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Progressive Collective-exercise Program on the Knee Osteoarthritis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01850862
Recruitment Status : Completed
First Posted : May 10, 2013
Last Update Posted : May 16, 2013
Sponsor:
Information provided by (Responsible Party):
Wouber Hérickson de Brito Vieira, Universidade Federal do Rio Grande do Norte

Brief 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.

Condition or disease Intervention/treatment Phase
Knee Osteoarthritis Other: Collective group exercise program in patients with KOA Other: Orientation (without exercise) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : June 2011
Actual Primary Completion Date : October 2011
Actual Study Completion Date : November 2011

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Collective group exercise program in patients with KOA
Collective exercises program for patients with osteoarthritis and orientation about this disease
Other: Collective group exercise program in patients with KOA
Active Comparator: Control group (without exercise)
Orientation about osteoarthritis disease but without any exercise program
Other: Orientation (without exercise)
Orientation about osteoarthritis disease but without any exercise program




Primary Outcome Measures :
  1. Pain [ Time Frame: Eight weeks ]
    pain assessed by Visual Analogue Scale


Secondary Outcome Measures :
  1. quality of life [ Time Frame: Eight weeks ]
    quality of life assessed by SF-36 questionnaire


Other Outcome Measures:
  1. functional capacity [ Time Frame: Eight weeks ]
    functional capacity assessed by Lequesne questionnaire and functional tests.



Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01850862


Locations
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Brazil
Federal University of Rio Grande do Norte
Natal, RN, Brazil, 59072-970
Sponsors and Collaborators
Universidade Federal do Rio Grande do Norte
Investigators
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Principal Investigator: Wouber Hérickson de Brito Vieira, PhD Universidade Federal do Rio Grande do Norte
Principal Investigator: Bento João Abreu, PhD Universidade Federal do Rio Grande do Norte
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Wouber Hérickson de Brito Vieira, PhD, Universidade Federal do Rio Grande do Norte
ClinicalTrials.gov Identifier: NCT01850862    
Other Study ID Numbers: CEP-UFRN 530/11
First Posted: May 10, 2013    Key Record Dates
Last Update Posted: May 16, 2013
Last Verified: May 2013
Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases