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End Stage Renal DiseaseNCT04774484

High-Intensity Interval Training and Regulatory T Cells

A study testing High Intensity Interval Training in people with End Stage Renal Disease, run by Francesc Marti at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

Regulatory T cells (Tregs) are a small population of T cells compromising of 1% to 5% of the total T cells in the body but they are playing a fundamental role in the maintenance of the immune homeostasis. Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
End Stage Renal Disease
What is being tested?
High Intensity Interval Training
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 siteUnited States
Study dates
Jan 2023to 30 Jun 2026
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Age between 18 and 65 years old.
  • BMI between 18.5 and 25 or above 30. Rationale: we want to include "obesity" as categorical covariate in the influence of HIIT and discriminate the participants between "lean" (BMI range 18.5-25) and "obese" (BMI > 30)
  • Sedentary lifestyle (fewer than 5,000 steps per day)
  • Fluent in English, able to understand and provide informed consent.
  • Subjects willing to participate in the study and comply with study requirements as evidenced by signed Institutional Review Board (IRB)-approved informed consent.

Who cannot join

  • Age under 18 or over 65
  • BMI under 18.5 or between 25 and 30.
  • Active lifestyle (more than 5,000 steps per day).
  • Previous chronic use of systemic glucocorticoids, immune-suppressors or immuno-modulators in the preceding 3 months.
  • Patients with significant or active infection: HIV negative by ELISA or reverse transcription polymerase chain reaction (RT-PCR) [if ELISA is positive and RT-PCR is negative, the ELISA is considered false positive]; negative serology for Hepatitis B and C.
  • Active malignancy or history of malignancy within 1 year.
Show all 22Show fewer
  • Be pregnant or breastfeeding.
  • Hemoglobin less than 9.0 g/dl at the time of blood drawing.
  • Platelet count less than 100,000/* at the time of blood drawing.
  • White blood count less than 4 and/or Absolute Neutrophil Count less than 1500/* at the time of blood drawing.
  • Participation in any other study that involved investigational drug or regimens in the preceding 12 months.
  • History of delayed or abnormal wound healing.
  • Any immuno-related condition, chronic illness or prior treatment which, in the opinion of the investigator, precludes study participation.
  • Inability or unwillingness of participant to comply with study protocol or procedures.
  • Impaired consent capacity.
  • Any chronic use of anticoagulation.
  • Recipient of blood transfusion in 3 months prior to blood drawing.
  • Any orthopedic condition or chronic pain that prevents them from cycling.
  • Any symptomatic coronary artery disease prior enrollment within 3 months or any intervention for it in the past 6 months.
  • Any symptomatic current heart failure (New York Heart Association class III and IV), significant valvar heart disease.
  • History of non-compliance.
  • The study will not include any vulnerable population such as fetuses, pregnant women, children, or prisoners.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Kentucky Transplant Center

    Lexington, Kentucky, 40536

Other trials in United States

About this study

Official title: Impact of High-Intensity Interval Training on Regulatory T Cells

Regulatory T cells (Tregs) are a small population of T cells compromising of 1% to 5% of the total T cells in the body but they are playing a fundamental role in the maintenance of the immune homeostasis. These cells modulate the immune system by suppressing the effector activity and thus preventing autoimmune diseases and chronic inflammatory processes. Treg cell numbers have shown to increase with physical activity, and this increment has been directly correlated with exercise intensity. These results suggest that the increased Treg frequency may contribute to the beneficial effects of exercise on disorders associated with autoimmune disease or chronic low-grade inflammation such as atherosclerosis, diabetes mellitus, chronic kidney disease or cancer.

The overall purpose of this study is to determine the influence High-intensity interval training (HIIT) on the frequency and quality of peripheral Treg cells.

Read the detailed description

Tregs have been studied in clinical practice for different therapeutic applications. In the past several years there has been a significant interest in the transplant community to develop tolerance in order to substantially decrease or even eliminate the need of immuno-suppressive regimens. A growing body of evidence recognizes the balance between graft-reactive effector cells and graft-protective suppressor Treg cells as the ultimate determinant of long-term allograft survival. As a result, there is a major interest in transplantation to enhance the suppressor immune response as an alternative or complementary approach to reach a clinical tolerogenic state and preserve graft function. Exercise improves baseline immune function and helps to maintain immune homeostasis. Treg cell numbers have shown to increase with physical activity, and this increment has been directly correlated with exercise intensity. These results suggest that the increased Treg frequency may contribute to the beneficial effects of exercise on disorders associated with autoimmune disease or chronic low-grade inflammation such as atherosclerosis, diabetes mellitus, chronic kidney disease or cancer.

Primary Objectives: The overall purpose of this study is to determine the influence High-intensity interval training (HIIT) on the frequency and quality of peripheral Treg cells.

Secondary Objectives: Effects of HIIT in other T cell populations. Effects of HIIT in plasma concentration of inflammatory and metabolic markers. Effects of HIIT in obese vs lean.

Design: This is a prospective, single center, single-arm "pre-test/post-test" study designed to evaluate the safety, feasibility and initial efficacy of a 12-week HIIT regimen to increase the frequency and quality of peripheral Treg cells. All participants will have a pre-test (baseline) evaluation followed by a treatment and then a post-test.

Being tested
High Intensity Interval Training
Keywords
high intensity, interval training, exercise, obesity, inflammation, Treg
Medical subject headings
Kidney Failure, Chronic, Motor Activity, Obesity, Inflammation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • High Intensity Interval TrainingOther

    After the acclimatization session and assessment of eligibility, a graded exercise test (GXT) will be given to the participant. After checking their vitals, the HIIT program will be performed on recumbent cycles. The first two weeks of training will consist of a gradual ramp where subjects will perform a moderate intensity cycling program consisting of a 5-minute warm up followed by progressively longer continuous cycling starting at 15 minutes and progressing up to 30 minutes prior to starting the HIIT training. For the HIIT training subjects will perform 5 minutes of low to moderate steady state cycling to warm up. Following the warm up, the subjects will complete the 4x4 HIIT program. This will consist of 4 minutes of cycling at 85% of the subject's maximum heart rate (HR) followed by 4 minutes of a low intensity cycling period for recovery.

Study groups in NCT04774484
Study groupRoleWhat they receive
All subjects will be in one armExperimentalBoth Lean and Obese, End-Stage Renal Disease (ESRD) patients and normal volunteers will be in one arm, that will receive the High Intensity Interval Training intervention.
Receives: Other: High Intensity Interval Training

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change from baseline concentration of circulating Regulatory T cells (Tregs) in blood at 12 weeks post HIIT intervention

    Change from baseline concentration of circulating Regulatory T cells (Tregs) in blood

    Measured: Baseline- and at 12 weeks post-HIIT intervention

  2. Change from baseline Serum C-Reactive protein at 12 weeks post HIIT intervention

    Change from baseline concentration of serologic cytokines/growth factors/metabolites

    Measured: Baseline- and at 12 weeks post-HIIT intervention

  3. Change from baseline Serum Adiponectin at 12 weeks post HIIT intervention

    Change from baseline concentration of serologic cytokines/growth factors/metabolites

    Measured: Baseline- and at 12 weeks post-HIIT intervention

  4. Change from baseline expansion rates of TRegs (in vitro) at 12 weeks post HIIT intervention

    Change from baseline expansion rates of TRegs

    Measured: Baseline- and at 12 weeks post-HIIT intervention

Secondary outcomes (18)

  1. Change from baseline Serum Interleukin-6 (IL6) at 12 weeks post HIIT intervention

    Change from baseline concentration of serologic cytokines/growth factors/metabolites

    Measured: Baseline- and at 12 weeks post-HIIT intervention

  2. Change from baseline Serum Tumor Necrosis Factor- Alpha (TNF-alpha) at 12 weeks post HIIT intervention

    Change from baseline concentration of serologic cytokines/growth factors/metabolites

    Measured: Baseline- and at 12 weeks post-HIIT intervention

  3. Change from baseline Serum Leptin at 12 weeks post HIIT intervention

    Change from baseline concentration of serologic cytokines/growth factors/metabolites

    Measured: Baseline- and at 12 weeks post-HIIT intervention

  4. Change from baseline Blood Glucose at 12 weeks post HIIT intervention

    Concentration of serologic cytokines/growth factors/metabolites

    Measured: Baseline- and at 12 weeks post-HIIT intervention

  5. Change from baseline Serum Triglycerides at 12 weeks post HIIT intervention

    Change from baseline concentration of serologic cytokines/growth factors/metabolites

    Measured: Baseline- and at 12 weeks post-HIIT intervention

  6. Change from baseline Total Cholesterol at 12 weeks post HIIT intervention

    Change from baseline concentration of serologic cytokines/growth factors/metabolites

    Measured: Baseline- and at 12 weeks post-HIIT intervention

  7. Change from baseline Low Density Lipoprotein (LDL) at 12 weeks post HIIT intervention

    Change from baseline concentration of serologic cytokines/growth factors/metabolites

    Measured: Baseline- and at 12 weeks post-HIIT intervention

  8. Change from baseline High Density Lipoprotein (HDL) at 12 weeks post HIIT intervention

    Change from baseline concentration of serologic cytokines/growth factors/metabolites

    Measured: Baseline- and at 12 weeks post-HIIT intervention

  9. Change from baseline Serum Insulin at 12 weeks post HIIT intervention

    Change from baseline concentration of serologic cytokines/growth factors/metabolites

    Measured: Baseline- and at 12 weeks post-HIIT intervention

  10. Change from baseline Intracellular Helios at 12 weeks post HIIT intervention

    Change from baseline percentage and intensity of the Treg phenotype marker

    Measured: Baseline- and at 12 weeks post-HIIT intervention

  11. Change from baseline Cell membrane CD36 at 12 weeks post HIIT intervention

    Change from baseline percentage and intensity of the Treg phenotype marker

    Measured: Baseline- and at 12 weeks post-HIIT intervention

  12. Change from baseline Cell membrane GLUT1 at 12 weeks post HIIT intervention

    Change from baseline percentage and intensity of the Treg phenotype marker

    Measured: Baseline- and at 12 weeks post-HIIT intervention

  13. Change from baseline Cell membrane Leptin-Receptor at 12 weeks post HIIT intervention

    Change from baseline percentage and intensity of the Treg phenotype marker

    Measured: Baseline- and at 12 weeks post-HIIT intervention

  14. Change from baseline Cell membrane TIGIT at 12 weeks post HIIT intervention

    Change from baseline percentage and intensity of the Treg phenotype marker

    Measured: Baseline- and at 12 weeks post-HIIT intervention

  15. Change from baseline Suppressor Activity at 12 weeks post HIIT intervention

    Change from baseline activty of the Functional activity of TRegs

    Measured: Baseline- and at 12 weeks post-HIIT intervention

  16. Change from baseline Intracellular FoxP3 at 12 weeks post HIIT intervention

    Change from baseline percentage and intensity of the Treg phenotype marker

    Measured: Baseline- and at 12 weeks post-HIIT intervention

  17. Change from baseline Membrane CD25 at 12 weeks post HIIT intervention

    Change from baseline percentage and intensity of the Treg phenotype marker

    Measured: Baseline- and at 12 weeks post-HIIT intervention

  18. Change from baseline Membrane CD127 at 12 weeks post HIIT intervention

    Change from baseline percentage and intensity of the Treg phenotype marker

    Measured: Baseline- and at 12 weeks post-HIIT intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Mar 2021
  2. Study startJan 2023 (estimated)
  3. Primary completion30 Jun 2026 (estimated)
  4. Study completion30 Jun 2026 (estimated)

Why it stopped: Funding was not available.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04774484
Sponsor's protocol ID
0001
Status last verified
Feb 2023
First submitted
11 Oct 2020
Last updated
14 Feb 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing High Intensity Interval Training in people with End Stage Renal Disease, run by Francesc Marti at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 14 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from baseline concentration of circulating Regulatory T cells (Tregs) in blood at 12 weeks post HIIT intervention (time frame: Baseline- and at 12 weeks post-HIIT intervention). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04774484.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Feb 2023.

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