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Respiratory Training in Patients With Leukemia

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ClinicalTrials.gov Identifier: NCT03876834
Recruitment Status : Completed
First Posted : March 15, 2019
Last Update Posted : March 15, 2019
Sponsor:
Information provided by (Responsible Party):
Heba Ahmed Ali Abdeen, Cairo University

Tracking Information
First Submitted Date  ICMJE March 8, 2019
First Posted Date  ICMJE March 15, 2019
Last Update Posted Date March 15, 2019
Actual Study Start Date  ICMJE March 1, 2018
Actual Primary Completion Date June 30, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 13, 2019)
  • Maximum voluntary ventilation [ Time Frame: change from baseline maximum voluntary ventilation at 4 weeks ]
    It was performed by breathing deeply and rapidly for 10 to 15 seconds using spirometer
  • 2 min walk test [ Time Frame: change from baseline 2 min walk test at 4 weeks ]
    Each patient was asked to cover as much ground as possible over 2 minutes
  • FACT-G questionnaire [ Time Frame: change from baseline FACT-G questionnaire at 4 weeks ]
    27 questions with four domains assessing physical well being,social well being, emotional well being and functional wellbeing
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Respiratory Training in Patients With Leukemia
Official Title  ICMJE Influence of Respiratory Training on Functional Capacity in Patients With Leukemia
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
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Leukemia
Intervention  ICMJE Other: respiratory training
Respiratory training was done by using threshold inspiratory muscle trainer(Respironics, New Jersey , USA, No.8373-0730)
Study Arms  ICMJE
  • 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
    Intervention: Other: respiratory training
  • No Intervention: control group (B)
    Group (B) included 10 leukemic patients receiving chemotherapy only
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 13, 2019)
40
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 30, 2018
Actual Primary Completion Date June 30, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 30 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Egypt
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03876834
Other Study ID Numbers  ICMJE 201617032.4
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Heba Ahmed Ali Abdeen, Cairo University
Study Sponsor  ICMJE Cairo University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Cairo University
Verification Date March 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP