Influence of Caffeine on HRV and Exercise Performance in Spinal Cord Injury
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|ClinicalTrials.gov Identifier: NCT02083328|
Recruitment Status : Completed
First Posted : March 11, 2014
Last Update Posted : March 18, 2015
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.
|Condition or disease||Intervention/treatment||Phase|
|Caffeine Spinal Cord Injury||Dietary Supplement: Caffeine Dietary Supplement: Placebo (Mannitol)||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||35 participants|
|Intervention Model:||Factorial Assignment|
|Masking:||Double (Participant, Care Provider)|
|Official Title:||Influence of Caffeine on Heart Rate Variability and Exercise Performance in in Tetraplegic and Paraplegic Subjects Compared to Able-bodied Subjects|
|Study Start Date :||July 2014|
|Actual Primary Completion Date :||December 2014|
|Actual Study Completion Date :||March 2015|
Active Comparator: Caffeine
Caffeine will be administrated at a dosage of 6mg/kg of body mass. It is ingested once, one hour before the exercise performance test.
Dietary Supplement: Caffeine
Caffeine will be filled in gelatine capsules and administrated in a dosage of 6mg per kg body mass
Placebo Comparator: Mannitol (Placebo)
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.
Dietary Supplement: Placebo (Mannitol)
Mannitol filled in gelatine capsules
- 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.
- Heart rate variability (HRV) before the ingestion of supplement [ Time Frame: over 2 weeks ]HRV measurement is conducted before the ingestion of any supplement (caffeine or placebo)
- Heart rate variability (HRV) after the exercise performance test [ Time Frame: over 2 weeks of study phase ]HRV measurement is conducted 5min after the exercise performance test
- Catecholamine [ Time Frame: over 2 weeks ]A blood withdrawal is taken before the ingestion of any supplement to analyse epinephrine and norepinephrine concentration in the blood.
- Heart rate variability 40min after the ingestion [ Time Frame: 40min after the ingestion ]HRV will be measured 40min after the ingestion of the supplement
- Blood pressure [ Time Frame: over 2 weeks of study phase ]Blood pressure measured before the ingestion of any supplement (caffeine or placebo)
- Blood pressure [ Time Frame: 40min after the ingestion of the supplement ]Blood pressure measured 40min after the ingestion of any supplement (caffeine or placebo)
- Heart rate [ Time Frame: during the 3min exercise test ]Heart rate will be measured during the 3min exercise performance test
- Tidal volume [ Time Frame: over 2 weeks of study phase ]Tidal volume will be measured during the HRV measurements
- Rate of perceived exertion [ Time Frame: after the 3min exercise performance test ]Rate of perceived exertion will be measured after the 3min exercise performance test using the Borg scale (6-20)
- Lactate concentration [ Time Frame: after the 3min exercise performance test ]Lactate concentration will be measured after the exercise performance test.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02083328
|Sports Medicine Nottwil|
|Nottwil, Lucerne, Switzerland, 6207|
|Principal Investigator:||Claudio Perret, Dr. sc. nat.||Swiss Paraplegic Centre Nottwil|