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High Intensity Interval Training and Rheumatoid Arthritis

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ClinicalTrials.gov Identifier: NCT02528344
Recruitment Status : Completed
First Posted : August 19, 2015
Last Update Posted : December 8, 2016
Sponsor:
Information provided by (Responsible Party):
Duke University

Brief Summary:
The overall objective is to determine whether High Intensity Interval Training (HIIT) has potential to improve disease activity scores for Rheumatoid Arthritis (RA) patients. By reducing inflammation and modifying immune function HIIT may offer a substantial paradigm shift in RA care, especially in older persons with RA who experience aging related-immunesenescence, increased systemic inflammation and greater physical inactivity than young persons. Prior to embarking on a large scale trial of HIIT-induced disease modification, this pilot study aims to demonstrate that HIIT can produce measurable responses in disease activity scores and peak VO2in persons undergoing routine pharmacologic treatment for RA.

Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Behavioral: HIIT Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effects of High-Intensity Interval Training on Inflammation in Adults With Rheumatoid Arthritis
Study Start Date : September 2015
Actual Primary Completion Date : October 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: HIIT - RA
All participants will undergo high intensity interval training 3x/week for 10-12 weeks. Intense exercise will be interspersed with appropriate rest periods of low intensity exercise
Behavioral: HIIT
All participants will undergo high intensity interval training 3x/week for 10-12 weeks. Intense exercise will be interspersed with appropriate rest periods of low intensity exercise




Primary Outcome Measures :
  1. Change in Disease Activity Scores [ Time Frame: Baseline and Post-Intervention (12-weeks) ]

Secondary Outcome Measures :
  1. Change in Peak Oxygen Consumption [ Time Frame: Baseline and Post-Intervention (12-weeks) ]


Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Seropositive (positive rheumatoid factor or anti-citrullinated protein antibody) or erosions typical of RA on radiographs.
  • History of fulfilling 2010 ACR/EULAR Classification Criteria for RA
  • Able to walk on a treadmill
  • Not participating in regular physical exercise (more than 60 minutes of moderate intensity or 30 minutes of vigorous intensity exercise per week) or weight reduction dieting.
  • No medication changes within the last three months.
  • Willing to forego knee joint injections, regular NSAID use, and use acetaminophen for any necessary analgesia during the course of the intervention.
  • No current (within the last three weeks) pharmacologic therapy with corticosteroids.

Exclusion Criteria:

  • Coronary artery disease
  • Diabetes mellitus
  • Chronic obstructive pulmonary disease
  • Absolute contra-indications to exercise: Recent (<6 months) acute cardiac event unstable angina, uncontrolled dysrhythmias causing symptoms or hemodynamic compromise, symptomatic aortic stenosis, uncontrolled symptomatic heart failure, acute pulmonary embolus, acute myocarditis or pericarditis, suspected or known dissecting aneurism and acute systemic infection.
  • Other inflammatory arthropathy or myopathy, Paget's disease, pigmented villonodular synovitis, joint infection, ochronosis, neuropathic arthropathy, osteochondromatosis, acromegaly, hemochromatosis, Wilson's disease, osteonecrosis, knee replacement.
  • Contraindicated Medicine: ticlopidine, clopidogrel, dipyridamole, warfarin, heparin, enoxaparin and other blood thinners.

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): NCT02528344


Locations
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United States, North Carolina
Duke Molecular Physiology Institute
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Duke University

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT02528344     History of Changes
Other Study ID Numbers: Pro00064057
First Posted: August 19, 2015    Key Record Dates
Last Update Posted: December 8, 2016
Last Verified: June 2016
Keywords provided by Duke University:
High Intensity Interval Training
Additional relevant MeSH terms:
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Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases