Manual Diaphragmatic Release Technique on Exercise Capacity and Sleep Quality (DM and sleep)

Effect of Manual Diaphragmatic Release Technique on Exercise Capacity and Sleep Quality in Older Adults With Type II Diabetes: a Randomized Controlled Trial

To investigate if there is a significant effect of manual diaphragmatic release technique on exercise capacity, sleep quality, chest expansion, ADL, fatigue and quality of life in older adults with type II diabetes.

Study Overview

• Status: Recruiting
• Conditions: Diabetes
• Intervention / Treatment: Other: manual diaphragm release technique; Other: deep breathing exercises

Detailed Description

Participants, including both genders, will have a history of Diabetes Type II for more than one year. They will be well controlled with HbA1c≤7. Patients will be aged from 55 years and above and had a body mass index less than 30 kg/m². Patients will follow up on the training program and instructions. They will be medically stable.

• Study Type: Interventional
• Enrollment (Estimated): 44
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mohammed Yo Elhamrawy, Ph.D; Phone Number: +201282805567; Email: dr_melhamrawy@yahoo.com

Study Locations

• Egypt
  • Banī Suwayf, Egypt, 62511
    • Recruiting
    • Beni suef hospital
    • Contact: Mohammed YO Elhamrawy, PHD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• History of Diabetes Type II for more than one year.
• They will be well controlled with HbA1c≤7.
• Patients will be aged from 55 years and above and had a body mass index less than 30 kg/m².
• Patients will follow up on the training program and instructions. They will be medically stable.

Exclusion Criteria:

• Chest diseases.
• Diaphragmatic hernia, clinical evidence of phrenic nerve injury, recent abdominal or thoracic surgery, or history of traumatic lesion possibly affecting diaphragm.
• History of Myocardial infarction and/or cardiothoracic surgery
• Unstable medical status.
• Cognitive disability hindering responding to the questionnaires.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Study Group; Participants will receive manual diaphragm release technique combined with deep breathing exercises	Other: manual diaphragm release technique; The participant should be supine with relaxed limbs, and the therapist should position themselves at the head, making manual contact with the pisiform, hypothenar region, and fingers. The therapist should gently pull the contact towards the head, deepen it during exhalation, and gradually increase the depth.; Other: deep breathing exercises; Participants in a crook laying position are instructed to inhale through the nose, lift the abdomen, and let out through the mouth, breathing six breaths per minute for 30 minutes.
Active Comparator: Control group; Participants will receive deep breathing exercises	Other: deep breathing exercises; Participants in a crook laying position are instructed to inhale through the nose, lift the abdomen, and let out through the mouth, breathing six breaths per minute for 30 minutes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
6-minute walk test	The 6 Minute Walk Test is a sub-maximal exercise test used to assess aerobic capacity and endurance. The distance covered over a time of 6 minutes is used as the outcome by which to compare changes in performance capacity.	up to 6 weeks
Pittsburgh Sleep Quality Index (PSQI)	The Pittsburgh Sleep Quality Index (PSQI) is a self-report questionnaire that assesses sleep quality over a 1-month time interval. The measure consists of 19 individual items, creating 7 components that produce one global score, and takes 5-10 minutes to complete	up to 6 weeks

Collaborators and Investigators

• Sponsor: Beni-Suef University

Study record dates

Study Major Dates

• Study Start (Actual): March 30, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): October 1, 2026

Study Registration Dates

• First Submitted: March 12, 2025
• First Submitted That Met QC Criteria: March 12, 2025
• First Posted (Actual): March 18, 2025

Study Record Updates

• Last Update Posted (Actual): April 15, 2025
• Last Update Submitted That Met QC Criteria: April 11, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: Diabetes and Sleep Quality

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No