NCT07632911

Brief Summary

Six-week exercise interventions in sedentary young women demonstrated that aerobic exercise and resistance exercise differentially optimize inflammatory and immune responses through their effects on osteocalcin and IgM, and IgA, respectively. These distinct effects of exercise modality on immune biomarkers can be utilized to design personalized exercise programs.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
5mo left

Started Jan 2025

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

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 Progress76%
Jan 2025Dec 2026

Study Start

First participant enrolled

January 2, 2025

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

May 21, 2026

Completed
18 days until next milestone

First Posted

Study publicly available on registry

June 8, 2026

Completed
7 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2026

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Expected
Last Updated

June 8, 2026

Status Verified

June 1, 2026

Enrollment Period

1.4 years

First QC Date

May 21, 2026

Last Update Submit

June 2, 2026

Conditions

Sedentary Behavior

Keywords

Aerobic exerciseresistance trainingsedentary womenexercise immunology

Outcome Measures

Primary Outcomes (7)

  • Change in C-Reactive Protein (CRP) Levels

    Serum C-reactive protein levels will be measured using an ELISA kit to evaluate systemic inflammation. (Unit of measurement: mg/L)

    Baseline (Week 0) and Post-intervention (Week 6)

  • Change in Interleukin-6 (IL-6) Levels

    Serum interleukin-6 levels will be analyzed to assess pro-inflammatory cytokine response. (Unit of measurement: pg/mL)

    Baseline (Week 0) and Post-intervention (Week 6)

  • Change in Tumor Necrosis Factor-Alpha (TNF-α) Levels

    Serum tumor necrosis factor-alpha levels will be measured to evaluate pro-inflammatory cytokine activity. (Unit of measurement: pg/mL)

    Baseline (Week 0) and Post-intervention (Week 6)

  • Change in Salivary Immunoglobulin A (IgA) Levels

    Salivary Immunoglobulin A levels will be measured to evaluate mucosal immune response. (Unit of measurement: mg/dL)

    Baseline (Week 0) and Post-intervention (Week 6)

  • Change in Immunoglobulin M (IgM) Levels

    Serum Immunoglobulin M levels will be measured to assess acute infection and humoral immune response. (Unit of measurement: mg/dL)

    Baseline (Week 0) and Post-intervention (Week 6)

  • Change in Immunoglobulin G (IgG) Levels

    Serum Immunoglobulin G levels will be measured to assess long-term immune memory and humoral immune response. (Unit of measurement: mg/dL)

    Baseline (Week 0) and Post-intervention (Week 6)

  • Change in Leukocyte (WBC) Count

    Total leukocyte (White Blood Cell) count will be analyzed to assess general immune and inflammatory status. (Unit of measurement: cells/µL)

    Baseline (Week 0) and Post-intervention (Week 6)

Study Arms (3)

Resistance exercise group

EXPERIMENTAL

Exercise group completed a 6-week supervised training program consisting of three sessions per week on non-consecutive days. Each session lasted 45-60 minutes and included a standardized warm-up, main exercise phase, and cool-down. Training stimulus was controlled using both internal and external load parameters. Internal load was monitored via heart rate (HR) and rating of perceived exertion (RPE), whereas external load was defined by exercise duration, intensity, and training volume.

Behavioral: Aerobic and resistance exercise

Aerobic Group

EXPERIMENTAL

The aerobic training group performed continuous exercise on a treadmill or cycle ergometer at 60-75% of heart rate reserve (HRR), corresponding to moderate-to-vigorous intensity. Exercise intensity was continuously monitored using HR and verified with RPE (target: 12-15). A progressive overload approach was applied, with intensity increasing from 60% HRR in the initial weeks to 70-75% HRR in the final phase.

Behavioral: Aerobic and resistance exercise

Control group

EXPERIMENTAL

The control group maintained habitual activities and refrained from structured exercise.

Behavioral: Aerobic and resistance exercise

Interventions

Aerobic and resistance exerciseBEHAVIORAL

Because it was done on young girls who lead a sedentary lifestyle.

Aerobic GroupControl groupResistance exercise group

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • University students aged 18-30
  • Individuals who have engaged in recreational exercise at least two days a week for the past three months
  • Those with low or no smoking or alcohol consumption who volunteer to participate in the study.

You may not qualify if:

  • Individuals who have had an infection or chronic illness in the last 6 months,
  • Those with a history of autoimmune disease,
  • Metabolic syndrome, or cardiovascular disease,
  • Those who have used antibiotics or anti-inflammatory drugs in the last 3 months,
  • Those who have suffered a serious injury during exercise or are unable to continue are not eligible.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

İnönu University

Malatya, Turkey (Türkiye)

Location

Related Publications (5)

  • Nash D, Hughes MG, Butcher L, Aicheler R, Smith P, Cullen T, Webb R. IL-6 signaling in acute exercise and chronic training: Potential consequences for health and athletic performance. Scand J Med Sci Sports. 2023 Jan;33(1):4-19. doi: 10.1111/sms.14241. Epub 2022 Oct 8.

    PMID: 36168944RESULT

  • Henson J, Yates T, Edwardson CL, Khunti K, Talbot D, Gray LJ, Leigh TM, Carter P, Davies MJ. Sedentary time and markers of chronic low-grade inflammation in a high risk population. PLoS One. 2013 Oct 29;8(10):e78350. doi: 10.1371/journal.pone.0078350. eCollection 2013.

    PMID: 24205208RESULT

  • Coughlin GH, Antush MT, Vella CA. Associations of sedentary behavior and screen time with biomarkers of inflammation and insulin resistance. J Behav Med. 2024 Oct;47(5):828-838. doi: 10.1007/s10865-024-00498-y. Epub 2024 May 25.

    PMID: 38796664RESULT

  • Thomas NE, Williams DR. Inflammatory factors, physical activity, and physical fitness in young people. Scand J Med Sci Sports. 2008 Oct;18(5):543-56. doi: 10.1111/j.1600-0838.2008.00824.x. Epub 2008 Jul 9.

    PMID: 18627553RESULT

  • Dogra S, Wolf M, Jeffrey MP, Foley RCA, Logan-Sprenger H, Jones-Taggart H, Green-Johnson JM. Disrupting prolonged sitting reduces IL-8 and lower leg swell in active young adults. BMC Sports Sci Med Rehabil. 2019 Oct 18;11:23. doi: 10.1186/s13102-019-0138-4. eCollection 2019.

    PMID: 31636910RESULT

MeSH Terms

Conditions

Sedentary Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Fahri Safa Çınarlı, Doç. Dr.

    Inonu University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
LECTURER DOCTOR

Study Record Dates

First Submitted

May 21, 2026

First Posted

June 8, 2026

Study Start

January 2, 2025

Primary Completion

June 15, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

June 8, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)