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Effects of Creatine Supplementation in Women With Knee Osteoarthritis and Fibromyalgia

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ClinicalTrials.gov Identifier: NCT00749983
Recruitment Status : Completed
First Posted : September 10, 2008
Last Update Posted : October 2, 2012
Sponsor:
Information provided by (Responsible Party):
Bruno Gualano, University of Sao Paulo

Brief Summary:
The purpose of this study is to determine whether creatine associated or not to exercise training can improve physical performance in patients with knee osteoarthritis and fibromyalgia.

Condition or disease Intervention/treatment Phase
Knee Osteoarthritis Fibromyalgia Dietary Supplement: Creatine supplementation Dietary Supplement: Dextrose supplementation Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : June 2009
Actual Primary Completion Date : July 2012
Actual Study Completion Date : July 2012

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 1
creatine intake
Dietary Supplement: Creatine supplementation
Placebo Comparator: 2
placebo (dextrose) intake
Dietary Supplement: Dextrose supplementation



Primary Outcome Measures :
  1. Physical function [ Time Frame: 12 weeks ]
    Assessed by the timed-stands test


Secondary Outcome Measures :
  1. Strength [ Time Frame: 12 weeks ]
    Assessed by the 1-repetition maximum test

  2. Quality of life [ Time Frame: 12 weeks ]
    health-related questionaires

  3. Body composition [ Time Frame: 12 weeks ]
    Assessed by DXA

  4. Renal function [ Time Frame: 12 weeks ]
    Assessed by 51Cr-EDTA



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Ages Eligible for Study:   25 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Fulfill ACR criteria of knee osteoarthritis
  • Fulfill ACR criteria of fibromyalgia

Exclusion Criteria:

  • Athletes
  • Drugs stable for at least three months before entering the study
  • No limitations to resistance training

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): NCT00749983


Locations
Brazil
University of Sao Paulo School of Medicine
Sao Paulo, Brazil, 01246903
Sponsors and Collaborators
University of Sao Paulo

Responsible Party: Bruno Gualano, Professor, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT00749983     History of Changes
Other Study ID Numbers: 0849/07
First Posted: September 10, 2008    Key Record Dates
Last Update Posted: October 2, 2012
Last Verified: October 2012

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Fibromyalgia
Myofascial Pain Syndromes
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Muscular Diseases
Neuromuscular Diseases
Nervous System Diseases