NCT07188389

Brief Summary

This study aims to examine the effects of acute aerobic exercise and cardiorespiratory fitness on cellular metabolism of CD8+ T cells and regulatory T cells (Tregs) found in the peripheral blood of humans. In addition, the study will investigate whether the effects of exercise differ based on exercise intensity, as well as whether the effects of exercise and fitness differ between subpopulations of CD8+ T cells and Tregs. Finally, the study aims to examine whether exercise- and fitness-induced changes in cell metabolism relate to changes in cell function.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
102

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2024

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2024

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 2, 2025

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 3, 2025

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

September 17, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 23, 2025

Completed
Last Updated

May 1, 2026

Status Verified

April 1, 2026

Enrollment Period

1.1 years

First QC Date

September 17, 2025

Last Update Submit

April 27, 2026

Conditions

Keywords

Cardiorespiratory fitnessacute exercise

Outcome Measures

Primary Outcomes (4)

  • Metabolic Function

    Cellular metabolic activity and poise of T cells as measured by flow cytometry (SCENITH)

    At rest, immediately after, and two hours after exercise

  • Immune Cell function

    Stimulated IFN-gamma, perforin and IL-10 production, as measured by flow cytometry

    At rest, immediately after, and two hours after exercise

  • Metabolic Regulation

    Expression of genes involved in cellular energy metabolism, as assessed by RT-PCR

    At rest, immediately after, and two hours after exercise

  • Mitochondrial Regulation

    Mitochondrial mass and membrane potential, as assessed by flow cytometry

    At rest, immediately after, and two hours after exercise

Secondary Outcomes (1)

  • Peripheral immune cell composition

    At rest, immediately after, and two hours after exercise

Study Arms (2)

Acute effects: Moderate Intensity Exercise

EXPERIMENTAL

Participants with a moderate fitness level (determined by VO2max value recorded during graded exercise test) will cycle 30minutes exercise below ventilatory threshold. Outcome measures will be compared within-subject across blood sampled before exercise, immediately after exercise, and 2h post exercise. The order of the exercise sessions (above vs below threshold) will be randomized.

Behavioral: Acute exercise-moderate intensity

Acute effects: Heavy intensity exercise

EXPERIMENTAL

Participants with a moderate fitness level (determined by VO2max value recorded during graded exercise test) will bicycle 30 minutes above ventilatory threshold. Outcome measures will be compared within-subject across blood sampled before exercise, immediately after exercise, and 2h post exercise. The order of the exercise sessions (above vs below threshold) will be randomized.

Behavioral: Acute effects-heavy intensity

Interventions

30 minutes of cycling exercise at moderate (90% of first ventilatory threshold)

Acute effects: Moderate Intensity Exercise

Participants will cycle 30 minutes at heavy (110% of first ventilatory threshold) intensity

Acute effects: Heavy intensity exercise

Eligibility Criteria

Age20 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Men and women, aged 20-40 years
  • individuals presenting with average (40th-60th percentile) cardiorespiratory fitness (i.e., VO2max/VO2peak) for their age and sex will be included in acute exercise experiments; individuals with VO2max/VO2peak value \>20ml/kg/min will be included in cardiorespiratory fitness experiments
  • individuals categorized as 'low risk' for a cardiovascular event/heart disease when screened by American College of Sports Medicine (ACSM) criteria

You may not qualify if:

  • adults under the age of 20 and over the age of 40
  • Individuals with contraindications to exercise testing will be excluded
  • Individuals with musculoskeletal impairments preventing them from exercising on a cycle ergometer
  • Individuals with disease history known to impact the immune system and/or systemic metabolism will be excluded, including autoimmune diseases, HIV, Hepatitis, diabetes, cancer (completed treatment within \<6 months prior), hyper- or hypothyroidism
  • Pregnancy
  • Individuals using medications known to impact the cardiopulmonary and/or immune response to exercise with be excluded, including those using medication to control blood pressure (e.g., beta-blockers), daily steroidal and nonsteroidal anti-inflammatories (except daily aspirin), prescription allergy medication, ADHD medication (Ritalin or Adderall), thyroid medication (e.g., Levothyroxine), and chemotherapy (including treatments within the last 6 months).
  • Individuals habitually using tobacco products within the last 6 months or with excessive alcohol intake (\>10 drinks/week)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Houston

Houston, Texas, 77204, United States

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

September 17, 2025

First Posted

September 23, 2025

Study Start

March 1, 2024

Primary Completion

April 2, 2025

Study Completion

April 3, 2025

Last Updated

May 1, 2026

Record last verified: 2026-04

Locations