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

NCT05104684 | Completed

• 1 other identifier: stem cell
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Allogeneic Hematopoietic Stem Cell Transplantation

Outcome Measures

Primary Outcomes (3)

• 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

  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

  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

  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 Outcomes (1)

• Respiratory muscle strength (RMS)

  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.

Study Arms (2)

group A:Chest Physical Therapy

EXPERIMENTAL

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

Control group (B):Routine medical treatment

ACTIVE COMPARATOR

patients in group B will receive routine medical treatment

Other: routine medical treatment

Interventions

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

Also known as: chest p.t

group A:Chest Physical Therapy

routine medical treatment OTHER

medical treatment

Control group (B):Routine medical treatment; group A:Chest Physical Therapy

Eligibility Criteria

• Age: 40 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• fever
• smokers

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Zizi Mohammed Ibrahim Ali

Giza, Nnjkjk, 2136, Egypt

Location

Study Officials

• INTSAR S WAKED, PHD

  Cairo University

  PRINCIPAL INVESTIGATOR

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 of physical therapy, Department of Physical Therapy for Burn and Plastic Surgery, Faculty of Physical Therapy, Cairo University, Egypt.

Model Details: Fifty 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 Record Dates

• First Submitted: October 9, 2021
• First Posted: November 3, 2021
• Study Start: January 10, 2021
• Primary Completion: August 12, 2021
• Study Completion: September 20, 2021
• Last Updated: November 3, 2021

Record last verified: 2021-10

Locations

EG (1)