Respiratory Training in Patients With Leukemia

Leukemia Clinical Trial

Official title:

Influence of Respiratory Training on Functional Capacity in Patients With Leukemia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03876834
• Other study ID #: 201617032.4
• Status: Completed
• Phase: N/A
• Start date: March 1, 2018
• Est. completion date: June 30, 2018

Study information

• Verified date: March 2019
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: June 30, 2018
• Est. primary completion date: June 30, 2018
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 30 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Leukemia

Intervention

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

Locations

Country	Name	City	State
Egypt	Faculty of Physical Therapy	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum voluntary ventilation	It was performed by breathing deeply and rapidly for 10 to 15 seconds using spirometer	change from baseline maximum voluntary ventilation at 4 weeks
Primary	2 min walk test	Each patient was asked to cover as much ground as possible over 2 minutes	change from baseline 2 min walk test at 4 weeks
Primary	FACT-G questionnaire	27 questions with four domains assessing physical well being,social well being, emotional well being and functional wellbeing	change from baseline FACT-G questionnaire at 4 weeks