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High Intensity Interval Training and Rheumatoid Arthritis

Primary Purpose

Rheumatoid Arthritis

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

HIIT

About this trial

This is an interventional treatment trial for Rheumatoid Arthritis focused on measuring High Intensity Interval Training

Eligibility Criteria

60 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Duke Molecular Physiology Institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

HIIT - RA

Arm Description

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

Outcomes

Primary Outcome Measures

Change in Disease Activity Scores

Secondary Outcome Measures

Change in Peak Oxygen Consumption

Full Information

NCT ID

NCT02528344

First Posted

August 17, 2015

Last Updated

December 7, 2016

Sponsor

Duke University

1. Study Identification

Unique Protocol Identification Number

NCT02528344

Brief Title

High Intensity Interval Training and Rheumatoid Arthritis

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2016

Overall Recruitment Status

Completed

Study Start Date

September 2015 (undefined)

Primary Completion Date

October 2016 (Actual)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Duke University

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Rheumatoid Arthritis

Keywords

High Intensity Interval Training

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

12 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

HIIT - RA

Arm Type

Experimental

Arm Description

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

Intervention Type

Behavioral

Intervention Name(s)

HIIT

Intervention Description

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 Measure Information:

Title

Change in Disease Activity Scores

Time Frame

Baseline and Post-Intervention (12-weeks)

Secondary Outcome Measure Information:

Title

Change in Peak Oxygen Consumption

Time Frame

Baseline and Post-Intervention (12-weeks)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

60 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility 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.

Facility Information:

Facility Name

Duke Molecular Physiology Institute

City

Durham

State/Province

North Carolina

ZIP/Postal Code

27710

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

35523821

Citation

Andonian BJ, Koss A, Koves TR, Hauser ER, Hubal MJ, Pober DM, Lord JM, MacIver NJ, St Clair EW, Muoio DM, Kraus WE, Bartlett DB, Huffman KM. Rheumatoid arthritis T cell and muscle oxidative metabolism associate with exercise-induced changes in cardiorespiratory fitness. Sci Rep. 2022 May 6;12(1):7450. doi: 10.1038/s41598-022-11458-4.

Results Reference

derived

PubMed Identifier

34246305

Citation

Andonian BJ, Johannemann A, Hubal MJ, Pober DM, Koss A, Kraus WE, Bartlett DB, Huffman KM. Altered skeletal muscle metabolic pathways, age, systemic inflammation, and low cardiorespiratory fitness associate with improvements in disease activity following high-intensity interval training in persons with rheumatoid arthritis. Arthritis Res Ther. 2021 Jul 10;23(1):187. doi: 10.1186/s13075-021-02570-3.

Results Reference

derived

PubMed Identifier

30587230

Citation

Andonian BJ, Bartlett DB, Huebner JL, Willis L, Hoselton A, Kraus VB, Kraus WE, Huffman KM. Effect of high-intensity interval training on muscle remodeling in rheumatoid arthritis compared to prediabetes. Arthritis Res Ther. 2018 Dec 27;20(1):283. doi: 10.1186/s13075-018-1786-6.

Results Reference

derived

PubMed Identifier

29898765

Citation

Bartlett DB, Willis LH, Slentz CA, Hoselton A, Kelly L, Huebner JL, Kraus VB, Moss J, Muehlbauer MJ, Spielmann G, Kraus WE, Lord JM, Huffman KM. Ten weeks of high-intensity interval walk training is associated with reduced disease activity and improved innate immune function in older adults with rheumatoid arthritis: a pilot study. Arthritis Res Ther. 2018 Jun 14;20(1):127. doi: 10.1186/s13075-018-1624-x.

Results Reference

derived

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High Intensity Interval Training and Rheumatoid Arthritis

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