Comparison Between Supervised Group Exercise and Home Exercise Program for Knee Osteoarthritis
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 46
- Locations
- 2
- Primary Endpoint
- Westerm Ontário and McMaster Universities
Study Overview
Brief Summary
Physical exercise is a widely recommended treatment modality for osteoarthritis, which can be performed through a supervised group exercise or a home exercise program. However, up to now only little research has been conducted on the home exercise program in Brazil. The objective of this study is to compare the efficacy between supervised group exercise and home exercise program in people with knee osteoarthritis. Methods: The study population consists of 46 men and woman with knee osteoarthritis aged between 40 and 65. The patients should be clinically diagnosed with knee osteoarthritis and classified in Kelgreen-Laurence grades I, II and III. Primary outcomes are the Westerm Ontário and McMaster Universities (WOMAC), Lower Extremity Functional Scale (LEFS), Pain Catastrophizing Scale (PCS), Tampa Scale for Kinesiophobia, 40-meter walk test, isometric strength of hip (abduction and adduction) and knee (flexion and extension) and postural control. The patients are randomized into 2 groups, with one group receiving 12 sessions of supervised group exercise and the other group following an exercise program at home. The program lasts 6 weeks with both groups receiving the same exercise protocol consisting of stretching, isometric and isotonic exercises for major muscle groups in both lower extremities. The Mann-Whitney U test is used to examine the Anthropometric variables. The ANOVA is used to compare outcomes before and after treatment. A value of p< 0.05 is considered to be statistically signifcant.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 40 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •age between 45 and 65 years;
- •Kellgren-Lawrence Grade I, II and III with knee osteoarthritis determined clinically and radiographically.
Exclusion Criteria
- •history of surgery in the lower limb;
- •patients who performed physiotherapy in the last six months;
- •disease or disability which contraindicate the performance of the exercise training (vestibular problems, cardiorespiratory, rheumatic and neurological diseases).
Outcomes
Primary Outcomes
Westerm Ontário and McMaster Universities
Time Frame: 15 min
The Westerm Ontário and McMaster Universities (WOMAC) questionnaire is a multidimensional measure of pain, stiffness, and physical functional disability in patients with osteoarthritis. In this study we will use the Visual Analogue Scale format with 24 items and five response levels for each item (none- 0 points, mild-25, moderate-50, severe-75 or extreme-100 points). The range of the scores is function (0-1700), pain (0-500) and stiffness (0-200) and the final score of each item is obtained by dividing the final result by the number of questions of each item. The total score is obtained by adding all the items and dividing by 24. Scores range from 0 to 100 for the total WOMAC, where 0 represents the best health status and 100 the worst possible status. The higher the score, the poorer the function.
Secondary Outcomes
- Isometric strength of hip and knee(35 min.)
- Pain Catastrophizing Scale (PCS)(10 min)
- Body Mass Index(5 min.)
- Tampa Scale for Kinesiophobia(10 min)
- Lower Extremity Functional Scale(10 min)
- 40-meter walk test(2 min)
- Postural control(30 min.)
Investigators
Michele Forgiarini Saccol
Professor of Physical Therapy and Rehabilitation's Department
Universidade Federal de Santa Maria