Sugar control following different exercises in diabetic patients with heart disease

• Register: IRCT
• Last refreshed on: 22 February 2018
• Main ID: IRCT2014120820239N1
• Date of registration: 2015-01-02
• Prospective Registration: No
• Primary sponsor: University Malaya Research Grant (UMRG)
• Public title: Sugar control following different exercises in diabetic patients with heart disease
• Scientific title: Effects of continuous aerobic training, high intensity interval training (HIIT) and combined aerobic with resistance training on glycated haemoglobin (HbA1c) in Type 2 Diabetes Mellitus patients with coronary artery disease
• Date of first enrolment: 2012-06-01
• Target sample size: 42
• Recruitment status: Complete
• URL: http://en.irct.ir/trial/17920
• Study type: interventional
• Study design: Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Other design features: This is a randomized prospective trial. Randomization is done using the Peto et al method.
• Phase: 2-3

Countries of recruitment

Malaysia

Contacts

• Name: Moriffin Mahpis
• Affiliation: University Malaya Medical Centre

• Name: Moriffin Mahpis
• Affiliation: University Malaya Medical Centre

Key inclusion & exclusion criteria

Inclusion criteria: Patients who fulfill the inclusion and exclusion criteria as listed below are recruited:
Inclusion criteria for the subjects are patients with type 2 diabetes mellitus with coronary artery disease co-morbidity manifested by one or more of these:
-Ischemic Heart Disease, but no current angina
-Post angioplasty / stenting or post coronary artery bypass surgery
-Stable pharmacological therapy
-Chronic Heart Failure New York Association (NYHA I, II and III) in the absence of congestive heart failure at the time of study

Patients with the listed criteria are excluded from the study:
-Myocardial Infarction, Cardiac arrest, symptomatic or sustained ventricular tachycardia in the previous 6 months
-Unstable heart failure, or NYHA Class IV patients
-Symptomatic or sustained ventricular tachycardia
-Current angina or baseline assessment suggesting unsatisfactory control of heart failure
-Current acute musculoskeletal event and/or neurological impairments that adversely affect exercise capacity.
-Any other symptoms that prevent the patients from exercising.
Exclusion criteria:

Age minimum: 36 years
Age maximum: 74 years
Gender: Both

Health Condition(s) or Problem(s) studied

non insulin dependent diabetes mellitus

type 2 diabetes mellitus with coronary artery disease.
non insulin dependent diabetes mellitus

Intervention(s)

Continuous aerobic training: 30 minutes walking on a treadmill and 30 minutes of cycling on an upright bike with moderate intensity (50-70% VO2max). Total training duration of 60 minutes.

High intensity interval training (HIIT): Subjects will train on cycling ergometer which last for 10 minute duration. They will start with gradual incremental intensity training for 6 minutes (maximum intensity 60-70% VO2max) then low intensity for another 4 minutes as their warm up session. Then the HIIT session consisted of 10 minutes exercise with every 60 seconds between low intensity and high intensity alternately. The cycle ergometer is set with resistance 40% VO2max for low intensity and 60-70% VO2max for high intensity. During the 60 second high intensity session, patients are to force and encourage to increase their cycle repetition per minute to maximum with the target in achieving Borg score of 17 and above. They were monitored and supervised during the 20 minute session.

Intervention 1: Continuous aerobic training: 30 minutes walking on a treadmill and 30 minutes of cycling on an upright bike with moderate intensity (50-70% VO2max). Total training duration of 60 minutes. Intervention 2: High intensity interval training (HIIT): Subjects will train on cycling ergometer which last for 10 minute duration. They will start with gradual incremental intensity training for 6 minutes (maximum intensity 60-70% VO2max) then low intensity for another 4 minutes as their warm up session. Then the HIIT session consisted of 10 minutes exercise with every 60 seconds between low intensity and high intensity alternately. The cycle ergometer is set with resistance 40% VO2max for low intensity and 60-70% VO2max for high intensity. During the 60 second high intensity session, patients are to force and encourage to increase their cycle repetition per minute to maximum with the target in achieving Borg score of 17 and above. They were monitored and supervised during the 20 minute session. Intervention 3: Combined aerobic with resistance training: Continuous 30 minutes walking on a treadmill and 30 minutes of cycling on an upright bike at moderate intensity (50-70% VO2max). Then they have to do resistance training such as chest press, latissimus dorsi pull, leg press, leg extension or leg curl, abdominal muscle crunch and back extension. Total training duration is about 90 minutes.

Combined aerobic with resistance training: Continuous 30 minutes walking on a treadmill and 30 minutes of cycling on an upright bike at moderate intensity (50-70% VO2max). Then they have to do resistance training such as chest press, latissimus dorsi pull, leg press, leg extension or leg curl, abdominal muscle crunch and back extension. Total training duration is about 90 minutes

Lifestyle

Primary Outcome(s)

HbA1c (glycated haemoglobin). Timepoint: 12 weeks following end of treatment. Method of measurement: Blood sample laboratory test.

Secondary Outcome(s)

Fasting blood glucose. Timepoint: 12 weeks following end of treatment. Method of measurement: Blood sample laboratory test.

Lipid profile. Timepoint: 12 weeks following end of treatment. Method of measurement: Blood sample laboratory test.

Maximum oxygen consumption (VO2max). Timepoint: 12 weeks following end of treatment. Method of measurement: cycling ergometer using Astrand or Naughton protocol.

Body composition. Timepoint: 12 weeks following end of treatment. Method of measurement: bioelectrical impedance analysis machine.

Source(s) of Monetary Support

University Malaya Research Grant (UMRG)

Ethics review

Status: Approved
Approval date:
Contact:

Medical Ethics Committee