Clinical trial NCT05104684: Chest Physical Therapy in Patients Waiting for Allogeneic Hematopoietic Stem Cell Transplantation"
Official title: Chest Physical Therapy in Patients Waiting for Allogeneic Hematopoietic Stem Cell
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Allogeneic Hematopoietic Stem Cell Transplantation
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2021-11-03
Enrollment: 50
Sex: ALL
Minimum age (years): 40
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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..
Primary purpose: TREATMENT

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

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.

Eligibility criteria: 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

Primary outcomes:
measure: Spirometry measures1
timeFrame: 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.
measure: Spirometry measures2
timeFrame: 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.
measure: Spirometry measures3
timeFrame: 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:
measure: Respiratory muscle strength (RMS)
timeFrame: 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.
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Zizi Mohammed Ibrahim Ali
state: Nnjkjk
Study officials:
affiliation: Cairo University
name: INTSAR S WAKED, PHD
role: PRINCIPAL_INVESTIGATOR
References: