Effect of Low-intensity Aerobic Regular Activity on Heart Rate Variability in Type 1 Diabetes

A monocentric prospective randomized trial included 35 patients with Type 1 diabetes. Participants were randomized into two groups: Group A with the patients who engaged in low-intensity physical activity matching aerobic threshold five days per week over a one-year observation period and Group B with the patients who engaged in physical activity less than five days per week. The study included three clinical visits: at baseline, at six months, and at one year. Assessments included cardiopulmonary exercise testing (CPET) and body composition analysis during the baseline visit and at six-month visit, while 24-hour Holter monitoring was conducted at baseline and at the final visit. Biochemical parameters and microvascular complication risk assessments were performed at every visit.

NCT Number	NCT07382856
Lead Sponsor	University of Banja Luka
Conditions	Type 1 Diabetes
Enrollment	35 participants
Start Date	2024-02-22
Primary Completion	2026-02-22 (estimated)
Study Completion	2026-06 (estimated)
Updated on ClinicalTrials.gov	2026-04-16