NCT04774484Withdrawn
High-Intensity Interval Training and Regulatory T Cells
Impact of High-Intensity Interval Training on Regulatory T Cells
Source: ClinicalTrials.gov · Last updated 14 Feb 2023
Reason given: Funding was not available.
Brief summary (registry, in English)
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.
- Status (registry)
- Withdrawn
- Study type
- Interventional
- Enrollment
- 0 (actual)
- First submitted
- 11 Oct 2020
- Start date
- Jan 2023
- Primary completion date
- 30 Jun 2026
- Lead sponsor
- Francesc Marti
- Diseases
- Chronic kidney disease, Obesity
- NCT number
- NCT04774484
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous chronic use of systemic glucocorticoids, immune-suppressors or immuno-modulators in the preceding 3 months.
- Participation in any other study that involved investigational drug or regimens in the preceding 12 months.
- Any immuno-related condition, chronic illness or prior treatment which, in the opinion of the investigator, precludes study participation.
- Recipient of blood transfusion in 3 months prior to blood drawing.
- Any symptomatic coronary artery disease prior enrollment within 3 months or any intervention for it in the past 6 months.
Other illness
- 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.
- History of delayed or abnormal wound healing.
- Any orthopedic condition or chronic pain that prevents them from cycling.
- Any symptomatic current heart failure (New York Heart Association class III and IV), significant valvar heart disease.
- History of non-compliance.
Lab values
- 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.
Age
- Age under 18 or over 65
Other
- BMI under 18.5 or between 25 and 30.
- Active lifestyle (more than 5,000 steps per day).
- Be pregnant or breastfeeding.
- Inability or unwillingness of participant to comply with study protocol or procedures.
- Impaired consent capacity.
- Any chronic use of anticoagulation.
- The study will not include any vulnerable population such as fetuses, pregnant women, children, or prisoners.
Who the study is looking for
- 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.
Age in the registry: 18 years to 65 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Kentucky Transplant Center | Lexington | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.