Manual Diaphragmatic Release Technique on Exercise Capacity and Sleep Quality

NCT ID: NCT06880783

Last Updated: 2025-04-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-03-30

Study Completion Date

2026-10-31

Brief Summary

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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

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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.

Conditions

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Diabetes

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Study Group

Participants will receive manual diaphragm release technique combined with deep breathing exercises

Group Type ACTIVE_COMPARATOR

manual diaphragm release technique

Intervention Type 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

Intervention Type 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.

Control group

Participants will receive deep breathing exercises

Group Type ACTIVE_COMPARATOR

deep breathing exercises

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

55 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Beni-Suef University

OTHER

Sponsor Role lead

Responsible Party

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Mohammed Youssef Elhamrawy

Lecturer of Physical therapy

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Beni suef hospital

Banī Suwayf, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Mohammed Yo Elhamrawy, Ph.D

Role: CONTACT

+201282805567

Facility Contacts

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Mohammed YO Elhamrawy, PHD

Role: primary

Other Identifiers

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Diabetes and Sleep Quality

Identifier Type: -

Identifier Source: org_study_id

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