The 10/7 HIIT Shock Cycle Study: Effectiveness of 10 HIIT Sessions in 7 Days

Healthy Clinical Trial

— THESIS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05067426
• Other study ID #: NHaller
• Status: Completed
• Phase: N/A
• Start date: August 15, 2021
• Est. completion date: December 31, 2022

Study information

• Verified date: January 2024
• Source: University of Salzburg
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A randomized, controlled trial to evaluate the effects of two versions of 10 high intensity interval trainings (HIIT) within a 7-day shock microcycle on endurance performance, well-being, health, stress and recovery in trained athletes.

Description:

Thirty-six trained endurance athletes will be recruited and randomly assigned to either a "high volume (HIIT-HV)" group, a "low volume (HIIT-LV)" group, or a control group. All participants will be monitored before (9 days), during (7 days), and after (14 days) a 7-day training intervention, for 30 days. Participants in both intervention groups will complete 10 HIIT sessions within the period of 7 days, with an additional 30 minutes of low-intensity training exclusively in HIIT-HV. HIIT sessions consist of aerobic HIIT, i.e., 5x4min at 90-95% of maximal heart rate interspersed by 2.5 min active recovery periods. To determine the effects of the intervention, performance diagnostics, and a 5 kilometer time trial will be conducted before and after the intervention. In addition, participants are closely monitored for general health, stress, fatigue, recovery, neuromuscular performance, executive functions and sleep.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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)

Related Conditions & MeSH terms

• Athlete
• Healthy
• Performance

Intervention

Other:
• Exercise
high-intensity interval training sessions

Locations

Country	Name	City	State
Austria	University of Salzburg	Salzburg

Sponsors (3)

Lead Sponsor	Collaborator
University of Salzburg	Johannes Gutenberg University Mainz, Paracelsus Medical University

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Endurance performance I	Change of maximal oxygen uptake (VO2max 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)
Primary	Endurance performance II	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)
Primary	Endurance performance III	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)
Primary	Endurance performance IV	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)
Primary	Endurance performance V	Change of ventilatory thresholds (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)
Primary	Endurance performance VI	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	Change of questionnaire scores - well-being	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.	30 days (questionnaires will be given to participants several times before, during, and after the intervention.)
Secondary	Change of questionnaire scores - muscular fatigue	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.)
Secondary	Change of questionnaire scores - vitality	Change of questionnaire scores compared to baseline and group as determined by a Likert-Scale (from 0-10). Higher scores indicate higher vitality.	30 days (questionnaires will be given to participants several times before, during, and after the intervention.)
Secondary	Change of questionnaire scores - rate of fatigue	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.)
Secondary	Change of questionnaire scores - sleep quality	Change of questionnaire scores compared to baseline and group as determined by a Likert-Scale (from 1-7). Higher scores indicate poorer sleep.	30 days (questionnaires will be given to participants several times before, during, and after the intervention.)
Secondary	Change of blood count	Change of blood count concentrations compared to baseline and group	30 days (blood is drawn from participants several times before, during, and after the intervention.)
Secondary	Change of cell-free DNA	Change of cell-free DNA concentrations compared to baseline and group	30 days (blood is drawn from participants several times before, during, and after the intervention.)
Secondary	Change of creatine kinase	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.)
Secondary	Change of urea	Change of urea concentrations compared to baseline and group	30 days (blood is drawn from participants several times before, during, and after the intervention.)
Secondary	Change of blood lactate	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.)
Secondary	Change of cytokines	Change of cytokine concentrations compared to baseline and group	30 days (blood is drawn from participants several times before, during, and after the intervention.)
Secondary	Change of miRNA	Change of miRNA compared to baseline and group	30 days (blood is drawn from participants several times before, during, and after the intervention.)
Secondary	Change of neuromuscular performance	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)
Secondary	Change of body weight	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)
Secondary	Change of fat free mass	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)
Secondary	Change of fat mass	Change of fat 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)
Secondary	Change of forced expiratory volume	Change of forced expiratory volume in liters 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	Change of power output during exercise	Change of power output in Watt (as determined via Stryd, Boulder, USA) during the intervention compared to baseline and group	7 days
Secondary	Change of sleep quality I - GPS watch	Change of sleep quality compared to baseline and group as determined by a GPS (Global Positioning System) watch	30 days (sleep is assessed several times before, during, and after the intervention)
Secondary	Change of sleep quality II - ABIOS App	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)
Secondary	Correlations between sleep quality devices	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
Secondary	Change of parameters recorded by an electrocardiogram - mean heart rate	Change of mean heart rate compared to baseline and group	30 days (an electrocardiogram is written several times before, during, and after the intervention)
Secondary	Change of parameters recorded by an electrocardiogram - heart rate variability	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)
Secondary	Change of executive functions - Eriksen flanker task	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.	30 days (executive functions are tested several times before, during, and after the intervention)
Secondary	Change of executive functions - 2 back task	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)
Secondary	Cardiac ultrasound	Description of an athlete cohort regarding cardiac chamber volume (in ml, determined via EPIQ CVX, X5-1, Philips Healthcare, Andover, MA, USA)	1 day (this outcome will be determined once before study start)
Secondary	Adherence to training program	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