PMID- 29793518
OWN - NLM
STAT- MEDLINE
DCOM- 20190314
LR  - 20220408
IS  - 1745-6215 (Electronic)
IS  - 1745-6215 (Linking)
VI  - 19
IP  - 1
DP  - 2018 May 24
TI  - A dose-response study of aerobic training for oxygen uptake, oxidative stress and 
      cardiac autonomic function in type 2 diabetes mellitus: study protocol for a 
      randomized controlled trial.
PG  - 289
LID - 10.1186/s13063-018-2671-y [doi]
LID - 289
AB  - BACKGROUND: Cardiac autonomic neuropathy is a commonly overlooked complication of 
      type 2 diabetes mellitus (T2DM) characterized by an imbalance between sympathetic 
      and parasympathetic supply to the heart, which contributes to cardiovascular 
      morbidity and mortality. T2DM has also been shown to negatively influence oxygen 
      kinetics and increase oxidative stress, which may be linked to the development of 
      various chronic complications. Aerobic training has been reported to improve 
      oxygen uptake, antioxidant defense, and cardiac autonomic function in T2DM; 
      however, the effects of varying doses of exercise on these variables are not 
      known. Therefore, the aim of the present study is to explore the effects of 
      manipulating training variables (volume and intensity) on the regulation of 
      oxygen uptake response, oxidative stress, and cardiac autonomic function in 
      patients with T2DM. METHODS: We will recruit 60 patients with T2DM, who will be 
      randomly allocated into one of the three aerobic training groups: low-intensity, 
      low-volume training; low-intensity, high volume-training; high-intensity, 
      high-volume training; or to the control group receiving no supervised exercise. 
      All participants will be assessed for the rate of oxygen uptake, levels of 
      antioxidant enzymes and cardiac autonomic function at baseline and after 12 weeks 
      of training. Secondary outcome measures will include cardiometabolic risk factors 
      and body composition. DISCUSSION: Despite a large body of evidence on the 
      efficacy of aerobic training in the prevention and treatment of T2DM, there is no 
      unequivocal exercise prescription for the same. Oxygen kinetics and oxidative 
      stress are highly sensitive to the magnitude of physical activity. It would 
      therefore, be interesting to study their interaction with chronic exposure to 
      various doses of exercises and explore the optimal volume and intensity to bring 
      about improvements in these parameters. TRIAL REGISTRATION: Clinical Trials 
      Registry - India, CTRI2017/08/009459 . Registered on 23 August 2017. 
      Retrospectively registered.
FAU - Verma, Shalini
AU  - Verma S
AD  - Centre for Physiotherapy and Rehabilitation Sciences, Jamia Millia Islamia 
      (Central University), New Delhi, 110025, India.
FAU - Moiz, Jamal Ali
AU  - Moiz JA
AD  - Centre for Physiotherapy and Rehabilitation Sciences, Jamia Millia Islamia 
      (Central University), New Delhi, 110025, India.
FAU - Anwer, Shahnawaz
AU  - Anwer S
AD  - Department of Rehabilitation, College of Applied Medical Sciences, King Saud 
      University, Riyadh, Saudi Arabia.
FAU - Alghadir, Ahmad H
AU  - Alghadir AH
AD  - Department of Rehabilitation, College of Applied Medical Sciences, King Saud 
      University, Riyadh, Saudi Arabia.
FAU - Hussain, Mohammed Ejaz
AU  - Hussain ME
AD  - Centre for Physiotherapy and Rehabilitation Sciences, Jamia Millia Islamia 
      (Central University), New Delhi, 110025, India. ehusainjmi@gmail.com.
LA  - eng
PT  - Clinical Trial Protocol
PT  - Journal Article
DEP - 20180524
PL  - England
TA  - Trials
JT  - Trials
JID - 101263253
RN  - 0 (Biomarkers)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Autonomic Nervous System/*physiopathology
MH  - Biomarkers/blood
MH  - Cardiorespiratory Fitness
MH  - Diabetes Mellitus, Type 2/blood/diagnosis/physiopathology/*therapy
MH  - Diabetic Neuropathies/blood/diagnosis/physiopathology/*therapy
MH  - Exercise Therapy/*methods
MH  - Exercise Tolerance
MH  - Female
MH  - Heart/*innervation
MH  - Heart Rate
MH  - Humans
MH  - India
MH  - Male
MH  - Middle Aged
MH  - *Muscle Contraction
MH  - Muscle, Skeletal/metabolism/*physiopathology
MH  - *Oxidative Stress
MH  - *Oxygen Consumption
MH  - Randomized Controlled Trials as Topic
MH  - Recovery of Function
MH  - Single-Blind Method
MH  - Time Factors
MH  - Treatment Outcome
PMC - PMC5968520
OTO - NOTNLM
OT  - Aerobic training
OT  - Cardiopulmonary fitness
OT  - Diabetes
OT  - Heart rate variability
OT  - Metabolic control
OT  - Oxygen uptake
COIS- ETHICS APPROVAL AND CONSENT TO PARTICIPATE: All of the participating patients 
      will receive verbal information and a written information sheet and will be able 
      to ask the investigators and study staff questions about the study. They will 
      voluntarily sign a consent form before starting the trial (Additional file 2). 
      COMPETING INTERESTS: The authors declare that they have no competing interests. 
      PUBLISHER'S NOTE: Springer Nature remains neutral with regard to jurisdictional 
      claims in published maps and institutional affiliations.
EDAT- 2018/05/26 06:00
MHDA- 2019/03/15 06:00
PMCR- 2018/05/24
CRDT- 2018/05/26 06:00
PHST- 2018/02/05 00:00 [received]
PHST- 2018/05/04 00:00 [accepted]
PHST- 2018/05/26 06:00 [entrez]
PHST- 2018/05/26 06:00 [pubmed]
PHST- 2019/03/15 06:00 [medline]
PHST- 2018/05/24 00:00 [pmc-release]
AID - 10.1186/s13063-018-2671-y [pii]
AID - 2671 [pii]
AID - 10.1186/s13063-018-2671-y [doi]
PST - epublish
SO  - Trials. 2018 May 24;19(1):289. doi: 10.1186/s13063-018-2671-y.