Stem Cell TransplantationNCT03915249
Physical Functions in Allogeneic-HSCT Candidates
An observational study of Stem Cell Transplantation, run by Gazi University.
Trial summary
Physical inactivity and impairments in physical functions have been observed in patients due to hematological malignancy itself and treatments of chemotherapy, radiotherapy, corticosteroids. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Stem Cell Transplantation
- How many people
- 49 participants
- Where
- No sites listed yet
- Study dates
- Jan 2017to Feb 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Adult, Older adult
Study population: Patients were previously diagnosed with a hematological malignancy and determined to be a candidate for allogeneic-HSCT who were orientated from Bone Marrow Transplantation Unit for rehabilitation program.Study was planned as retrospective, cross sectional and approved by the local Ethics Committee. Informed consent was obtained from all individual participants included in the study.
Who may be able to join
- being 18-65 years of age,
- having a diagnosis with hematologic malignancy
- being clinically stabile,
- being an allogeneic-HSCT candidate
- receiving optimal standard medical therapy including antibiotics, supplements and other drugs.
Who cannot join
- having cooperation problems,
- having orthopedic or neurological disease with a potential to prevent assessment of exercise capacity,
- having comorbidities such as chronic obstructive pulmonary disease, cardiac diseases,
- acute infections and/or hemorrhage.
About this study
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.
Read the detailed description
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.
- Conditions
- Stem Cell Transplantation
- Keywords
- Energy metabolism, Exercise test, Leisure activities, Hematopoietic stem cell transplantation, Muscle strength, Respiratory function test, Exercise
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Allogeneic-HSCT candidates | Physical activity, pulmonary functions (FEV1, FVC, FEV1/FVC, FEF25-75%, PEF), exercise capacity, respiratory (maximal inspiratory and expiratory pressures (MIP, MEP)) and peripheral muscle strength were evaluated in allogeneic-HSCT candidates. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical activity measurement
Physical activity levels of candidates were assessed with a metabolic holter device.
Measured: during a total of 48 hours
Secondary outcomes (4)
Pulmonary function assessment
It was evaluated using a spirometry by which is evaluated dynamic lung functions involving forced vital capacity (FVC), forced expiratory volume in one second (FEV1), forced expiratory volume in one second/forced vital capacity (FEV1/FVC), peak expiratory flow (PEF) and forced expiratory flow at 25%-75% (FEF25-75%). All of them are expressed as both liter (L) and percentages (%) of expected values. We used only percentages (%) of expected values for this study.
Measured: 5 minutes
inspiratory and expiratory muscle strength (MIP, MEP)
Respiratory muscle strength was evaluated with a mouth pressure device
Measured: 5-10 minutes
Quadriceps femoris muscle strength
Peripheral muscle strength was evaluated with a hand-held dynamometer
Measured: 5 minutes
Six-minute walk test
Six-minute walk test was used to evaluate exercise capacity of candidates with reference to American Thoracic Society criteria.
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2019
- Study startJan 2017
- Primary completionDec 2018
- Study completionFeb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Stem Cell TransplantationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Meral Boşnak Güçlü, Gazi University
- Investigators
- Gülşah Barğı, PhD, Study chair, Gazi UniversityMeral Boşnak Güçlü, PhD, Study director, Gazi UniversityGülsan Türköz Sucak, PhD., Principal investigator, Medikalpark hastanesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03915249
- Sponsor's protocol ID
- GaziUniversity17
- Status last verified
- Apr 2019
- First submitted
- 11 Apr 2019
- Last updated
- 19 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bergenthal N, Will A, Streckmann F, Wolkewitz KD, Monsef I, Engert A, Elter T, Skoetz N. Aerobic physical exercise for adult patients with haematological malignancies. Cochrane Database Syst Rev. 2014 Nov 11;(11):CD009075. doi: 10.1002/14651858.CD009075.pub2.
PubMed 25386666Vermaete N, Wolter P, Verhoef G, Gosselink R. Physical activity and physical fitness in lymphoma patients before, during, and after chemotherapy: a prospective longitudinal study. Ann Hematol. 2014 Mar;93(3):411-24. doi: 10.1007/s00277-013-1881-3. Epub 2013 Aug 21.
PubMed 23963412Gillis TA, Donovan ES. Rehabilitation following bone marrow transplantation. Cancer. 2001 Aug 15;92(4 Suppl):998-1007. doi: 10.1002/1097-0142(20010815)92:4+3.0.co;2-k.
PubMed 11519026Steinberg A, Asher A, Bailey C, Fu JB. The role of physical rehabilitation in stem cell transplantation patients. Support Care Cancer. 2015 Aug;23(8):2447-60. doi: 10.1007/s00520-015-2744-3. Epub 2015 May 14.
PubMed 25971213Hung YC, Bauer J, Horsley P, Waterhouse M, Bashford J, Isenring E. Changes in nutritional status, body composition, quality of life, and physical activity levels of cancer patients undergoing autologous peripheral blood stem cell transplantation. Support Care Cancer. 2013 Jun;21(6):1579-86. doi: 10.1007/s00520-012-1698-y. Epub 2013 Jan 10.
PubMed 23306934White AC, Terrin N, Miller KB, Ryan HF. Impaired respiratory and skeletal muscle strength in patients prior to hematopoietic stem-cell transplantation. Chest. 2005 Jul;128(1):145-52. doi: 10.1378/chest.128.1.145.
PubMed 16002928Morishita S, Kaida K, Ikegame K, Yoshihara S, Taniguchi K, Okada M, Kodama N, Ogawa H, Domen K. Impaired physiological function and health-related QOL in patients before hematopoietic stem-cell transplantation. Support Care Cancer. 2012 Apr;20(4):821-9. doi: 10.1007/s00520-011-1156-2. Epub 2011 Apr 9.
PubMed 21479522
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03915249
- Acronym / sponsor ID
- GaziUniversity17
- Conditions
- Stem Cell Transplantation
- Keywords
- Energy metabolism, Exercise test, Leisure activities, Hematopoietic stem cell transplantation, Muscle strength, Respiratory function test, Exercise
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Gazi UniversityUniversity, hospital or other
- Study start
- Jan 2017 (actual)
- Primary completion
- Dec 2018 (actual)
- Study completion
- Feb 2019 (actual)
- First posted
- 16 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Allogeneic-HSCT candidates | – | –Physical activity, pulmonary functions (FEV1, FVC, FEV1/FVC, FEF25-75%, PEF), exercise capacity, respiratory (maximal inspiratory and expiratory pressures (MIP, MEP)) and peripheral muscle strength were evaluated in allogeneic-HSCT candidates. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients were previously diagnosed with a hematological malignancy and determined to be a candidate for allogeneic-HSCT who were orientated from Bone Marrow Transplantation Unit for rehabilitation program.Study was planned as retrospective, cross sectional and approved by the local Ethics Committee. Informed consent was obtained from all individual participants included in the study.
Key inclusion criteria (5 listed)
- being 18-65 years of age,
- having a diagnosis with hematologic malignancy
- being clinically stabile,
- being an allogeneic-HSCT candidate
- receiving optimal standard medical therapy including antibiotics, supplements and other drugs.
Key exclusion criteria (4 listed)
- having cooperation problems,
- having orthopedic or neurological disease with a potential to prevent assessment of exercise capacity,
- having comorbidities such as chronic obstructive pulmonary disease, cardiac diseases,
- acute infections and/or hemorrhage.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Physical activity measurement
Time frame: during a total of 48 hours
Physical activity levels of candidates were assessed with a metabolic holter device.
4 secondary outcomes
Pulmonary function assessment
Time frame: 5 minutes
inspiratory and expiratory muscle strength (MIP, MEP)
Time frame: 5-10 minutes
Quadriceps femoris muscle strength
Time frame: 5 minutes
Six-minute walk test
Time frame: 10 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2019.
- Results publication: PubMed 25386666Bergenthal N, Will A, Streckmann F, Wolkewitz KD, Monsef I, Engert A, Elter T, Skoetz N. Aerobic physical exercise for adult patients with haematological malignancies. Cochrane Database Syst Rev. 2014 Nov 11;(11):CD009075. doi: 10.1002/14651858.CD009075.pub2.
- Results publication: PubMed 23963412Vermaete N, Wolter P, Verhoef G, Gosselink R. Physical activity and physical fitness in lymphoma patients before, during, and after chemotherapy: a prospective longitudinal study. Ann Hematol. 2014 Mar;93(3):411-24. doi: 10.1007/s00277-013-1881-3. Epub 2013 Aug 21.
- Results publication: PubMed 11519026Gillis TA, Donovan ES. Rehabilitation following bone marrow transplantation. Cancer. 2001 Aug 15;92(4 Suppl):998-1007. doi: 10.1002/1097-0142(20010815)92:4+3.0.co;2-k.
- Results publication: PubMed 25971213Steinberg A, Asher A, Bailey C, Fu JB. The role of physical rehabilitation in stem cell transplantation patients. Support Care Cancer. 2015 Aug;23(8):2447-60. doi: 10.1007/s00520-015-2744-3. Epub 2015 May 14.
- Results publication: PubMed 23306934Hung YC, Bauer J, Horsley P, Waterhouse M, Bashford J, Isenring E. Changes in nutritional status, body composition, quality of life, and physical activity levels of cancer patients undergoing autologous peripheral blood stem cell transplantation. Support Care Cancer. 2013 Jun;21(6):1579-86. doi: 10.1007/s00520-012-1698-y. Epub 2013 Jan 10.
- Results publication: PubMed 16002928White AC, Terrin N, Miller KB, Ryan HF. Impaired respiratory and skeletal muscle strength in patients prior to hematopoietic stem-cell transplantation. Chest. 2005 Jul;128(1):145-52. doi: 10.1378/chest.128.1.145.
- Results publication: PubMed 21479522Morishita S, Kaida K, Ikegame K, Yoshihara S, Taniguchi K, Okada M, Kodama N, Ogawa H, Domen K. Impaired physiological function and health-related QOL in patients before hematopoietic stem-cell transplantation. Support Care Cancer. 2012 Apr;20(4):821-9. doi: 10.1007/s00520-011-1156-2. Epub 2011 Apr 9.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gülşah Barğı, PhD study chair
Gazi University
Meral Boşnak Güçlü, PhD study director
Gazi University
Gülsan Türköz Sucak, PhD. principal investigator
Medikalpark hastanesi
Questions about this trial
What is this clinical trial studying?
An observational study of Stem Cell Transplantation, run by Gazi University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physical activity measurement (time frame: during a total of 48 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03915249, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2019.