Musculoskeletal Diseases

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Arthritis, Rheumatoid

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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

This group will be allocated to "control" and therefore no supervised exercise regimen

Supervised high-intensity interval training for 12 weeks three times per week. The supervision may be physical or online supervision

Exercise

Control group, therefore no supervised exercise regime

No exercise

Regitse Christensen

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.

80 patients with rheumatoid arthritis who are being treated with either interleukin-6 receptor blockers (IL-6Rb) or tumor necrosis factor inhibitors (TNFi) for a minimum of four months prior to enrollment will be recruited and undergo baseline testing, including examination, biochemistry, ECG, DXA, OGTT, pulmonary function, VO2max, echocardiography, cardiac MRI.

After baseline testing, 40 patients in IL-6 receptor blocker treatment and 40 patients in TNF inhibitor treatment.will be randomly allocated into one group receiving standard of care (control group) or a group performing supervised high-intensity interval training three times a week over a period of 12 weeks. The randomization procedure involves a computer-generated block randomization schedule in a ratio of 1:1 stratified by sex by an independent person. Following the 12-week intervention period, all groups will complete a series of follow-up tests (as baseline testing).

Exercise-induced Cardiac Adaptions in Rheumatoid Arthritis Patients During IL-6 vs. TNF Antibody Therapy

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

Anonymised IPD obtained through this study may be provided to qualified researchers upon reasonable request.

Structural cardiac parameter: measured by MRI scan and echocardiography

Functional cardiac parameters: measured by MRI scan and echocardiography

Functional vascular parameter: measured by MRI

Measured with an incremental VO2 protocol on exercise bike

Free-living physical activity is measured using axial accelerometer-based physical activity monitors (AX3; Axivity, Newcastle upon Tyne, UK) for a 5-day period

Self reported intake of all foods and liquids

Change in fasting total cholesterol, low-density lipoprotein (LDL)-cholesterol and high-density lipoprotein (HDL)-cholesterol (mmol/L). Following an overnight fast (10 hours), blood samples are collected and processed by a trained laboratory technician and analysed according to standard procedures.

Change in triglycerides (mmol/L). Following an overnight fast (10 hours), blood samples are collected and processed by a trained laboratory technician and analysed according to standard procedures.

Change in measures of the international Core Outcome Set for rheumatoid arthritis : 66/68 tender and swollen joint count

Change in visual analogue scale (VAS) pain, VAS physician global assessment, VAS patient global assessment

The Visual Analogue Scale (VAS) is a self-report measure consisting simply of a 100 mm horixontal line with a statement at each end representing one extreme (0mm = nothing, 100mm = extreme)

Change in Health Assessment Questionnaire (HAQ-DI)

Total score is between 0-3.0. Increasing scores indicate worse functioning with 0 indicating no functional impairment and 3 indicating complete impairment.

Change in Short Form 36 (SF-36) Health Survey Questionnaire

A 8-scale score within 8 domains.All items are scored so that a high score defines a more favorable health state.

Change in the composite Disease Activity Score-28 ESR for Rheumatoid Arthritis (DAS28).

A DAS28 of greater than 5.1 implies active disease, less than 3.2 low disease activity, and less than 2.6 remission

Change in response criteria will be assessed according the clinical disease activity index (CDAI).

The CDAI composite index quantifies disease activity in RA, by utilising four clinical parameters including tender and swollen joints and global assessment from both patient and assessor on a vasual analogue scale.

CDAI interpretation score CDAI ≥ 22,1: High Activity CDAI \< 22,1 og ≥10,1: Moderate Activity CDAI \<10,0 og ≥ 2,9: Low Activity CDAI \<2,9: Remission

Change in response criteria will be assessed according the American College of Rheumatology (ACR 20/50/70) response

Change in response criteria will be assessed according the European League Against Rheumatism (EULAR none/good/moderate response)

Rigshospitalet, Denmark

Principal investigator

Lupus Erythematosus, Systemic

Anti-Infective Agents

Antineoplastic Agents

Interferons

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 3-10 min cool-down of 50% Hrmax

Control group, therefore no supervised exercise regime. Subjects are asked to not increase habitual exercise routines.

Supervised high-intensity interval training for 12 weeks three times per week

High Intensity Interval Training

Ronan Martin G Berg, MD, DMSc

Iben E Rasmussen, MSc

Simon Jønck, MD

Malte L Adamsen, MD

Investigating the physiological effects of the interferons type 1 and 2 (IFNs), and the cytokines Interleukin 6 (IL-6) and tumor necrosis factor (TNF) on the adaptive changes to exercise in patients with systemic lupus erythematosus (SLE).

The investigators hypothesize that the pathogenic blockage of IL-6 signalling that occurs in SLE, will decrease the cardiac and metabolic adaptations to aerobic exercise, and this decrease can be related to the IFN signature.

55 patients was included in a 12-week investigator blinded 1:1 randomised high intensity aerobic exercise intervention study.

55 patients with SLE have been included and randomized in a 1:1 fashion to a 12 week high intensity interval training (HIIT) course or standard care.

Randomization was stratified by sex.

All patients will undergo baseline and followup testing including: VO2Max, Pulmonary Function, Capillaroscopy, OGTT, Blood Tests, Epigenetic Markers of IFN, TNF and IL-6 signalling, Echocardiography,DXA, Medical Examination, Acute Exercise Bout with blood tests during and after an exercise bout similar to the intervention. A subgroup of patients will be offered a 82-Rb Pet CT of the heart as opt-in.

The exercise programme consists of 12 weeks of tri-weekly exercise bouts of 38-45 minutes, following warm-up subjects will undergo 4 sets of 4 minute high intensity exercise, measured as the pulse being above 85% of HRmax for more than half the time; and 3 minute low to medium intensity exercise between the high intensity sets, measured as the pulse being between 40 to 60% of HRmax.

Type 1 Interferon Induced Changes to Exercise Adaptations in Systemic Lupus Erythematosus Patients

Type 1 Interferon Induced Changes to Exercise Adaptations in Systemic Lupus

Data obtained through this study may be provided to qualified researchers with academic interest in Systemic Lupus Erythematosus.

Data or samples shared will be coded, with no PHI included. Approval of the request and execution of all applicable agreements (i.e. a material transfer agreement) are prerequisites to the sharing of data with the requesting party.

Itemized Physician evaluated changes in measures of SLEDAI-2K on a scale from 0-22 that account for partial improvements in condition, higher scores indicate increased disease activity.

Physician evaluated changes in measures of SLE (0-100% of line segment), higher scores equal higher disease activity (worse)

Patient reported outcome measures (PROMs) , higher scores equal higher fatigue (worse)

Patient reported outcome measures (PROMs), higher scores equal more pain (worse)

Patient reported outcome measures (PROMs), Possible scores range from 0 to 33, with higher scores representing more active SLE (worse)

Patient reported outcome measures (PROMs), Possible scores range from 1 to 10, with higher scores representing more active SLE

Measured by Dipstick in a semiquantitive manner with the following categories indicating increased concentration, negative, +/-, 1+, 2+, 3+, 4+.

Pulmonary function testing, FEV1/FVC ratio

Pulmonary function testing, FEV1/FVC ratio %

Measured by Nailfold Capillaroscopy by trained physician (score of 1-4, higher scores equal fewer capillaries)

Measured by Nailfold Capillaroscopy by trained physician - Width Measured in µm

Measured by Nailfold Capillaroscopy by trained physician - Length Measured in µm

Measured by Nailfold Capillaroscopy by trained physician - Avascular Areas (1-4 higher scores indicate more avascular areas)

Measured by Nailfold Capillaroscopy by trained physician - Capillary Disorganization (1-4 higher scores indicate more avascular areas)

Measured by Nailfold Capillaroscopy by trained physician - Microhemorrhages (avg per finger)

Measured by Nailfold Capillaroscopy by trained physician - Bushy Capillaries (average per millimeter)

Measured by Nailfold Capillaroscopy by trained physician - Megacapillaries (average per millimeter)

Measured by Nailfold Capillaroscopy by trained physician - Meandering capillaries (average per millimeter)

Measured by Nailfold Capillaroscopy by trained physician - Tortous capillaries (average per millimeter)

Measured by Nailfold Capillaroscopy by trained physician - Physicians comment

blood samples are collected and processed by a trained laboratory technician and analysed according to standard procedures.monitors (AX3; Axivity, Newcastle upon Tyne, UK) for a 3 to 5 day period

measured by echocardiography (\& 82Rb-PET-CT)

Measured by 82Rb-Pet-CT, on a subset of 40 participants

Free-living physical activity is measured using axial accelerometer-based physical activity monitors (AX3; Axivity, Newcastle upon Tyne, UK) for a 3 to 5 day period

Optional for Participants: mRNA expression of genes related to TNF, IL-6, IFN alpha, beta and Gamma signalling

Optional for Participants: NF-κB p65 DNA binding activity (ELISA), phosphorylated and total JNK, phosphorylated AMPK (p-AMPK) total AMPK (Western blotting).

Optional for Participants: NF-κB p65 DNA binding activity (ELISA) \& NF-κB binding activity (Western blotting).

Optional for Participants: phosphorylated and total JNK,

Optional for Participants: phosphorylated AMPK (p-AMPK) total AMPK (Western blotting).

Resting heart rate measured by R-R intervals on 1-lead ECG

Rise from supine ratio of R-R intervals on 1-lead ECG

Expiration/Inspiration ratio of R-R intervals on 1-lead ECG

Valsalva Maneuver ratio of R-R intervals on 1-lead ECG

measured by Fatigue Severity Scale Questionnaire (FSS)

Physician evaluated changes in measures of SLE on a scale of 0-105 encompassing symptoms from 9 organs, higher scores indicate increased disease activity.

Patient reported outcome measures (PROMs), Possible scores range from 0 to 100, with higher scores representing better health status

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Exercise-induced Cardiac Adaptions in Rheumatoid Arthritis Patients During IL-6 vs. TNF Antibody Therapy	NCT05215509	Rheumatoid Arth...	Exercise No exercise	18 Years - 70 Years	Rigshospitalet, Denmark
Type 1 Interferon Induced Changes to Exercise Adaptations in Systemic Lupus Erythematosus Patients	NCT05478018	Systemic Lupus ... Interferon Defi...	High Intensity ...	18 Years -	Rigshospitalet, Denmark

Spots Global Cancer Trial Database for cardiac adaptations