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

NCT07382856 | Active Not Recruiting DMC

• 1 other identifier: PAT1D2025
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief 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

Type 1 Diabetes

Keywords

Type 1 diabetes; Heart rate variability; Low-intensity physical activity

Outcome Measures

Primary Outcomes (1)

• Change in Heart Rate Variability (HRV) parameters.

  Assessment of HRV as a marker for Cardiovascular Autonomic Neuropathy (CAN). The measurement tool is a 24-hour Holter ECG monitor. Specific parameters include the Standard Deviation of NN intervals (SDNN) and Root Mean Square of Successive Differences (RMSSD). Unit of Measure: Milliseconds (ms).

  Twelve months from the baseline.

Secondary Outcomes (3)

• Change in Peak Oxygen Consumption (VO2 peak)

  Six months from the baseline.

• Change in Time in Range (TIR).

  Six and twelve months from the baseline.

• Change in Urine Albumin-to-Creatinine Ratio (UACR).

  Six months from the baseline.

Study Arms (2)

Experimental group

EXPERIMENTAL

The exercise group will consist of patients with type 1 diabetes who will perform low-intensity physical activity in the postprandial period five days per week over a one-year observation period.

Behavioral: low-intensity physical activity; Other: Intensive insulin therapy

Control group

ACTIVE COMPARATOR

Type 1 diabetes patients characterized by a sedentary lifestyle, defined as engaging in low-intensity physical activity less than five days per week.

Other: Intensive insulin therapy

Interventions

low-intensity physical activity BEHAVIORAL

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.

Experimental group

Intensive insulin therapy OTHER

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).

Control group; Experimental group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Diagnosis of Type 1Diabetes at least six months prior to study enrollment
• Male or female patients over 18 years
• Willingness to perform physical activity 5 days/week.
• Absence of heavy, chronic microvascular complications.
• Absence of established Cardiovascular neuropathy.
• Absence of established ASCVD.

You may not qualify if:

• Type 2 Diabetes
• Active engagement in professional sports
• Limb amputation
• Blindness
• Active malignancy

Sponsors & Collaborators

• University of Banja Luka: lead

Study Sites (1)

University Clinical Centre of the Republic of Srpska

Banja Luka, 78000, Bosnia and Herzegovina

Location

Related Publications (22)

• Alarcon-Gomez J, Chulvi-Medrano I, Martin-Rivera F, Calatayud J. Effect of High-Intensity Interval Training on Quality of Life, Sleep Quality, Exercise Motivation and Enjoyment in Sedentary People with Type 1 Diabetes Mellitus. Int J Environ Res Public Health. 2021 Nov 30;18(23):12612. doi: 10.3390/ijerph182312612.

  PMID: 34886337 BACKGROUND

• Bekker I,Kooistra A,van Dijk PR,Lefrandt JD,Veeger NJGM,van Beek AP

  BACKGROUND

• Wilson LC, Peebles KC, Hoye NA, Manning P, Sheat C, Williams MJA, Wilkins GT, Wilson GA, Baldi JC. Resting heart rate variability and exercise capacity in Type 1 diabetes. Physiol Rep. 2017 Apr;5(8):e13248. doi: 10.14814/phy2.13248.

  PMID: 28420762 BACKGROUND

• Moser O, Zaharieva D, Adolfsson P, Battelino T, Bracken RM, Buckingham BA, Danne T, Davis EA, Dovc K, Forlenza GP, Gillard P, Hofer SE, Hovorka R, Jacobs PJ, Mader JK, Mathieu C, Norgaard K, Oliver NS, O'Neal DN, Pemberton J, Rabasa-Lhoret R, Sherr JL, Sourij H, Tauschmann M, Yardley JE, Riddell MC. The Use of Automated Insulin Delivery around Physical Activity and Exercise in Type 1 Diabetes: A Position Statement of the European Association for the Study of Diabetes (EASD) and the International Society for Pediatric and Adolescent Diabetes (ISPAD). Horm Res Paediatr. 2024 Dec 10:1-28. doi: 10.1159/000542287. Online ahead of print.

  PMID: 39657609 BACKGROUND

• Riddell MC, Li Z, Gal RL, Calhoun P, Jacobs PG, Clements MA, Martin CK, Doyle Iii FJ, Patton SR, Castle JR, Gillingham MB, Beck RW, Rickels MR; T1DEXI Study Group. Examining the Acute Glycemic Effects of Different Types of Structured Exercise Sessions in Type 1 Diabetes in a Real-World Setting: The Type 1 Diabetes and Exercise Initiative (T1DEXI). Diabetes Care. 2023 Apr 1;46(4):704-713. doi: 10.2337/dc22-1721.

  PMID: 36795053 BACKGROUND

• Riddell MC, Peters AL. Exercise in adults with type 1 diabetes mellitus. Nat Rev Endocrinol. 2023 Feb;19(2):98-111. doi: 10.1038/s41574-022-00756-6. Epub 2022 Oct 31.

  PMID: 36316391 BACKGROUND

• Moser O, Zaharieva DP, Adolfsson P, Battelino T, Bracken RM, Buckingham BA, Danne T, Davis EA, Dovc K, Forlenza GP, Gillard P, Hofer SE, Hovorka R, Jacobs PG, Mader JK, Mathieu C, Norgaard K, Oliver NS, O'Neal DN, Pemberton J, Rabasa-Lhoret R, Sherr JL, Sourij H, Tauschmann M, Yardley JE, Riddell MC. The use of automated insulin delivery around physical activity and exercise in type 1 diabetes: a position statement of the European Association for the Study of Diabetes (EASD) and the International Society for Pediatric and Adolescent Diabetes (ISPAD). Diabetologia. 2025 Feb;68(2):255-280. doi: 10.1007/s00125-024-06308-z.

  PMID: 39653802 BACKGROUND

• Colberg SR, Sigal RJ, Yardley JE, Riddell MC, Dunstan DW, Dempsey PC, Horton ES, Castorino K, Tate DF. Physical Activity/Exercise and Diabetes: A Position Statement of the American Diabetes Association. Diabetes Care. 2016 Nov;39(11):2065-2079. doi: 10.2337/dc16-1728. No abstract available.

  PMID: 27926890 BACKGROUND

• Maran A, Pavan P, Bonsembiante B, Brugin E, Ermolao A, Avogaro A, Zaccaria M. Continuous glucose monitoring reveals delayed nocturnal hypoglycemia after intermittent high-intensity exercise in nontrained patients with type 1 diabetes. Diabetes Technol Ther. 2010 Oct;12(10):763-8. doi: 10.1089/dia.2010.0038.

  PMID: 20807120 BACKGROUND

• Yardley JE, Sigal RJ, Kenny GP, Riddell MC, Lovblom LE, Perkins BA. Point accuracy of interstitial continuous glucose monitoring during exercise in type 1 diabetes. Diabetes Technol Ther. 2013 Jan;15(1):46-9. doi: 10.1089/dia.2012.0182. Epub 2012 Nov 8.

  PMID: 23137050 BACKGROUND

• Tikkanen-Dolenc H, Waden J, Forsblom C, Harjutsalo V, Thorn LM, Saraheimo M, Elonen N, Rosengard-Barlund M, Gordin D, Tikkanen HO, Groop PH; FinnDiane Study Group. Frequent and intensive physical activity reduces risk of cardiovascular events in type 1 diabetes. Diabetologia. 2017 Mar;60(3):574-580. doi: 10.1007/s00125-016-4189-8. Epub 2016 Dec 24.

  PMID: 28013340 BACKGROUND

• Zebrowska A, Hall B, Kochanska-Dziurowicz A, Janikowska G. The effect of high intensity physical exercise and hypoxia on glycemia, angiogenic biomarkers and cardiorespiratory function in patients with type 1 diabetes. Adv Clin Exp Med. 2018 Feb;27(2):207-216. doi: 10.17219/acem/66354.

  PMID: 29521064 BACKGROUND

• Rahbar S, Naimi SS, Reza Soltani A, Rahimi A, Akbarzadeh Baghban A, Khorami N. Are Twenty-Four Sessions of Aerobic Exercise Sufficient for Improving Cardiac Parameters in Diabetes Mellitus? A Randomized Controlled Trial. J Tehran Heart Cent. 2018 Apr;13(2):43-51.

  PMID: 30483312 BACKGROUND

• de Moraes R, Van Bavel D, Gomes MB, Tibirica E. Effects of non-supervised low intensity aerobic excise training on the microvascular endothelial function of patients with type 1 diabetes: a non-pharmacological interventional study. BMC Cardiovasc Disord. 2016 Jan 27;16:23. doi: 10.1186/s12872-016-0191-9.

  PMID: 26817606 BACKGROUND

• Valletta JJ, Chipperfield AJ, Clough GF, Byrne CD. Daily energy expenditure, cardiorespiratory fitness and glycaemic control in people with type 1 diabetes. PLoS One. 2014 May 14;9(5):e97534. doi: 10.1371/journal.pone.0097534. eCollection 2014.

  PMID: 24826899 BACKGROUND

• Serhiyenko VA, Serhiyenko AA. Cardiac autonomic neuropathy: Risk factors, diagnosis and treatment. World J Diabetes. 2018 Jan 15;9(1):1-24. doi: 10.4239/wjd.v9.i1.1.

  PMID: 29359025 BACKGROUND

• Rohling M, Strom A, Bonhof GJ, Roden M, Ziegler D. Cardiorespiratory Fitness and Cardiac Autonomic Function in Diabetes. Curr Diab Rep. 2017 Oct 23;17(12):125. doi: 10.1007/s11892-017-0959-z.

  PMID: 29063207 BACKGROUND

• Nystoriak MA, Bhatnagar A. Cardiovascular Effects and Benefits of Exercise. Front Cardiovasc Med. 2018 Sep 28;5:135. doi: 10.3389/fcvm.2018.00135. eCollection 2018.

  PMID: 30324108 BACKGROUND

• Bohn B, Herbst A, Pfeifer M, Krakow D, Zimny S, Kopp F, Melmer A, Steinacker JM, Holl RW; DPV Initiative. Impact of Physical Activity on Glycemic Control and Prevalence of Cardiovascular Risk Factors in Adults With Type 1 Diabetes: A Cross-sectional Multicenter Study of 18,028 Patients. Diabetes Care. 2015 Aug;38(8):1536-43. doi: 10.2337/dc15-0030. Epub 2015 May 26.

  PMID: 26015557 BACKGROUND

• Adu-Sarkodie NY. Clinical Management of Diabetes Mellitus in the Older Adult Patient. Curr Diabetes Rev. 2017;13(3):225-238. doi: 10.2174/1573399812666161206151706.

  PMID: 27924723 BACKGROUND

• Pedersen BK, Saltin B. Exercise as medicine - evidence for prescribing exercise as therapy in 26 different chronic diseases. Scand J Med Sci Sports. 2015 Dec;25 Suppl 3:1-72. doi: 10.1111/sms.12581.

  PMID: 26606383 BACKGROUND

• Pedersen BK. Which type of exercise keeps you young? Curr Opin Clin Nutr Metab Care. 2019 Mar;22(2):167-173. doi: 10.1097/MCO.0000000000000546.

  PMID: 30640736 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 7, 2026
• First Posted: February 3, 2026
• Study Start: February 22, 2024
• Primary Completion: February 22, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: April 16, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data will be available beginning six month following publication of the final study results and will be available for up to three years.
• Access Criteria: Data request should be submitted to the Principal Investigator. Data requestors will need to sign a data access agreement and provide a scientifically sound research proposal.

Locations

BO (1)