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Exercise Program for Diabetes Patients - Testing a New Method

Meditational Exercise Training (MET-7) for Adults with Type 2 Diabetes: A Study Protocol for a Feasibility Randomized Controlled Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/12/099541
Enrollment
60
Registered
2025-12-19
Start date
Unknown
Completion date
Unknown
Last updated
2026-01-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: E118- Type 2 diabetes mellitus with unspecified complications

Interventions

Intervention1: Meditational Exercise Training (MET 7): Standardized 12-step protocol integrating pranayama breathing, moderate to vigorous intensity whole-body exercises (~7 METs), and sustained medit

Sponsors

Diabcare India Diabetes Center
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1 Adults aged 18 to 60 years 2 Diagnosed with Type 2 Diabetes based on American Diabetes Association (ADA) criteria for 6 months to less than 10 years 3 Glycated hemoglobin (HbA1c) 6.5 to 8.5 4 On stable Oral Hypoglycemic Agents (no change in last 3 months) 5 Sedentary lifestyle (less than 90 minutes moderate to vigorous exercise per week) 6 Able to provide informed consent

Exclusion criteria

Exclusion criteria: 1 Type 1 or secondary diabetes 2 Current insulin therapy 3 Major cardiovascular events in past 6 months 4 Uncontrolled hypertension (more than 160/100 mmHg) 5 Severe diabetic complications 6 Regular mind-body exercise practice (more than 1 session per week in last 3 months) 7 Pregnancy or lactation

Design outcomes

Primary

MeasureTime frame
Change in HbA1CTimepoint: Baseline and after 12 weeks—

Secondary

MeasureTime frame
1 Recruitment rate- Proportion of eligible participants who provide informed consent 2 Retention rate- Proportion of randomized participants completing 12-week assessment 3 Adherence- Attendance at supervised sessions and home practice completion 4 Acceptability- Satisfaction scores and qualitative feedback 5 Safety- Number and severity of adverse events 6 Fasting blood glucose (FBG) and post prandial blood glucose (PPBG) 7 Autonomic function- Heart Rate Variability parameters 8 Psychological measures- Perceived Stress Scale (PSS) score, Patient Health Questionnaire-9 (PHQ-9) scores 9 Quality of life- Audit of Diabetes Dependent Quality of Life (ADDQoL) score 10 Anthropometrics- Weight, body mass index (BMI), waist circumference Timepoint: Baseline and after 12 weeks—

Countries

India

Contacts

Public ContactDr P Sureshkumar

Diabcare India Diabetes Center

doctor@diabcareindia.com9747050000

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026