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Recruiting NCT06757829

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

No phase Interventional Sickle Cell Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: inspiratory muscle training and acupucnture like transcutanoeus electrical nerve stimulation, inspiratory muscle training.
Who it may be relevant to
Registry conditions: Sickle Cell Disease. Basic parameters: 20 years — 50 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Egypt
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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

  • Behavioral inspiratory 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 p
  • Behavioral inspiratory 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.

Primary outcome measures

  • FEV1/FVC ratio [Time frame: it will be assessed after12 weeks]
Secondary outcome measures (7)
  • forced expiratory volume at the first second of expiration [Time frame: it will be assessed after12 weeks]
  • forced vital capacity [Time frame: it will be assessed after12 weeks]
  • six minute walk distance [Time frame: it will be assessed after12 weeks]
  • physical summary of short form 36 [Time frame: it will be assessed after12 weeks]
  • mental summary of short form 36 [Time frame: it will be assessed after12 weeks]
  • right diaphragmatic excrusion [Time frame: it will be measured after 12 weeks]
  • left diaphragmatic excrusion [Time frame: it will be measured after 12 weeks]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Prevention

Study locations

Egypt · 1 center
  • faculty of physical therapy Cairo university — Dokki

Identifiers

NCT: NCT06757829 · IRB00014233-17

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗