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

NCT03593746 | Unknown DMC

• 1 other identifier: T2Dexercise.photobiomodulation
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (3)

• Functional exercise capacity

  Oxygen consumption measurement during cardiopulmonary test

  Change from Baseline to 12 weeks

• Incremental shuttle walking test

  Distance in meters

  Change from Baseline to 12 weeks

• Glycemic control

  Evaluated by the percentage of glycated hemoglobin

  Change from Baseline to 12 weeks

Secondary Outcomes (7)

• Autonomic Nervous System

  Change from Baseline to 12 weeks

• Musculoskeletal Function

  Change from Baseline to 12 weeks

• Physical Activity Questionnaire

  Change from Baseline to 12 weeks

• Endothelial Function

  Change from Baseline to 12 weeks

• Quality of Life Questionary

  Change from Baseline to 12 weeks

Study Arms (4)

HIIT and LED therapy

EXPERIMENTAL

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

Other: Physical training; Other: Light-Emitting Diode (LED) therapy

High intensity interval training (HIIT)

SHAM COMPARATOR

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

Other: Physical training; Other: Light-Emitting Diode (LED) therapy

Combined training and LED therapy

EXPERIMENTAL

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

Other: Physical training; Other: Light-Emitting Diode (LED) therapy

Combined training

SHAM COMPARATOR

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

Other: Physical training; Other: Light-Emitting Diode (LED) therapy

Interventions

Physical training OTHER

Type 2 diabetic patients will be subjected to different types of physical training (high intensity interval training or combined training).

Combined training; Combined training and LED therapy; HIIT and LED therapy; High intensity interval training (HIIT)

Light-Emitting Diode (LED) therapy OTHER

Type 2 diabetic patients will be subjected to Light-Emitting Diode (LED) therapy (active or sham).

Combined training; Combined training and LED therapy; HIIT and LED therapy; High intensity interval training (HIIT)

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Nove de Julho: lead

Study Sites (1)

UNINOVE

São Paulo, São Paulo, 03332010, Brazil

RECRUITING

Related Publications (9)

• 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.

  PMID: 27563535 BACKGROUND

• 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.

  PMID: 11559268 BACKGROUND

• 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.

  PMID: 23002086 BACKGROUND

• 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.

  PMID: 25467842 BACKGROUND

• 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.

  PMID: 26258597 BACKGROUND

• 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.

  PMID: 25717277 BACKGROUND

• 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.

  PMID: 26471849 BACKGROUND

• 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.

  PMID: 21708874 BACKGROUND

• 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.

  PMID: 21115771 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Physical Conditioning, Human; Therapeutics

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Luciana MM Sampaio, Professor

  Nove de Julho University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Luciana MM Sampaio, Professor

CONTACT

+551133859241; lucianamalosa@gmail.com

Cauê Padovani, Phd

CONTACT

+55969288228; cauepadovani@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of the postgraduate program in Rehabilitation Sciences

Study Record Dates

• First Submitted: May 7, 2018
• First Posted: July 20, 2018
• Study Start: August 1, 2020
• Primary Completion: October 1, 2020
• Study Completion: December 1, 2022
• Last Updated: May 17, 2022

Record last verified: 2022-05

Locations

BR (1)