Manual Diaphragmatic Release Technique on Exercise Capacity and Sleep Quality

Not Applicable

Recruiting

• Conditions: Diabetes

• Registration Number: NCT06880783
• Lead Sponsor: Beni-Suef University

Brief Summary

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.

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 Timeline

• Status Verified: 2025-03
• Study First Submitted: 2025-03-12
• Study First Submitted QC: 2025-03-12
• Study First Posted: 2025-03-18
• Study Start: 2025-03-30
• Last Update Submitted: 2025-04-11
• Last Update Posted: 2025-04-15
• Primary Completion: 2026-06
• Study Completion: 2026-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 44

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
6-minute walk test	up to 6 weeks	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.
Pittsburgh Sleep Quality Index (PSQI)	up to 6 weeks	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

Trial Locations

Locations (1)

Beni suef hospital; 🇪🇬 Banī Suwayf, Egypt