Nurse-Led Self-Management and Breathing Intervention in Type 2 Diabetes

NCT07847177 | Completed

• 1 other identifier: SOHAG-T2DM-HRV-23
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

Brief Summary This study evaluated the effect of a structured nurse-led home-based self-management and paced-breathing intervention on cardiovascular autonomic function and blood pressure among adults with type 2 diabetes mellitus. Participants with type 2 diabetes were randomly assigned in a 1:1 ratio to either an intervention group or a control group. The intervention included a structured home-based walking program, paced breathing at six breaths per minute, blood pressure and heart rate self-monitoring, lifestyle counseling, behavioral reinforcement, and weekly telephone follow-up by a nurse. Outcomes were assessed at baseline and at Weeks 4, 8, and 12.

Conditions

Type 2 Diabetes Mellitus; Cardiovascular Autonomic Dysfunction

Outcome Measures

Primary Outcomes (1)

• Change in Root Mean Square of Successive Differences (rMSSD) of Heart Rate Variability

  rMSSD was used as a time-domain measure of heart rate variability reflecting cardiac parasympathetic autonomic activity. Higher rMSSD values indicate greater beat-to-beat heart rate variability and stronger parasympathetic modulation. Changes in rMSSD were evaluated across the study period to determine the effect of the nurse-led home-based intervention on cardiovascular autonomic function.

  Time Frame: Baseline, Week 4, Week 8, and Week 12

Secondary Outcomes (2)

• Change in Systolic Blood Pressure

  Baseline, Week 4, Week 8, and Week 12

• Change in Low-Frequency to High-Frequency Heart Rate Variability Ratio (LF/HF)

  Baseline, Week 4, Week 8, and Week 12

Study Arms (2)

Nurse-Led Home-Based Intervention

EXPERIMENTAL

Participants assigned to the intervention group received a 12-week structured nurse-led home-based self-management program. The program included regular home-based walking, paced breathing exercises at approximately six breaths per minute, blood pressure and heart rate self-monitoring, individualized lifestyle and diabetes self-management counseling, behavioral reinforcement, and weekly telephone follow-up by a nurse.

Behavioral: Structured Nurse-Led Home-Based Self-Management and Paced-Breathing Program

Usual Care Control

NO INTERVENTION

Participants assigned to the control group continued to receive usual diabetes care and routine clinical follow-up. They did not receive the structured nurse-led home-based self-management and paced-breathing program during the 12-week study period.

Interventions

Structured Nurse-Led Home-Based Self-Management and Paced-Breathing Program BEHAVIORAL

A 12-week nurse-led home-based intervention designed to improve cardiovascular autonomic function and cardiovascular self-management among adults with type 2 diabetes mellitus. The intervention consisted of regular home-based walking, paced breathing exercises performed at approximately six breaths per minute, self-monitoring of blood pressure and heart rate, individualized education and lifestyle counseling, behavioral reinforcement, and weekly telephone follow-up by a nurse.

Nurse-Led Home-Based Intervention

Eligibility Criteria

• Age: 35 Years - 55 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Male participants aged 35-55 years.
• Documented diagnosis of type 2 diabetes mellitus for at least 1 year.
• Receiving stable pharmacological treatment for at least 3 months before enrollment.
• Clinically stable at the time of assessment.
• Willing to participate and provide written informed consent.

You may not qualify if:

• Current or previous smoking.
• Ischemic heart disease.
• Cardiac arrhythmias.
• Chronic liver disease.
• Chronic kidney disease.
• Neurological disorders unrelated to diabetes.
• Use of medications known to substantially influence autonomic nervous system function.

Sponsors & Collaborators

• Aziza Ibrahim Mohamed: lead

Study Sites (1)

Mansoura University Hospitals

Al Mansurah, Dakahlia Governorate, Egypt

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Nursing

Model Details: Participants with type 2 diabetes mellitus were randomly assigned in a 1:1 ratio to one of two parallel groups: an intervention group receiving a 12-week structured nurse-led home-based self-management and paced-breathing program, or a control group receiving usual diabetes care. Outcomes were assessed at baseline and at Weeks 4, 8, and 12.

Study Record Dates

• First Submitted: September 23, 2026
• First Posted: September 29, 2026
• Study Start: November 12, 2023
• Primary Completion: April 9, 2024
• Study Completion: June 11, 2024
• Last Updated: September 30, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)