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OpenTrials
Completed

NCT Number: NCT02528344

High Intensity Interval Training and Rheumatoid Arthritis

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.

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Key information

Age range

60 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Duke Molecular Physiology Institute

Durham, North Carolina, 27710, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

HIIT

Behavioral

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 outcomes

  1. Change in Disease Activity Scores

    Time frame: Baseline and Post-Intervention (12-weeks)

Secondary outcomes

  1. Change in Peak Oxygen Consumption

    Time frame: Baseline and Post-Intervention (12-weeks)

Sponsors and collaborators

Lead sponsor

Duke University

Other

Registry information

Official study title

The Effects of High-Intensity Interval Training on Inflammation in Adults With Rheumatoid Arthritis

Important dates

Study start
2015
Primary completion
2016
First posted
Aug 19, 2015
Registry last updated
Dec 8, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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