HealthyNCT04508738
Effects of Combined Interventions to Optimize Recovery During High-intensity Exercises in Healthy Adults
A study testing ERP in people with Healthy, run by Swiss Federal Institute of Technology at 1 site in Switzerland.
Trial summary
The objective of the study is to evaluate the effects a complex recovery intervention during the breaks of a repeated sprint test on exercise performance compared to placebo and control conditions. Read more about this study
- Who is it for?
- Ages 18 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- ERP
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 1 siteSwitzerland
- Study dates
- 10 Sep 2020to 30 Jun 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Informed Consent as documented by signature (Appendix Informed Consent Form)
- Healthy
- Male
- Age: 18-40 years
- Body-Mass-Index (BMI): 18.5-24.9 kg･m-2
- Trained individuals: max. Power output ≥ 4.0 Watts･kg-1
- Non-smoking
- Willingness to adhere to the study rules
Who cannot join
- Known or suspected non-compliance, drug or alcohol abuse
- Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participants
- Previous enrolment into the current study
- Intake of medications affecting performance or the respiratory, cardiovascular or neuromuscular system
- Acute or chronic illness affecting performance or the respiratory, cardiovascular or neuromuscular system
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
ETH Zürich, Exercise Physiology Lab
Zurich, Canton of Zurich, 8057
About this study
The objective of the study is to evaluate the effects a complex recovery intervention during the breaks of a repeated sprint test on exercise performance compared to placebo and control conditions. The enhanced recovery package (ERP) includes neck cooling with an iced gel pad, drinking a 6% CHO solution, mouth-rinsing with a 10% CHO, 6 mg･kg -1 caffeine solution, performing submaximal squats and hyperventilating a hyperoxic mixture; all applied in each 3-min break in-between the six 30-s sprints. This intervention will be compared to a placebo and a control condition.
- Conditions
- Healthy
- Being tested
- ERP, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ERPOther
The ERP intervention is applied in a randomized and counter-balanced order across visits 2-4 in each 3-min break in-between the six 30-s sprints, with one intervention per visit. The order and timing of the constituents of the interventions will be strictly constant within and between participants.
ERP: 1) neck cooling with an iced gel pad, 2) drinking a ∼ 6% CHO solution, 3) mouth-rinsing with a ∼10% CHO, ∼6 mg ･ kg -1 caffeine solution, 4) performing submaximal squats and 5) hyperventilating a hyperoxic mixture
PlaceboOther
The control intervention is applied in a randomized and counter-balanced order across visits 2-4 in each 3-min break in-between the six 30-s sprints, with one intervention per visit. The order and timing of the constituents of the interventions will be strictly constant within and between participants.
- neck "cooling" with room temperature gel pack, 2) drinking an artificially sweetened solution, 3) mouth-rinsing with artificially sweetened solution (containing no caffeine), 4) performing unloaded squat manoeuvres, 5) deep breaths with room air
| Study group | Role | What they receive |
|---|---|---|
| ERP Intervention | Experimental | Combination of different methods to improve recovery. Receives: Other: ERP |
| Control | No intervention | Passive recovery by sitting on a chair |
| Placebo | Placebo comparator | A combination of methods similar to the ERP intervention but at an intensity / mixture supposed to be ineffective at improving recovery. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in mean power output
Measured over the six 30s high-intensity cycling sprints in each of the three conditions. Mean power mirrors the body's ability to generate muscle power and physical energy. Any meaningful effects of the recovery interventions will eventually translate into a higher power output.
Measured: through study completion, an expected average of 3 weeks per participant
Change in fatigue index
Fatigue index = drop in power output from the beginning to the end a 30s sprint test. The change in this index will be calculated from the 1st to the 6th sprint test in each condition.
Measured: through study completion, an expected average of 3 weeks per participant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2020
- Study start10 Sep 2020
- Primary completion30 Jun 2021
- Study completion30 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Each participant will be tested on 4 different days with a control, a placebo and an interventional condition in random order.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Swiss Federal Institute of Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christina M. Spengler, Prof., Principal investigator, Christina M. Spengler, Prof. Study Principal Investigator Exercise Physiology Lab, Institute of Human Movement Sciences and Sport, ETH Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04508738
- Sponsor's protocol ID
- ERP_2020
- Status last verified
- Oct 2020
- First submitted
- 4 Aug 2020
- Last updated
- 2 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Combined Interventions to Optimize Recovery During High-intensity Exercises in Healthy Adults
- ClinicalTrials.gov ID
- NCT04508738
- Acronym / sponsor ID
- ERP_2020
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Swiss Federal Institute of TechnologyUniversity, hospital or other
- Study start
- 10 Sep 2020 (actual)
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 30 Jun 2021 (actual)
- First posted
- 11 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of the study is to evaluate the effects a complex recovery intervention during the breaks of a repeated sprint test on exercise performance compared to placebo and control conditions. The enhanced recovery package (ERP) includes neck cooling with an iced gel pad, drinking a 6% CHO solution, mouth-rinsing with a 10% CHO, 6 mg･kg -1 caffeine solution, performing submaximal squats and hyperventilating a hyperoxic mixture; all applied in each 3-min break in-between the six 30-s sprints. This intervention will be compared to a placebo and a control condition.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- Each participant will be tested on 4 different days with a control, a placebo and an interventional condition in random order.
| Arm | Type | Receives |
|---|---|---|
| ERP Intervention | Experimental | Other: ERPCombination of different methods to improve recovery. |
| Control | No intervention | –Passive recovery by sitting on a chair |
| Placebo | Placebo comparator | Other: PlaceboA combination of methods similar to the ERP intervention but at an intensity / mixture supposed to be ineffective at improving recovery. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Informed Consent as documented by signature (Appendix Informed Consent Form)
- Healthy
- Male
- Age: 18-40 years
- Body-Mass-Index (BMI): 18.5-24.9 kg･m-2
Key exclusion criteria (5 listed)
- Known or suspected non-compliance, drug or alcohol abuse
- Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participants
- Previous enrolment into the current study
- Intake of medications affecting performance or the respiratory, cardiovascular or neuromuscular system
- Acute or chronic illness affecting performance or the respiratory, cardiovascular or neuromuscular system
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ERPThe ERP intervention is applied in a randomized and counter-balanced order across visits 2-4 in each 3-min break in-between the six 30-s sprints, with one intervention per visit. The order and timing of the constituents of the interventions will be strictly constant within and between participants. ERP: 1) neck cooling with an iced gel pad, 2) drinking a ∼ 6% CHO solution, 3) mouth-rinsing with a ∼10% CHO, ∼6 mg ･ kg -1 caffeine solution, 4) performing submaximal squats and 5) hyperventilating a hyperoxic mixture | Other | ERP Intervention |
| PlaceboThe control intervention is applied in a randomized and counter-balanced order across visits 2-4 in each 3-min break in-between the six 30-s sprints, with one intervention per visit. The order and timing of the constituents of the interventions will be strictly constant within and between participants. 1) neck "cooling" with room temperature gel pack, 2) drinking an artificially sweetened solution, 3) mouth-rinsing with artificially sweetened solution (containing no caffeine), 4) performing unloaded squat manoeuvres, 5) deep breaths with room air | Other | Placebo |
Primary outcome
Change in mean power output
Time frame: through study completion, an expected average of 3 weeks per participant
Measured over the six 30s high-intensity cycling sprints in each of the three conditions. Mean power mirrors the body's ability to generate muscle power and physical energy. Any meaningful effects of the recovery interventions will eventually translate into a higher power output.
Change in fatigue index
Time frame: through study completion, an expected average of 3 weeks per participant
Fatigue index = drop in power output from the beginning to the end a 30s sprint test. The change in this index will be calculated from the 1st to the 6th sprint test in each condition.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2021.
Related trials for Healthy
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christina M. Spengler, Prof. principal investigator
Christina M. Spengler, Prof. Study Principal Investigator Exercise Physiology Lab, Institute of Human Movement Sciences and Sport, ETH Zurich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ERP in people with Healthy, run by Swiss Federal Institute of Technology at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in mean power output (time frame: through study completion, an expected average of 3 weeks per participant). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2021.