Skip to content

Effect of guided training on sensations and functioning of heart in patients of diabetes mellitus

Effect of heart rate variability biofeedback training on peripheral sensory status and cardiac autonomic status in type 2 diabetes mellitus

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/04/065375
Enrollment
30
Registered
2024-04-08
Start date
Unknown
Completion date
Unknown
Last updated
2024-04-29

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

Conditions

Health Condition 1: E11- Type 2 diabetes mellitus

Interventions

Intervention1: HRV Biofeedback: The HRV Biofeedback group will be receiving 8 weeks of HRV biofeedback intervention with each session of 10 minutes of every day. Control Intervention1: Control group:

Sponsors

AIIMS
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1 Age: 18-50 years 2 Type 2 diabetes mellitus

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
1. Change in heart rate variability (time and frequency domain) 2. Change in peripheral sensory profile (Quantitative sensory testing) 3. Change in glycemic status (Fasting blood glucose, HbA1c) Timepoint: At the end of 4 weeks of heart rate variability biofeedback training.

Secondary

MeasureTime frame
1. Change in heart rate variability (time & frequency domain) 2. Change in peripheral sensory profile (Quantitative sensory testing) 3. Change in glycemic status (Fasting blood glucose, HbA1c)Timepoint: At 8 weeks.

Countries

India

Contacts

Public ContactDr Monica Rawat

AIIMS

drakanksha111@gmail.com8377933797

Outcome results

None listed

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