Influence of Caffeine on HRV and Exercise Performance in Spinal Cord Injury

NCT02083328 | Completed

• 1 other identifier: 2014-03
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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.

Conditions

Caffeine; Spinal Cord Injury

Keywords

heart rate variability; exercise performance

Outcome Measures

Primary Outcomes (1)

• 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.

  during 3min of arm cranking over a 2 week period

Secondary Outcomes (4)

• Heart rate variability (HRV) before the ingestion of supplement

  over 2 weeks

• Heart rate variability (HRV) after the exercise performance test

  over 2 weeks of study phase

• Catecholamine

  over 2 weeks

• Heart rate variability 40min after the ingestion

  40min after the ingestion

Other Outcomes (6)

• Blood pressure

  over 2 weeks of study phase

• Blood pressure

  40min after the ingestion of the supplement

• Heart rate

  during the 3min exercise test

Study Arms (2)

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.

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.

Dietary Supplement: Placebo (Mannitol)

Interventions

Caffeine DIETARY_SUPPLEMENT

Caffeine will be filled in gelatine capsules and administrated in a dosage of 6mg per kg body mass

Caffeine

Placebo (Mannitol) DIETARY_SUPPLEMENT

Mannitol filled in gelatine capsules

Mannitol (Placebo)

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Swiss Paraplegic Research, Nottwil: lead
• Insel Gruppe AG, University Hospital Bern: collaborator

Study Sites (1)

Sports Medicine Nottwil

Nottwil, Canton of Lucerne, 6207, Switzerland

Location

Related Publications (1)

• 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.

  PMID: 27776149 DERIVED

MeSH Terms

Conditions

Spinal Cord Injuries

Interventions

Caffeine; Mannitol

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Xanthines; Alkaloids; Heterocyclic Compounds; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Sugar Alcohols; Alcohols; Organic Chemicals; Carbohydrates

Study Officials

• Claudio Perret, Dr. sc. nat.

  Swiss Paraplegic Research, Nottwil

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2014
• First Posted: March 11, 2014
• Study Start: July 1, 2014
• Primary Completion: December 1, 2014
• Study Completion: March 1, 2015
• Last Updated: March 18, 2015

Record last verified: 2015-03

Locations

CH (1)