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Clinical Trials/CTRI/2023/11/060077
CTRI/2023/11/060077Not yet recruitingPhase 4

Effect of exercise training on cardiac autonomic function and left ventricular mass index in type 2 diabetes mellitus with cardiac autonomic neuropathy

Human Resource Development Group- Council of Scientific Research1 site in 1 country84 target enrollmentStarted: December 1, 2023Last updated:

Trial Snapshot

Phase
Phase 4
Status
Not yet recruiting
Sponsor
Enrollment
84
Locations
1
Primary Endpoint
Cardiac autonomic function and left ventricular mass index

Study Overview

Brief Summary

The study is randomized controlled trial in individuals with type 2 diabetes mellitus with cardiac autonomic neuropathy, between ages 40 to 65 years of any gender. Participants with type 2 diabetes mellitus will be screened for cardiac autonomic neuropathy (CAN) using Cardiac Autonomic Reflex Tests (Ewing’s battery of 5 tests). Participants falling in the inclusion will be informed about the study and written informed consent will be taken. Baseline assessments of cardiac autonomic function (using cardiac autonomic reflex tests) left ventricular mass index (2D Echocardiography), heart rate variability, glycemic parameters, functional capacity (6-minute walk test) and quality of life (WHO QOL-BREF Questionnaire).  Participants will be randomized into intervention group (Standard care, routine physical activity education, exercise training) and control group (Standard care and routine physical activity education). The intervention will be for the duration of 12 weeks- consisting of aerobic, resistance and flexibility exercises. First 2 weeks of intervention will be supervised followed by a virtually supervised exercise program (using a validated digital application). After 12 weeks, cardiac autonomic function, heart rate variability, functional capacity and quality of life will be assessed in all participants. At 24th week (maintenance phase), all outcomes assessed at baseline will be reassessed in all participants.

Study Design

Study Type
Interventional
Allocation
Randomized
Masking
Participant Blinded

Eligibility Criteria

Ages
40.00 Year(s) to 65.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • Individuals with type 2 diabetes mellitus with cardiac autonomic neuropathy.

Exclusion Criteria

  • Type 1 diabetes mellitus, gestational diabetes mellitus and other genetic forms.
  • Presence of underlying conditions- Rheumatic heart disease, recent myocardial infarction, coronary artery bypass graft, heart failure, abdominal surgery in past 3 months, end stage renal disease, acute kidney injury, diabetic foot ulcers, severe systemic disease, any systemic neuromuscular disorder, any orthopedic surgery in past 6 months or injury limiting participation in exercise.

Outcomes

Primary Outcomes

Cardiac autonomic function and left ventricular mass index

Time Frame: Cardiac autonomic function at 3 time points- baseline, 12th week and 24th week | left ventricular mass index at 2 time points- baseline and 24th week

Secondary Outcomes

  • Heart rate variability, glycemic parameters, functional capacity, quality of life(Heart rate variability, functional capacity, quality of life at 3 timepoints- baseline, 12th week and 24th week)

Investigators

Sponsor
Human Resource Development Group- Council of Scientific Research
Sponsor Class
Government funding agency
Responsible Party
Principal Investigator
Principal Investigator

Sohini Shailesh Raje

Manipal Academy of Higher Education

Study Sites (1)

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