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

Not Applicable

Recruiting

• Conditions: Sickle Cell Disease

• Registration Number: NCT06757829
• Lead Sponsor: Cairo University

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.

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 Timeline

• Status Verified: 2024-12
• Study Start: 2024-12-15
• Study First Submitted: 2024-12-26
• Study First Submitted QC: 2024-12-26
• Last Update Submitted: 2024-12-26
• Study First Posted: 2025-01-03
• Last Update Posted: 2025-01-03
• Primary Completion: 2025-05-01
• Study Completion: 2025-05-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
FEV1/FVC ratio	it will be assessed after12 weeks	will be measured by spirometry

Secondary Outcome Measures

Name	Time	Method
forced expiratory volume at the first second of expiration	it will be assessed after12 weeks	will be measured by spirometry
forced vital capacity	it will be assessed after12 weeks	will be measured by spirometry
six minute walk distance	it will be assessed after12 weeks	it will be a measure of physical capacity
physical summary of short form 36	it will be assessed after12 weeks	it is a questionnaire measure of quality of life
mental summary of short form 36	it will be assessed after12 weeks	it is a questionnaire measure of quality of life
right diaphragmatic excrusion	it will be measured after 12 weeks	it will be assessed by ultrasonography
left diaphragmatic excrusion	it will be measured after 12 weeks	it will be assessed by ultrasonography

Trial Locations

Locations (1)

faculty of physical therapy Cairo university; 🇪🇬 Dokki, Giza, Egypt