Effect of Exercise-based Intervention on Mitochondrial Dysfunction in Type 2 Diabetes Mellitus with Sarcopenia- A Randomized Controlled Trial

Evaluating the effect of Exercise-based intervention in Type 2 Diabetes mellitus(T2DM) with Sarcopenia on Skeletal mass index, SARC-F, Hand grip strength, Limb girth of Quadriceps and Calf muscle, Physical performance using Timed-up and Go test and few blood biomarkers and ultrasound imaging of quadriceps and calf muscle.

Patients with T2DM and Sarcopenia coming to the Center for Podiatry and Diabetic Foot Care and Research, Department of Physiotherapy, and Department of Endocrinology, Kasturba Hospital Manipal will be thoroughly screened in accordance with the inclusion and exclusion criteria and will be included in the study. Each participant will be informed in detail about the study and the participant information sheet (PIS) along with an informed consent form will be provided to them. If they agree to take part in the study, We will get their written informed permission.

The participants will be screened for Sarcopenia using the SARC-F questionnaire and Calf Circumference measurement will be done. A GPAQ questionnaire will be used to assess the Physical activity level.

Demographic details and detailed clinical evaluation of the study participants will be done.

The baseline primary and secondary outcome measures SARC- F questionnaire, Hand grip strength, Limb girth assessment of Quadriceps and calf muscle, Skeletal mass index, blood biomarkers, ultrasound imaging to observe the soft tissue changes of Quadriceps and calf muscles, and Timed up and go test will be evaluated at the time of the initial visit along with the demographic details of each participant.

Once the patient completes all the baseline assessments, Individuals will be randomized into Interventional and Control groups with a computer-generated varied blocked randomization method. The allocation will be conducted with the sealed envelope method, the sequence will be written in paper which will be put inside an envelope and will be opened by an assistant at the time of each recruitment.

Exercise-based intervention protocol will be explained to each participant and the first session will be conducted under the supervision of the primary investigator.

Exercise-based intervention involves Resistance exercise, Aerobic training, and Balance training exercises. Exercises will be for 12 weeks. These exercises will be progressed as per the resistance, and repetition in the 4th and 8th week. Supervised exercise sessions will be planned every two weeks.

Participants in the control group will be instructed to continue their activities of daily living as usual and also Maintain standard care by the physician.

All the outcome measures will be assessed at the baseline, the 12th week of treatment, and at the 24th week(Follow-up).

The participant has to visit the hospital 3 times.