Heart Rate During Exercise in Type 2 Diabetes

NCT03917576 | Completed

• 1 other identifier: RP010317
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

Exercise training is a cornerstone for the prevention and treatment of metabolic disorders and associated cardiometabolic complications such as type 2 diabetes mellitus (T2D) and hypertension. Similar to the beneficial health effects after performing conventional continuous exercise modalities, high intensity interval training (HIIT) has been reported as an effective alternative exercise-modality to improve glucose homeostasis in both prediabetes subjects and individuals with T2D diagnosed. In this regard, although multiple HIIT-based interventions commonly report acute and long term benefits on body composition, cardiorespiratory fitness and insulin sensitivity in metabolically compromised subjects, little is known about the acute cardiovascular response (i.e., at heart rate level) during HIIT in subjects with different glucose control. HIIT is described as performing brief periods of exercise at vigorous or maximal intensity, interspersed with inactive or low intensity recovery phases of variable duration. In order to characterize different HIIT-based protocols, exercise intensity is usually defined as relative percentages of individual maximal cardiorespiratory fitness (VO2max) or relative maximal power output values. Nevertheless, the need for specific technological equipment to assess these parameters usually limit the prescription and recommendations of HIIT in clinical settings and other public health contexts at massive level. Additionally, the use of self-perceived exertion scales and heart rate (HR) variations upon HIIT have been demonstrating to be accessible and feasible strategies to regulate exercise intensity during HIIT. For example, it was reported that HR and self-perceived exertion scores increased progressively in T2D subjects, parallel to the oxygen consumption rate throughout an acute HIIT session performed on cycle ergometer. Consequently, it is conceivable to hypothesize that determining HR variations during HIIT might optimize the recommendation of this training methodology in metabolically compromised subjects as those at risk or with T2D diagnosed. Therefore, the aim of the present study was To describe and compare the acute heart rate changes in response to an incremental maximal exercise test and a single HIIT session between normoglycaemic (NG), prediabetes (Pre-T2D) and type 2 diabetes mellitus (T2D) subjects.

Conditions

Type2 Diabetes Mellitus; Hyperglycemia; Heart Rate; Exercise Training

Outcome Measures

Primary Outcomes (1)

• Maximum heart rate

  Measured before and after 12 weeks of high-intensity interval training

  12 weeks

Secondary Outcomes (3)

• Resting heart rate

  12 weeks

• Heart rate pre each HIIT-interval

  12 weeks

• Heart rate post each HIIT-interval

  12 weeks

Study Arms (3)

Normoglicamic group

ACTIVE COMPARATOR

Control normoglycaemic participants

Other: Exercise training intervention

Hyperglicaemic group

ACTIVE COMPARATOR

Control hyperglicaemic group

Other: Exercise training intervention

Experimental group

EXPERIMENTAL

Experimental Type 2 Diabetes Mellitus Group

Other: Behavioral

Interventions

Behavioral OTHER

The resting heart rate (HRrest), maximum HR (HRmax), HR recovery (HRRTEST), delta HR recovery (ΔHRRTEST) were measured by continuous telemetric heart rate sensor (Polar FT4, PolarTM, Finland) during an incremental exercise test designed to obtain maximum oxygen consumption (VO2max) on a cycle ergometer (Lode Corival, Groningen, The Netherlands) similar with previous studies using similar cohort. An indirect calorimetry/ergospirometry system (Ultima CPXTM metabolic system, Medgraphics, Minnesota, USA) was used to measure VO2max until volitional exhaustion. Thus, the modified Astrand volitional protocol was applied in the participants of all NG, Pre-T2D and T2D groups increasing the load (i.e., Watts) 25 W each 2 min to women, and 50 W each 2 min to men.

Also known as: Incremental exercise test

Experimental group

Exercise training intervention OTHER

Subjects also participated in a single HIIT session composed of 10-cycling intervals, using a Lode Corival cycle ergometer. The exercise session consisted of 1-minute cycling at high intensity (workload during each interval was set at \~80-100 % maximal power achieved during the incremental exercise test with a workload that allowed to work until the volitional muscle failure in 1-minute), followed by 2-minutes of inactive resting period (sitting still on the cycle ergometer), and was repeated 10 times (1x2x10 protocol; 1:2:10 to work:rest:repetitions respectively).

Also known as: Exercise training intervention with HIIT

Hyperglicaemic group; Normoglicamic group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• aged 18-60 y
• previously screened by physician professional
• diagnosed with normoglycaemic, prediabetes or T2D state
• living in Temuco city

You may not qualify if:

• low maximal cardiorespiratory fitness (defined as VO2max ≤21 ml/kg-1/min-1) below the expected value for the subject's sex and age
• not receiving pharmacologic hypotensive treatment with β-blockers
• having no musculoskeletal limitations to perform exercise cycling

Sponsors & Collaborators

• Universidad de Los Lagos: lead
• Universidad de La Frontera: collaborator

Study Sites (1)

Cristian ALvarez

Osorno, 5290000, Chile

Location

MeSH Terms

Conditions

Hyperglycemia

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: The exercise session consisted of 1-minute cycling at high intensity (workload during each interval was set at \~80-100 % maximal power (i.e., load in Watts) achieved during the incremental exercise test with a workload that allowed to work until the volitional muscle failure in 1-minute), followed by 2-minutes of inactive resting period (sitting still on the cycle ergometer), and was repeated 10 times (1x2x10 protocol; 1:2:10 to work:rest:repetitions respectively). The exercise session was supervised individually by exercise professionals, monitoring the heart rate with a continuous telemetric heart rate sensor (Polar FT4, PolarTM, Finland). During the single HIIT session, the HR pre each interval (HR-preINT) and the HR post each interval (HR-postINT) of cycling was recorded individually. In addition, we calculated and report the percentage of maximum heart rate in each interval, delta of HR increment and delta HR recovery for each 10-interval HIIT are reported.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: We will compare a type 2 diabetes mellitus group during exercise, with another hyperglicaemic, and normoglicaemic group in the heart rate maxymum.

Study Record Dates

• First Submitted: April 7, 2019
• First Posted: April 17, 2019
• Study Start: January 4, 2018
• Primary Completion: April 4, 2018
• Study Completion: April 7, 2018
• Last Updated: April 17, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

CL (1)