Effects of a Yoga Program on the Functionality of Individuals
ConditionKnee Osteoarthritis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40-80
SponsorUniversity of Nove de Julho
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
Bilateral hip or KOA
Severe osteoporosis
Fibromyalgia
Clinical history of tumors or cancer
Trial design
Design model
Parallel
Treatments tested in this trial
Therapeutic exercise
Other interventionTherapeutic exercise focused on muscle strengthening, balance, and functional performance.
Yoga therapeutic exercise
Other interventionYoga 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
Treatment groups
90 Participants
are divided into 2 treatment groupsGroup A: Therapeutic exercise groupActive comparator 1 intervention
Group B: Yoga therapeutic exerciseExperimental treatment 1 intervention
Trial outcomes
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).
Time frame
Change from Baseline, after 4 weeks of intervention and 8 weeks after the end of the intervention.Secondary outcomes
1
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'.
Time frame
Change from Baseline, after 4 weeks of intervention and 8 weeks after the end of the intervention.2
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.
Time frame
Change from Baseline, after 4 weeks of intervention and 8 weeks after the end of the intervention.3
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.
Time frame
Change from Baseline, after 4 weeks of intervention and 8 weeks after the end of the intervention.4
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.
Time frame
Change from Baseline, after 4 weeks of intervention and 8 weeks after the end of the intervention.Sponsors and contacts
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Source ClinicalTrials.gov