a functional assessment of static and dynamic balance. It consists of 14 items, each scored on a 4-point Likert scale, with a total score ranging from 0 to 56 points. Risk of falls is classified as follows:
0 to 20: high risk of falls, 21 to 40: moderate risk of falls, and 41 to 56: low risk of falls. The Brazilian Portuguese version of the BBS has been translated, cross-culturally adapted, and validated, demonstrating adequate levels of reliability and measurement consistency.
Measured: Change from Baseline, after 4 weeks of intervention and 8 weeks after the end of the intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2025
- Study start1 Aug 2025
- Primary completion30 Jan 2029 (estimated)
- Study completion30 Jan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Nove de Julho
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cid André Fidelis de Paula Gomes, University of Nove de Julho
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07006883
- Sponsor's protocol ID
- 85065624.0.0000.5511
- Status last verified
- Dec 2025
- First submitted
- 28 May 2025
- Last updated
- 18 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Yoga Program on the Functionality of Individuals With Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT07006883
- Acronym / sponsor ID
- 85065624.0.0000.5511
- Conditions
- Knee Osteoarthritis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- University of Nove de JulhoUniversity, hospital or other
- Study start
- 1 Aug 2025 (actual)
- Primary completion
- 30 Jan 2029 (estimated)
- Study completion
- 30 Jan 2029 (estimated)
- First posted
- 5 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Therapeutic exercise group | Active comparator | Other: Therapeutic exerciseThe 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. |
| Yoga therapeutic exercise | Experimental | Other: Yoga therapeutic exerciseThe 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. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Therapeutic exerciseTherapeutic exercise focused on muscle strengthening, balance, and functional performance. | Other | Therapeutic exercise group |
| Yoga therapeutic exerciseYoga 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 | Other | Yoga therapeutic exercise |
Primary outcome
Functional disability
Time frame: Change from Baseline, after 4 weeks of intervention and 8 weeks after the end of the intervention.
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).
7 secondary outcomes
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Therapeutic exercise and Yoga therapeutic exercise in people with Knee Osteoarthritis, run by University of Nove de Julho at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional disability (time frame: Change from Baseline, after 4 weeks of intervention and 8 weeks after the end of the intervention.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2025.