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

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06757829
Enrollment
40
Registered
2025-01-03
Start date
2024-12-15
Completion date
2025-05-01
Last updated
2025-01-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sickle Cell Disease

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.

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.

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
20 Years to 50 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
FEV1/FVC ratioit will be assessed after12 weekswill be measured by spirometry

Secondary

MeasureTime frameDescription
forced vital capacityit will be assessed after12 weekswill be measured by spirometry
six minute walk distanceit will be assessed after12 weeksit will be a measure of physical capacity
physical summary of short form 36it will be assessed after12 weeksit is a questionnaire measure of quality of life
forced expiratory volume at the first second of expirationit will be assessed after12 weekswill be measured by spirometry
right diaphragmatic excrusionit will be measured after 12 weeksit will be assessed by ultrasonography
left diaphragmatic excrusionit will be measured after 12 weeksit will be assessed by ultrasonography
mental summary of short form 36it will be assessed after12 weeksit is a questionnaire measure of quality of life

Countries

Egypt

Contacts

Primary ContactAli Isamil, Lecturer
ali.mohamed@pt.cu.edu.eg0201005154209
Backup Contactali ismail, Lecturer
ali.mohamed@pt.cu.edu.eg0201005154209

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026