Clinical trial NCT03356431: Comparison Between Supervised Group Exercise and Home Exercise Program for Knee Osteoarthritis
Official title: Comparison Between Supervised Group Exercise and Home Exercise Program for Knee Osteoarthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis, Knee
Keywords: Exercise therapy
Physical Therapy
Lead sponsor: Universidade Federal de Santa Maria
Sponsor class: OTHER
First posted: 2017-11-29
Enrollment: 46
Sex: ALL
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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).

Primary outcomes:
measure: Westerm Ontário and McMaster Universities
timeFrame: 15 min
Secondary outcomes:
measure: Lower Extremity Functional Scale
timeFrame: 10 min
measure: Pain Catastrophizing Scale (PCS)
timeFrame: 10 min
measure: Tampa Scale for Kinesiophobia
timeFrame: 10 min
measure: 40-meter walk test
timeFrame: 2 min
measure: Isometric strength of hip and knee
timeFrame: 35 min.
measure: Postural control
timeFrame: 30 min.
measure: Body Mass Index
timeFrame: 5 min.
Other outcomes:
Locations:
city: Santa Maria
country: Brazil
facility: Federal University of Santa Maria
state: RS
Study officials:
References: