Exercise-induced Cardiac Adaptions in Rheumatoid Arthritis Patients During Interleukin-6 vs. Tumor Necrosis Factor Antibody Therapy: a Randomised, Controlled Study.

Status: Completed
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The present study will investigative the physiological effects of the cytokines interleukin-6 (IL-6) and tumor necrosis factor (TNF) on the adaptive changes to exercise in patients with rheumatoid arthritis. The investigators hypothesize that blockage of IL-6 receptors will decrease the cardiac and metabolic adaptations to exercise training compared to the inhibition of TNF. 80 patients will be included in a 12-week investigator blinded randomised exercise training intervention study.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: t
View:

• Age \>= 18 and \<70 years

• Informed consent

• Diagnosed RA based on the 2010 American College of Rheumatology/ EULAR criteria. In biological treatment with either IL-6rB og TNFi over four months prior to enrollment

• Low RA disease activity, based on the Disease Activity Score-28 ESR for Rheumatoid Arthritis (DAS28) \<=3.2

• An electrocardiogram without features of left ventricular hypertrophy defined by the European Society of Cardiology

• Females of childbearing potential have to use one or more of the following highly effective methods for contraception in order to be included:

‣ Vasectomized partner

⁃ Bilateral tubal occlusion

⁃ Sexual abstinence

⁃ Intrauterine device

⁃ Hormonal contraception

• Females who are considered to have no childbearing potential are

‣ Bilateral tubal ligation

⁃ Bilateral oophorectomy

⁃ Complete hysterectomy

⁃ Postmenopausal defined as 12 months with no menses without an alternative medical cause

Locations
Other Locations
Denmark
Rigshospitalet
Copenhagen
Time Frame
Start Date: 2021-01-01
Completion Date: 2023-12-31
Participants
Target number of participants: 69
Treatments
Experimental: RA patients TNFi Exercise
The patients will be randomized to 12-week supervised exercise training intervention or no exercise training. The exercise training program includes three supervised sessions per week over a 12-week period.~The program consists of high intensity endurance training on ergometer bicycles. The intensity will progress throughout the 12 weeks of training. The training consists of 10 minutes of warm up at 40-60% maximum heart rate (HRmax), followed by 25 minutes of high intensity interval training (4 bouts of 4 min at \>85% HRmax interspaced by 3 minutes of low intensity training at 40-60% Hrmax) and finally a 5 min cool-down of 50% Hrmax
Active_comparator: RA patients TNFi Control
This group will be allocated to control and therefore no supervised exercise regimen
Experimental: RA patients IL-6Rb Exercise
The patients will be randomized to 12-week supervised exercise training intervention or no exercise training. The exercise training program includes three supervised sessions per week over a 12-week period.~The program consists of high intensity endurance training on ergometer bicycles. The intensity will progress throughout the 12 weeks of training. The training consists of 10 minutes of warm up at 40-60% maximum heart rate (HRmax), followed by 25 minutes of high intensity interval training (4 bouts of 4 min at \>85% HRmax interspaced by 3 minutes of low intensity training at 40-60% Hrmax) and finally a 5 min cool-down of 50% Hrmax
Active_comparator: RA patients IL-6Rb Control
This group will be allocated to control and therefore no supervised exercise regimen
Sponsors
Leads: Rigshospitalet, Denmark

This content was sourced from clinicaltrials.gov