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NCT Number: NCT06880783

Manual Diaphragmatic Release Technique on Exercise Capacity and Sleep Quality

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.

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Key information

Conditions

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

Age range

55 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Beni suef hospital

Banī Suwayf, 62511, Egypt

Location status: Recruiting

Location contact

Mohammed YO Elhamrawy, PHD

CONTACT

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

manual diaphragm release technique

Other

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.

Deep breathing exercises

Other

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.

Primary outcomes

  1. 6-minute walk test

    Time frame: 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.

  2. Pittsburgh Sleep Quality Index (PSQI)

    Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

Mohammed Yo Elhamrawy, Ph.D

CONTACT

[email protected]

+201282805567

Sponsors and collaborators

Lead sponsor

Beni-Suef University

Other

Registry information

Official study title

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

Acronym: DM and sleep

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Mar 18, 2025
Registry last updated
Apr 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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