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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
Sponsor:
Collaborator:
University Hospital Inselspital, Berne
Information provided by (Responsible Party):
Swiss Paraplegic Centre Nottwil

Brief 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).

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 35 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

Drug Information available for: Mannitol

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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)

  2. 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

  3. 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.

  4. Heart rate variability 40min after the ingestion [ Time Frame: 40min after the ingestion ]
    HRV will be measured 40min after the ingestion of the supplement


Other Outcome Measures:
  1. Blood pressure [ Time Frame: over 2 weeks of study phase ]
    Blood pressure measured before the ingestion of any supplement (caffeine or placebo)

  2. Blood pressure [ Time Frame: 40min after the ingestion of the supplement ]
    Blood pressure measured 40min after the ingestion of any supplement (caffeine or placebo)

  3. Heart rate [ Time Frame: during the 3min exercise test ]
    Heart rate will be measured during the 3min exercise performance test

  4. Tidal volume [ Time Frame: over 2 weeks of study phase ]
    Tidal volume will be measured during the HRV measurements

  5. 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)

  6. Lactate concentration [ Time Frame: after the 3min exercise performance test ]
    Lactate concentration will be measured after the exercise performance test.



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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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,
  • 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)

Information from the National Library of Medicine

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


Locations
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Switzerland
Sports Medicine Nottwil
Nottwil, Lucerne, Switzerland, 6207
Sponsors and Collaborators
Swiss Paraplegic Centre Nottwil
University Hospital Inselspital, Berne
Investigators
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Principal Investigator: Claudio Perret, Dr. sc. nat. Swiss Paraplegic Centre Nottwil
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Swiss Paraplegic Centre Nottwil
ClinicalTrials.gov Identifier: NCT02083328    
Other Study ID Numbers: 2014-03
First Posted: March 11, 2014    Key Record Dates
Last Update Posted: March 18, 2015
Last Verified: March 2015
Keywords provided by Swiss Paraplegic Centre Nottwil:
heart rate variability
exercise performance
Additional relevant MeSH terms:
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Spinal Cord Injuries
Wounds and Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Mannitol
Caffeine
Central Nervous System Stimulants
Physiological Effects of Drugs
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Purinergic P1 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Diuretics, Osmotic
Diuretics
Natriuretic Agents