Sensorimotor Training Versus Resistance Training in Patients With Knee Osteoarthritis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Aline Basolli Gomiero, Federal University of São Paulo
ClinicalTrials.gov Identifier:
NCT01529398
First received: February 6, 2012
Last updated: February 8, 2012
Last verified: February 2012
  Purpose

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.


Condition Intervention Phase
Knee Osteoarthritis
Other: Sensorimotor training (SMT)
Other: Resistance training (RT)
Other: Control group (CG)
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy of a Sensorimotor Training in Patients With Knee Osteoarthritis: a Randomized Clinical Trial

Resource links provided by NLM:


Further study details as provided by Federal University of São Paulo:

Primary Outcome Measures:
  • Visual analogue scale of pain (VAS) [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
  • Get Up and Go Test [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
  • electromyographic analysis of quadriceps muscle (EMG) [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
  • isometric quadriceps strength [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
  • Medical Outcomes Study Short Form (SF-36) [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]

    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

  • Berg Balance Test [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
  • Tinetti Test [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
  • activities of daily living scale (ADLS) [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]

Enrollment: 96
Study Start Date: March 2008
Study Completion Date: August 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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.

  Eligibility

Ages Eligible for Study:   50 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01529398

Locations
Brazil
Department of Rheumatology and Physiotherapy of Interlagos Ambulatory - Santo Amaro University
São Paulo, Brazil, 04815-180
Sponsors and Collaborators
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
  More Information

Publications:
Responsible Party: Aline Basolli Gomiero, Physical Therapist, Federal University of São Paulo
ClinicalTrials.gov Identifier: NCT01529398     History of Changes
Other Study ID Numbers: ABG MASTER
Study First Received: February 6, 2012
Last Updated: February 8, 2012
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by Federal University of São Paulo:
knee osteoarthritis
exercise therapy
resistance training
proprioception

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on July 22, 2014