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Completed

NCT Number: NCT03876834

Respiratory Training 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

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Key information

Conditions

Leukemia Hematologic Diseases Hemic and Lymphatic Diseases Neoplasms Neoplasms by Histologic Type

Age range

30 year–50 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Physical Therapy

Cairo, 12316, Egypt

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Respiratory Training

Other

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

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

Influence of Respiratory Training on Functional Capacity in Patients With Leukemia

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Mar 15, 2019
Registry last updated
Mar 15, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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