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

NCT06757829 | Recruiting

• 1 other identifier: IRB00014233-17
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Sickle Cell Disease

Outcome Measures

Primary Outcomes (1)

• FEV1/FVC ratio

  will be measured by spirometry

  it will be assessed after12 weeks

Secondary Outcomes (7)

• forced expiratory volume at the first second of expiration

  it will be assessed after12 weeks

• forced vital capacity

  it will be assessed after12 weeks

• six minute walk distance

  it will be assessed after12 weeks

• physical summary of short form 36

  it will be assessed after12 weeks

• mental summary of short form 36

  it will be assessed after12 weeks

Study Arms (2)

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.

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.

Behavioral: inspiratory muscle training

Interventions

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.

group I

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.

Group II

Eligibility Criteria

• Age: 20 Years - 50 Years
• Gender Eligibility Details: based on self-representation of gender identity.
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• sickle cell disease patients
• non obese patients

You may not qualify if:

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

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

faculty of physical therapy Cairo university

Dokki, Giza Governorate, Egypt

RECRUITING

MeSH Terms

Conditions

Anemia, Sickle Cell

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemoglobinopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Ali Ismail, lecturer

  Cairo University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ali Isamil, Lecturer

CONTACT

0201005154209; ali.mohamed@pt.cu.edu.eg

ali ismail, Lecturer

CONTACT

0201005154209; ali.mohamed@pt.cu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Department of Physical Therapy for Cardiovascular/Respiratory Disorder and Geriatrics, Faculty of Physical Therapy

Study Record Dates

• First Submitted: December 26, 2024
• First Posted: January 3, 2025
• Study Start: December 15, 2024
• Primary Completion: May 1, 2025
• Study Completion: May 1, 2025
• Last Updated: January 3, 2025

Record last verified: 2024-12

Locations

EG (1)