- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving 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
Studieoversikt
Status
Forhold
Detaljert beskrivelse
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.
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
-
-
Merkez
-
Bitlis, Merkez, Tyrkia (Türkiye), 13100
- Bitlis Eren University
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: 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.
|
|
Aktiv komparator: MICT
Participants will perform Moderate-Intensity Continuous Training (MICT) protocol.
|
Moderate-intensity continuous training protocol performed under supervision.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Peripheral immune cell counts
Tidsramme: 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)
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Inflammatory cytokine levels
Tidsramme: Baseline and 8 weeks (post-intervention)
|
Changes in serum IL-6, TNF-α, and CRP levels from baseline to post-intervention (8 weeks).
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Baseline and 8 weeks (post-intervention)
|
|
Immunoglobulin levels
Tidsramme: 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
Tidsramme: 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)
|
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Maximal oxygen uptake (VO₂max)
Tidsramme: Baseline and 8 weeks (post-intervention)
|
Changes in VO₂max measured by cardiopulmonary exercise testing from baseline to post-intervention.
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Baseline and 8 weeks (post-intervention)
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Melih Çalışır, PhD, Bitlis Eren Üniversitesi University
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Andre studie-ID-numre
- 2020-189
Plan for individuelle deltakerdata (IPD)
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IPD-planbeskrivelse
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