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NCT Number: NCT06757829

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

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.

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Key information

Conditions

Sickle Cell Disease Anemia Anemia, Hemolytic Anemia, Hemolytic, Congenital Anemia, Sickle Cell Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Hematologic Diseases Hemic and Lymphatic Diseases Hemoglobinopathies

Age range

20 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

faculty of physical therapy Cairo university

Dokki, Giza Governorate, Egypt

Location status: Recruiting

Location contact

Ali Ismail, lecturer

CONTACT

[email protected]

+201005154209

Ali MA Ismail, Lecturer

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • sickle cell disease patients
  • non obese patients

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

Treatment and study plan

inspiratory muscle training and acupucnture like transcutanoeus electrical nerve stimulation

Behavioral

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 Training

Behavioral

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.

Primary outcomes

  1. FEV1/FVC ratio

    Time frame: it will be assessed after12 weeks

    will be measured by spirometry

Secondary outcomes

  1. forced expiratory volume at the first second of expiration

    Time frame: it will be assessed after12 weeks

    will be measured by spirometry

  2. forced vital capacity

    Time frame: it will be assessed after12 weeks

    will be measured by spirometry

  3. six minute walk distance

    Time frame: it will be assessed after12 weeks

    it will be a measure of physical capacity

  4. physical summary of short form 36

    Time frame: it will be assessed after12 weeks

    it is a questionnaire measure of quality of life

  5. mental summary of short form 36

    Time frame: it will be assessed after12 weeks

    it is a questionnaire measure of quality of life

  6. right diaphragmatic excrusion

    Time frame: it will be measured after 12 weeks

    it will be assessed by ultrasonography

  7. left diaphragmatic excrusion

    Time frame: it will be measured after 12 weeks

    it will be assessed by ultrasonography

Study contacts

Contact information is provided by the study sponsor or research team.

Ali Isamil, Lecturer

CONTACT

[email protected]

0201005154209

ali ismail, Lecturer

CONTACT

[email protected]

0201005154209

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

Pulmonary Functions in Sickle Cell Disease: Response of Adding Acu-TENS to Inspiratory Muscle Training

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jan 3, 2025
Registry last updated
Jan 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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