- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07618455
Effects of Whole-Body HIIT and Moderate Continuous Exercise on Immune Function (WBHIIT-IMM)
Effects of Whole-Body High-Intensity Interval Training and Moderate-Intensity Continuous Exercise on Immune Function in Recreationally Active Men
Study Overview
Status
Conditions
Detailed Description
This study was designed as a two-arm, parallel-group, randomized controlled trial. A total of 20 recreationally active male participants were randomly assigned to either the Whole Body High-Intensity Interval Training (WB-HIIT) group or the Moderate-Intensity Continuous Training (MICT) group. The intervention lasted 12 weeks and involved supervised training sessions multiple times a week.
The WB-HIIT protocol consisted of repeated high-intensity whole-body exercises performed at near-maximum effort with intermittent rest periods, while the MICT group performed moderate-intensity continuous aerobic exercise. Immune function was assessed through selected hematological and biochemical markers collected at baseline and post-intervention. In addition, physical performance variables were evaluated to examine secondary adaptations to different exercise modalities. The primary aim of the study was to compare the effects of WB-HIIT and MICT on immune system responses, while secondary outcomes included changes in exercise performance. This study provides insights into how different training intensities affect immune regulation in individuals who are active in their leisure time.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Merkez
-
Bitlis, Merkez, Turkey (Türkiye), 13100
- Bitlis Eren University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
Healthy male adults Aged 18-25 years Not engaged in regular structured exercise training (>3 sessions/week) VO₂max within normal healthy range Willingness to participate and provide informed consent No acute or chronic inflammatory, metabolic, or cardiovascular disease
Exclusion Criteria:
Female participants (not included in study design) Smoking or alcohol abuse Use of anti-inflammatory or immunomodulatory drugs Participation in regular high-intensity training programs Musculoskeletal limitations preventing exercise testing or training Acute infection within last 2 weeks Chronic metabolic, cardiovascular, or autoimmune diseases
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Whole-Body HIIT
Participants will perform Whole-Body High-Intensity Interval Training (WB-HIIT) protocol.
|
Whole-body high-intensity interval training protocol performed under supervision.
|
|
Active Comparator: MICT
Participants will perform Moderate-Intensity Continuous Training (MICT) protocol.
|
Moderate-intensity continuous training protocol performed under supervision.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Peripheral immune cell counts
Time Frame: Baseline and 8 weeks (post-intervention)
|
Changes in peripheral blood leukocyte, lymphocyte subsets, neutrophil, and monocyte counts from baseline to post-intervention (8 weeks).
|
Baseline and 8 weeks (post-intervention)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Inflammatory cytokine levels
Time Frame: Baseline and 8 weeks (post-intervention)
|
Changes in serum IL-6, TNF-α, and CRP levels from baseline to post-intervention (8 weeks).
|
Baseline and 8 weeks (post-intervention)
|
|
Immunoglobulin levels
Time Frame: Baseline and 8 weeks (post-intervention)
|
Changes in serum immunoglobulin (IgA, IgG, IgM) concentrations from baseline to post-intervention (8 weeks).
|
Baseline and 8 weeks (post-intervention)
|
|
Cortisol levels
Time Frame: Baseline and 8 weeks (post-intervention)
|
Changes in serum cortisol levels as a marker of exercise-induced stress response from baseline to post-intervention (8 weeks).
|
Baseline and 8 weeks (post-intervention)
|
|
Maximal oxygen uptake (VO₂max)
Time Frame: Baseline and 8 weeks (post-intervention)
|
Changes in VO₂max measured by cardiopulmonary exercise testing from baseline to post-intervention.
|
Baseline and 8 weeks (post-intervention)
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Melih Çalışır, PhD, Bitlis Eren Üniversitesi University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 2020-189
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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