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

NCT ID: NCT03356431

Last Updated: 2022-02-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 46 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-04-18
• Study Completion Date: 2019-12-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Supervised group exercise

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

Group Type: EXPERIMENTAL

Supervised group exercise

Intervention Type: 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.

Home-based exercise

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.

Group Type: EXPERIMENTAL

Home-based exercise

Intervention Type: 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.

Interventions

Supervised group exercise

• 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.

Intervention Type: OTHER

Home-based exercise

• 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.

Intervention Type: OTHER

Other Intervention Names

Exercise therapy; Exercise therapy

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).

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universidade Federal de Santa Maria

OTHER

Sponsor Role: lead

Responsible Party

Michele Forgiarini Saccol

Professor of Physical Therapy and Rehabilitation's Department

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Federal University of Santa Maria

Santa Maria, Rio Grande do Sul, Brazil

Countries

Brazil

Other Identifiers

997051404

Identifier Type: -

Identifier Source: org_study_id