Back to resultsRespiratory Training in Patients With Leukemia
Primary Purpose
Leukemia
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
respiratory training
Sponsored by
About this trial
This is an interventional treatment trial for Leukemia focused on measuring leukemia, chemotherapy, respiratory training
Eligibility Criteria
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
Sites / Locations
- Faculty of Physical Therapy
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
study group (group A)
control group (B)
Arm Description
Group (A) included 30 leukemic patients receiving chemotherapy in addition to training by inspiratory muscle trainer(IMT) for 4 weeks, 5 sessions /week
Group (B) included 10 leukemic patients receiving chemotherapy only
Outcomes
Primary Outcome Measures
Maximum voluntary ventilation
It was performed by breathing deeply and rapidly for 10 to 15 seconds using spirometer
2 min walk test
Each patient was asked to cover as much ground as possible over 2 minutes
FACT-G questionnaire
27 questions with four domains assessing physical well being,social well being, emotional well being and functional wellbeing
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03876834
Brief Title
Respiratory Training in Patients With Leukemia
Official Title
Influence of Respiratory Training on Functional Capacity in Patients With Leukemia
Study Type
Interventional
2. Study Status
Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
March 1, 2018 (Actual)
Primary Completion Date
June 30, 2018 (Actual)
Study Completion Date
June 30, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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
Detailed Description
Forty male leukemic patients receiving chemotherapy for at least one cycle and their mean ages 37.1 ± 4.89 years.The patients were selected from National Cancer Institute, Cairo ( inpatient ward). The study lasted from March 2018 to June 2018. Patients were randomly assigned into two groups.Group A (30 patients) who received inspiratory muscles training for 4 successive weeks, 5 sessions/week; and Group B (10 patients) acted as a control group on chemotherapy only. Data obtained from both groups regarding (MVV), 2 min walk test and Quality of life questionnaire (FACT-G) were statistically analyzed and compared
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Leukemia
Keywords
leukemia, chemotherapy, respiratory training
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
study group (group A)
Arm Type
Experimental
Arm Description
Group (A) included 30 leukemic patients receiving chemotherapy in addition to training by inspiratory muscle trainer(IMT) for 4 weeks, 5 sessions /week
Arm Title
control group (B)
Arm Type
No Intervention
Arm Description
Group (B) included 10 leukemic patients receiving chemotherapy only
Intervention Type
Other
Intervention Name(s)
respiratory training
Intervention Description
Respiratory training was done by using threshold inspiratory muscle trainer(Respironics, New Jersey , USA, No.8373-0730)
Primary Outcome Measure Information:
Title
Maximum voluntary ventilation
Description
It was performed by breathing deeply and rapidly for 10 to 15 seconds using spirometer
Time Frame
change from baseline maximum voluntary ventilation at 4 weeks
Title
2 min walk test
Description
Each patient was asked to cover as much ground as possible over 2 minutes
Time Frame
change from baseline 2 min walk test at 4 weeks
Title
FACT-G questionnaire
Description
27 questions with four domains assessing physical well being,social well being, emotional well being and functional wellbeing
Time Frame
change from baseline FACT-G questionnaire at 4 weeks
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Faculty of Physical Therapy
City
Cairo
ZIP/Postal Code
12316
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Respiratory Training in Patients With Leukemia
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