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Completed

NCT Number: NCT05104684

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

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

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Key information

Conditions

Allogeneic Hematopoietic Stem Cell Transplantation

Age range

40 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Zizi Mohammed Ibrahim Ali

Giza, Nnjkjk, 2136, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Chest physical therapy

Other

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

routine medical treatment

Other

medical treatment

Primary outcomes

  1. 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

  2. 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.

  3. 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

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

Chest Physical Therapy in Patients Waiting for Allogeneic Hematopoietic Stem Cell

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Nov 3, 2021
Registry last updated
Nov 3, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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