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

Allogeneic Hematopoietic Stem Cell Transplantation Clinical Trial

Official title:

Chest Physical Therapy in Patients Waiting for Allogeneic Hematopoietic Stem Cell

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05104684
• Other study ID #: stem cell
• Status: Completed
• Phase: N/A
• Start date: January 10, 2021
• Est. completion date: September 20, 2021

Study information

• Verified date: October 2021
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: September 20, 2021
• Est. primary completion date: August 12, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Allogeneic Hematopoietic Stem Cell Transplantation

Intervention

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
• routine medical treatment
medical treatment

Locations

Country	Name	City	State
Egypt	Zizi Mohammed Ibrahim Ali	Giza	Nnjkjk

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	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	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	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.