NCT07841561

Brief Summary

This randomized crossover study investigated whether exercise intensity influences the mobilization of circulating CD34+ progenitor cells when total external work is matched. Forty trained male endurance athletes completed two cycling exercise conditions in randomized order: a higher-intensity condition at 70% of peak work rate (WRpeak) and a lower-intensity condition at 30% WRpeak. Both conditions were performed until 250 kJ of external work had been completed and were separated by a washout period of at least 7 days. Venous blood samples were obtained before exercise, immediately after exercise, and at 15, 30, and 60 minutes of recovery. The primary outcome was the absolute concentration of viable circulating CD34+ cells measured using single-platform flow cytometry. Secondary outcomes included CD34+CD45dim, CD34+CD133+, and CD34+VEGFR2+ cell phenotypes, together with adrenergic, metabolic, chemokine, growth-factor, and cardiovascular responses. The study was designed to determine whether exercise intensity produces distinct progenitor-cell mobilization responses despite identical external work.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2026

Shorter than P25 for not_applicable

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

August 3, 2026

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 9, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 9, 2026

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

September 19, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 25, 2026

Completed
Last Updated

September 25, 2026

Status Verified

September 1, 2026

Enrollment Period

1 month

First QC Date

September 19, 2026

Last Update Submit

September 19, 2026

Conditions

Keywords

Exercise IntensityCD34+ Progenitor CellsCirculating Progenitor CellsEndurance AthletesCrossover StudyAdrenergic ResponseCXCL12

Outcome Measures

Primary Outcomes (1)

  • Change From Baseline in Absolute Circulating Viable CD34+ Progenitor Cell Concentration

    Absolute circulating viable CD34+ progenitor cells were quantified in peripheral blood using single-platform flow cytometry with counting beads and expressed as cells/µL. Measurements were obtained before exercise and during recovery after each exercise condition. Change from baseline was calculated for each post-exercise time point and compared between the 70% WRpeak and 30% WRpeak work-matched exercise conditions.

    Baseline, immediately post-exercise, and 15, 30, and 60 minutes post-exercise during each intervention session.

Secondary Outcomes (3)

  • Change From Baseline in Circulating CD34+CD45dim Progenitor Cell Concentration

    Baseline, immediately post-exercise, and 15, 30, and 60 minutes post-exercise during each intervention session.

  • Change From Baseline in Circulating CD34+CD133+ Progenitor Cell Concentration

    Baseline, immediately post-exercise, and 15, 30, and 60 minutes post-exercise during each intervention session.

  • Change From Baseline in Circulating CD34+VEGFR2+ Progenitor Cell Concentration

    Baseline, immediately post-exercise, and 15, 30, and 60 minutes post-exercise during each intervention session.

Study Arms (2)

Sequence AB: 70% WRpeak Then 30% WRpeak

EXPERIMENTAL

Participants first completed a cycling exercise bout at 70% of individual peak work rate (WRpeak) until 250 kJ of external work was achieved. After a washout period of at least 7 days, participants completed a second cycling bout at 30% WRpeak, also matched to 250 kJ of external work.

Behavioral: Higher-Intensity Work-Matched Cycling ExerciseBehavioral: Lower-Intensity Work-Matched Cycling Exercise

Sequence BA: 30% WRpeak Then 70% WRpeak

EXPERIMENTAL

Participants first completed a cycling exercise bout at 30% of individual peak work rate (WRpeak) until 250 kJ of external work was achieved. After a washout period of at least 7 days, participants completed a second cycling bout at 70% WRpeak, also matched to 250 kJ of external work.

Behavioral: Higher-Intensity Work-Matched Cycling ExerciseBehavioral: Lower-Intensity Work-Matched Cycling Exercise

Interventions

Participants performed cycle-ergometer exercise at 70% of individual peak work rate (WRpeak) until a total external mechanical work of 250 kJ was completed. Venous blood samples were obtained before exercise, immediately after exercise, and at 15, 30, and 60 minutes of recovery.

Sequence AB: 70% WRpeak Then 30% WRpeakSequence BA: 30% WRpeak Then 70% WRpeak

Participants performed cycle-ergometer exercise at 30% of individual peak work rate (WRpeak) until a total external mechanical work of 250 kJ was completed. Venous blood samples were obtained before exercise, immediately after exercise, and at 15, 30, and 60 minutes of recovery.

Sequence AB: 70% WRpeak Then 30% WRpeakSequence BA: 30% WRpeak Then 70% WRpeak

Eligibility Criteria

Age18 Years - 35 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

College of Physical Education and Sports Sciences, University of Samarra

Samarra, Muhafazat Salah ad Din, 34010, Iraq

Location

Study Officials

  • SAIF RASHEED GHANIM, PhD

    College of Physical Education and Sports Sciences, University of Samarra

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
assays were blinded to exercise condition and intervention sequence. Blood samples were labeled using coded identifiers that did not reveal participant identity, exercise intensity, or sequence assignment. Participants and exercise staff could not be blinded because of the obvious difference between the two exercise intensities.
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Model Details: Participants completed two work-matched cycling exercise conditions in a randomized, counterbalanced crossover design. Each participant performed exercise at 70% and 30% of individual peak work rate (WRpeak), with both conditions matched for 250 kJ of external work and separated by a washout period of at least 7 days. Participants were assigned to either sequence AB (70% followed by 30% WRpeak) or sequence BA (30% followed by 70% WRpeak).
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

September 19, 2026

First Posted

September 25, 2026

Study Start

August 3, 2026

Primary Completion

September 9, 2026

Study Completion

September 9, 2026

Last Updated

September 25, 2026

Record last verified: 2026-09

Data Sharing

IPD Sharing
Will share

De-identified individual participant data underlying the results reported in the published article may be shared upon reasonable request.

Shared Documents
STUDY PROTOCOL, SAP, ANALYTIC CODE
Time Frame
Beginning after publication of the study results and continuing for 5 years thereafter.
Access Criteria
De-identified individual participant data will be available to qualified researchers upon reasonable request to the corresponding author. Requests should include a scientifically valid research proposal and a description of the intended a

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