Progressive Collective-exercise Program on the Knee Osteoarthritis

Knee Osteoarthritis Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01850862
• Other study ID #: CEP-UFRN 530/11
• Status: Completed
• Phase: N/A
• First received: May 4, 2013
• Last updated: May 15, 2013
• Start date: June 2011
• Est. completion date: November 2011

Study information

• Verified date: May 2013
• Source: Universidade Federal do Rio Grande do Norte
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial Summary

The investigators hypothesized that an eight-week collective group exercise program would improve pain, quality of life and functional capacity in patients with knee osteoarthritis (KOA) compared with those receiving no exercise intervention.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: November 2011
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years to 80 Years

Eligibility

Inclusion Criteria:

• symptomatic and moderate to severe medical diagnostic of KOA.

• Subjects with normal cognitive functions and no restriction to perform physical activities were recruited from the hospital's KOA database and eligible to participate if they had presented: Lequesne questionnaire criteria (5 - 13.5), knee pain score between 3 and 7 (on a 0 -10 Visual Analogue Scale), stable doses of non-steroidal anti-inflammatory drugs (NSAIDs) and no regular physical exercise or use of canes in the months prior to the study.

Exclusion Criteria:

• Symptomatic heart disease; symptomatic disease of the lower limbs (other than KOA); symptomatic lung disease; severe systemic disease; severe psychiatric illness; regular physical exercise (three or more times per week for at least 3 months); drug injection in the knee in the previous 3 months; physiotherapy on the lower limbs in the previous 3 months and absence in two consecutive training sessions or three nonconsecutive sessions

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:
• Collective group exercise program in patients with KOA

• Orientation (without exercise)
Orientation about osteoarthritis disease but without any exercise program

Locations

Country	Name	City	State
Brazil	Federal University of Rio Grande do Norte	Natal	RN

Sponsors (1)

Lead Sponsor	Collaborator
Universidade Federal do Rio Grande do Norte

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	functional capacity	functional capacity assessed by Lequesne questionnaire and functional tests.	Eight weeks	No
Primary	Pain	pain assessed by Visual Analogue Scale	Eight weeks	No
Secondary	quality of life	quality of life assessed by SF-36 questionnaire	Eight weeks	No

External Links

•   Ethics in Human Research Committee of the Federal University of Rio Grande do Norte