NCT01529398

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
96

participants targeted

Target at P50-P75 for phase_2 knee-osteoarthritis

Timeline
Completed

Started Mar 2008

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2008

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2009

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

February 6, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 8, 2012

Completed
Last Updated

February 9, 2012

Status Verified

February 1, 2012

Enrollment Period

1.4 years

First QC Date

February 6, 2012

Last Update Submit

February 8, 2012

Conditions

Knee Osteoarthritis

Keywords

knee osteoarthritisexercise therapyresistance trainingproprioception

Outcome Measures

Primary Outcomes (2)

  • Visual analogue scale of pain (VAS)

    16 weeks

  • Get Up and Go Test

    16 weeks

Secondary Outcomes (7)

  • Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)

    16 weeks

  • electromyographic analysis of quadriceps muscle (EMG)

    16 weeks

  • isometric quadriceps strength

    16 weeks

  • Medical Outcomes Study Short Form (SF-36)

    16 weeks

  • Berg Balance Test

    16 weeks

  • +2 more secondary outcomes

Study Arms (3)

sensorimotor training (SMT)

ACTIVE COMPARATOR
Other: Sensorimotor training (SMT)

Resistance training (RT)

ACTIVE COMPARATOR
Other: Resistance training (RT)

Control group (CG)

SHAM COMPARATOR
Other: Control group (CG)

Interventions

Sensorimotor training (SMT)OTHER

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.

Also known as: Agility/perturbation training; proprioceptive training; neuromuscular training
sensorimotor training (SMT)
Resistance training (RT)OTHER

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.

Resistance training (RT)
Control group (CG)OTHER

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.

Control group (CG)

Eligibility Criteria

Age50 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

São Paulo, São Paulo, 04815-180, Brazil

Location

Related Publications (5)

  • 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.

    PMID: 21330451BACKGROUND

  • 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.

    PMID: 11922853BACKGROUND

  • 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.

    PMID: 16371799BACKGROUND

  • 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.

    PMID: 18843657BACKGROUND

  • 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.

    PMID: 29236934DERIVED

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Resistance TrainingControl Groups

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesPhysical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaEpidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

  • Virginia FM Trevisani, MD, MS, PhD

    Federal University of São Paulo and Santo Amaro University

    STUDY DIRECTOR

  • Maria S Peccin, PT, MS, PhD

    Federal University of São Paulo

    STUDY CHAIR

  • Marcelo Abrahão, PT

    Federal University of São Paulo

    STUDY CHAIR

  • Alvaro N Atallah, MD, PhD

    Federal University of São Paulo

    STUDY DIRECTOR

  • Aline B Gomiero, PT

    Federal University of São Paulo

    PRINCIPAL INVESTIGATOR

  • Andrea H Kayo, PT, MS

    Federal University of São Paulo

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Physical Therapist

Study Record Dates

First Submitted

February 6, 2012

First Posted

February 8, 2012

Study Start

March 1, 2008

Primary Completion

August 1, 2009

Study Completion

August 1, 2009

Last Updated

February 9, 2012

Record last verified: 2012-02

Locations

BR(1)