Comparison Between Supervised Group Exercise and Home Exercise Program for Knee Osteoarthritis

NCT03356431 | Completed

• 1 other identifier: 997051404
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoarthritis, Knee

Keywords

Exercise therapy; Physical Therapy

Outcome Measures

Primary Outcomes (1)

• Westerm Ontário and McMaster Universities

  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.

  15 min

Secondary Outcomes (7)

• Lower Extremity Functional Scale

  10 min

• Pain Catastrophizing Scale (PCS)

  10 min

• Tampa Scale for Kinesiophobia

  10 min

• 40-meter walk test

  2 min

• Isometric strength of hip and knee

  35 min.

Study Arms (2)

Supervised group exercise

EXPERIMENTAL

The supervised exercise group will receive a lower extremity exercise treatment, under physiotherapist supervision for 60 min, two times a week (12 sessions).

Other: Supervised group exercise

Home-based exercise

EXPERIMENTAL

For the home-based exercise group, exercises will be demonstrated to the patient with the supervision and guidance of a physiotherapist in an exercise session. These patients will perform the same exercise protocol at home at least twice a week. In addition to the initial session, subjects will perform further two supervised sessions (at one week and four weeks after the initial session). The exercise program are the same as the supervised group exercise.

Other: Home-based exercise

Interventions

Supervised group exercise OTHER

* Quadriceps muscle isometric contraction in sitting position 1 set of 3-3 reps × 1 min hold. * Isotonic quadriceps contraction with resistance band 3 sets of 10 reps x 1min hold. * Isotonic hamstring contraction with resistance band 3 sets of 10 reps x 1min hold. * Sit to stand exercise during 1 min. * Dynamic stepping exercise (walking up and down one step/stair during 1 min). * Standing calf stretch 3 x 20 sec. * Standing quadriceps stretching 3 x 20 sec. * Supine hamstring stretching 3 x 20 sec.

Also known as: Exercise therapy

Supervised group exercise

Home-based exercise OTHER

* Quadriceps muscle isometric contraction in sitting position 1 set of 3-3 reps × 1 min hold. * Isotonic quadriceps contraction with resistance band 3 sets of 10 reps x 1min hold. * Isotonic hamstring contraction with resistance band 3 sets of 10 reps x 1min hold. * Sit to stand exercise during 1 min. * Dynamic stepping exercise (walking up and down one step/stair during 1 min). * Standing calf stretch 3 x 20 sec. * Standing quadriceps stretching 3 x 20 sec. * Supine hamstring stretching 3 x 20 sec.

Also known as: Exercise therapy

Home-based exercise

Eligibility Criteria

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

You may qualify if:

• age between 45 and 65 years;
• Kellgren-Lawrence Grade I, II and III with knee osteoarthritis determined clinically and radiographically.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Universidade Federal de Santa Maria: lead

Study Sites (1)

Federal University of Santa Maria

Santa Maria, Rio Grande do Sul, 97105900, Brazil

Location

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 of Physical Therapy and Rehabilitation's Department

Study Record Dates

• First Submitted: October 10, 2017
• First Posted: November 29, 2017
• Study Start: April 18, 2017
• Primary Completion: December 31, 2017
• Study Completion: December 31, 2019
• Last Updated: February 11, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)