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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03285386
Other study ID # LiverpoolHopeUni
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 1, 2018
Est. completion date December 1, 2018

Study information

Verified date February 2019
Source Liverpool Hope University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 7
Est. completion date December 1, 2018
Est. primary completion date December 1, 2018
Accepts healthy volunteers No
Gender Male
Age group 18 Years to 40 Years
Eligibility Inclusion Criteria:

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

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.

Study Design


Intervention

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

Locations

Country Name City State
United Kingdom Liverpool Hope University Liverpool Merseyside

Sponsors (1)

Lead Sponsor Collaborator
Liverpool Hope University

Country where clinical trial is conducted

United Kingdom, 

References & Publications (5)

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. — View Citation

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. — View Citation

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. — View Citation

Kindig CA, Sexton WL, Fedde MR, Poole DC. Skeletal muscle microcirculatory structure and hemodynamics in diabetes. Respir Physiol. 1998 Feb;111(2):163-75. — View Citation

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. Erratum in: Am J Physiol 1994 Jun;266(6 Pt 2):section H followi. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Critical power The power asymptote of the hyperbolic relationship between power and the tolerable duration of exercise. 3-9 weeks
Primary Phase II time constant of pulmonary oxygen uptake kinetics Time taken for oxygen uptake to attain 63% of its asymptotic amplitude. 3-9 weeks
Primary Time constant for muscle deoxygenation kinetics (assessed by near-infrared spectroscopy) Time taken for muscle deoxyhaemoglobin to attain 63% of its asymptotic amplitude. 3-9 weeks
Secondary W' Curvature constant of the power-duration relationship. Finite work capacity available above critical power. 3-9 weeks
Secondary Time constant for heart rate kinetics Time taken for heart rate to attain 63% of its asymptotic amplitude. 3-9 weeks
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