- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03876834
Respiratory Training in Patients With Leukemia
Influence of Respiratory Training on Functional Capacity in Patients With Leukemia
Forty male leukemic patients receiving chemotherapy were selected from National Cancer Institute, They were randomly assigned into two groups. Group (A) included 30 patients who were trained by Inspiratory muscle trainer for 4 weeks ;5 sessions/week and Group (B) included 10 patients as a control group.
The following measures were taken before and after the study period : Maximum voluntary ventilation(MVV) , 2 min walk test, FACT-G questionnaire
Study Overview
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Cairo, Egypt, 12316
- Faculty of physical therapy
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- male patient with age ranges from 30-50 years
- All patients were leukemic receiving chemotherapy for at least one cycle as a treatment of malignant tumor
- All patients were hemodynamically stable
- All patients were ambulant
Exclusion Criteria:
- lung cancer
- History of any pulmonary disease.
- Metastasis of lungs, ribs, mediastinal structure
- Pulmonary pathology(e.g acute respiratory distress syndrome or exacerbation of chronic obstructive pulmonary disease)
- ruptured ear drum or any other condition of the ear
- High peak airway pressure (barotraumas)
- patients with marked elevated left ventricular end diastolic volume and pressure
- patients with worsening heart failure signs and symptoms
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: study group (group A)
Group (A) included 30 leukemic patients receiving chemotherapy in addition to training by inspiratory muscle trainer(IMT) for 4 weeks, 5 sessions /week
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Respiratory training was done by using threshold inspiratory muscle trainer(Respironics, New Jersey , USA, No.8373-0730)
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No Intervention: control group (B)
Group (B) included 10 leukemic patients receiving chemotherapy only
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Maximum voluntary ventilation
Time Frame: change from baseline maximum voluntary ventilation at 4 weeks
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It was performed by breathing deeply and rapidly for 10 to 15 seconds using spirometer
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change from baseline maximum voluntary ventilation at 4 weeks
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2 min walk test
Time Frame: change from baseline 2 min walk test at 4 weeks
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Each patient was asked to cover as much ground as possible over 2 minutes
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change from baseline 2 min walk test at 4 weeks
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FACT-G questionnaire
Time Frame: change from baseline FACT-G questionnaire at 4 weeks
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27 questions with four domains assessing physical well being,social well being, emotional well being and functional wellbeing
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change from baseline FACT-G questionnaire at 4 weeks
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 201617032.4
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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