High Intensity Interval Training and Rheumatoid Arthritis

Rheumatoid Arthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02528344
• Other study ID #: Pro00064057
• Status: Completed
• Phase: N/A
• First received: August 17, 2015
• Last updated: December 7, 2016
• Start date: September 2015

Study information

• Verified date: June 2016
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 60 Years to 80 Years

Eligibility

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.

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

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

Locations

Country	Name	City	State
United States	Duke Molecular Physiology Institute	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Disease Activity Scores		Baseline and Post-Intervention (12-weeks)	No
Secondary	Change in Peak Oxygen Consumption		Baseline and Post-Intervention (12-weeks)	No