Chest Physical Therapy in Patients Waiting for Allogeneic Hematopoietic Stem Cell Transplantation"

October 21, 2021 updated by: ZIZI MOHAMMED IBRAHIM ALI, Cairo University

Chest Physical Therapy in Patients Waiting for Allogeneic Hematopoietic Stem Cell

evaluate the efficacy of Chest Physical Therapy (CPT) performed during the pre-transplant period on spirometric values as well as Respiratory Muscle Strength (RMS) in patients waiting for Allogeneic Hematopoietic Stem Cell Transplantation

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

patients scheduled for HSCT at the bone marrow transplant will randomly be assigned into two groups; one will receive Chest Physical Therapy in addition to routine medical treatment and the control group will receive routine medical treatment only. Outcomes will be a pulmonary function that will be measured by spirometry and respiratory muscle strength measure by Respiratory Pressure Meter. Measurements will be before three weeks before then at the end of treatment immediately before Hematopoietic Stem Cell Transplantation and the last assessment at three weeks after hematopoietic Stem Cell Transplantation for all measured variables.

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Nnjkjk
      • Giza, Nnjkjk, Egypt, 2136
        • Zizi Mohammed Ibrahim Ali

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients consecutively admitted to HSCT unit, completed the induction therapy and awaiting for allogeneic HSCT Study. Candidates' ages from 40-55 years old, both males and females will be included, Non-smokers patients, Non-alcoholics patients, patients medically cleared to exercise that decided by the transplant physician; patients able to understand training instructions and follow the study protocol

Exclusion Criteria:

  • fever
  • smokers

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: group A:Chest Physical Therapy
Patients in group A will receive CPT program daily for three weeks before HSCT (hospital stay for allogeneic-HCT). The program consists of postural drainage, diaphragmatic breathing exercises, coughing, huffing, percussion, shaking, and exercise training using an incentive spirometer in addition to routine medical treatment. The total duration of each CPT session ranged from 45-60 minutes according to patient tolerance. The choice of airway clearance method that will be applied depends on two factors; patient preference and the individual response of the patient to treatment.
Other: chest physical therapy
The program will consist of postural drainage, diaphragmatic breathing exercises, coughing, huffing, percussion, shaking, and exercise training using an incentive spirometer in addition to routine medical treatment
Other Names:
  • chest p.t
Other: routine medical treatment
medical treatment
Active Comparator: Control group (B):Routine medical treatment
patients in group B will receive routine medical treatment
Other: routine medical treatment
medical treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Spirometry measures1
Time Frame: Change from Baseline (three weeks before HSCT) , the end of treatment immediately before HSCT(T1) to three weeks after HSCT(T2) for all measured variables.
The forced expiratory volume in one second (FEV1), FEV1 is the volume of air exhaled in the first second of the FVC maneuver
Change from Baseline (three weeks before HSCT) , the end of treatment immediately before HSCT(T1) to three weeks after HSCT(T2) for all measured variables.
Spirometry measures2
Time Frame: Change from Baseline (three weeks before HSCT) , the end of treatment immediately before HSCT(T1) to three weeks after HSCT(T2) for all measured variables.
the forced vital capacity (FVC)To measure FVC, the patient inhales maximally, then exhales as rapidly and as completely as possible.
Change from Baseline (three weeks before HSCT) , the end of treatment immediately before HSCT(T1) to three weeks after HSCT(T2) for all measured variables.
Spirometry measures3
Time Frame: Change from Baseline (three weeks before HSCT) , the end of treatment immediately before HSCT(T1) to three weeks after HSCT(T2) for all measured variables.
the relation between FEV1 and FVC
Change from Baseline (three weeks before HSCT) , the end of treatment immediately before HSCT(T1) to three weeks after HSCT(T2) for all measured variables.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Respiratory muscle strength (RMS)
Time Frame: A baseline assessment will be done three weeks before HSCT (T0) then at the end of treatment immediately before HSCT(T1) and the last assessment at three weeks after HSCT(T2) for all measured varibles.
Maximal inspiratory pressure (MIP or PImax) and maximal expiratory pressure (MEP or PEmax) will be measured to assess respiratory muscle strength (RMS) using MicroMedical MicroRPM 01 (Respiratory Pressure Meter) according to ATS/ERS guidelines
A baseline assessment will be done three weeks before HSCT (T0) then at the end of treatment immediately before HSCT(T1) and the last assessment at three weeks after HSCT(T2) for all measured varibles.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Investigators

  • Principal Investigator: INTSAR S WAKED, PHD, Cairo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 10, 2021

Primary Completion (Actual)

August 12, 2021

Study Completion (Actual)

September 20, 2021

Study Registration Dates

First Submitted

October 9, 2021

First Submitted That Met QC Criteria

October 21, 2021

First Posted (Actual)

November 3, 2021

Study Record Updates

Last Update Posted (Actual)

November 3, 2021

Last Update Submitted That Met QC Criteria

October 21, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • stem cell

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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