Influence of Respiratory Training on Functional Capacity in Patients With Leukemia
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Cairo University
- Enrollment
- 40
- Locations
- 2
- Primary Endpoint
- Maximum voluntary ventilation
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 30 Years to 50 Years (Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
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: respiratory training (Other)
control group (B)
Group (B) included 10 leukemic patients receiving chemotherapy only
Outcomes
Primary Outcomes
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
Secondary Outcomes
No secondary outcomes reported
Investigators
Heba Ahmed Ali Abdeen
Assistant professor
Cairo University