search
Back to results

Sensorimotor Training Versus Resistance Training in Patients With Knee Osteoarthritis

Primary Purpose

Knee Osteoarthritis

Status
Completed
Phase
Phase 2
Locations
Brazil
Study Type
Interventional
Intervention
Sensorimotor training (SMT)
Resistance training (RT)
Control group (CG)
Sponsored by
Federal University of São Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Knee Osteoarthritis focused on measuring knee osteoarthritis, exercise therapy, resistance training, proprioception

Eligibility Criteria

50 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Department of Rheumatology and Physiotherapy of Interlagos Ambulatory - Santo Amaro University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Sham Comparator

Arm Label

sensorimotor training (SMT)

Resistance training (RT)

Control group (CG)

Arm Description

Outcomes

Primary Outcome Measures

Visual analogue scale of pain (VAS)
Get Up and Go Test

Secondary Outcome Measures

Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
electromyographic analysis of quadriceps muscle (EMG)
isometric quadriceps strength
Medical Outcomes Study Short Form (SF-36)
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
Berg Balance Test
Tinetti Test
activities of daily living scale (ADLS)

Full Information

First Posted
February 6, 2012
Last Updated
February 8, 2012
Sponsor
Federal University of São Paulo
search

1. Study Identification

Unique Protocol Identification Number
NCT01529398
Brief Title
Sensorimotor Training Versus Resistance Training in Patients With Knee Osteoarthritis
Official Title
Efficacy of a Sensorimotor Training in Patients With Knee Osteoarthritis: a Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
February 2012
Overall Recruitment Status
Completed
Study Start Date
March 2008 (undefined)
Primary Completion Date
August 2009 (Actual)
Study Completion Date
August 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federal University of São Paulo

4. Oversight

Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis
Keywords
knee osteoarthritis, exercise therapy, resistance training, proprioception

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
96 (Actual)

8. Arms, Groups, and Interventions

Arm Title
sensorimotor training (SMT)
Arm Type
Active Comparator
Arm Title
Resistance training (RT)
Arm Type
Active Comparator
Arm Title
Control group (CG)
Arm Type
Sham Comparator
Intervention Type
Other
Intervention Name(s)
Sensorimotor training (SMT)
Other Intervention Name(s)
Agility/perturbation training; proprioceptive training; neuromuscular training
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Resistance training (RT)
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Control group (CG)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Visual analogue scale of pain (VAS)
Time Frame
16 weeks
Title
Get Up and Go Test
Time Frame
16 weeks
Secondary Outcome Measure Information:
Title
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Time Frame
16 weeks
Title
electromyographic analysis of quadriceps muscle (EMG)
Time Frame
16 weeks
Title
isometric quadriceps strength
Time Frame
16 weeks
Title
Medical Outcomes Study Short Form (SF-36)
Description
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
Time Frame
16 weeks
Title
Berg Balance Test
Time Frame
16 weeks
Title
Tinetti Test
Time Frame
16 weeks
Title
activities of daily living scale (ADLS)
Time Frame
16 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Virginia FM Trevisani, MD, MS, PhD
Organizational Affiliation
Federal University of São Paulo and Santo Amaro University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Maria S Peccin, PT, MS, PhD
Organizational Affiliation
Federal University of São Paulo
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Marcelo Abrahão, PT
Organizational Affiliation
Federal University of São Paulo
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Alvaro N Atallah, MD, PhD
Organizational Affiliation
Federal University of São Paulo
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Aline B Gomiero, PT
Organizational Affiliation
Federal University of São Paulo
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Andrea H Kayo, PT, MS
Organizational Affiliation
Federal University of São Paulo
Official's Role
Study Chair
Facility Information:
Facility Name
Department of Rheumatology and Physiotherapy of Interlagos Ambulatory - Santo Amaro University
City
São Paulo
ZIP/Postal Code
04815-180
Country
Brazil

12. IPD Sharing Statement

Citations:
PubMed Identifier
21330451
Citation
Fitzgerald GK, Piva SR, Gil AB, Wisniewski SR, Oddis CV, Irrgang JJ. Agility and perturbation training techniques in exercise therapy for reducing pain and improving function in people with knee osteoarthritis: a randomized clinical trial. Phys Ther. 2011 Apr;91(4):452-69. doi: 10.2522/ptj.20100188. Epub 2011 Feb 17.
Results Reference
background
PubMed Identifier
11922853
Citation
Fitzgerald GK, Childs JD, Ridge TM, Irrgang JJ. Agility and perturbation training for a physically active individual with knee osteoarthritis. Phys Ther. 2002 Apr;82(4):372-82.
Results Reference
background
PubMed Identifier
16371799
Citation
Diracoglu D, Aydin R, Baskent A, Celik A. Effects of kinesthesia and balance exercises in knee osteoarthritis. J Clin Rheumatol. 2005 Dec;11(6):303-10. doi: 10.1097/01.rhu.0000191213.37853.3d.
Results Reference
background
PubMed Identifier
18843657
Citation
Fransen M, McConnell S. Exercise for osteoarthritis of the knee. Cochrane Database Syst Rev. 2008 Oct 8;(4):CD004376. doi: 10.1002/14651858.CD004376.pub2.
Results Reference
background
PubMed Identifier
29236934
Citation
Gomiero AB, Kayo A, Abraao M, Peccin MS, Grande AJ, Trevisani VF. Sensory-motor training versus resistance training among patients with knee osteoarthritis: randomized single-blind controlled trial. Sao Paulo Med J. 2018 Jan-Feb;136(1):44-50. doi: 10.1590/1516-3180.2017.0174100917. Epub 2017 Dec 7.
Results Reference
derived

Learn more about this trial

Sensorimotor Training Versus Resistance Training in Patients With Knee Osteoarthritis

We'll reach out to this number within 24 hrs