Sickle Cell DiseaseNCT06757829
Pulmonary Functions in Sickle Cell Disease: Response to Acu-TENS
A study testing inspiratory muscle training and acupucnture like transcutanoeus electrical nerve stimulation and inspiratory muscle training in people with Sickle Cell Disease, run by Cairo University at 1 site in Egypt.
Trial summary
pulmonary complications are common in sickle cell disease patients. Respiratory training using inspiratory muscle trainer (IMT) is usually a good choice to improve these complications. Recently, acupuncture like transcutaneous electrical nerve stimulation (AC-tens) may also improve these complications. Read more about this study
- Who is it for?
- Ages 20 to 50 years
- Conditions the study is for
- Sickle Cell Disease
- What is being tested?
- inspiratory muscle training and acupucnture like transcutanoeus electrical nerve stimulation and inspiratory muscle training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Dec 2024to 1 May 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 20 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- sickle cell disease patients
- non obese patients
Who cannot join
- patients with any systemic or chest or renal or hepatic or neurological diseases
- women with lactation or pregnancy
- patients atacks of vasoocclusive crisis
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
faculty of physical therapy Cairo university
Dokki, Giza Governorate
Ali Ismail, lecturer, +201005154209, ali.mohamed@pt.cu.edu.eg
Ali MA Ismail, Lecturer
About this study
Official title: Pulmonary Functions in Sickle Cell Disease: Response of Adding Acu-TENS to Inspiratory Muscle Training
pulmonary complications are common in sickle cell disease patients. Respiratory training using inspiratory muscle trainer (IMT) is usually a good choice to improve these complications. Recently, acupuncture like transcutaneous electrical nerve stimulation (AC-tens) may also improve these complications.
Read the detailed description
sickle cell disease patients whose number will be forty patients will be divided to group I who will trained with IMT (threshold inspiratory muscle training) and treated with AC-tens (the number of patients will be 20) or group II who will trained with IMT (the number of patients will be 20) . The number of sessions per week will be three sessions for IMT or AC-tens for 12 weeks. the IMT will be performed for six sets of respiratory training cycles and the set will contain 10 respiratory cycles. Also the session of AC-tens will be 45 minute on bilateral Ex-B1 acupoint. the parameters of AC-tens will be four hertz and 200 microsecond pulse duration.
- Conditions
- Sickle Cell Disease
- Being tested
- inspiratory muscle training and acupucnture like transcutanoeus electrical nerve stimulation, inspiratory muscle training
- Medical subject headings
- Anemia, Sickle Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
inspiratory muscle training and acupucnture like transcutanoeus electrical nerve stimulationBehavioural
sickle cell disease patients whose number will be 20 patients will be trained with IMT (threshold inspiratory muscle training) and treated with AC-tens. The number of sessions per week will be three sessions for IMT or AC-tens for 12 weeks. the IMT will be performed for six sets of respiratory training cycles and the set will contain 10 respiratory cycles. Also the session of AC-tens will be 45 minute on bilateral Ex-B1 acupoint. the parameters of AC-tens will be four hertz and 200 microsecond pulse duration.
inspiratory muscle trainingBehavioural
sickle cell disease patients whose number will be 20 patients who will trained with IMT (threshold inspiratory muscle training). The number of sessions per week will be three sessions for IMT for 12 weeks. the IMT will be performed for six sets of respiratory training cycles and the set will contain 10 respiratory cycles.
| Study group | Role | What they receive |
|---|---|---|
| group I | Experimental | sickle cell disease patients whose number will be 20 patients will be trained with IMT (threshold inspiratory muscle training) and treated with AC-tens. The number of sessions per week will be three sessions for IMT or AC-tens for 12 weeks. the IMT will be performed for six sets of respiratory training cycles and the set will contain 10 respiratory cycles. Also the session of AC-tens will be 45 minute on bilateral Ex-B1 acupoint. the parameters of AC-tens will be four hertz and 200 microsecond pulse duration. Receives: Behavioral: inspiratory muscle training and acupucnture like transcutanoeus electrical nerve stimulation |
| Group II | Active comparator | sickle cell disease patients whose number will be 20 patients who will trained with IMT (threshold inspiratory muscle training). The number of sessions per week will be three sessions for IMT for 12 weeks. the IMT will be performed for six sets of respiratory training cycles and the set will contain 10 respiratory cycles. Receives: Behavioral: inspiratory muscle training |
What is being measured
The primary outcome is the main question the study is designed to answer.
FEV1/FVC ratio
will be measured by spirometry
Measured: it will be assessed after12 weeks
Secondary outcomes (7)
forced expiratory volume at the first second of expiration
will be measured by spirometry
Measured: it will be assessed after12 weeks
forced vital capacity
will be measured by spirometry
Measured: it will be assessed after12 weeks
six minute walk distance
it will be a measure of physical capacity
Measured: it will be assessed after12 weeks
physical summary of short form 36
it is a questionnaire measure of quality of life
Measured: it will be assessed after12 weeks
mental summary of short form 36
it is a questionnaire measure of quality of life
Measured: it will be assessed after12 weeks
right diaphragmatic excrusion
it will be assessed by ultrasonography
Measured: it will be measured after 12 weeks
left diaphragmatic excrusion
it will be assessed by ultrasonography
Measured: it will be measured 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 posted3 Jan 2025
- Study start15 Dec 2024
- Primary completion1 May 2025 (estimated)
- Study completion1 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sickle Cell DiseaseStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ali Mohamed Ali ismail, Cairo University
- Investigators
- Ali Ismail, lecturer, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06757829
- Sponsor's protocol ID
- IRB00014233-17
- Status last verified
- Dec 2024
- First submitted
- 26 Dec 2024
- Last updated
- 3 Jan 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pulmonary Functions in Sickle Cell Disease: Response of Adding Acu-TENS to Inspiratory Muscle Training
- ClinicalTrials.gov ID
- NCT06757829
- Acronym / sponsor ID
- IRB00014233-17
- Conditions
- Sickle Cell Disease
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 15 Dec 2024 (actual)
- Primary completion
- 1 May 2025 (estimated)
- Study completion
- 1 May 2025 (estimated)
- First posted
- 3 Jan 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.
pulmonary complications are common in sickle cell disease patients. Respiratory training using inspiratory muscle trainer (IMT) is usually a good choice to improve these complications. Recently, acupuncture like transcutaneous electrical nerve stimulation (AC-tens) may also improve these complications.
Detailed description
sickle cell disease patients whose number will be forty patients will be divided to group I who will trained with IMT (threshold inspiratory muscle training) and treated with AC-tens (the number of patients will be 20) or group II who will trained with IMT (the number of patients will be 20) . The number of sessions per week will be three sessions for IMT or AC-tens for 12 weeks. the IMT will be performed for six sets of respiratory training cycles and the set will contain 10 respiratory cycles. Also the session of AC-tens will be 45 minute on bilateral Ex-B1 acupoint. the parameters of AC-tens will be four hertz and 200 microsecond pulse duration.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group I | Experimental | Behavioral: inspiratory muscle training and acupucnture like transcutanoeus electrical nerve stimulationsickle cell disease patients whose number will be 20 patients will be trained with IMT (threshold inspiratory muscle training) and treated with AC-tens. The number of sessions per week will be three sessions for IMT or AC-tens for 12 weeks. the IMT will be performed for six sets of respiratory training cycles and the set will contain 10 respiratory cycles. Also the session of AC-tens will be 45 minute on bilateral Ex-B1 acupoint. the parameters of AC-tens will be four hertz and 200 microsecond pulse duration. |
| Group II | Active comparator | Behavioral: inspiratory muscle trainingsickle cell disease patients whose number will be 20 patients who will trained with IMT (threshold inspiratory muscle training). The number of sessions per week will be three sessions for IMT for 12 weeks. the IMT will be performed for six sets of respiratory training cycles and the set will contain 10 respiratory cycles. |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- sickle cell disease patients
- non obese patients
Key exclusion criteria (3 listed)
- patients with any systemic or chest or renal or hepatic or neurological diseases
- women with lactation or pregnancy
- patients atacks of vasoocclusive crisis
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 |
|---|---|---|
| inspiratory muscle training and acupucnture like transcutanoeus electrical nerve stimulationsickle cell disease patients whose number will be 20 patients will be trained with IMT (threshold inspiratory muscle training) and treated with AC-tens. The number of sessions per week will be three sessions for IMT or AC-tens for 12 weeks. the IMT will be performed for six sets of respiratory training cycles and the set will contain 10 respiratory cycles. Also the session of AC-tens will be 45 minute on bilateral Ex-B1 acupoint. the parameters of AC-tens will be four hertz and 200 microsecond pulse duration. | Behavioural | group I |
| inspiratory muscle trainingsickle cell disease patients whose number will be 20 patients who will trained with IMT (threshold inspiratory muscle training). The number of sessions per week will be three sessions for IMT for 12 weeks. the IMT will be performed for six sets of respiratory training cycles and the set will contain 10 respiratory cycles. | Behavioural | Group II |
Primary outcome
FEV1/FVC ratio
Time frame: it will be assessed after12 weeks
will be measured by spirometry
7 secondary outcomes
forced expiratory volume at the first second of expiration
Time frame: it will be assessed after12 weeks
forced vital capacity
Time frame: it will be assessed after12 weeks
six minute walk distance
Time frame: it will be assessed after12 weeks
physical summary of short form 36
Time frame: it will be assessed after12 weeks
mental summary of short form 36
Time frame: it will be assessed after12 weeks
right diaphragmatic excrusion
Time frame: it will be measured after 12 weeks
left diaphragmatic excrusion
Time frame: it will be measured 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 3 Jan 2025.
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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.
Ali Ismail, lecturer principal investigator
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing inspiratory muscle training and acupucnture like transcutanoeus electrical nerve stimulation and inspiratory muscle training in people with Sickle Cell Disease, 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 2 inclusion and 3 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 3 Jan 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 Ali Isamil, Lecturer (0201005154209, ali.mohamed@pt.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
FEV1/FVC ratio (time frame: it will be assessed after12 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 3 Jan 2025.