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Effects of High Intensity Interval Training and Combined Training in Type 2 Diabetic (T2D) Patients

Primary Purpose

Diabetes Mellitus, Type 2, High-Intensity Interval Training, Exercise Training

Status
Recruiting
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Physical training
Light-Emitting Diode (LED) therapy
Sponsored by
University of Nove de Julho
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 2 focused on measuring Cardiopulmonary Exercise Test, Rehabilitation, Diabetes Mellitus, Type 2, Functional Capacity, Photobiomodulation Therapy

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age ≥ 18 years;
  • Confirmed diagnosis of type 2 diabetes;
  • Sedentary lifestyle in the last six months, according to the criteria established by the American Heart Association (AHA).

Exclusion Criteria:

  • Confirmed diagnosis of any (1) heart disease; (2) musculoskeletal disorder; (3) respiratory disease; (4) uncontrolled arterial hypertension; (5) peripheral neuropathy or (6) factors that limit the performance of any of the study evaluations and/or training.
  • During the study, individuals with a presence of less than 80% in the training sessions will be excluded.

Sites / Locations

  • UNINOVERecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Sham Comparator

Experimental

Sham Comparator

Arm Label

HIIT and LED therapy

High intensity interval training (HIIT)

Combined training and LED therapy

Combined training

Arm Description

Light-Emitting Diode (LED) therapy followed by physical training with high intensity interval training (HIIT)

Light-Emitting Diode (LED) therapy simulation followed by physical training with high intensity interval training (HIIT)

Light-Emitting Diode (LED) therapy followed by physical training with combined training

Light-Emitting Diode (LED) therapy simulation followed by physical training with combined training.

Outcomes

Primary Outcome Measures

Functional exercise capacity
Oxygen consumption measurement during cardiopulmonary test
Incremental shuttle walking test
Distance in meters
Glycemic control
Evaluated by the percentage of glycated hemoglobin

Secondary Outcome Measures

Autonomic Nervous System
Assesment by Heat Rate Variability analysis
Musculoskeletal Function
Muscular strength and endurance will be evaluated by Isokinetic Dynamometry
Physical Activity Questionnaire
The level of physical activity will be assessed using the international questionnaire short version physical activity (IPAQ). The continuous score allows assessing energy expenditure expressed in MET minutes/week. The IPAQ categories include: Insufficiently active (does not perform any physical activity); Sufficiently active (conducts vigorous activity at least three days a week >600 MET - 1400 MET); Very active (performs more than three days per week of vigorous activity 1500 MET - 3000 MET).
Endothelial Function
Endothelial function will be assessed by arterial flow-mediated dilation (FMD)
Quality of Life Questionary
Assesment by using the questionnaire Medical Outcomes Study 36 - Item Short - Form Health Survey (SF36). The SF-36 has eight sections (Vitality, Physical functioning, Bodily pain, General health perceptions, Physical role functioning, Emotional role functioning, Social role functioning and Mental health). The scores are weighted sums of the questions in each section. Scores range from 0 - 100. Lower scores = more disability and higher scores = less disability.
Body mass index (BMI)
Weight and height will be combined to report BMI (kg/m2)
Other Biochemical Analyzes
Total cholesterol (Total-C) (mg/dl), low-density lipoprotein cholesterol (LDL-C) (mg/dl), high-density lipoprotein cholesterol (HDL-C) (mg/dl) and triglycerides (mg/dl)

Full Information

First Posted
May 7, 2018
Last Updated
May 16, 2022
Sponsor
University of Nove de Julho
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1. Study Identification

Unique Protocol Identification Number
NCT03593746
Brief Title
Effects of High Intensity Interval Training and Combined Training in Type 2 Diabetic (T2D) Patients
Official Title
Effects of High Intensity Interval Training and Combined Training Associated With Photobiomodulation in Type 2 Diabetic (T2D) Patients: a Randomized Controlled Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 1, 2020 (Actual)
Primary Completion Date
October 1, 2020 (Actual)
Study Completion Date
December 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Nove de Julho

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Diabetes has become a widespread epidemic, primarily because of the increasing prevalence and incidence of type 2 diabetes (T2D). T2D is a significant cause of premature mortality and morbidity related to cardiovascular disease, blindness, kidney and nerve disease, and amputation. Physical activity improves blood glucose control and can prevent or delay T2D, along with positively affecting lipids, blood pressure, cardiovascular events, mortality, and quality of life. At present, although physical activity is a key element in the prevention and management of T2D, the most effective exercise strategy (intensity, duration, and type of exercise) for improving glucose control and reducing cardiometabolic risk in type 2 diabetes has not been defined. Studies with Light-Emitting Diode (LED) therapy have demonstrated its ability to promote pain relief, improve muscle and cardiopulmonary performance, minimize muscle fatigue, and stimulate wound healing. In relation to patients with T2D, who have prolonged conditions of hyperglycemia, studies to investigate the impact of photobiomodulation associated with physical training have not been found so far. The objective of this study is to investigate the effects of different types of physical training associated with Light-Emitting Diode (LED) therapy on cardiometabolic status and quality of life in patients with T2D.
Detailed Description
Type 2 diabetes (T2D) is a significant health problem worldwide due to its high prevalence and mortality. It is chronic metabolic disorder characterized by hyperglycemia resulting from a relative deficiency in insulin through either reduced insulin secretion or reduced insulin action or both. The subsequent chronic hyperglycaemia causes glycation of tissues, which almost inevitably leads to acute disturbances in metabolism and long term end organ damage, especially the blood vessels, heart, and nerves, and severe health complications. Individuals with T2D have reduced aerobic fitness characterized by lower peak pulmonary oxygen uptake. Many potential mechanisms could explain this impaired response, for example, reduced muscle blood flow and capillary density, defects in muscular oxygen diffusion, and lower mitochondrial oxygen utilization and function. T2D is also associated with lower baroreflex sensitivity and abnormal chronotropic response, altering heart rate regulation. In addition, prolonged hyperglycemia in T2D causes a number of pathological changes in vascular endothelial cells, increasing the production of reactive oxygen species and inflammatory cytokines that cause mitochondrial dysfunction and oxidative damage.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2, High-Intensity Interval Training, Exercise Training, Hyperglycaemia Due to Type 2 Diabetes Mellitus
Keywords
Cardiopulmonary Exercise Test, Rehabilitation, Diabetes Mellitus, Type 2, Functional Capacity, Photobiomodulation Therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
HIIT and LED therapy
Arm Type
Experimental
Arm Description
Light-Emitting Diode (LED) therapy followed by physical training with high intensity interval training (HIIT)
Arm Title
High intensity interval training (HIIT)
Arm Type
Sham Comparator
Arm Description
Light-Emitting Diode (LED) therapy simulation followed by physical training with high intensity interval training (HIIT)
Arm Title
Combined training and LED therapy
Arm Type
Experimental
Arm Description
Light-Emitting Diode (LED) therapy followed by physical training with combined training
Arm Title
Combined training
Arm Type
Sham Comparator
Arm Description
Light-Emitting Diode (LED) therapy simulation followed by physical training with combined training.
Intervention Type
Other
Intervention Name(s)
Physical training
Intervention Description
Type 2 diabetic patients will be subjected to different types of physical training (high intensity interval training or combined training).
Intervention Type
Other
Intervention Name(s)
Light-Emitting Diode (LED) therapy
Intervention Description
Type 2 diabetic patients will be subjected to Light-Emitting Diode (LED) therapy (active or sham).
Primary Outcome Measure Information:
Title
Functional exercise capacity
Description
Oxygen consumption measurement during cardiopulmonary test
Time Frame
Change from Baseline to 12 weeks
Title
Incremental shuttle walking test
Description
Distance in meters
Time Frame
Change from Baseline to 12 weeks
Title
Glycemic control
Description
Evaluated by the percentage of glycated hemoglobin
Time Frame
Change from Baseline to 12 weeks
Secondary Outcome Measure Information:
Title
Autonomic Nervous System
Description
Assesment by Heat Rate Variability analysis
Time Frame
Change from Baseline to 12 weeks
Title
Musculoskeletal Function
Description
Muscular strength and endurance will be evaluated by Isokinetic Dynamometry
Time Frame
Change from Baseline to 12 weeks
Title
Physical Activity Questionnaire
Description
The level of physical activity will be assessed using the international questionnaire short version physical activity (IPAQ). The continuous score allows assessing energy expenditure expressed in MET minutes/week. The IPAQ categories include: Insufficiently active (does not perform any physical activity); Sufficiently active (conducts vigorous activity at least three days a week >600 MET - 1400 MET); Very active (performs more than three days per week of vigorous activity 1500 MET - 3000 MET).
Time Frame
Change from Baseline to 12 weeks
Title
Endothelial Function
Description
Endothelial function will be assessed by arterial flow-mediated dilation (FMD)
Time Frame
Change from Baseline to 12 weeks
Title
Quality of Life Questionary
Description
Assesment by using the questionnaire Medical Outcomes Study 36 - Item Short - Form Health Survey (SF36). The SF-36 has eight sections (Vitality, Physical functioning, Bodily pain, General health perceptions, Physical role functioning, Emotional role functioning, Social role functioning and Mental health). The scores are weighted sums of the questions in each section. Scores range from 0 - 100. Lower scores = more disability and higher scores = less disability.
Time Frame
Change from Baseline to 12 weeks
Title
Body mass index (BMI)
Description
Weight and height will be combined to report BMI (kg/m2)
Time Frame
Change from Baseline to 12 weeks
Title
Other Biochemical Analyzes
Description
Total cholesterol (Total-C) (mg/dl), low-density lipoprotein cholesterol (LDL-C) (mg/dl), high-density lipoprotein cholesterol (HDL-C) (mg/dl) and triglycerides (mg/dl)
Time Frame
Change from Baseline to 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age ≥ 18 years; Confirmed diagnosis of type 2 diabetes; Sedentary lifestyle in the last six months, according to the criteria established by the American Heart Association (AHA). Exclusion Criteria: Confirmed diagnosis of any (1) heart disease; (2) musculoskeletal disorder; (3) respiratory disease; (4) uncontrolled arterial hypertension; (5) peripheral neuropathy or (6) factors that limit the performance of any of the study evaluations and/or training. During the study, individuals with a presence of less than 80% in the training sessions will be excluded.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Luciana MM Sampaio, Professor
Phone
+551133859241
Email
lucianamalosa@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Cauê Padovani, Phd
Phone
+55969288228
Email
cauepadovani@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Luciana MM Sampaio, Professor
Organizational Affiliation
Nove de Julho University
Official's Role
Principal Investigator
Facility Information:
Facility Name
UNINOVE
City
Sao Paulo
State/Province
SP
ZIP/Postal Code
03332010
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Luciana Sampaio, PhD

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
27563535
Citation
Bassi D, Mendes RG, Arakelian VM, Caruso FC, Cabiddu R, Junior JC, Arena R, Borghi-Silva A. Potential Effects on Cardiorespiratory and Metabolic Status After a Concurrent Strength and Endurance Training Program in Diabetes Patients - a Randomized Controlled Trial. Sports Med Open. 2016 Aug 11;2:31. doi: 10.1186/s40798-016-0052-1. eCollection 2015 Jun.
Results Reference
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PubMed Identifier
11559268
Citation
Boule NG, Haddad E, Kenny GP, Wells GA, Sigal RJ. Effects of exercise on glycemic control and body mass in type 2 diabetes mellitus: a meta-analysis of controlled clinical trials. JAMA. 2001 Sep 12;286(10):1218-27. doi: 10.1001/jama.286.10.1218.
Results Reference
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PubMed Identifier
23002086
Citation
Karstoft K, Winding K, Knudsen SH, Nielsen JS, Thomsen C, Pedersen BK, Solomon TP. The effects of free-living interval-walking training on glycemic control, body composition, and physical fitness in type 2 diabetic patients: a randomized, controlled trial. Diabetes Care. 2013 Feb;36(2):228-36. doi: 10.2337/dc12-0658. Epub 2012 Sep 21.
Results Reference
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PubMed Identifier
25467842
Citation
Chen L, Pei JH, Kuang J, Chen HM, Chen Z, Li ZW, Yang HZ. Effect of lifestyle intervention in patients with type 2 diabetes: a meta-analysis. Metabolism. 2015 Feb;64(2):338-47. doi: 10.1016/j.metabol.2014.10.018. Epub 2014 Oct 23.
Results Reference
background
PubMed Identifier
26258597
Citation
Madsen SM, Thorup AC, Overgaard K, Jeppesen PB. High Intensity Interval Training Improves Glycaemic Control and Pancreatic beta Cell Function of Type 2 Diabetes Patients. PLoS One. 2015 Aug 10;10(8):e0133286. doi: 10.1371/journal.pone.0133286. eCollection 2015.
Results Reference
background
PubMed Identifier
25717277
Citation
Francois ME, Little JP. Effectiveness and safety of high-intensity interval training in patients with type 2 diabetes. Diabetes Spectr. 2015 Jan;28(1):39-44. doi: 10.2337/diaspect.28.1.39.
Results Reference
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PubMed Identifier
26471849
Citation
Madsen SM, Thorup AC, Overgaard K, Bjerre M, Jeppesen PB. Functional and structural vascular adaptations following 8 weeks of low volume high intensity interval training in lower leg of type 2 diabetes patients and individuals at high risk of metabolic syndrome. Arch Physiol Biochem. 2015;121(5):178-86. doi: 10.3109/13813455.2015.1087033. Epub 2015 Oct 15.
Results Reference
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PubMed Identifier
21708874
Citation
Gibbs BB, Dobrosielski DA, Lima M, Bonekamp S, Stewart KJ, Clark JM. The association of arterial shear and flow-mediated dilation in diabetes. Vasc Med. 2011 Aug;16(4):267-74. doi: 10.1177/1358863X11411361. Epub 2011 Jun 27.
Results Reference
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PubMed Identifier
21115771
Citation
Colberg SR, Sigal RJ, Fernhall B, Regensteiner JG, Blissmer BJ, Rubin RR, Chasan-Taber L, Albright AL, Braun B; American College of Sports Medicine; American Diabetes Association. Exercise and type 2 diabetes: the American College of Sports Medicine and the American Diabetes Association: joint position statement executive summary. Diabetes Care. 2010 Dec;33(12):2692-6. doi: 10.2337/dc10-1548. No abstract available.
Results Reference
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Effects of High Intensity Interval Training and Combined Training in Type 2 Diabetic (T2D) Patients

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