Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Creatine, Exercise and Inflammatory Markers in 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: NCT02290275
Recruitment Status : Completed
First Posted : November 14, 2014
Last Update Posted : May 16, 2016
Sponsor:
Information provided by (Responsible Party):
Dr. Stephen Mark Cornish, University of Manitoba

Brief Summary:
The goal of this research project is to determine the effectiveness of creatine supplementation and supported low-load walking exercise for managing systemic inflammatory biomarkers and joint symptoms in individuals diagnosed with chronic symptomatic knee osteoarthritis. The central hypothesis of this investigation is that creatine supplementation and exercise will significantly lower systemic biomarkers of inflammation in patients diagnosed with knee osteoarthritis.

Condition or disease Intervention/treatment Phase
Osteoarthritis, Knee Dietary Supplement: Creatine Other: Walking Exercise Dietary Supplement: placebo (maltodextrin) Not Applicable

  Show Detailed Description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Creatine, Exercise and Inflammatory Markers in Knee Osteoarthritis
Study Start Date : January 2015
Actual Primary Completion Date : April 2016
Actual Study Completion Date : April 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Placebo
The subjects in this arm will receive 20 grams of a placebo (maltodextrin) for 1 week and then 5 grams of placebo (maltodextrin) for 11 weeks in addition to their regular diets.
Dietary Supplement: placebo (maltodextrin)
Subjects will supplement their regular diet with 20 grams of maltodextrin for 1 week and then 5 grams of maltodextrin for the following 11 weeks.

Experimental: Creatine
The subjects in this arm will receive 20 grams of creatine for 1 week and then 5 grams of creatine for 11 weeks in addition to their regular diets.
Dietary Supplement: Creatine
Subjects will supplement their regular diet with 20 grams of creatine for 1 week and then 5 grams of creatine for the following 11 weeks.

Experimental: Walking Exercise
The subjects in this arm will receive a walking exercise program on a motorized treadmill where they will walk for 30 minutes at 3.1 mph, 3 days per week for 12 weeks.
Other: Walking Exercise
Subjects will walk on a specialized treadmill that lowers the impact of walking by taking up to 80% of their body weight away. The subjects will exercise by walking on this treadmill at 3.1 mph, 3 days per week for 30 minutes per day for 12 weeks.




Primary Outcome Measures :
  1. C-reactive protein [ Time Frame: 12 weeks ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   45 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • (1) Ages 45-65; (2) Body mass index (BMI) over 25 kg/m2; (3) Knee pain when performing normal activities of daily living (walking, squatting, or kneeling); (4) Kellgren & Lawrence grades II & III radiographic evidence of mild to moderate knee osteoarthritis in one or both knees.

Exclusion Criteria:

  • (1) Radiographic evidence of severe knee osteoarthritis; (2) History of traumatic hip, knee, or ankle injury or surgery; (3) Use of crutches or a walking aid during ambulation; (3) History of medical conditions that prevent physical activity; (4) Unable to provide consent due to language barrier or mental status; (5) History of diabetes, cardiovascular disease, or screen positive for ankylosing spondylitis, psoriatic arthritis, chronic reactive arthritis, or renal problems requiring peritoneal dialysis or hemodialysis; (6) Unwillingness or inability to return for follow-up appointments.

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): NCT02290275


Locations
Layout table for location information
Canada, Manitoba
Alison Longo
Winnipeg, Manitoba, Canada, R3M 3E4
Sponsors and Collaborators
University of Manitoba
Investigators
Layout table for investigator information
Principal Investigator: Stephen M Cornish, PhD University of Manitoba

Layout table for additonal information
Responsible Party: Dr. Stephen Mark Cornish, Assistant Professor, University of Manitoba
ClinicalTrials.gov Identifier: NCT02290275     History of Changes
Other Study ID Numbers: E2014:117
First Posted: November 14, 2014    Key Record Dates
Last Update Posted: May 16, 2016
Last Verified: May 2016
Additional relevant MeSH terms:
Layout table for MeSH terms
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases