Sensorimotor Training Versus Resistance Training in Patients With Knee Osteoarthritis

February 8, 2012 updated by: Aline Basolli Gomiero, Federal University of São Paulo

Efficacy of a Sensorimotor Training in Patients With Knee Osteoarthritis: a Randomized Clinical Trial

People with knee osteoarthritis (OA) have functional instability and defective neuromuscular function, it was recently suggested that sensorimotor exercises may be important and needed to improve the effectiveness of training programs for these patients. This study objective was to compare the effectiveness of a supervised resistance muscular training (RT) versus sensorimotor training (SMT) for patients with Knee OA, on decrease of pain and functional improvement.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

96

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • São Paulo, Brazil, 04815-180
        • Department of Rheumatology and Physiotherapy of Interlagos Ambulatory - Santo Amaro University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients diagnosed with tibiofemoral osteoarthritis;
  • Both genders;
  • Age> 50 years <75 years;
  • Completion of clinical and radiological criteria of the American College of Rheumatology (ACR) criteria for knee OA;
  • No physical activity in the previous 3 months;
  • Education level from the 4th grade of primary school.

Exclusion Criteria:

  • uncontrolled hypertension;
  • decompensated diabetes mellitus;
  • uncontrolled thyroid diseases;
  • cardiorespiratory disease (ischemia, arrhythmia, chest pain, or exercise-induced bronchospasm), liver abnormalities;
  • Patients with grade IV functional limitation that needed devices to walk(Kellgren-Lawrence radiographic classification);
  • Patients in a period of sick leave by the INSS or any other related factor;
  • Other rheumatic diseases.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: sensorimotor training (SMT)
Other: Sensorimotor training (SMT)
The group realized 16 weeks of sensorimotor training, twice a week, with duration of 30 minutes each session. The intervention included agility and coordination exercises, perturbation training and stretching exercises. Also, the participants received orientation about the knee osteoarthritis.
Other Names:
  • Agility/perturbation training; proprioceptive training; neuromuscular training
ACTIVE_COMPARATOR: Resistance training (RT)
Other: Resistance training (RT)
The group realized 16 weeks of resistance training for the quadriceps and hamstring muscles, twice a week, with duration of 30 minutes each session. The intervention included strength leg raises, simple quadriceps and hamstring strengthening with cuff weights realized in 3 sets of ten repetition maximum(10RM) for each muscle group. The group also realized stretching exercises for lower limbs and received orientation about the knee osteoarthritis.
SHAM_COMPARATOR: Control group (CG)
Other: Control group (CG)
Patients in this group also received information about knee osteoarthritis and realized the same warm-up and cool-down intervention realized in the interventional groups. During 16 weeks they went to the ambulatory twice a week to perform 5 minutes of stationary bicycle and 5 minutes of stretching exercises for lower limbs.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Visual analogue scale of pain (VAS)
Time Frame: 16 weeks
16 weeks
Get Up and Go Test
Time Frame: 16 weeks
16 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Time Frame: 16 weeks
16 weeks
electromyographic analysis of quadriceps muscle (EMG)
Time Frame: 16 weeks
16 weeks
isometric quadriceps strength
Time Frame: 16 weeks
16 weeks
Medical Outcomes Study Short Form (SF-36)
Time Frame: 16 weeks

Generic, patient-report measure designed to assess health-related quality of life, comprises 36 items divided into 8 subscales.

  1. Physical Functioning
  2. Role Limitations due to Physical Problems
  3. General Health Perceptions
  4. Vitality
  5. Social Functioning
  6. Role Limitations due to Emotional Problems
  7. General Mental Health
  8. Health Transition
16 weeks
Berg Balance Test
Time Frame: 16 weeks
16 weeks
Tinetti Test
Time Frame: 16 weeks
16 weeks
activities of daily living scale (ADLS)
Time Frame: 16 weeks
16 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Federal University of São Paulo

Investigators

  • Study Director: Virginia FM Trevisani, MD, MS, PhD, Federal University of São Paulo and Santo Amaro University
  • Study Chair: Maria S Peccin, PT, MS, PhD, Federal University of São Paulo
  • Study Chair: Marcelo Abrahão, PT, Federal University of São Paulo
  • Study Director: Alvaro N Atallah, MD, PhD, Federal University of São Paulo
  • Principal Investigator: Aline B Gomiero, PT, Federal University of São Paulo
  • Study Chair: Andrea H Kayo, PT, MS, Federal University of São Paulo

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2008

Primary Completion (ACTUAL)

August 1, 2009

Study Completion (ACTUAL)

August 1, 2009

Study Registration Dates

First Submitted

February 6, 2012

First Submitted That Met QC Criteria

February 6, 2012

First Posted (ESTIMATE)

February 8, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

February 9, 2012

Last Update Submitted That Met QC Criteria

February 8, 2012

Last Verified

February 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ABG MASTER

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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