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RecruitingNCT06757829Updated Jan 3, 2025

Pulmonary Functions in Sickle Cell Disease: Response to Acu-TENS

An interventional study of inspiratory muscle training and acupucnture like transcutanoeus electrical nerve stimulation and inspiratory muscle training in Sickle Cell Disease, sponsored by Cairo University. Recruiting at 1 site in Egypt. Open to participants aged 20 Years to 50 Years. Per ClinicalTrials.gov, last updated 2025-01-03.

Sponsored by Cairo University · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Primary completion was expected by May 2025, 1 year 5 months ago, but the record still lists the study as recruiting.
  • Started Dec 2024; still recruiting 1 year 9 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
20 Years to 50 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Sickle Cell Disease

Browse trials for

03

In context

Anemia, Sickle Cell

1,103 studies on the registry are indexed under Anemia, Sickle Cell; 235 are open to participants now.

This study's planned enrollment of 40 is close to the median of 40 across 750 interventional studies indexed under Anemia, Sickle Cell.

Browse Anemia, Sickle Cell studies →

Lead sponsor

Cairo University is the lead sponsor of 4,780 studies on the registry; 1,427 are open to participants now.

Of its 36 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • sickle cell disease patients
  • non obese patients

Exclusion criteria

Exclusion Criteria:

  • patients with any systemic or chest or renal or hepatic or neurological diseases
  • women with lactation or pregnancy
  • patients atacks of vasoocclusive crisis
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
40 participants (estimated)

Study arms

  • Experimental
    group I

    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.

    Behavioral: inspiratory muscle training and acupucnture like transcutanoeus electrical nerve stimulation

  • Active comparator
    Group II

    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.

    Behavioral: inspiratory muscle training

Interventions

  • Behavioralinspiratory muscle training and acupucnture like transcutanoeus electrical nerve stimulation

    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.

  • Behavioralinspiratory muscle training

    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.

06

What researchers measure

Primary outcomes

  1. FEV1/FVC ratio

    will be measured by spirometry

    Time frame: it will be assessed after12 weeks

Secondary outcomes

  1. forced expiratory volume at the first second of expiration

    will be measured by spirometry

    Time frame: it will be assessed after12 weeks

  2. forced vital capacity

    will be measured by spirometry

    Time frame: it will be assessed after12 weeks

  3. six minute walk distance

    it will be a measure of physical capacity

    Time frame: it will be assessed after12 weeks

  4. physical summary of short form 36

    it is a questionnaire measure of quality of life

    Time frame: it will be assessed after12 weeks

  5. mental summary of short form 36

    it is a questionnaire measure of quality of life

    Time frame: it will be assessed after12 weeks

  6. right diaphragmatic excrusion

    it will be assessed by ultrasonography

    Time frame: it will be measured after 12 weeks

  7. left diaphragmatic excrusion

    it will be assessed by ultrasonography

    Time frame: it will be measured after 12 weeks

07

Study locations

1 of 1 sites recruiting
  • faculty of physical therapy Cairo university
    Dokki, Giza, Egypt
    • Ali Ismail, lecturer · Contact · ali.mohamed@pt.cu.edu.eg · +201005154209
    • Ali MA Ismail, Lecturer · Principal investigator
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 3, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06757829
Lead sponsor
Cairo University
Responsible party
Ali Mohamed Ali ismail (Department of Physical Therapy for Cardiovascular/Respiratory Disorder and Geriatrics, Faculty of Physical Therapy, Cairo University) — Principal investigator
First posted
Jan 3, 2025
Start date
Dec 15, 2024
Primary completion
May 1, 2025 (estimated)
Completion
May 1, 2025 (estimated)
Last update
Jan 3, 2025

Study contacts

Ali Isamil, Lecturer
Contact
ali.mohamed@pt.cu.edu.eg
0201005154209
ali ismail, Lecturer
Contact
ali.mohamed@pt.cu.edu.eg
0201005154209
Ali Ismail, lecturer
principal investigator · Cairo University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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