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Do Obese Patients With Primary Knee Osteoarthritis Benefit From a Single Bout of Moderate Intensity Aerobic Exercise?

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ClinicalTrials.gov Identifier: NCT03927339
Recruitment Status : Completed
First Posted : April 25, 2019
Last Update Posted : March 12, 2020
Sponsor:
Information provided by (Responsible Party):
Mansoura University

Brief Summary:

Background: Obesity and degenerative joint disease are typically concomitant . Each are in the course of aerobic focus and excited inflammatory response. Exercise is taken into account a considerable treatment in rehabilitation of each conditions. nevertheless most of literature reported the good thing about regular exercise, whereas there's dearth regarding the consequence of base hit low to centrist usage session .

Objective:Hence, this report aimed to analyze the attainable effects of a single bout of moderate excercise in obese patients with KOA.

Methods:Thirty four rotund OA untrained semantic role and thirty age and sex matched healthy controls were registered during this sketch . OA patients were allotted to single session of low to moderate exercise on treadmill whereas controls remained unexercised. Perceived pain, GR activity, IL-6 , CRP, fasting blood glucose and lipid profile were assessed at baseline , once exercise and 24h after. Meanwhile, WOMAC score determined at baseline and once 24h.


Condition or disease Intervention/treatment
Knee Osteoarthriis and Oxidative Stress Diagnostic Test: pre and post excercise group

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Study Type : Observational
Actual Enrollment : 34 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Aerobic Exercise and Knee Osteoarthritis
Actual Study Start Date : June 29, 2019
Actual Primary Completion Date : September 1, 2019
Actual Study Completion Date : October 1, 2019

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Group/Cohort Intervention/treatment
pre and post excercise group Diagnostic Test: pre and post excercise group

Treadmill Training Protocol

Each eligible participant in the patients group was then prospectively assigned to undergo exercise session of full-body-free weight treadmill training. Once the participants were prepped, they performed stretching for 5 min and slow walking for 3 min as a warm-up exercise before starting the training. Stretch was carried out similarly to all the subjects to quadriceps femoris and the hamstring. In the warm-up time period , it was enforced for 3 min at the speed of1 km/h. Then patients began the walking trials and walked at 1 to 1.34 m/s on an electric car treadmill (JACO fitness: JACO-212C).





Primary Outcome Measures :
  1. change in degree of pain from base line [ Time Frame: assessed immediately before excercise, 10 minutes after excercise and 24 hours after excercise ]
    1-Pain Visual Analogue Scale: The VAS-pain score is composed of a continuous horizontal line. This line is 100 mm in length. To measure the intensity of pain, the score is anchored by (0 score = no pain) at one end and (100 score = worst imaginable pain) on the other end. The patient places a mark to the VAS line at the point which represents the intensity of his pain(1

  2. CHange in function from base line [ Time Frame: Assessed before excercise immediately,10 minutes after, excercise,24 hours after excercise ]

    Western Ontario and McMaster Universities Arthritis Index (WOMAC) scores of the OA patients were collected (10).

    Scores from the Western Ontario and Mc-Master University (WOMAC) OA index were used to assess pain, stiffness and function in OA patients [11]. Total WOMAC is the sum of 3 subscales scores. High WOMAC score indicates more pain and stiffness and severe functional limitation.



Secondary Outcome Measures :
  1. CHANGE INserum IL6 FROM BASE LINE, [ Time Frame: assessed immediately before excercise, 10 minutesafter excercise,and 24 hours after excercise ]
    Serum concentrations of IL-6 were determined using sandwich high sensitivity ELISA kit for quantitative detection of human IL-6 according to manufacturer's protocol (Boster Immunoleader by Boster Biological Technology Co. Inc.)

  2. change in serum C REACTIVE PROTEIN from base line [ Time Frame: assessed immediately before excercise, 10 minutesafter excercise,and 24 hours after excercise ]
    Detection of serum CRP was performed by Solid Phase Sandwich ELISA according to manufacturer's instructions (Quantikine Human CRP Immunoassay, R&D systems)

  3. change inSERUM LIPID PROFILE from base line [ Time Frame: assessed immediately before excercise, 10 minutesafter excercise,and 24 hours after excercise ]
    Blood macromolecule profiles, together with total cholesterol (TC), HDL cholesterol (HDL-C), calculated LDL cholesterol(LDL-C), and triglycerides (TG) concentrations were determined by protein assays.,

  4. change in serum Glutathione reductase assay: from base line [ Time Frame: assessed immediately before excercise, 10 minutesafter excercise,and 24 hours after excercise ]
    Spectrophotometric determination of GR activity in the serum was measured as described by Calberg and Mannervic (14) using commercially available Glutathione Reductase Assay Kit(Sigma chemical company, St Louis, Missouri, USA). Glutathione reductase catalyzes the reduction of GSSG by oxidizing NADPH to NADP+. The decrease in absorbance was measured at 340.



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Ages Eligible for Study:   40 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
a cohort of egyptian patients suffering from obesity and knee osteoarthritis
Criteria

Inclusion Criteria:

  • : knee OA with obesity; sedentary with no previous education ; ability to understand and follow commands; and ability to walk independently.

Exclusion Criteria:

  • Medical conditions contraindicating moderate aerobic exercising (as determined through prescreening questions, i.e., cardiac or coronary artery disease as ischemic cardiomyopathy , chronic lung disease, asthma, uncontrolled hypertension), inability to exercise via treadmill(i.e. no neuromuscular or lower extremity conditions or any other medical contraindication that could prevent them from floor walking as upset affecting movement of the pelvic arch or pace , story of previous hip or knee operating room ,periarticular fractures, or lower limb injuries).History of recent reefer transmission or acute joint lighting .History of recent joint injection (steroid, hyaluronic acid , etc.) within 6 calendar week of study. Ingestion of antioxidant supplementation and the use of psychotropic agents.

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): NCT03927339


Locations
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Egypt
Reham Magdy Shaat
Mansoura, Dakahlia Provence, Egypt, 050
Sponsors and Collaborators
Mansoura University
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Responsible Party: Mansoura University
ClinicalTrials.gov Identifier: NCT03927339    
Other Study ID Numbers: code R.18.04.137
First Posted: April 25, 2019    Key Record Dates
Last Update Posted: March 12, 2020
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Mansoura University:
Osteoarthritis- Obesity- single aerobic exercise session
Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases