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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

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


Condition or disease Intervention/treatment Phase
Leukemia Other: respiratory training Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Influence of Respiratory Training on Functional Capacity in Patients With Leukemia
Actual Study Start Date : March 1, 2018
Actual Primary Completion Date : June 30, 2018
Actual Study Completion Date : June 30, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Leukemia

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
Other: respiratory training
Respiratory training was done by using threshold inspiratory muscle trainer(Respironics, New Jersey , USA, No.8373-0730)

No Intervention: control group (B)
Group (B) included 10 leukemic patients receiving chemotherapy only



Primary Outcome Measures :
  1. 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. 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

  3. 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



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Ages Eligible for Study:   30 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03876834


Locations
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Egypt
Faculty of Physical Therapy
Cairo, Egypt, 12316
Sponsors and Collaborators
Cairo University

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Responsible Party: Heba Ahmed Ali Abdeen, Assistant professor, Cairo University
ClinicalTrials.gov Identifier: NCT03876834     History of Changes
Other Study ID Numbers: 201617032.4
First Posted: March 15, 2019    Key Record Dates
Last Update Posted: March 15, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Heba Ahmed Ali Abdeen, Cairo University:
leukemia
chemotherapy
respiratory training

Additional relevant MeSH terms:
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Leukemia
Neoplasms by Histologic Type
Neoplasms