Stem Cell Transplantation Clinical Trial
Official title:
Investigation of Relationship Among Physical Activity, Pulmonary Functions and Physical Functions in Candidates With Allogeneic Hematopoietic Stem Cell Transplantation: a Cross Sectional Study
Physical inactivity and impairments in physical functions have been observed in patients due to hematological malignancy itself and treatments of chemotherapy, radiotherapy, corticosteroids. However, no study investigated relationship of physical activity with pulmonary and physical functions in allogeneic hematopoietic stem cell transplantation (HSCT) candidates. Therefore, investigation of the relationship among outcomes in allogeneic HSCT candidates was aimed.
Hematological malignancies arise from deficiencies in blood cell lineage which represent a
heterogeneous group including leukemias, lymphomas, myelomas, myeloproliferative diseases and
myelodysplastic syndromes. In recent years, a great majority of patients with hematological
malignancies often experience side effects of disease related treatments such as chemotherapy
with multiple agents, radiotherapy, corticosteroids, combination of medical drugs, autologous
and/or allogeneic hematopoietic stem cell transplantation (HSCT) throughout their remaining
lives. Furthermore, there are substantial outcomes regarding the initial time of diagnosis
that pulmonary function involvements, sedentary life style (39%), decreased exercise capacity
and lower extremity muscle weakness have been present in patients with lymphoma even before
first cycle of chemotherapy is administered to patients. During the period of or after
chemotherapy, patients have suffered from decreased maximal oxygen uptake, advanced muscle
weakness, decreased hemoglobin levels and evident fatigue, as well.
As the treatment process continues for patients with hematological malignancies, HSCT is
begun to schedule for almost all patients which has a significant potential for good clinical
outcomes along with longer life expectancy. However, especially allogeneic-HSCT is a quite
aggressive treatment option due to serious complications such as graft versus host disease,
long term severe treatments of these complications and severe immune suppression related
infections. Moreover, patients have already been exposed to immobility condition, low level
of physical activity, pulmonary functions involvements, respiratory and peripheral muscle
weakness as well as exercise intolerance before HSCT. In addition, the outcomes obtained from
candidates just before HSCT have indicated that quadriceps femoris muscle strength, exercise
capacity evaluated with 6-minute walk test, inspiratory and expiratory muscle strength are
decreased respectively in 23%, 58%, 42% and 89% of candidates. Sarcopenia (50.6%), reduction
in hip flexor, hip abductors and ankle flexors muscles strength and decreased diffusing
capacity of the lung for carbon monoxide (78%) have also been mostly observed in HSCT
candidates. In a study, candidates who were evaluated using a metabolic holter device are
inactive (average 2180 steps/day) before HSCT. In another study, number of steps evaluated
using a pedometer which provides only one output about step count are approximately 201.1
steps per a day for HSCT candidates. Accuracy of pedometers can be reduced at slow walking
speeds so that pedometers may not be suitable for cancer patients. On the other hand,
metabolic holter devices use pattern recognition technology to evaluate physical activity
level that may produce more accurate estimation of energy expenditure in cancer population.
Besides, it has also been stated that quadriceps femoris muscle weakness is related to
reduced daily number of steps, therefore if the muscles are strengthened, number of steps may
be increased at the process of HSCT.
Physical activity is any bodily movement which is produced by skeletal muscles concluded
energy expenditure. While total daily energy expenditure demonstrates all types of energy
costs including resting, diet-induced and activity-induced energy expenditures within 24
hours, active energy expenditure related with physical activity is produced by daily living
activities such as employment, sport and any other activities. Activity energy expenditure
also decreases with excess body weight, older age, female gender, loss of muscle mass and
diseases throughout life span . On the other hand, Canadian Academy of Sports and Exercise
Medicine recommends that people prefer moderate-to-vigorous physical activity (>3.0 metabolic
equivalents (METs)) including brisk walking, aerobic and resistance exercises, jogging,
hiking, swimming and field games with ball or racquet for 150 min/week and a total
sustainable activity duration from 30 min to 60 min per practice rather than sedentary
behavior (<1.5 METs) in order to decrease risk of most major chronic disease by 25-50%.
Moreover, a 15 min/d or 75 min/week of moderate-to-vigorous physical activity is also
recommended as about 15% mortality risk reduces in diseases and benefits increase . Given the
importance of physical activity assessment and counseling in people with/without chronic
disease, according to literature, studies objectively investigating either detailed physical
activity condition rather than number of steps or relations of physical activity with
pulmonary and physical functions in allogeneic-HSCT candidates are scarce. Therefore, primary
aim of the current study was to exhibit possible all detailed aspects of physical activity
outcomes evaluated with a metabolic holter, an objective measurement device, secondary aim
was to investigate relationship among physical activity parameters, pulmonary functions and
physical functions in allogeneic-HSCT candidates and as finally, to identify independent
predictors of physical inactivity in candidates was aimed.
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT03918343 -
Lipopolysaccharide Metabolism and Identification of Potential Biomarkers Predictive of Graft-versus-host Disease After Allogeneic Stem Cell Transplantation
|
N/A | |
Not yet recruiting |
NCT05438823 -
Technology Supported Education Program Based on Human Care Theory
|
N/A | |
Not yet recruiting |
NCT02193399 -
Physiotherapy in Hematopoietic Stem Cell Transplantation
|
N/A | |
Withdrawn |
NCT00972101 -
Infusion of Expanded Cord Blood T Cells
|
Phase 1 | |
Completed |
NCT05421299 -
A Study to Assess 7/8 HLA-matched Hematopoietic Stem Cell Transplantation Participants Treated With or Without Abatacept in Combination With a Calcineurin Inhibitor and Methotrexate
|
||
Completed |
NCT04976933 -
Post-HSCT Medication Adherence mHealth App
|
||
Completed |
NCT04798495 -
Feasibility of a Rehabilitation Programme Targeted Patients Treated With Non-myeloablative Stem Cell Transplantation
|
N/A | |
Completed |
NCT00612274 -
Sirolimus, Tacrolimus and Short Course Methotrexate for Prevention of Acute GVHD in Recipients of Mismatched Unrelated Donor Allogeneic Stem Cell Transplantation
|
Phase 0 | |
Active, not recruiting |
NCT04511130 -
Efficacy of MT-401 in Patients With AML Following Stem Cell Transplant
|
Phase 2 | |
Recruiting |
NCT05968963 -
Electronic Health Mindfulness-based Music Therapy Intervention for Patients Undergoing Allogeneic Stem Cell Transplantation
|
N/A | |
Recruiting |
NCT02940093 -
Pipeline Integrating Gut Metagenome Data, Host Immunogenetic Characteristics and Clinical Gut Inflammatory Biomarkers
|
N/A | |
Not yet recruiting |
NCT06077734 -
Muscle Stem Cell Quality in Atrophy
|
||
Terminated |
NCT00587990 -
Prospective Randomized Study of Mesenchymal Stem Cell Therapy in Patients Undergoing Cardiac Surgery (PROMETHEUS)
|
Phase 1/Phase 2 | |
Terminated |
NCT00597441 -
Phase I Study of Umbilical Cord Blood Transplantation Followed by Third Party Thymus Transplantation
|
Phase 1 | |
Active, not recruiting |
NCT03684083 -
Inflammatory Response to Paramyxovirus Infection in an Ex-vivo Model of Bronchial Epithelial Cells in Allogeneic HSCT Recipients
|
||
Recruiting |
NCT00884338 -
Cognitive Function After Stem Cell Transplantation
|
Phase 3 | |
Completed |
NCT00284713 -
Progenitor Cell Therapy in Dilative Cardiomyopathy
|
Phase 1/Phase 2 | |
Withdrawn |
NCT00062543 -
Hepatic Artery Infusion of CD34+ Cells
|
Phase 1 | |
Completed |
NCT00781170 -
Dose-Reduced Allogeneic Stem Cell Transplantation After Autologous High-Dose Chemotherapy in Patients With Multiple Myeloma
|
Phase 2 | |
Recruiting |
NCT03364257 -
iDTECT Blood Performance for the Identification of Viral or Bacterial Pathogens in Febrile Neutropenic Patients
|