Multicentre randomised controlled trial protocol comparing structured physical exercise programme (SPEP) and medication versus conventional care for glycaemic control in type 2 diabetes mellitus.

Abstract:

Introduction: One of the most widespread non-communicable diseases in the world is type 2 diabetes mellitus (T2DM) which increases the risk of cardiovascular mortality and morbidity, in addition to elevated blood pressure, and lipid disorders, for which physical activity and exercise programmes have shown a great impact on reducing cholesterol and glucose level. So, this study aims to generate a proper or Structured Physical Exercise Programme (SPEP) for the glycaemic control of people with T2DM.

Methods and analysis: The study will be a double-blinded, multicentre, randomised controlled trial where participants with T2DM will be enrolled from three Diabetic Centres in Bangladesh. All the participants will be allocated to experimental and control groups in a 1:1 ratio. Both groups will receive 18 sessions/6 weeks of intervention with an additional 24-week follow-up. Warm-up exercises, stretching and aerobic exercise will be provided along with medication for experimental and conventional approaches will be provided in the control group. A glucometer will measure the primary outcome (capillary blood glucose level). The secondary outcomes (cardiorespiratory fitness, T2DM-related comorbidities and quality of life) will be measured by a 6-min walk-test, self-structured questionnaire and SF-36. All outcomes will be measured at baseline, post-test after 6 weeks and follow-up after 24 weeks.

Trial registration number: CTRI/2023/08/057032.