DiabetesDM and sleepNCT06880783
Manual Diaphragmatic Release Technique on Exercise Capacity and Sleep Quality
A study testing manual diaphragm release technique and deep breathing exercises in people with Diabetes, run by Beni-Suef University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 55 to 80 years
- Conditions the study is for
- Diabetes
- What is being tested?
- manual diaphragm release technique and deep breathing exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteEgypt
- Study dates
- 30 Mar 2025to Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Beni suef hospital
Banī Suwayf, 62511
Mohammed YO Elhamrawy, PHD
About this study
Official title: 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.
Read the 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.
- Conditions
- Diabetes
- Being tested
- manual diaphragm release technique, deep breathing exercises
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
manual diaphragm release techniqueOther
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 exercisesOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Study Group | Active comparator | Participants will receive manual diaphragm release technique combined with deep breathing exercises Receives: Other: manual diaphragm release technique; Other: deep breathing exercises |
| Control group | Active comparator | Participants will receive deep breathing exercises Receives: Other: deep breathing exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: up to 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2025
- Study start30 Mar 2025
- Primary completionJun 2026 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies of the same condition, open and under way.
- More trials run by Beni-Suef UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beni-Suef University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammed Youssef Elhamrawy, Beni-Suef University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06880783
- Sponsor's protocol ID
- Diabetes and Sleep Quality
- Acronym
- DM and sleep
- Status last verified
- Mar 2025
- First submitted
- 12 Mar 2025
- Last updated
- 15 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Manual Diaphragmatic Release Technique on Exercise Capacity and Sleep Quality in Older Adults With Type II Diabetes: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06880783
- Acronym / sponsor ID
- DM and sleep / Diabetes and Sleep Quality
- Conditions
- Diabetes
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Beni-Suef UniversityUniversity, hospital or other
- Study start
- 30 Mar 2025 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 18 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study Group | Active comparator | Other: manual diaphragm release technique, Other: deep breathing exercisesParticipants will receive manual diaphragm release technique combined with deep breathing exercises |
| Control group | Active comparator | Other: deep breathing exercisesParticipants will receive deep breathing exercises |
Who may qualify
- Ages
- 55 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| manual diaphragm release techniqueThe 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 | Study Group |
| deep breathing exercisesParticipants 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. | Other | Control group, Study Group |
Primary outcome
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.
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2025.
- Individual participant dataSharing planned: No
Related trials for Diabetes
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Effects of Lean Pork Loin Intake on Protein Homeostasis and Glucose Regulation in Prediabetic Adults
Hyperglycaemia (Non Diabetic), Prediabetes
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing manual diaphragm release technique and deep breathing exercises in people with Diabetes, run by Beni-Suef University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mohammed Yo Elhamrawy, Ph.D (+201282805567, dr_melhamrawy@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
6-minute walk test (time frame: up to 6 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2025.