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CompletedNCT05104684Updated Nov 3, 2021

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

An interventional study of chest physical therapy and routine medical treatment in Allogeneic Hematopoietic Stem Cell Transplantation, sponsored by Cairo University. Completed at 1 site in Egypt. Open to participants aged 40 Years to 55 Years. Per ClinicalTrials.gov, last updated 2021-11-03.

Sponsored by Cairo University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 8 months after the study started (first participant enrolled Jan 2021, registered Oct 2021).
Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
40 Years to 55 Years
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Allogeneic Hematopoietic Stem Cell Transplantation
03

In context

Lead sponsor

Cairo University is the lead sponsor of 4,780 studies on the registry; 1,427 are open to participants now.

Of its 36 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • fever
  • smokers
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
50 participants (actual)

Study arms

  • 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 · Other: routine medical treatment

  • Active comparator
    Control group (B):Routine medical treatment

    patients in group B will receive routine medical treatment

    Other: routine medical treatment

Interventions

  • Otherchest 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

    Also known as: chest p.t

  • Otherroutine medical treatment

    medical treatment

06

What researchers measure

Primary outcomes

  1. Spirometry measures1

    The forced expiratory volume in one second (FEV1), FEV1 is the volume of air exhaled in the first second of the FVC maneuver

    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.

  2. Spirometry measures2

    the forced vital capacity (FVC)To measure FVC, the patient inhales maximally, then exhales as rapidly and as completely as possible.

    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.

  3. Spirometry measures3

    the relation between FEV1 and FVC

    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.

Secondary outcomes

  1. Respiratory muscle strength (RMS)

    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

    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.

07

Study locations

1 site
  • Zizi Mohammed Ibrahim Ali
    Giza, Nnjkjk 2136, Egypt
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 3, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05104684
Lead sponsor
Cairo University
Responsible party
ZIZI MOHAMMED IBRAHIM ALI (Assistant Professor of physical therapy, Department of Physical Therapy for Burn and Plastic Surgery, Faculty of Physical Therapy, Cairo University, Egypt., Cairo University) — Principal investigator
First posted
Nov 3, 2021
Start date
Jan 10, 2021
Primary completion
Aug 12, 2021
Completion
Sep 20, 2021
Last update
Nov 3, 2021

Study contacts

INTSAR S WAKED, PHD
principal investigator · Cairo University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2021. You cannot join it, but the record below documents what was studied.

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