Respiratory Training in Patients With Leukemia

NCT03876834 | Completed

• 1 other identifier: 201617032.4
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Conditions

Leukemia

Keywords

leukemia; chemotherapy; respiratory training

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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

Study Arms (2)

study group (group A)

EXPERIMENTAL

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

control group (B)

NO INTERVENTION

Group (B) included 10 leukemic patients receiving chemotherapy only

Interventions

respiratory training OTHER

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

study group (group A)

Eligibility Criteria

• Age: 30 Years - 50 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of Physical Therapy

Cairo, 12316, Egypt

Location

MeSH Terms

Conditions

Leukemia

Interventions

Breathing Exercises

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Exercise Movement Techniques; Physical Therapy Modalities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: March 8, 2019
• First Posted: March 15, 2019
• Study Start: March 1, 2018
• Primary Completion: June 30, 2018
• Study Completion: June 30, 2018
• Last Updated: March 15, 2019

Record last verified: 2019-03

Locations

EG (1)