NCT05655559

Brief Summary

The study will be conducted on healthy young adults. Hemodynamic effects such as heart rate, blood pressure, oxygen saturation (SpO2), including muscle oxygenation, will be compared in treadmill and bicycle exercises.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2022

Shorter than P25 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 9, 2022

Completed
10 days until next milestone

First Posted

Study publicly available on registry

December 19, 2022

Completed
11 days until next milestone

Study Start

First participant enrolled

December 30, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2023

Completed
Last Updated

December 19, 2022

Status Verified

November 1, 2022

Enrollment Period

3 months

First QC Date

December 9, 2022

Last Update Submit

December 9, 2022

Conditions

Keywords

muscle oxygenationtreadmillcyclemoxyexercise

Outcome Measures

Primary Outcomes (2)

  • Measurement of Patient-Reported Dyspnea and Fatigue

    Measurement of dyspnea during submaximal exercise with The Modified Borg Dyspnea Scale (MBS).

    Baseline

  • Measurement of Muscle Oxygenation

    Measurement of muscle oxygenation with Moxy Monitor.

    Baseline

Study Arms (2)

Treadmill Group

EXPERIMENTAL

Hemodynamic effects such as heart rate, blood pressure, oxygen saturation (SpO2), dyspnea and fatigue including muscle oxygenation, will be compared during treadmill exercises.

Other: QuestionnareDevice: Moxy Muscle Oxygen Monitor

Cycle Group

EXPERIMENTAL

Hemodynamic effects such as heart rate, blood pressure, oxygen saturation (SpO2), dyspnea and fatigue including muscle oxygenation, will be compared during cycling exercises.

Other: QuestionnareDevice: Moxy Muscle Oxygen Monitor

Interventions

Measurement of Dyspnea and Fatigue during submaximal exercise with The Modified Borg Scale (MBS).

Cycle GroupTreadmill Group

Measurement of muscle oxygenation with Moxy Muscle Oxygen Monitor.

Cycle GroupTreadmill Group

Eligibility Criteria

Age18 Years - 25 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Volunteering to participate in the study
  • No known disease
  • Be between the ages of 18-25

You may not qualify if:

  • Having cardiopulmonary disease,
  • Have had lower extremity muscle or joint injuries
  • Having an orthopedic/neurological disorder
  • Smoking and alcohol use,
  • Have suffered a lower extremity muscle or joint injury,
  • Having an orthopedic/neurological disorder,
  • Uncontrollable asthma,
  • PaO2\< 50 mmHg,
  • PaCO2\> 70mmHg,
  • Individuals with a resting systolic blood pressure of 200 mmHg

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Esra PEHLİVAN, Assoc. Prof.

    Saglik Bilimleri Universitesi

    STUDY DIRECTOR

Central Study Contacts

Esra PEHLİVAN, Assoc. Prof.

CONTACT

Dilara KALAYCI

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 9, 2022

First Posted

December 19, 2022

Study Start

December 30, 2022

Primary Completion

March 30, 2023

Study Completion

May 30, 2023

Last Updated

December 19, 2022

Record last verified: 2022-11

Data Sharing

IPD Sharing
Will not share