CI

At a glance

ClinicalIndex Comparison Record
N/AActive· 35 enrolled
Drug / intervention
low-intensity physical activity +1 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT07382856
NCT07382856N/AActive

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

University of Banja Luka·interventional·Posted Feb 3, 2026·Updated Apr 16, 2026

In Brief

A clinical study evaluating low-intensity physical activity and Intensive insulin therapy for Type 1 Diabetes. Active but no longer recruiting, targeting 35 participants across 1 site.

Detailed 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 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsType 1 Diabetes
CountriesBosnia and Herzegovina
Collaborators--

Timeline

N/AActiveOverdue
20252026
First PostedFeb 3, 2026
Enrollment StartFeb 22, 2024
Primary CompletionFeb 22, 2026
Study CompletionJun 1, 2026
TodayJul 2, 2026
Enrollment to primary: 2 yearsPosted 5 months ago

Interventions

low-intensity physical activitybehavioral

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.

Intensive insulin therapyother

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).