DiabetesNCT06724744
Manual Diaphragmatic Release on Ventilatory Functions in Elderly Diabetic Women
A study testing Aerobic training and Manual Diaphragm Release in people with Diabetes and Elderly, run by Cairo University at 1 site in Egypt.
Trial summary
Evaluate the effect of manual diaphragmatic release on ventilatory functions and functional capacity in elderly diabetic women. Read more about this study
- Who is it for?
- Ages 65 to 70 years, women only
- What is being tested?
- Aerobic training and Manual Diaphragm Release
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Sep 2024to 10 Feb 2025
- 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 65 to 70 years
- Women only
- No healthy volunteers
- Older adult
Who may be able to join
- Type 2 diabetic for more than 5 years.
- Well controlled diabetes with glycated hemoglobin≤7%.
- Normal to mild ventilatory functions impairment.
- Their ages ranges from 65 to 70 years old.
- Their body mass index are less than 30 Kg/m2.
Who cannot join
- Other types of diabetes.
- Patients with any other chronic chest diseases .
- Cardiovascular disorders (coronary heart disease, heart failure, cardiac arrhythmia, peripheral arterial disease, uncontrolled hypertension).
- Smokers.
- Rheumatoid arthritis.
- Musculoskeletal/ neurological limitations to exercise.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Mohammed Sayed Saif, Ph.D contact
Egypt1 site, 1 recruiting
- Recruiting
Endocrinology outpatient clinic at Mansoura University
Al Mansurah, Dakahlya, 11831
Hossam Arafa Ghazi, PhD, 00201281064314, selgayar@meu.edu.jo
About this study
Official title: Effect of Manual Diaphragmatic Release on Ventilatory Functions and Functional Capacity in Elderly Diabetic Women
Evaluate the effect of manual diaphragmatic release on ventilatory functions and functional capacity in elderly diabetic women.
Read the detailed description
Sixty elderly type 2 diabetic women were sourced from the endocrinology outpatient clinic at Mansoura University hospitals in Egypt, with referrals from endocrinologists. Patients were randomly assigned into two groups.
The study group includes 30 women participating in manual diaphragmatic release plus aerobic training for 12 weeks, while the control group includes 30 women participating in aerobic training only for 12 weeks. At baseline and poststudy, the following outcomes are assessed:
- Ventilatory functions (Forced vital capacity and forced expiratory volume in the first second).
- Functional capacity using modified Bruce treadmill incremental exercise test (Maximal oxygen consumption estimation).
- Being tested
- Aerobic training, Manual Diaphragm Release
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerobic trainingOther
For twelve weeks, the women participate in aerobic training on cycle ergometer. Each session consists of 30-45 minutes of cycling at a moderate intensity, accompanied by a workout heart rate ranging from 65% to 75% of the maximal heart rate and ranging between 12 and 14 on the Borg rating of perceived exertion 20-point scale. After ten minutes of warm-up, every session ends with a brief 3-minute period of cool-down.
Manual Diaphragm ReleaseOther
The participant is asked assume a supine position with relaxed limbs. The therapist should position themselves at the head of the participant and make manual contact with the pisiform, hypothenar region, and the last three fingers on both sides, underneath the seventh to tenth rib costal cartilages. The therapist's forearms should be aligned towards the participant's shoulders. During the inspiratory phase, the therapist gently pulled the points of contact with both hands in the direction of the head and slightly laterally, accompanying the elevation of the ribs. Therapist progressively increases the depth of their contact within the costal margin.
| Study group | Role | What they receive |
|---|---|---|
| Manual diaphragmatic release group | Active comparator | 30 elderly diabetic women participating in manual diaphragmatic release plus aerobic training Receives: Other: Aerobic training; Other: Manual Diaphragm Release |
| Control group | Active comparator | 30 elderly diabetic women participating in aerobic training only Receives: Other: Aerobic training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ventilatory functions
Ventilatory function parameters, including forced vital capacity and forced expiratory volume in the first second are measured by experienced technicians at baseline and after 12 weeks in all groups using the Medgraphics pulmonary function testing system (Breezesuite Ultima PFX, Milano, Italy) in strict adherence to the guidelines outlined in the user manual.
Measured: At baseline and after 12 weeks
Secondary outcomes (1)
Functional capacity
Cardiopulmonary exercise test will be conducted for all women at baseline and post-study based on the guidelines set by the American College of Sports Medicine to determine maximal oxygen consumption for each women.
Measured: At baseline and after 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2024
- Study start15 Sep 2024
- Primary completion1 Feb 2025 (estimated)
- Study completion10 Feb 2025 (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 Cairo 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Saad, Cairo University
- Investigators
- Saher Lotfy Elgayar, Ph.D, Study director, Department of Physiotherapy Faculty of Allied Medical Sciences Middle East University Amman Jordan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06724744
- Sponsor's protocol ID
- Manual Diaphragmatic Release
- Status last verified
- Dec 2024
- First submitted
- 5 Dec 2024
- Last updated
- 9 Dec 2024
- 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 9 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Manual Diaphragmatic Release on Ventilatory Functions and Functional Capacity in Elderly Diabetic Women
- ClinicalTrials.gov ID
- NCT06724744
- Acronym / sponsor ID
- Manual Diaphragmatic Release
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 15 Sep 2024 (actual)
- Primary completion
- 1 Feb 2025 (estimated)
- Study completion
- 10 Feb 2025 (estimated)
- First posted
- 9 Dec 2024 (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.
Evaluate the effect of manual diaphragmatic release on ventilatory functions and functional capacity in elderly diabetic women.
Detailed description
Sixty elderly type 2 diabetic women were sourced from the endocrinology outpatient clinic at Mansoura University hospitals in Egypt, with referrals from endocrinologists. Patients were randomly assigned into two groups.
The study group includes 30 women participating in manual diaphragmatic release plus aerobic training for 12 weeks, while the control group includes 30 women participating in aerobic training only for 12 weeks. At baseline and poststudy, the following outcomes are assessed:
- Ventilatory functions (Forced vital capacity and forced expiratory volume in the first second).
- Functional capacity using modified Bruce treadmill incremental exercise test (Maximal oxygen consumption estimation).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Manual diaphragmatic release group | Active comparator | Other: Aerobic training, Other: Manual Diaphragm Release30 elderly diabetic women participating in manual diaphragmatic release plus aerobic training |
| Control group | Active comparator | Other: Aerobic training30 elderly diabetic women participating in aerobic training only |
Who may qualify
- Ages
- 65 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- Type 2 diabetic for more than 5 years.
- Well controlled diabetes with glycated hemoglobin≤7%.
- Normal to mild ventilatory functions impairment.
- Their ages ranges from 65 to 70 years old.
- Their body mass index are less than 30 Kg/m2.
Key exclusion criteria (6 listed)
- Other types of diabetes.
- Patients with any other chronic chest diseases .
- Cardiovascular disorders (coronary heart disease, heart failure, cardiac arrhythmia, peripheral arterial disease, uncontrolled hypertension).
- Smokers.
- Rheumatoid arthritis.
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 |
|---|---|---|
| Aerobic trainingFor twelve weeks, the women participate in aerobic training on cycle ergometer. Each session consists of 30-45 minutes of cycling at a moderate intensity, accompanied by a workout heart rate ranging from 65% to 75% of the maximal heart rate and ranging between 12 and 14 on the Borg rating of perceived exertion 20-point scale. After ten minutes of warm-up, every session ends with a brief 3-minute period of cool-down. | Other | Control group, Manual diaphragmatic release group |
| Manual Diaphragm ReleaseThe participant is asked assume a supine position with relaxed limbs. The therapist should position themselves at the head of the participant and make manual contact with the pisiform, hypothenar region, and the last three fingers on both sides, underneath the seventh to tenth rib costal cartilages. The therapist's forearms should be aligned towards the participant's shoulders. During the inspiratory phase, the therapist gently pulled the points of contact with both hands in the direction of the head and slightly laterally, accompanying the elevation of the ribs. Therapist progressively increases the depth of their contact within the costal margin. | Other | Manual diaphragmatic release group |
Primary outcome
Ventilatory functions
Time frame: At baseline and after 12 weeks
Ventilatory function parameters, including forced vital capacity and forced expiratory volume in the first second are measured by experienced technicians at baseline and after 12 weeks in all groups using the Medgraphics pulmonary function testing system (Breezesuite Ultima PFX, Milano, Italy) in strict adherence to the guidelines outlined in the user manual.
1 secondary outcome
Functional capacity
Time frame: At baseline and after 12 weeks
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 9 Dec 2024.
- Individual participant dataSharing planned: No
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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.
Mohammed Sayed Saif, Ph.D contact
Saher Lotfy Elgayar, Ph.D study director
Department of Physiotherapy Faculty of Allied Medical Sciences Middle East University Amman Jordan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aerobic training and Manual Diaphragm Release in people with Diabetes and Elderly, run by Cairo 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 5 inclusion and 6 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 9 Dec 2024. 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 Saad Mohamed Elgendy, Ph.D (+201020429911, saherelgayar@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ventilatory functions (time frame: At baseline and after 12 weeks). 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 9 Dec 2024.