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Physical Functions in Allogeneic-HSCT Candidates

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03915249
Recruitment Status : Completed
First Posted : April 16, 2019
Last Update Posted : April 19, 2019
Information provided by (Responsible Party):
Meral Boşnak Güçlü, Gazi University

Brief Summary:
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.

Condition or disease
Stem Cell Transplantation

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Study Type : Observational
Actual Enrollment : 49 participants
Observational Model: Case-Control
Time Perspective: Retrospective
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
Actual Study Start Date : January 2017
Actual Primary Completion Date : December 2018
Actual Study Completion Date : February 2019

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.

Primary Outcome Measures :
  1. Physical activity measurement [ Time Frame: during a total of 48 hours ]
    Physical activity levels of candidates were assessed with a metabolic holter device.

Secondary Outcome Measures :
  1. Pulmonary function assessment [ Time Frame: 5 minutes ]
    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.

  2. inspiratory and expiratory muscle strength (MIP, MEP) [ Time Frame: 5-10 minutes ]
    Respiratory muscle strength was evaluated with a mouth pressure device

  3. Quadriceps femoris muscle strength [ Time Frame: 5 minutes ]
    Peripheral muscle strength was evaluated with a hand-held dynamometer

  4. Six-minute walk test [ Time Frame: 10 minutes ]
    Six-minute walk test was used to evaluate exercise capacity of candidates with reference to American Thoracic Society criteria.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
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.

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03915249

Sponsors and Collaborators
Gazi University
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Study Chair: Gülşah Barğı, PhD Gazi Üniversitesi
Study Director: Meral Boşnak Güçlü, PhD Gazi Üniversitesi
Principal Investigator: Gülsan Türköz Sucak, PhD. Medikalpark hastanesi
Publications of Results:

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Responsible Party: Meral Boşnak Güçlü, Associate professor, Gazi University Identifier: NCT03915249    
Other Study ID Numbers: GaziUniversity17
First Posted: April 16, 2019    Key Record Dates
Last Update Posted: April 19, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Meral Boşnak Güçlü, Gazi University:
Energy metabolism
Exercise test
Leisure activities
Hematopoietic stem cell transplantation
Muscle strength
Respiratory function test