NCT06896838

Brief Summary

The differences in physiological responses due to gender during exercise tests have recently begun to be investigated. The oxygen use of respiratory muscles and lower extremity muscles may differ during upper and lower extremity exercise tests, but there is no study on this subject in the literature. The primary aim of this study was to compare intercostal and quadriceps femoris muscle oxygenation during upper extremity and lower extremity maximal exercise tests in women and men. The secondary aim of the study was to investigate the relationship between intercostal and quadriceps femoris muscle oxygenation and upper extremity and lower extremity exercise capacity, body composition, respiratory muscle strength, and respiratory muscle endurance in women and men.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2025

Shorter than P25 for all trials

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

First Submitted

Initial submission to the registry

March 10, 2025

Completed
16 days until next milestone

First Posted

Study publicly available on registry

March 26, 2025

Completed
2 months until next milestone

Study Start

First participant enrolled

June 4, 2025

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 2, 2025

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 6, 2026

Completed
Last Updated

April 8, 2026

Status Verified

April 1, 2026

Enrollment Period

6 months

First QC Date

March 10, 2025

Last Update Submit

April 7, 2026

Conditions

Keywords

muscle oxygenationexercise capacitybody composition

Outcome Measures

Primary Outcomes (4)

  • Maximal symptom limited cycle ergometer test

    In order to evaluate the exercise capacity of individuals, a symptom-limited increasing workload exercise test will be applied on a bicycle ergometer. In the test, patients will warm up at 0 watts for 3 minutes and then proceed to the loading period of the test. During the loading period, patients will be provided with a 20-watt workload increase every 2 minutes to reach their maximal workload. Patients will be encouraged to continue testing to the maximum level they can sustain during the test. The test will be terminated by the practitioner when patients reach their maximal heart rate or if they wish to terminate the test due to symptoms.

    First day

  • Maximal symptom limited arm ergometer test

    Arm ergometer test will be used to evaluate the upper extremity exercise capacity of individuals. The test will be performed in a sitting position with the ergometer height at shoulder level. The arm ergometer test will begin at 0 watts (W) workload and 45-55 rpm at each stage. The workload will be increased by 10 W every two minutes. The highest workload reached during the test will be recorded as watt.

    Second day

  • Evaluation of Quadriceps Femoris Muscle Oxygenation

    Muscle oxygen level and total hemoglobin level of quadriceps femoris will be measured using Moxy® monitor (Moxy, Fortiori Design LLC, Minnesota, USA) before cycle ergometer test, during testing and during post-test recovery.

    First day

  • Evaluation of Intercostals Muscle Oxygenation

    Muscle oxygen level and total hemoglobin level of and intercostal muscles will be measured using Moxy® monitor (Moxy, Fortiori Design LLC, Minnesota, USA) before arm ergometer test, during testing and during post-test recovery.

    Second day

Secondary Outcomes (3)

  • Evaluation of respiratory muscle strength

    Second day

  • Evaluation of respiratory muscle endurance

    Second day

  • Evaluation of body composition

    First day

Study Arms (2)

Female Group

Healthy, active individuals with no history of respiratory, cardiovascular, metabolic, musculoskeletal or acute infection at least 2 weeks before the test will be included in the study. Individuals whose activity level is in category 3 according to the International Physical Activity Questionnaire results (at least 3 days of vigorous activity providing a minimum of 1500 metabolic equivalent (MET)-minutes (min)/week or more days of walking, moderate or vigorous activity providing a minimum of 3000 MET-min/week, 7 or more days) will be included.

Male Group

Healthy, active individuals with no history of respiratory, cardiovascular, metabolic, musculoskeletal or acute infection at least 2 weeks before the test will be included in the study. Individuals whose activity level is in category 3 according to the International Physical Activity Questionnaire results (at least 3 days of vigorous activity providing a minimum of 1500 MET-min/week or more days of walking, moderate or vigorous activity providing a minimum of 3000 MET-min/week, 7 or more days) will be included.

Eligibility Criteria

Age18 Years - 35 Years
Sexall(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Active individuals who are healthy, with no history of respiratory, cardiovascular, metabolic, musculoskeletal, or acute infections for at least 2 weeks prior to testing will be enrolled in the study.

You may qualify if:

  • Aged between 18-35 years,
  • Physically active (doing moderate intensity physical activity 3 days a week for 150 minutes / week)
  • Volunteer to participate in the study will be included in the study.

You may not qualify if:

  • Healthy individuals with any diagnosed chronic or systemic disease,
  • Those who smoke 10 packs x years or more,
  • Those with pneumonia or any acute infection,
  • Those with any psychiatric disorder will not be included in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kırşehir Ahi Evran University, Physical Therapy and Rehabilitation Center, Cardiopulmonary Unit

Kırşehir, Merkez, 40100, Turkey (Türkiye)

Location

Study Officials

  • Başak KAVALCI KOL, PhD

    Kirsehir Ahi Evran Universitesi

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle Investigator

Study Record Dates

First Submitted

March 10, 2025

First Posted

March 26, 2025

Study Start

June 4, 2025

Primary Completion

December 2, 2025

Study Completion

April 6, 2026

Last Updated

April 8, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

In the study, all data will be stored in a locked cabinet.

Locations