- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05067426
The 10/7 HIIT Shock Cycle Study: Effectiveness of 10 HIIT Sessions in 7 Days (THESIS)
The 10/7 HIIT Shock Cycle Study: The Effects of a 7-Day High-Intensity-Interval Training Shock Microcycle on Endurance Performance, Well-Being, Stress and Recovery in Endurance Trained Athletes - Randomized Controlled Trial
Study Overview
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Salzburg, Austria, 5400
- University of Salzburg
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Female or male
- aged 18-45 years
- Proof of physical fitness (e.g. sports medical examination required) for measurements with higher intensities (e.g. endurance tests, competition simulation)
- Competition experience at the national or international level in an endurance sport
- VO2max ≥50ml/kg/min for females; ≥55 ml/kg/min for males or a 5-kilometer (km) time trial performance of ≤ 20:00 min (female), or ≤ 18:30 min (male)
Exclusion Criteria:
- Systemic disease or other known pathology in the organs: heart, lungs, kidney, stomach, spleen, liver, gall bladder, and intestines.
- Evidence of pulmonary disease: forced expiratory volume in one second/forced expiratory volume < 70% with/without symptoms (cough, sputum) or other evidence of pulmonologic disease.
- Diabetes II.
- Neurological or psychological disease of any kind.
- Currently undergoing medical or psycho-therapeutic treatment.
- Health condition that does not allow regular participation in the training forms (e.g. acute illnesses such as fever or other flu-like infections within the last 7 days before the start of the study), orthopedic diseases, injuries to the muscular, bone, joint or tendon apparatus within the last three months.
- Alcohol or drug abuse.
- Already high training volume with high intensity training (more than 2 weekly training sessions of high-intensity training)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: HIIT-HV
HIIT-HV - high intensity interval training high volume Participants complete a total of 10 HIIT sessions over a 7-day period consisting of 5 x 4-minute intervals at an intensity of 90-95% of their individual maximum heart rate (HRmax), interspersed with a 2.5-minute active recovery period. Each training session is followed by 30 minutes of low-intensity training (total of 300 minutes of additional low-intensity training during this period). |
high-intensity interval training sessions
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|
Experimental: HIIT-LV
HIIT- LV - high intensity interval training low volume Participants complete a total of 10 HIIT sessions over a 7-day period consisting of 5 x 4-minute intervals at an intensity of 90-95% of their individual maximum heart rate (HRmax), interspersed with a 2.5-minute active recovery period. |
high-intensity interval training sessions
|
|
No Intervention: Control group
Participants continue with their regular training program.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Endurance performance I
Time Frame: 10 to 21 days (assessment is conducted once before the intervention and repeated three times afterwards, i.e. 3, 7 and 14 days after the completion of the intervention)
|
Change of maximal oxygen uptake (VO2max in ml/min/kg) compared to baseline and group
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10 to 21 days (assessment is conducted once before the intervention and repeated three times afterwards, i.e. 3, 7 and 14 days after the completion of the intervention)
|
|
Endurance performance II
Time Frame: 10 to 21 days (assessment is conducted once before the intervention and repeated three times afterwards, i.e. 3, 7 and 14 days after the completion of the intervention)
|
Change of peak performance (Ppeak in Watt) compared to baseline and group
|
10 to 21 days (assessment is conducted once before the intervention and repeated three times afterwards, i.e. 3, 7 and 14 days after the completion of the intervention)
|
|
Endurance performance III
Time Frame: 20 to 22 days (the assessment is conducted once before, and once after the intervention)
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Change of 5 kilometer time trial performance (in sec) compared to baseline and group
|
20 to 22 days (the assessment is conducted once before, and once after the intervention)
|
|
Endurance performance IV
Time Frame: 10 to 21 days (assessment is conducted once before the intervention and repeated three times afterwards, i.e. 3, 7 and 14 days after the completion of the intervention)
|
Change of lactate threshold (in km/h) compared to baseline and group
|
10 to 21 days (assessment is conducted once before the intervention and repeated three times afterwards, i.e. 3, 7 and 14 days after the completion of the intervention)
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Endurance performance V
Time Frame: 10 to 21 days (assessment is conducted once before the intervention and repeated three times afterwards, i.e. 3, 7 and 14 days after the completion of the intervention)
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Change of ventilatory thresholds (in km/h) compared to baseline and group
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10 to 21 days (assessment is conducted once before the intervention and repeated three times afterwards, i.e. 3, 7 and 14 days after the completion of the intervention)
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|
Endurance performance VI
Time Frame: 10 to 21 days (assessment is conducted once before the intervention and repeated three times afterwards, i.e. 3, 7 and 14 days after the completion of the intervention)
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Change of running economy (in ml/min/kg) compared to baseline and group
|
10 to 21 days (assessment is conducted once before the intervention and repeated three times afterwards, i.e. 3, 7 and 14 days after the completion of the intervention)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change of questionnaire scores - well-being
Time Frame: 30 days (questionnaires will be given to participants several times before, during, and after the intervention.)
|
Change of questionnaire scores compared to baseline and group as determined by a Visual-Analogue-Scale (from 0-100 millimeters).
Higher scores indicate poorer well-being.
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30 days (questionnaires will be given to participants several times before, during, and after the intervention.)
|
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Change of questionnaire scores - muscular fatigue
Time Frame: 30 days (questionnaires will be given to participants several times before, during, and after the intervention.)
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Change of questionnaire scores compared to baseline and group as determined by a Visual-Analogue-Scale (from 0-100 millimeters).
Higher scores indicate higher degree of fatigue.
|
30 days (questionnaires will be given to participants several times before, during, and after the intervention.)
|
|
Change of questionnaire scores - vitality
Time Frame: 30 days (questionnaires will be given to participants several times before, during, and after the intervention.)
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Change of questionnaire scores compared to baseline and group as determined by a Likert-Scale (from 0-10).
Higher scores indicate higher vitality.
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30 days (questionnaires will be given to participants several times before, during, and after the intervention.)
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Change of questionnaire scores - rate of fatigue
Time Frame: 30 days (questionnaires will be given to participants several times before, during, and after the intervention.)
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Change of questionnaire scores compared to baseline and group as determined by a Likert-Scale (from 0-10).
Higher scores indicate higher degree of fatigue.
|
30 days (questionnaires will be given to participants several times before, during, and after the intervention.)
|
|
Change of questionnaire scores - sleep quality
Time Frame: 30 days (questionnaires will be given to participants several times before, during, and after the intervention.)
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Change of questionnaire scores compared to baseline and group as determined by a Likert-Scale (from 1-7).
Higher scores indicate poorer sleep.
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30 days (questionnaires will be given to participants several times before, during, and after the intervention.)
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Change of blood count
Time Frame: 30 days (blood is drawn from participants several times before, during, and after the intervention.)
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Change of blood count concentrations compared to baseline and group
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30 days (blood is drawn from participants several times before, during, and after the intervention.)
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Change of cell-free DNA
Time Frame: 30 days (blood is drawn from participants several times before, during, and after the intervention.)
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Change of cell-free DNA concentrations compared to baseline and group
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30 days (blood is drawn from participants several times before, during, and after the intervention.)
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|
Change of creatine kinase
Time Frame: 30 days (blood is drawn from participants several times before, during, and after the intervention.)
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Change of creatine kinase concentrations compared to baseline and group
|
30 days (blood is drawn from participants several times before, during, and after the intervention.)
|
|
Change of urea
Time Frame: 30 days (blood is drawn from participants several times before, during, and after the intervention.)
|
Change of urea concentrations compared to baseline and group
|
30 days (blood is drawn from participants several times before, during, and after the intervention.)
|
|
Change of blood lactate
Time Frame: 30 days (blood is drawn from participants several times before, during, and after the intervention.)
|
Change of blood lactate concentrations compared to baseline and group
|
30 days (blood is drawn from participants several times before, during, and after the intervention.)
|
|
Change of cytokines
Time Frame: 30 days (blood is drawn from participants several times before, during, and after the intervention.)
|
Change of cytokine concentrations compared to baseline and group
|
30 days (blood is drawn from participants several times before, during, and after the intervention.)
|
|
Change of miRNA
Time Frame: 30 days (blood is drawn from participants several times before, during, and after the intervention.)
|
Change of miRNA compared to baseline and group
|
30 days (blood is drawn from participants several times before, during, and after the intervention.)
|
|
Change of neuromuscular performance
Time Frame: 30 days (neuromuscular performance is assessed several times before, during, and after the intervention)
|
Change of neuromuscular performance (counter movement jump height in cm) measured on a contact plate (AMTI, Watertown, USA) compared to baseline and group
|
30 days (neuromuscular performance is assessed several times before, during, and after the intervention)
|
|
Change of body weight
Time Frame: 10 to 21 days (assessment is conducted once before the intervention and repeated three times afterwards, i.e. 3, 7 and 14 days after the completion of the intervention)
|
Change of body weight in kg compared to baseline and group
|
10 to 21 days (assessment is conducted once before the intervention and repeated three times afterwards, i.e. 3, 7 and 14 days after the completion of the intervention)
|
|
Change of fat free mass
Time Frame: 10 to 21 days (assessment is conducted once before the intervention and repeated three times afterwards, i.e. 3, 7 and 14 days after the completion of the intervention)
|
Change of fat free mass in kg compared to baseline and group
|
10 to 21 days (assessment is conducted once before the intervention and repeated three times afterwards, i.e. 3, 7 and 14 days after the completion of the intervention)
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Change of fat mass
Time Frame: 10 to 21 days (assessment is conducted once before the intervention and repeated three times afterwards, i.e. 3, 7 and 14 days after the completion of the intervention)
|
Change of fat mass in kg compared to baseline and group
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10 to 21 days (assessment is conducted once before the intervention and repeated three times afterwards, i.e. 3, 7 and 14 days after the completion of the intervention)
|
|
Change of forced expiratory volume
Time Frame: 10 to 21 days (assessment is conducted once before the intervention and repeated three times afterwards, i.e. 3, 7 and 14 days after the completion of the intervention)
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Change of forced expiratory volume in liters compared to baseline and group
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10 to 21 days (assessment is conducted once before the intervention and repeated three times afterwards, i.e. 3, 7 and 14 days after the completion of the intervention)
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|
Change of power output during exercise
Time Frame: 7 days
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Change of power output in Watt (as determined via Stryd, Boulder, USA) during the intervention compared to baseline and group
|
7 days
|
|
Change of sleep quality I - GPS watch
Time Frame: 30 days (sleep is assessed several times before, during, and after the intervention)
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Change of sleep quality compared to baseline and group as determined by a GPS (Global Positioning System) watch
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30 days (sleep is assessed several times before, during, and after the intervention)
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Change of sleep quality II - ABIOS App
Time Frame: 30 days (sleep is assessed several times before, during, and after the intervention)
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Change of sleep quality compared to baseline and group as determined by the ABIOS (Algorithmik Biodata System) application
|
30 days (sleep is assessed several times before, during, and after the intervention)
|
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Correlations between sleep quality devices
Time Frame: 30 days
|
To determine the correlations between different sleep monitoring devices, i.e. the GPS watch (see outcome 27), the ABIOS system (see outcome 28) and the sleep quality questionnaire (see outcome 11)
|
30 days
|
|
Change of parameters recorded by an electrocardiogram - mean heart rate
Time Frame: 30 days (an electrocardiogram is written several times before, during, and after the intervention)
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Change of mean heart rate compared to baseline and group
|
30 days (an electrocardiogram is written several times before, during, and after the intervention)
|
|
Change of parameters recorded by an electrocardiogram - heart rate variability
Time Frame: 30 days (an electrocardiogram is written several times before, during, and after the intervention)
|
Change of heart rate variability (root mean sum of squared distance in ms) compared to baseline and group
|
30 days (an electrocardiogram is written several times before, during, and after the intervention)
|
|
Change of executive functions - Eriksen flanker task
Time Frame: 30 days (executive functions are tested several times before, during, and after the intervention)
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Change of executive functions compared to baseline and group.
This is recorded through a modified Eriksen flanker task consisting of 108 images showing five white arrows on a black screen.
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30 days (executive functions are tested several times before, during, and after the intervention)
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Change of executive functions - 2 back task
Time Frame: 30 days (executive functions are tested several times before, during, and after the intervention)
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Change of executive functions compared to baseline and group.
This is assessed through a 2-back task showing dots on a dice, numbers and geometrical figures.
|
30 days (executive functions are tested several times before, during, and after the intervention)
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Cardiac ultrasound
Time Frame: 1 day (this outcome will be determined once before study start)
|
Description of an athlete cohort regarding cardiac chamber volume (in ml, determined via EPIQ CVX, X5-1, Philips Healthcare, Andover, MA, USA)
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1 day (this outcome will be determined once before study start)
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Adherence to training program
Time Frame: 7 days
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Adherence to the HIIT training programs (determined as the ratio of training sessions performed to prescribed training sessions).
This is determined by the researchers by checking the training data of the athletes.
For example, if 9 out of 10 sessions were performed, this means 90% adherence.
|
7 days
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Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Thomas Stoeggl, Professor, PhD, University of Salzburg
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- NHaller
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.
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