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CompletedNCT03285386PET1DUpdated Mar 1, 2019

Priming Exercise in Type 1 Diabetes

An interventional study of Priming exercise and Control Exercise in Type 1 Diabetes Mellitus, sponsored by Liverpool Hope University. Completed at 1 site in United Kingdom. Open to male participants aged 18 Years to 40 Years. Per ClinicalTrials.gov, last updated 2019-03-01.

Sponsored by Liverpool Hope University · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
7
Allocation
Non-randomized
Ages
18 Years to 40 Years
Sex
Male
01

Study summary

Critical power is an important threshold in exercise physiology, and is an important determinant of the ability to tolerate high-intensity exercise. The ability to tolerate such exercise is drastically impaired in certain chronic conditions, such as type 1 diabetes. Whilst the most important physiological factors that determine critical power have yet to be determined, previous work from our laboratory suggests that it is related to the speed of oxygen uptake at the onset of exercise. This study will look to utilise "priming" exercise as an intervention to improve the speed of these oxygen uptake "kinetics", and thus critical power and exercise tolerance in individuals with type 1 diabetes. We hypothesize that oxygen uptake kinetics will be faster and critical power will be higher when exercise is performed with compared to without a prior bout of high-intensity priming exercise in a population of individuals with type 1 diabetes.

Read the detailed description

The ability to tolerate high-intensity exercise, or exercise tolerance, is a key factor that can influence clinical outcomes in a range of conditions. The "critical power" is an important physiological threshold that demarcates exercise intensities that can be sustained for prolonged periods (i.e. below critical power) from intensities that result in exhaustion in a relatively short period of time (i.e. 2-30 minutes, above critical power). Critical power is therefore a key determinant of exercise tolerance. The speed with which oxygen uptake rises at the onset of exercise (i.e. oxygen uptake "kinetics") has been shown by work from our laboratory to be a key determinant of critical power. One intervention that can acutely improve the oxygen uptake kinetics is the performance of a prior bout of high-intensity exercise, known as "priming exercise". Patients with type 1 diabetes have previously been shown to have impaired exercise tolerance compared to healthy controls. The performance of priming exercise therefore represents a potential intervention to acutely improve oxygen uptake kinetics, and therefore critical power and exercise tolerance, in type 1 diabetic individuals. The purpose of this study is therefore to assess the influence of priming exercise on oxygen uptake kinetics and critical power in a population of type 1 diabetic individuals.

02

Conditions studied

  • Type 1 Diabetes Mellitus
03

Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
Male
Accepts healthy volunteers
No

Inclusion criteria

Suffering from Type 1 diabetes with a diagnosed disease duration of 2 - 20 years and no comorbidities.

Exclusion criteria

Exclusion Criteria:

History of stroke, congestive heart failure, hypertension, or cardiopulmonary disease.

Current smoking or have been smoking within the last 12 months Symptomatic autonomic or distal neuropathy HbA1c > 64 mmol/mol Hypoglycaemia unawareness in the last 6 months Taking any medications other than insulin.

04

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
7 participants (actual)

Study arms

  • Experimental
    Priming Exercise

    Participants will perform constant power output tests at four separate, fixed intensities to exhaustion on a cycle ergometer on separate days. These exhaustive, constant power tests will be preceded by 3 minutes of light cycling, 6 minutes of high intensity cycling, 7 minutes of rest and 3 minutes of light cycling.

    Behavioral: Priming exercise

  • Active comparator
    Control

    Participants will perform constant power output tests at four separate, fixed intensities to exhaustion on a cycle ergometer on separate days. These exhaustive, constant power tests will be preceded by 3 minutes of light cycling only.

    Behavioral: Control Exercise

Interventions

  • BehavioralPriming exercise

    All participants will perform a bout of high-intensity "priming" exercise for 6 minutes, 10 minutes prior to undertaking an exhaustive exercise test on four separate occasions.

  • BehavioralControl Exercise

    All participants will perform 3 minutes of baseline cycling prior to undertaking an exhaustive exercise test on four separate occasions.

05

What researchers measure

Primary outcomes

  1. Critical power

    The power asymptote of the hyperbolic relationship between power and the tolerable duration of exercise.

    Time frame: 3-9 weeks

  2. Phase II time constant of pulmonary oxygen uptake kinetics

    Time taken for oxygen uptake to attain 63% of its asymptotic amplitude.

    Time frame: 3-9 weeks

  3. Time constant for muscle deoxygenation kinetics (assessed by near-infrared spectroscopy)

    Time taken for muscle deoxyhaemoglobin to attain 63% of its asymptotic amplitude.

    Time frame: 3-9 weeks

Secondary outcomes

  1. W'

    Curvature constant of the power-duration relationship. Finite work capacity available above critical power.

    Time frame: 3-9 weeks

  2. Time constant for heart rate kinetics

    Time taken for heart rate to attain 63% of its asymptotic amplitude.

    Time frame: 3-9 weeks

06

Study locations

1 site
  • Liverpool Hope University
    Liverpool, Merseyside L169JD, United Kingdom
07

References and documents

Publications

  • Goulding RP, Roche DM, Marwood S. Prior exercise speeds pulmonary oxygen uptake kinetics and increases critical power during supine but not upright cycling. Exp Physiol. 2017 Sep 1;102(9):1158-1176. doi: 10.1113/EP086304. Epub 2017 Jul 26. PubMed 28627041 ↗
  • Behnke BJ, Kindig CA, McDonough P, Poole DC, Sexton WL. Dynamics of microvascular oxygen pressure during rest-contraction transition in skeletal muscle of diabetic rats. Am J Physiol Heart Circ Physiol. 2002 Sep;283(3):H926-32. doi: 10.1152/ajpheart.00059.2002. PubMed 12181120 ↗
  • Sexton WL, Poole DC, Mathieu-Costello O. Microcirculatory structure-function relationships in skeletal muscle of diabetic rats. Am J Physiol. 1994 Apr;266(4 Pt 2):H1502-11. doi: 10.1152/ajpheart.1994.266.4.H1502. Erratum In: Am J Physiol 1994 Jun;266(6 Pt 2):section H followi. PubMed 8184927 ↗
  • Kindig CA, Sexton WL, Fedde MR, Poole DC. Skeletal muscle microcirculatory structure and hemodynamics in diabetes. Respir Physiol. 1998 Feb;111(2):163-75. doi: 10.1016/s0034-5687(97)00122-9. PubMed 9574868 ↗
  • Burnley M, Davison G, Baker JR. Effects of priming exercise on VO2 kinetics and the power-duration relationship. Med Sci Sports Exerc. 2011 Nov;43(11):2171-9. doi: 10.1249/MSS.0b013e31821ff26d. PubMed 21552161 ↗

Individual participant data

Plan to share: No — Anonymized participant data will be made available to the public in the form of research presentations and a journal article. Anonymized individual participant data not featured in either the journal article or presentations will only be made available upon request to the authors.

08

Registry details

Key details

Study ID
NCT03285386
Lead sponsor
Liverpool Hope University
Responsible party
Sponsor
First posted
Sep 18, 2017
Start date
Jan 1, 2018
Primary completion
Dec 1, 2018
Completion
Dec 1, 2018
Last update
Mar 1, 2019

Study contacts

Richie P Goulding
principal investigator · Liverpool Hope University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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