CaffeineNCT02083328
Influence of Caffeine on HRV and Exercise Performance in Spinal Cord Injury
A study testing Caffeine in people with Caffeine and Spinal Cord Injury, run by Swiss Paraplegic Research, Nottwil at 1 site in Switzerland.
Trial summary
The aim is to investigate the influence of caffeine on heart rate variability and on performance in a 3 min exercise test in different population groups (able-bodied, paraplegic and tetraplegic subjects). Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Caffeine, Spinal Cord Injury
- What is being tested?
- Caffeine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 35 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jul 2014to Mar 2015
- 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 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Informed Consent as documented by signature (Appendix Informed Consent Form)
- Age between 18 and 60 years
- Healthy, non-smoking men
- Tetraplegic subjects: C5-7, AIS A (sensory and motoric complete injury)
- Paraplegic subjects: sub Th8, AIS A (sensory and motoric complete injury)
- Min. 3x45min physical activity per week
Who cannot join
- Contraindications to the class of drugs under study, e.g. known hypersensitivity or allergy to class of drugs or the investigational product,
- Caffeine 12 hours before the test session
- Women
- Other clinically significant concomitant disease states (e.g., renal failure, hepatic dysfunction, cardiovascular disease, etc.),
- 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 participant,
Show all 12Show fewer
- Participation in another study with investigational drug within the 30 days preceding and during the present study,
- Previous enrolment into the current study,
- Enrolment of the investigator, his/her family members, employees and other dependent persons,
- Diabetes
- Less than 7 hours of sleep in the nights before the exercise testing
- Not following the nutrition guidelines (no standardised nutrition)
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Sports Medicine Nottwil
Nottwil, Canton of Lucerne, 6207
About this study
Official title: Influence of Caffeine on Heart Rate Variability and Exercise Performance in in Tetraplegic and Paraplegic Subjects Compared to Able-bodied Subjects
The aim is to investigate the influence of caffeine on heart rate variability and on performance in a 3 min exercise test in different population groups (able-bodied, paraplegic and tetraplegic subjects).
In general, the investigators are interested in the differences between the heart rate variability before and after caffeine supplementation and if the subjects exercise performance is enhanced using this type of supplementation. Another objective is to see whether there are differences between able-bodied and disabled subjects.
Tetraplegic subjects showed in some previous studies no Low-Frequency-component (LF) for heart rate variability and no increase in catecholamines after the ingestion of caffeine. Therefore the investigators think, that tetraplegic subjects won't show any ergogenic effect in exercise performance after the intake of caffeine. On the other hand, paraplegic subjects should show similar differences of heart rate variability after the ingestion of caffeine as able-bodied subjects. Paraplegic subjects should benefit from caffeine supplementation in an increase in exercise performance.
Read the detailed description
This study will be conducted in a placebo-controlled, double-blind and randomised study protocol. Every subject has to undergo three test session at the sports medicine in Nottwil. At the first visit, the investigators will check the subjects fitness using a health questionnaire with specific question about diseases and family health history. Additionally, subjects has to perform a maximal exercise test (ramp protocol at the arm crank ergometer) to measure maximal oxygen uptake, maximal heart rate and maximal power output. After a little break, subjects have to perform a familiarization trial at the arm crank ergometer. They have to perform exactly the same test as they have to perform later in the two test sessions.
Minimum two days later the subjects visits the sports medicine Nottwil for the first test session. At first, they have to answer some specific question about sleep, recent training, recent nutritional intake and the actual health condition. Afterwards, they have to lie down for a 10min rest where after 9min blood pressure will be measured. With a heart rate monitor HRV will be measured during 5 min in supine position and afterwards during 6 min in sitting position. Metronomic breathing (15x/min) is mandatory and will be simulated through a metronome. During the HRV measurement also tidal volume will be measured. As the first HRV measurement session is finished, a blood withdrawal will be taken to measure catecholamine concentrations. Then, when all these measurements are completed, a supplement (either caffeine or the placebo) will be ingested in gelatine capsules. After the ingestion of these capsules, the subject has a 40 min break where they can read something or just relax. During these 40 min physical activity or the ingestion of any nutrition is prohibited.
After these 40min, the second HRV measurement starts. The process of this measurement is exactly the same as for the first HRV measurement. They lay down for a 10min rest with blood pressure measurement after 9 min. Afterwards again a 5min HRV measurement in supine position and a 6min measurement in sitting position. Tidal volume is measured during this HRV measurement.
When this second HRV measurement session is finished, a second blood withdrawal has to be taken. That means, one hour after the ingestion of either placebo or caffeine, catecholamine are analysed for a second time. If the blood is taken, the warm up can start. After the standardised warm up lactate concentration of the blood is analysed taking 10 ul of blood from the earlobe. The subject will be asked to evaluate the warm up with the rate of perceived exertion (following the Borg scale). If everything is in order, the 3min exercise test can start. During this test, respiratory parameters will be measured using an Oxycon Pro device (device to measure oxygen consumption). Just after having finished these 3 min of exercising, for a second time lactate concentration will be measured and again they have to rate the exertion using the Borg scale.
After a short 5min break the third HRV measurement starts. Again HRV will be measured during a 5min time in supine position and a 6min time in sitting position. Tidal volume will be measured during the whole HRV measurement. With this HRV measurement the first test session is finished and a second test session will be conducted at least more than two days later in a randomised manner.
The first session with the familiarization trial will be finished in around 75 min. For the two test sessions the subject has to be at the sports medicine for around 2 hours.
In the following chart, the test sessions are visually displayed. The administrated dose of caffeine is defined to 6mg per kg bodyweight for all our subjects. Caffeine will be filled in gelatine capsules.
Also the placebo (Mannitol) will be filled in gelatine capsules and the subjects have to ingest the same amount of capsules for both supplements.
30 subjects will be tested in total. In each group 10 subjects will participate. That means 10 healthy able-bodied subjects, 10 tetraplegic (C5-7, American Impairment Score (AIS) A) and 10 paraplegic (sub Th8, AIS A) subjects will be tested. As it is not easy to find 10 physically active, completely injured tetraplegic subjects, a number of 10 subjects should be sufficient for this pilot study.
As the investigators know from previous studies conducted with disabled subjects, the level of the lesion is one critical point. Therefore, the investigators tried to include subjects with almost the same lesion level and all sensory and motoric completely lesioned. This could aid us to have more homogenous groups of different populations.
Inclusion criteria: healthy, non-smoking men, minimal 3x45min physical activity per week, tetraplegic (C5 to C7) or paraplegic (sub Th8), complete lesion, more than 6 month after rehabilitation program Exclusion: drugs or supplements which influences heart rate variability, Diabetes
- Conditions
- Caffeine, Spinal Cord Injury
- Being tested
- Caffeine, Placebo (Mannitol)
- Keywords
- heart rate variability, exercise performance
- Medical subject headings
- Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CaffeineDietary supplement
Caffeine will be filled in gelatine capsules and administrated in a dosage of 6mg per kg body mass
Placebo (Mannitol)Dietary supplement
Mannitol filled in gelatine capsules
| Study group | Role | What they receive |
|---|---|---|
| Caffeine | Active comparator | Caffeine will be administrated at a dosage of 6mg/kg of body mass. It is ingested once, one hour before the exercise performance test. Receives: Dietary Supplement: Caffeine |
| Mannitol (Placebo) | Placebo comparator | Placebo capsules will be administrated one hour before the exercise performance test. The subject gets exactly the same number of capsules as for the caffeine dosage. Caffeine and placebo capsules look the same. Receives: Dietary Supplement: Placebo (Mannitol) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Exercise performance
An exercise performance test of 3min will be performed at an arm crank ergometer to measure exercise performance output after the ingestion of a placebo or caffeine supplement.
Measured: during 3min of arm cranking over a 2 week period
Secondary outcomes (4)
Heart rate variability (HRV) before the ingestion of supplement
HRV measurement is conducted before the ingestion of any supplement (caffeine or placebo)
Measured: over 2 weeks
Heart rate variability (HRV) after the exercise performance test
HRV measurement is conducted 5min after the exercise performance test
Measured: over 2 weeks of study phase
Catecholamine
A blood withdrawal is taken before the ingestion of any supplement to analyse epinephrine and norepinephrine concentration in the blood.
Measured: over 2 weeks
Heart rate variability 40min after the ingestion
HRV will be measured 40min after the ingestion of the supplement
Measured: 40min after the ingestion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2014 (estimated)
- Study startJul 2014
- Primary completionDec 2014
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CaffeineStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Swiss Paraplegic Research, Nottwil
- Sponsor type
- Research network
- Collaborators
- Insel Gruppe AG, University Hospital Bern
- Responsible party
- Sponsor
- Investigators
- Claudio Perret, Dr. sc. nat., Principal investigator, Swiss Paraplegic Research, Nottwil
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02083328
- Sponsor's protocol ID
- 2014-03
- Status last verified
- Mar 2015
- First submitted
- 6 Mar 2014
- Last updated
- 18 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Flueck JL, Schaufelberger F, Lienert M, Schafer Olstad D, Wilhelm M, Perret C. Acute Effects of Caffeine on Heart Rate Variability, Blood Pressure and Tidal Volume in Paraplegic and Tetraplegic Compared to Able-Bodied Individuals: A Randomized, Blinded Trial. PLoS One. 2016 Oct 24;11(10):e0165034. doi: 10.1371/journal.pone.0165034. eCollection 2016.
PubMed 27776149
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Caffeine on Heart Rate Variability and Exercise Performance in in Tetraplegic and Paraplegic Subjects Compared to Able-bodied Subjects
- ClinicalTrials.gov ID
- NCT02083328
- Acronym / sponsor ID
- 2014-03
- Conditions
- Caffeine, Spinal Cord Injury
- Keywords
- heart rate variability, exercise performance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Swiss Paraplegic Research, NottwilResearch network
- Collaborators
- Insel Gruppe AG, University Hospital Bern
- Study start
- Jul 2014
- Primary completion
- Dec 2014 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 11 Mar 2014 (estimated)
- 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 aim is to investigate the influence of caffeine on heart rate variability and on performance in a 3 min exercise test in different population groups (able-bodied, paraplegic and tetraplegic subjects).
In general, the investigators are interested in the differences between the heart rate variability before and after caffeine supplementation and if the subjects exercise performance is enhanced using this type of supplementation. Another objective is to see whether there are differences between able-bodied and disabled subjects.
Tetraplegic subjects showed in some previous studies no Low-Frequency-component (LF) for heart rate variability and no increase in catecholamines after the ingestion of caffeine. Therefore the investigators think, that tetraplegic subjects won't show any ergogenic effect in exercise performance after the intake of caffeine. On the other hand, paraplegic subjects should show similar differences of heart rate variability after the ingestion of caffeine as able-bodied subjects. Paraplegic subjects should benefit from caffeine supplementation in an increase in exercise performance.
Detailed description
This study will be conducted in a placebo-controlled, double-blind and randomised study protocol. Every subject has to undergo three test session at the sports medicine in Nottwil. At the first visit, the investigators will check the subjects fitness using a health questionnaire with specific question about diseases and family health history. Additionally, subjects has to perform a maximal exercise test (ramp protocol at the arm crank ergometer) to measure maximal oxygen uptake, maximal heart rate and maximal power output. After a little break, subjects have to perform a familiarization trial at the arm crank ergometer. They have to perform exactly the same test as they have to perform later in the two test sessions.
Minimum two days later the subjects visits the sports medicine Nottwil for the first test session. At first, they have to answer some specific question about sleep, recent training, recent nutritional intake and the actual health condition. Afterwards, they have to lie down for a 10min rest where after 9min blood pressure will be measured. With a heart rate monitor HRV will be measured during 5 min in supine position and afterwards during 6 min in sitting position. Metronomic breathing (15x/min) is mandatory and will be simulated through a metronome. During the HRV measurement also tidal volume will be measured. As the first HRV measurement session is finished, a blood withdrawal will be taken to measure catecholamine concentrations. Then, when all these measurements are completed, a supplement (either caffeine or the placebo) will be ingested in gelatine capsules. After the ingestion of these capsules, the subject has a 40 min break where they can read something or just relax. During these 40 min physical activity or the ingestion of any nutrition is prohibited.
After these 40min, the second HRV measurement starts. The process of this measurement is exactly the same as for the first HRV measurement. They lay down for a 10min rest with blood pressure measurement after 9 min. Afterwards again a 5min HRV measurement in supine position and a 6min measurement in sitting position. Tidal volume is measured during this HRV measurement.
When this second HRV measurement session is finished, a second blood withdrawal has to be taken. That means, one hour after the ingestion of either placebo or caffeine, catecholamine are analysed for a second time. If the blood is taken, the warm up can start. After the standardised warm up lactate concentration of the blood is analysed taking 10 ul of blood from the earlobe. The subject will be asked to evaluate the warm up with the rate of perceived exertion (following the Borg scale). If everything is in order, the 3min exercise test can start. During this test, respiratory parameters will be measured using an Oxycon Pro device (device to measure oxygen consumption). Just after having finished these 3 min of exercising, for a second time lactate concentration will be measured and again they have to rate the exertion using the Borg scale.
After a short 5min break the third HRV measurement starts. Again HRV will be measured during a 5min time in supine position and a 6min time in sitting position. Tidal volume will be measured during the whole HRV measurement. With this HRV measurement the first test session is finished and a second test session will be conducted at least more than two days later in a randomised manner.
The first session with the familiarization trial will be finished in around 75 min. For the two test sessions the subject has to be at the sports medicine for around 2 hours.
In the following chart, the test sessions are visually displayed. The administrated dose of caffeine is defined to 6mg per kg bodyweight for all our subjects. Caffeine will be filled in gelatine capsules.
Also the placebo (Mannitol) will be filled in gelatine capsules and the subjects have to ingest the same amount of capsules for both supplements.
30 subjects will be tested in total. In each group 10 subjects will participate. That means 10 healthy able-bodied subjects, 10 tetraplegic (C5-7, American Impairment Score (AIS) A) and 10 paraplegic (sub Th8, AIS A) subjects will be tested. As it is not easy to find 10 physically active, completely injured tetraplegic subjects, a number of 10 subjects should be sufficient for this pilot study.
As the investigators know from previous studies conducted with disabled subjects, the level of the lesion is one critical point. Therefore, the investigators tried to include subjects with almost the same lesion level and all sensory and motoric completely lesioned. This could aid us to have more homogenous groups of different populations.
Inclusion criteria: healthy, non-smoking men, minimal 3x45min physical activity per week, tetraplegic (C5 to C7) or paraplegic (sub Th8), complete lesion, more than 6 month after rehabilitation program Exclusion: drugs or supplements which influences heart rate variability, Diabetes
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Caffeine | Active comparator | Dietary Supplement: CaffeineCaffeine will be administrated at a dosage of 6mg/kg of body mass. It is ingested once, one hour before the exercise performance test. |
| Mannitol (Placebo) | Placebo comparator | Dietary Supplement: Placebo (Mannitol)Placebo capsules will be administrated one hour before the exercise performance test. The subject gets exactly the same number of capsules as for the caffeine dosage. Caffeine and placebo capsules look the same. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Informed Consent as documented by signature (Appendix Informed Consent Form)
- Age between 18 and 60 years
- Healthy, non-smoking men
- Tetraplegic subjects: C5-7, AIS A (sensory and motoric complete injury)
- Paraplegic subjects: sub Th8, AIS A (sensory and motoric complete injury)
Key exclusion criteria (12 listed)
- Contraindications to the class of drugs under study, e.g. known hypersensitivity or allergy to class of drugs or the investigational product,
- Caffeine 12 hours before the test session
- Women
- Other clinically significant concomitant disease states (e.g., renal failure, hepatic dysfunction, cardiovascular disease, etc.),
- Known or suspected non-compliance, drug or alcohol abuse,
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 |
|---|---|---|
| CaffeineCaffeine will be filled in gelatine capsules and administrated in a dosage of 6mg per kg body mass | Dietary supplement | Caffeine |
| Placebo (Mannitol)Mannitol filled in gelatine capsules | Dietary supplement | Mannitol (Placebo) |
Primary outcome
Exercise performance
Time frame: during 3min of arm cranking over a 2 week period
An exercise performance test of 3min will be performed at an arm crank ergometer to measure exercise performance output after the ingestion of a placebo or caffeine supplement.
4 secondary outcomes
Heart rate variability (HRV) before the ingestion of supplement
Time frame: over 2 weeks
Heart rate variability (HRV) after the exercise performance test
Time frame: over 2 weeks of study phase
Catecholamine
Time frame: over 2 weeks
Heart rate variability 40min after the ingestion
Time frame: 40min after the ingestion
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 18 Mar 2015.
- Derived from this study: PubMed 27776149Flueck JL, Schaufelberger F, Lienert M, Schafer Olstad D, Wilhelm M, Perret C. Acute Effects of Caffeine on Heart Rate Variability, Blood Pressure and Tidal Volume in Paraplegic and Tetraplegic Compared to Able-Bodied Individuals: A Randomized, Blinded Trial. PLoS One. 2016 Oct 24;11(10):e0165034. doi: 10.1371/journal.pone.0165034. eCollection 2016.
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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.
Claudio Perret, Dr. sc. nat. principal investigator
Swiss Paraplegic Research, Nottwil
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Caffeine in people with Caffeine and Spinal Cord Injury, run by Swiss Paraplegic Research, Nottwil 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 6 inclusion and 12 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 18 Mar 2015. 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?
Exercise performance (time frame: during 3min of arm cranking over a 2 week period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02083328, which also lists 1 linked publication.
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 18 Mar 2015.