Sensorimotor Training Versus Resistance Training in Patients With Knee Osteoarthritis

Knee Osteoarthritis Clinical Trial

Official title:

Efficacy of a Sensorimotor Training in Patients With Knee Osteoarthritis: a Randomized Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01529398
• Other study ID #: ABG MASTER
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: February 6, 2012
• Last updated: February 8, 2012
• Start date: March 2008
• Est. completion date: August 2009

Study information

• Verified date: February 2012
• Source: Federal University of São Paulo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 96
• Est. completion date: August 2009
• Est. primary completion date: August 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years to 75 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
Brazil	Department of Rheumatology and Physiotherapy of Interlagos Ambulatory - Santo Amaro University	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Federal University of São Paulo

Country where clinical trial is conducted

Brazil, 

References & Publications (4)

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. — View 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. — View 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. — View 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. Review. Update in: Cochrane Database Syst Rev. 2015;1:CD004376. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual analogue scale of pain (VAS)		16 weeks	No
Primary	Get Up and Go Test		16 weeks	No
Secondary	Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)		16 weeks	No
Secondary	electromyographic analysis of quadriceps muscle (EMG)		16 weeks	No
Secondary	isometric quadriceps strength		16 weeks	No
Secondary	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	16 weeks	No
Secondary	Berg Balance Test		16 weeks	No
Secondary	Tinetti Test		16 weeks	No
Secondary	activities of daily living scale (ADLS)		16 weeks	No