Pulmonary Functions in Sickle Cell Disease: Response of Adding Acu-TENS to Inspiratory Muscle Training
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Cairo University
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- FEV1/FVC ratio
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 20 Years to 50 Years (Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
group I
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.
Intervention: inspiratory muscle training and acupucnture like transcutanoeus electrical nerve stimulation (Behavioral)
Group II
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.
Intervention: inspiratory muscle training (Behavioral)
Outcomes
Primary Outcomes
FEV1/FVC ratio
Time Frame: it will be assessed after12 weeks
will be measured by spirometry
Secondary Outcomes
- 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)
- right diaphragmatic excrusion(it will be measured after 12 weeks)
- left diaphragmatic excrusion(it will be measured after 12 weeks)
Investigators
Ali Mohamed Ali ismail
Department of Physical Therapy for Cardiovascular/Respiratory Disorder and Geriatrics, Faculty of Physical Therapy
Cairo University