Respiratory Training in Patients With Leukemia

NCT ID: NCT03876834

Last Updated: 2019-03-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-03-01

Study Completion Date

2018-06-30

Brief Summary

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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

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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

Conditions

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Leukemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

respiratory training

Intervention Type OTHER

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

control group (B)

Group (B) included 10 leukemic patients receiving chemotherapy only

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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respiratory training

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

30 Years

Maximum Eligible Age

50 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Heba Ahmed Ali Abdeen

Assistant professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Faculty of Physical Therapy

Cairo, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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201617032.4

Identifier Type: -

Identifier Source: org_study_id

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