We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Sensorimotor Training Versus Resistance Training in Patients With Knee Osteoarthritis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01529398
Recruitment Status : Completed
First Posted : February 8, 2012
Last Update Posted : February 9, 2012
Sponsor:
Information provided by (Responsible Party):

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

Study Design

Study Type : Interventional  (Clinical Trial)
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 : March 2008
Primary Completion Date : August 2009
Study Completion Date : August 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis
U.S. FDA Resources

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 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.


Outcome Measures

Primary Outcome Measures :
  1. Visual analogue scale of pain (VAS) [ Time Frame: 16 weeks ]
  2. Get Up and Go Test [ Time Frame: 16 weeks ]

Secondary Outcome Measures :
  1. Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) [ Time Frame: 16 weeks ]
  2. electromyographic analysis of quadriceps muscle (EMG) [ Time Frame: 16 weeks ]
  3. isometric quadriceps strength [ Time Frame: 16 weeks ]
  4. 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

  5. Berg Balance Test [ Time Frame: 16 weeks ]
  6. Tinetti Test [ Time Frame: 16 weeks ]
  7. activities of daily living scale (ADLS) [ Time Frame: 16 weeks ]

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   50 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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
First Posted: February 8, 2012    Key Record Dates
Last Update Posted: February 9, 2012
Last Verified: February 2012

Keywords provided by Aline Basolli Gomiero, 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