- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07735507
Effects of a Familiarization Protocol on Time to Exhaustion Performance
Effects of a Familiarization Protocol on Time to Exhaustion Performance Treadmill Running Protocol
Familiarization is widely recommended before exercise performance testing to improve measurement consistency and reduce learning effects. However, practical constraints often limit researchers to a single-or no-familiarization session, raising the possibility that improvements observed following an intervention may partially reflect increased familiarity with the testing procedure rather than genuine physiological adaptations. This issue may be particularly relevant for time-to-exhaustion (TTE) protocols, which have been reported to exhibit greater between-session variability than self-paced endurance tests.
This exploratory analysis examined the magnitude of the familiarization effect during treadmill TTE testing by comparing a familiarization trial with a subsequent experimental trial. Linear mixed-effects models will be used to evaluate changes in TTE performance while accounting for pre-exercise fatigue and recovery, and between-session agreement was assessed using intraclass correlation coefficients and Bland-Altman analysis.
Study Overview
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- healthy and physically active
Exclusion Criteria:
- current or recently injured participants
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: familiarization
familiarization group
|
Time to exhaustion performed at 95% VO2max
|
|
Experimental: experimental
Experimental group (2nd session)
|
Time to exhaustion performed at 95% VO2max
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
time to exhaustion
Time Frame: immediate (0 hours)
|
time spent running at a speed of 95% VO2max
|
immediate (0 hours)
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- LE_TTE
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.