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

Cairo University (CU)

Status: Enrolling

Conditions: Sickle Cell Disease

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

Study type: Interventional

Funder types: Other

Identifiers

NCT06757829

IRB00014233-17

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 20 to 50 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 2 patient groups

group I

Experimental group

Description:

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.

Treatment:

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

Group II

Active Comparator group

Description:

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.

Treatment:

Behavioral: inspiratory muscle training