Resistance Training in Knee Osteoarthritis

• Sponsor: Federal University of São Paulo (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT01099371
• Collaborator: Fundação de Amparo à Pesquisa do Estado de São Paulo (Other)
• Enrollment: 70
• Location: 1
• Arm: 1
• Duration (Months): 24
• Patients Per Site Per Month: 2.9

Study Details

Study Description

Brief 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

Condition or Disease	Intervention/Treatment	Phase
Knee Osteoarthritis	Other: exercise	Phase 2/Phase 3

Detailed 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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 70 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Progressive Resistance Training in Women With Knee Osteoarthritis
• Study Start Date: Feb 1, 2009
• Anticipated Primary Completion Date: Feb 1, 2009
• Anticipated Study Completion Date: Feb 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: exercise	Other: exercise; progressive resistance training

Outcome Measures

Primary Outcome Measures

1. Pain assessed on a 10-point numeric pain scale [week 0]

   Scale: visual analog scale

Secondary Outcome Measures

1. Disability assessed on WOMAC [week 6]

   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

2. Quality of life assessed on the SF-36 [week 6]

   Questionnaire Short-form-36

3. Six-minute walk test [week 12]

   To assess distance walked in 6 minutes

Eligibility Criteria

Criteria

• Ages Eligible for Study: 40 Years to 70 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Federal University of Sao Paulo	Sao Paulo	SP	Brazil	04023-062

Sponsors and Collaborators

• Federal University of São Paulo
• Fundação de Amparo à Pesquisa do Estado de São Paulo

Investigators

• Study Chair: Jamil Natour, PhD, Federal University of São Paulo

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT01099371
• Other Study ID Numbers: FDAAAA
• First Posted: Apr 7, 2010
• Last Update Posted: May 7, 2010
• Last Verified: Jan 1, 2009

• Keywords provided by , ,: Knee; Osteoarthritis; Exercise
• Additional relevant MeSH terms: Osteoarthritis; Osteoarthritis, Knee

Study Results

No Results Posted as of May 7, 2010