Resistance Training in Knee Osteoarthritis

Knee Osteoarthritis Clinical Trial

Official title:

Progressive Resistance Training in Women With Knee Osteoarthritis

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01099371
• Other study ID #: FDAAAA
• Status: Active, not recruiting
• Phase: Phase 2/Phase 3
• First received: April 1, 2010
• Last updated: May 6, 2010
• Start date: February 2009
• Est. completion date: February 2011

Study information

• Verified date: January 2009
• Source: Federal University of São Paulo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine whether:

1. Progressive resistance training improves pain and disability

2. Progressive Resistance training improves muscular strength, ability to walk and quality of life

Description:

Patients in experimental group participated in a 12-week progressive resistance training using a repetition maximum (RM) exercise in which patients performed 1RM with the maximum bearable weight. Once the 1RM was determined, training was divided into the following regimen: 2 series of 8 repetitions, the first with 50% and the second with 70% of 1RM.

The exercises were knee extension and flexion and hip abduction and adduction, all performed in machines. The 1RM load was reevaluated every 2 weeks.

The control group remained on a three-month waiting list for physiotherapy. Patients were assessed for pain, function, quality of life, muscle strength and six-minute walk test.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 70
• Est. completion date: February 2011
• Est. primary completion date: February 2009
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 40 Years to 70 Years

Eligibility

Inclusion Criteria:

• Woman

• Age between 40-70 years old

• Pain between 3 and 8 on a 10-point numeric pain scale

• Radiographically confirmed knee OA

Exclusion Criteria:

• Inflammatory diseases or any comorbidity that prohibit exercises, regular physical activity

• Trip plans for the next 12 months

Study Design

Allocation: Randomized, Endpoint Classification: Safety/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:
• exercise
progressive resistance training

Locations

Country	Name	City	State
Brazil	Federal University of Sao Paulo	Sao Paulo	SP

Sponsors (2)

Lead Sponsor	Collaborator
Federal University of São Paulo	Fundação de Amparo à Pesquisa do Estado de São Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain assessed on a 10-point numeric pain scale	Scale: visual analog scale	week 0	Yes
Secondary	Disability assessed on WOMAC	Western Ontario McMaster University Osteoarthritis Index Rheumatology An arthritic pain scoring system ranging from 0-no pain/disability to 100-most severe pain/disability; WOMAC-pain, WOMAC-function and WOMAC-stifness	week 6	Yes
Secondary	Quality of life assessed on the SF-36	Questionnaire Short-form-36	week 6	Yes
Secondary	Six-minute walk test	To assess distance walked in 6 minutes	week 12	Yes