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

NCT07382856 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2026-04-16

No results posted yet for this study

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.

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).

Sponsors & Collaborators

  • University of Banja Luka

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-02-22
Primary Completion
2026-02-22
Completion
2026-06-30

Countries

  • Bosnia and Herzegovina

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07382856 on ClinicalTrials.gov