Effect of guided training on sensations and functioning of heart in patients of diabetes mellitus
Phase 3
- Conditions
- Health Condition 1: E11- Type 2 diabetes mellitus
- Registration Number
- CTRI/2024/04/065375
- Lead Sponsor
- AIIMS
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
1 Age: 18-50 years
2 Type 2 diabetes mellitus
Exclusion Criteria
1 Neuropathic pain due to causes other than diabetes
2 Central nervous system lesions
3 History indicating a disease, condition, or treatment that might be a potential cause of polyneuropathy other than diabetes
4 Blunted response to deep breathing test with delta heart rate less than 5 during deep breathing
5 Yogic breathing or meditation practitioners practicing supervised or unsupervised sessions one or more than once per week in the last 6 months
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Change in heart rate variability (time and frequency domain) <br/ ><br>2. Change in peripheral sensory profile (Quantitative sensory testing) <br/ ><br>3. Change in glycemic status (Fasting blood glucose, HbA1c) <br/ ><br>Timepoint: At the end of 4 weeks of heart rate variability biofeedback training.
- Secondary Outcome Measures
Name Time Method 1. Change in heart rate variability (time & frequency domain) <br/ ><br>2. Change in peripheral sensory profile (Quantitative sensory testing) <br/ ><br>3. Change in glycemic status (Fasting blood glucose, HbA1c)Timepoint: At 8 weeks.