Sensorimotor Training Versus Resistance Training in Patients With Knee Osteoarthritis

Sponsor
Federal University of São Paulo (Other)
Overall Status
Completed
CT.gov ID
NCT01529398
Collaborator
(none)
96
1
3
17
5.6

Study Details

Study Description

Brief Summary

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 or Disease Intervention/Treatment Phase
  • Other: Sensorimotor training (SMT)
  • Other: Resistance training (RT)
  • Other: Control group (CG)
Phase 2/Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
96 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Efficacy of a Sensorimotor Training in Patients With Knee Osteoarthritis: a Randomized Clinical Trial
Study Start Date :
Mar 1, 2008
Actual Primary Completion Date :
Aug 1, 2009
Actual Study Completion Date :
Aug 1, 2009

Arms and Interventions

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.

    Outcome Measures

    Primary Outcome Measures

    1. Visual analogue scale of pain (VAS) [16 weeks]

    2. Get Up and Go Test [16 weeks]

    Secondary Outcome Measures

    1. Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) [16 weeks]

    2. electromyographic analysis of quadriceps muscle (EMG) [16 weeks]

    3. isometric quadriceps strength [16 weeks]

    4. Medical Outcomes Study Short Form (SF-36) [16 weeks]

      Generic, patient-report measure designed to assess health-related quality of life, comprises 36 items divided into 8 subscales. Physical Functioning Role Limitations due to Physical Problems General Health Perceptions Vitality Social Functioning Role Limitations due to Emotional Problems General Mental Health Health Transition

    5. Berg Balance Test [16 weeks]

    6. Tinetti Test [16 weeks]

    7. activities of daily living scale (ADLS) [16 weeks]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    50 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Aline Basolli Gomiero, Physical Therapist, Federal University of São Paulo
    ClinicalTrials.gov Identifier:
    NCT01529398
    Other Study ID Numbers:
    • ABG MASTER
    First Posted:
    Feb 8, 2012
    Last Update Posted:
    Feb 9, 2012
    Last Verified:
    Feb 1, 2012
    Keywords provided by Aline Basolli Gomiero, Physical Therapist, Federal University of São Paulo
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Feb 9, 2012