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ACTIVE NOT RECRUITING
NCT07382856
NA

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

Sponsor: University of Banja Luka

View on ClinicalTrials.gov

Summary

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 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 cyclo-ergometry 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.

Key Details

Gender

All

Age Range

18 Years - 60 Years

Study Type

INTERVENTIONAL

Enrollment

35

Start Date

2024-02-22

Completion Date

2026-06

Last Updated

2026-02-03

Healthy Volunteers

No

Conditions

Interventions

BEHAVIORAL

low-intensity physical activity

The exercise intervention consists of low-intensity physical activity (brisk walking) lasting 30-60 minutes, performed five times weekly. Participants will maintain a workload corresponding to Training Zone 2 over the course of the one-year follow-up.

OTHER

Intensive insulin therapy

The patients with diabetes type 1 in Control group will be physical active (low-intensity physical activity) less than five days per week (not exceeding 30 minutes per activity).

Locations (1)

University Clinical Centre of the Republic of Srpska

Banja Luka, Bosnia and Herzegovina