Effects of supervised structured aerobic exercise training (SSAET) on patients with type 2 diabetes mellitus compared with routine medical management

• Register: ISRCTN
• Last refreshed on: 11 February 2019
• Main ID: ISRCTN16466697
• Date of registration: 12/12/2016
• Prospective Registration: No
• Primary sponsor: Riphah International University
• Public title: Effects of supervised structured aerobic exercise training (SSAET) on patients with type 2 diabetes mellitus compared with routine medical management
• Scientific title: Effects of supervised structured aerobic exercise training (SSAET) on patients with type 2 diabetes mellitus compared with routine medical management: a randomised controlled trial
• Date of first enrolment: 01/01/2015
• Target sample size: 100
• Recruitment status: Completed
• URL: http://isrctn.com/ISRCTN16466697
• Study type: Interventional
• Study design: Randomised controlled trial (Treatment)

Countries of recruitment

Pakistan

Contacts

• Name: Syed Shakil-ur-Rehman

Key inclusion & exclusion criteria

Inclusion criteria:
1. Patients with type 2 diabetes mellitus diagnosed as per WHO criteria
2. Established diagnosis of type 2 diabetes mellitus with 1 year history
3. Age 30-70
4. No other post-diabetic complications or comorbidity
5. No prior history of regular physical exercise

Exclusion criteria:
1. Patients with type 1 diabetes mellitus or pregnancy induced diabetes
2. Aged less than 30/more than 70
3. Patients with any other post-diabetic complications or comorbidity
4. Musculoskeletal, cardiopulmonary or neurological problems.
5. Smokers
6. Patients with type 2 diabetes mellitus with a history of regular exercise


Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Diabetes mellitus type 2
Nutritional, Metabolic, Endocrine
Non-insulin-dependent diabetes mellitus

Intervention(s)

1. The control group received routine medication and dietary plan (non-exercised group)
2. The experimental group received the SSAET program, routine medication and dietary plan (exercise group).

Patients in the experimental group will be subjected to long-term (25 weeks) supervised and structured aerobic exercise (SSAE) training (treadmill activity). The effect of supervised, and structured aerobic exercises training (treadmill activity) will be studied on glycaemic control, insulin in blood, aerobic capacity, cholesterol, proteins and enzymes in muscles, waist, weight, body mass index, level of exertion, breathlessness during physical activity, blood pressure and complications if any in such patients.

Primary Outcome(s)

1. Insulin resistance, measured using the HOMA Method
2. Glycemic control (HbA1c), measured using a kit
3. Plasma insulin level, measured using a kit
4. Fasting blood glucose level, estimated by glucometer
Measured at baseline and at the completion of 6 month (25 weeks) intervention.

Secondary Outcome(s)

1. LDL and HDL cholesterol, measured from blood by using kits
2. Aerobic capacity (VO2 peak), measured by resting heart rate based method
3. Body weight
4. Body mass index (BMI)
5. Level of exertion, measured using the Borge scale
6. Dyspnea, measured by dyspnea index
7. Blood pressure, measured by BP apparatus
8. Post diabetic complications, measured by physical examination
9. Inflammatory markers, measured by Human ELISA Kits
Measured at baseline and at the completion of 6 month (25 weeks) intervention.

Source(s) of Monetary Support

Riphah International University

Ethics review

Status:
Approval date:
Contact:

Ethics Committee University of Lahore, Pakistan, 10/03/2015, ref: IRB-UOL/00314/0A35

Results

• Results available: Yes
• Date Completed: 30/06/2016