Analysis of Bioenergetics and Fatigue Responses in Basketball (TEAM) (TEAM)

November 22, 2025 updated by: Ioannis G. Fatouros, University of Thessaly

sTudy of the bioEnergetics and fAtigue Responses of a Basketball gaMe: The TEAM Trial

The aims of the study are:

  1. To examine skeletal muscle and blood metabolites during an official basketball game and to relate those to skeletal muscle performance during and after the game.
  2. To investigate whether skeletal muscle and blood metabolites are related to game-induced fatigue.
  3. To relate field activity during a basketball game with the responses of skeletal muscle and blood metabolites.
  4. To investigate how blood lactate reflects muscle lactate concentration during a basketball game.
  5. To determine whether temporary fatigue develops during a basketball game. game.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The basketball players will participate in three experimental games (N = 10/game) on an indoors basketball stadium. During a 2-week familiarization period, volunteers will be familiarized with the experimental procedures and participate in very light training (at local basketball facilities) aimed at developing match tactics and team cohesion. At the end of the familiarization period and before the experimental game, participants will undergo a 3-day baseline performance testing (resting conditions) at University (Department of Physical Education and Sport Sciences, University of Thessaly) facilities. Prior to the games, the players will refrain from strenuous exercise and intake of alcohol for 48 hours and from tobacco and caffeine for 12 h. Dietary intake will be monitored with daily diet recalls for 7 days before the experimental period and will be standardized for all participants by a registered dietitian. The dietitian will also prescribe the meals and snacks on the game-day. On the day of the game, participants will arrive at the stadium 1.5 h before for resting skeletal muscle and blood sampling. For the first muscle biopsy and in preparation for later obtainment of biopsies from vastus lateralis muscle. An incision will be made under local anesthesia (20 mg/ml xylocaine without adrenalin) and covered by sterile band-aid strips and a thigh and shoulder bandages. In addition, an inertial measurement unit (IMU) and a heart rate monitor will be placed on each subject. During the match, a number of physiological measurements will be performed at fixed times (before the game, at half-time and post-match) and after intense exercise periods within the four 10-min periods of the game. Volunteers will be randomly assigned, using the sealed envelope procedure, in six teams representing all field positions and each team will play in one of three experimental games (random allocation using standard procedures) against each other in a full 40-minute game according to official regulations. A total of 10 additional players (from various playing positions) will serve as substitute players that could enter the pitch for a few minutes when a player will have to leave the court (either participate in measurements or will have completed it's pre-determined playing time or in case of an injury). Fifteen players (pre/post game measurement group) will have muscle and blood samples taken at rest, at the end of the 2nd period (half-time) and at the end of the 4th period (end of game). A second group of eight players (intense periods measurement group 1) will have muscle and blood samples collected at rest and during the first and third period of the game (immediately after an intense period of game-play). A third group of seven players (intense periods measurement group 1) will have muscle and blood samples collected at rest and during the second and fourth period of the game (immediately after an intense period of game-play). An intense exercise period of game-play is identified as a period with a heart rate of > 90% of maximal [as assessed by the maximal heart rate obtained during a graded exercise test to measure the maximal oxygen consumption (VO2max)], a high number of high-intensity runs (speed of > 18 km/h), sprints (speed of > 25 km/h) and/or jumps evaluated by a professional licensed coach. All muscle biopsies will be sampled from the vastus lateralis. All players will have their field activity and heart rate measured throughout the game using IMU units and heart rate monitors. Games will start at 17.00 - 18 p.m. to avoid diurnal variations and will be held under normal environmental conditions. A standardized 30-min warm-up period will be performed before each game. All games will be videotaped.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Ioannis G Fatouros, Professor
  • Phone Number: +302431047047
  • Email: ifatouros@uth.gr

Study Contact Backup

Study Locations

  • Greece
    • Thessaly
      • Trikala, Thessaly, Greece, 42100
        • Recruiting
        • University of Thessaly, Department of Physical Education and Sports Science
        • Contact:
          • Ioannis G Fatouros, Professor
          • Phone Number: +30 24310 47047
          • Email: ifatouros@uth.gr
        • Contact:
        • Principal Investigator:
          • Ioannis G Fatouros, Professor

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Health status: were free of recent musculoskeletal injuries and/or illnesses (≥ 8 months before the study).
  • Not consuming ergogenic supplements/medications (≥ 6 months before the study)
  • Not smokers

Exclusion Criteria:

  • Completion of the pre-determined participation time during the experimental game.
  • Completion of all field measurements.
  • Completion of all pre-determined sampling points for biological tissue.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: BASKETBALL GROUP
Other: BASKETBALL GAME
Participants will arrive 1.5 hours pre-game for initial vastus lateralis muscle biopsies and blood sampling under local anesthesia (20 mg/ml xylocaine without adrenalin). They will be fitted with IMU sensors and heart rate monitors. Volunteers are randomly assigned to teams(6 teams) for a full 40-minute game. During the match, physiological measurements will be performed at fixed times (pre, at half-time, and post-match) and after intense exercise periods (HR>90% max, high-speed runs>18km/h) within the four 10-min periods. Three groups provide samples: Group 1 (n=15): rest, half-time, end-game. Group 2 (n=8): rest, post-intense period in 1st/3rd periods. Group 3 (n=7): rest, post-intense period in 2nd/4th periods. Ten players serve as substitutes. Games will start at 17.00 - 18 p.m. to avoid diurnal variations and will be held under normal environmental conditions. A standardized 30-min warm-up period will be performed before each game.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Measurement of countermovement jump height
Time Frame: Change from baseline to the: a. 20th minute (half-time) and 40th minute (end of the game) (N=10), b. 5th minute (mid-1st period) and 25th minute (mid-3rd period) (N=10) and c. 15th minute (mid-2nd period) and 35th minute (mid-4th period) (N=10).
Will be measured using a force platform system
Change from baseline to the: a. 20th minute (half-time) and 40th minute (end of the game) (N=10), b. 5th minute (mid-1st period) and 25th minute (mid-3rd period) (N=10) and c. 15th minute (mid-2nd period) and 35th minute (mid-4th period) (N=10).
Bilateral strength peak force and rate of force development on mid-thigh pull
Time Frame: Change from baseline to the: a. 20th minute (half-time) and 40th minute (end of the game) (N=10), b. 5th minute (mid-1st period) and 25th minute (mid-3rd period) (N=10) and c. 15th minute (mid-2nd period) and 35th minute (mid-4th period) (N=10).
Will be measured using a dynamometer.
Change from baseline to the: a. 20th minute (half-time) and 40th minute (end of the game) (N=10), b. 5th minute (mid-1st period) and 25th minute (mid-3rd period) (N=10) and c. 15th minute (mid-2nd period) and 35th minute (mid-4th period) (N=10).
Measurement of maximal sprinting speed over 5 meters
Time Frame: Change from baseline to the: a. 20th minute (half-time) and 40th minute (end of the game) (N=10), b. 5th minute (mid-1st period) and 25th minute (mid-3rd period) (N=10) and c. 15th minute (mid-2nd period) and 35th minute (mid-4th period) (N=10).
5-m sprinting speed will be assessed on the basketball court using infrared photocells
Change from baseline to the: a. 20th minute (half-time) and 40th minute (end of the game) (N=10), b. 5th minute (mid-1st period) and 25th minute (mid-3rd period) (N=10) and c. 15th minute (mid-2nd period) and 35th minute (mid-4th period) (N=10).
Measurement of maximal sprinting speed over 20 meters
Time Frame: Change from baseline to the: a. 20th minute (half-time) and 40th minute (end of the game) (N=10), b. 5th minute (mid-1st period) and 25th minute (mid-3rd period) (N=10) and c. 15th minute (mid-2nd period) and 35th minute (mid-4th period) (N=10).
20-m sprinting speed will be assessed on the basketball court using infrared photocells
Change from baseline to the: a. 20th minute (half-time) and 40th minute (end of the game) (N=10), b. 5th minute (mid-1st period) and 25th minute (mid-3rd period) (N=10) and c. 15th minute (mid-2nd period) and 35th minute (mid-4th period) (N=10).
Measurement of the capacity to perform repeated sprints
Time Frame: Change from baseline to the: a. 20th minute (half-time) and 40th minute (end of the game) (N=10), b. 5th minute (mid-1st period) and 25th minute (mid-3rd period) (N=10) and c. 15th minute (mid-2nd period) and 35th minute (mid-4th period) (N=10).
5 x 20m repeated maximal sprints will be performed with 25 sec rest in between. Speed will be recorded using infrared photocells
Change from baseline to the: a. 20th minute (half-time) and 40th minute (end of the game) (N=10), b. 5th minute (mid-1st period) and 25th minute (mid-3rd period) (N=10) and c. 15th minute (mid-2nd period) and 35th minute (mid-4th period) (N=10).
Measurement of field activity variables during the basketball game
Time Frame: Continuous monitoring during each 40-minute game.
Field activity will be continuously recorded during the basketball game using a microsensor inertial measurement unit (Kinexon Perform IMU).
Continuous monitoring during each 40-minute game.
Measurement of heart rate during the basketball game ad recording the average and maximal heart rate of the game.
Time Frame: Continuous monitoring during each 40-minute game.
Field activity will be continuously recorded during the basketball game using a Team Polar Pro heart rate monitor.
Continuous monitoring during each 40-minute game.
Measurement of skeletal muscle glycogen content
Time Frame: Change from baseline to the: a. 20th minute (half-time) and 40th minute (end of the game) (N=10), b. 5th minute (mid-1st period) and 25th minute (mid-3rd period) (N=10) and c. 15th minute (mid-2nd period) and 35th minute (mid-4th period) (N=10).
Will be assessed on muscle biopsy samples. Muscle glycogen content will be determined spectrophotometrically.
Change from baseline to the: a. 20th minute (half-time) and 40th minute (end of the game) (N=10), b. 5th minute (mid-1st period) and 25th minute (mid-3rd period) (N=10) and c. 15th minute (mid-2nd period) and 35th minute (mid-4th period) (N=10).
Measurement of skeletal muscle fiber-type distribution and fiber-type- specific glycogen content.
Time Frame: Change from baseline to the: a. 20th minute (half-time) and 40th minute (end of the game) (N=10), b. 5th minute (mid-1st period) and 25th minute (mid-3rd period) (N=10) and c. 15th minute (mid-2nd period) and 35th minute (mid-4th period) (N=10).
Will be assessed on muscle biopsy samples by histochemical analysis
Change from baseline to the: a. 20th minute (half-time) and 40th minute (end of the game) (N=10), b. 5th minute (mid-1st period) and 25th minute (mid-3rd period) (N=10) and c. 15th minute (mid-2nd period) and 35th minute (mid-4th period) (N=10).
Measurement of skeletal muscle phosphocreatine levels
Time Frame: Change from baseline to the: a. 20th minute (half-time) and 40th minute (end of the game) (N=10), b. 5th minute (mid-1st period) and 25th minute (mid-3rd period) (N=10) and c. 15th minute (mid-2nd period) and 35th minute (mid-4th period) (N=10).
Will be assessed on muscle biopsy samples by a flurometric assay.
Change from baseline to the: a. 20th minute (half-time) and 40th minute (end of the game) (N=10), b. 5th minute (mid-1st period) and 25th minute (mid-3rd period) (N=10) and c. 15th minute (mid-2nd period) and 35th minute (mid-4th period) (N=10).
Measurement of skeletal muscle lactate
Time Frame: Change from baseline to the: a. 20th minute (half-time) and 40th minute (end of the game) (N=10), b. 5th minute (mid-1st period) and 25th minute (mid-3rd period) (N=10) and c. 15th minute (mid-2nd period) and 35th minute (mid-4th period) (N=10).
Will be assessed on muscle biopsy samples by a flurometric assay.
Change from baseline to the: a. 20th minute (half-time) and 40th minute (end of the game) (N=10), b. 5th minute (mid-1st period) and 25th minute (mid-3rd period) (N=10) and c. 15th minute (mid-2nd period) and 35th minute (mid-4th period) (N=10).
Measurement of effort and fatigue
Time Frame: Change from baseline to the: a. 20th minute (half-time) and 40th minute (end of the game) (N=10), b. 5th minute (mid-1st period) and 25th minute (mid-3rd period) (N=10) and c. 15th minute (mid-2nd period) and 35th minute (mid-4th period) (N=10).
Will be measured by using the Borg Rating of Perceived Exertion (RPE) scale
Change from baseline to the: a. 20th minute (half-time) and 40th minute (end of the game) (N=10), b. 5th minute (mid-1st period) and 25th minute (mid-3rd period) (N=10) and c. 15th minute (mid-2nd period) and 35th minute (mid-4th period) (N=10).

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Body mass index (BMI)
Time Frame: At baseline
BMI will be calculated using the Quetelet's equation
At baseline
Fat mass (FM)
Time Frame: At baseline
FM (kg) will be assessed by whole-body dual-energy X-ray absorptiometry (DXA)
At baseline
Fat-free mass (FFM)
Time Frame: At baseline
FFM (kg) will be assessed by whole-body dual-energy X-ray absorptiometry (DXA)
At baseline
Dietary intake
Time Frame: At baseline
Dietary intake will be assesed over a 7-day period using diet recalls
At baseline
Peak Maximal oxygen consumption (Peak VO2)
Time Frame: At baseline
Peak VO2 will be estimated by open circuit spirometry via breath by breath method
At baseline
Bone mass density
Time Frame: At baseline
Bone mass density will be measured by using Dual-emission X-ray absorptiometry
At baseline
Bone mass content
Time Frame: At baseline
Bone mass content will be measured by using Dual-emission X-ray absorptiometry
At baseline
Rest Heart Rate
Time Frame: At baseline
The rest heart rate will be estimated using a heart rate monitor
At baseline
Body fat (BF)
Time Frame: At baseline
Body fat (%) will be assessed by whole-body dual-energy X-ray absorptiometry (DXA)
At baseline
Body mass
Time Frame: Change from baseline (pre-game) to 40 minutes of the game
Body mass will be measured using a beam balance
Change from baseline (pre-game) to 40 minutes of the game
Body height
Time Frame: At baseline
Body height will be measured using a beam balance with a stadiometer
At baseline
Evaluation of physical activity (PA)
Time Frame: At baseline
International Physical Activity Questionnaire - IPAQ
At baseline
Basketball-specific conditioning (endurance)
Time Frame: At baseline
Yo-Yo intermittent endurance test 1
At baseline
Basketball-specific conditioning (recovery)
Time Frame: At baseline
Yo-Yo intermittent recovery test 1
At baseline
Concentric and eccentric isokinetic peak torque of knee extensors and flexors of both dominant and non-dominant limbs
Time Frame: At baseline
Will be measured at 60°/s using a three-repetition protocol via an isokinetic dynamometer
At baseline
Maximal heart rate
Time Frame: Change from baseline (pre-game) to that recorded during the 40-minute game
Will be measured using an automated online pulmonary gas exchange system via breath- by- breath analysis during a graded exercise testing on a treadmill
Change from baseline (pre-game) to that recorded during the 40-minute game
Measurement of blood lactate
Time Frame: Change from baseline to the: a. 20th minute (half-time) and 40th minute (end of the game) (N=10), b. 5th minute (mid-1st period) and 25th minute (mid-3rd period) (N=10) and c. 15th minute (mid-2nd period) and 35th minute (mid-4th period) (N=10).
Will be measured in capillary blood collected from the index finger using a handheld portable analyzer
Change from baseline to the: a. 20th minute (half-time) and 40th minute (end of the game) (N=10), b. 5th minute (mid-1st period) and 25th minute (mid-3rd period) (N=10) and c. 15th minute (mid-2nd period) and 35th minute (mid-4th period) (N=10).
Measurement of plasma glucose concentration
Time Frame: Change from baseline to the: a. 20th minute (half-time) and 40th minute (end of the game) (N=10), b. 5th minute (mid-1st period) and 25th minute (mid-3rd period) (N=10) and c. 15th minute (mid-2nd period) and 35th minute (mid-4th period) (N=10).
Will be measured using a Clinical Chemistry Analyzer and a commercially available kit
Change from baseline to the: a. 20th minute (half-time) and 40th minute (end of the game) (N=10), b. 5th minute (mid-1st period) and 25th minute (mid-3rd period) (N=10) and c. 15th minute (mid-2nd period) and 35th minute (mid-4th period) (N=10).
Measurement of blood Glycerol concentration
Time Frame: Change from baseline to the: a. 20th minute (half-time) and 40th minute (end of the game) (N=10), b. 5th minute (mid-1st period) and 25th minute (mid-3rd period) (N=10) and c. 15th minute (mid-2nd period) and 35th minute (mid-4th period) (N=10).
Will be measured using a commercially available kit using a coupled enzyme assay involving glycerol kinase and glycerol phosphate oxidase, resulting in a colorimetric/fluorometric product proportional to the glycerol present.
Change from baseline to the: a. 20th minute (half-time) and 40th minute (end of the game) (N=10), b. 5th minute (mid-1st period) and 25th minute (mid-3rd period) (N=10) and c. 15th minute (mid-2nd period) and 35th minute (mid-4th period) (N=10).
Measurement of Plasma ammonia concentration
Time Frame: Change from baseline to the: a. 20th minute (half-time) and 40th minute (end of the game) (N=10), b. 5th minute (mid-1st period) and 25th minute (mid-3rd period) (N=10) and c. 15th minute (mid-2nd period) and 35th minute (mid-4th period) (N=10).
Will be quantitatively determined on an analyzer using a commercially available kit
Change from baseline to the: a. 20th minute (half-time) and 40th minute (end of the game) (N=10), b. 5th minute (mid-1st period) and 25th minute (mid-3rd period) (N=10) and c. 15th minute (mid-2nd period) and 35th minute (mid-4th period) (N=10).
Measurement of Plasma potassium concentration
Time Frame: Change from baseline to the: a. 20th minute (half-time) and 40th minute (end of the game) (N=10), b. 5th minute (mid-1st period) and 25th minute (mid-3rd period) (N=10) and c. 15th minute (mid-2nd period) and 35th minute (mid-4th period) (N=10).
Will be measured using a flame photometer (Radiometer FLM3), with lithium as the internal standard
Change from baseline to the: a. 20th minute (half-time) and 40th minute (end of the game) (N=10), b. 5th minute (mid-1st period) and 25th minute (mid-3rd period) (N=10) and c. 15th minute (mid-2nd period) and 35th minute (mid-4th period) (N=10).
Measurement of Plasma- free fatty acid
Time Frame: Change from baseline to the: a. 20th minute (half-time) and 40th minute (end of the game) (N=10), b. 5th minute (mid-1st period) and 25th minute (mid-3rd period) (N=10) and c. 15th minute (mid-2nd period) and 35th minute (mid-4th period) (N=10).
Will be measured spectophotometrically using an enzymatic kit
Change from baseline to the: a. 20th minute (half-time) and 40th minute (end of the game) (N=10), b. 5th minute (mid-1st period) and 25th minute (mid-3rd period) (N=10) and c. 15th minute (mid-2nd period) and 35th minute (mid-4th period) (N=10).
Measurement of blood hemoglobin and hematocrit
Time Frame: Change from baseline to the: a. 20th minute (half-time) and 40th minute (end of the game) (N=10), b. 5th minute (mid-1st period) and 25th minute (mid-3rd period) (N=10) and c. 15th minute (mid-2nd period) and 35th minute (mid-4th period) (N=10).
Will be measured using an automated hematology analyzer
Change from baseline to the: a. 20th minute (half-time) and 40th minute (end of the game) (N=10), b. 5th minute (mid-1st period) and 25th minute (mid-3rd period) (N=10) and c. 15th minute (mid-2nd period) and 35th minute (mid-4th period) (N=10).
Measurement of fluid loss and intake
Time Frame: Change from baseline (pre-game) to 40 minutes of the game
Will be measured using the measures of body mass (using a digital weight scale) and water consumption during a game.
Change from baseline (pre-game) to 40 minutes of the game

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Thessaly

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of Southern Denmark
Democritus University of Thrace

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 30, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 30, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 28, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 28, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 22, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 26, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 26, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 22, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • The TEAM trial

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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