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Physical Inactivity in Candidates of HSCT

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ClinicalTrials.gov Identifier: NCT03915210
Recruitment Status : Completed
First Posted : April 16, 2019
Last Update Posted : October 22, 2020
Sponsor:
Information provided by (Responsible Party):
Meral Boşnak Güçlü, Gazi University

Brief Summary:
Decreased number of steps and poorer quality of life are prevalently observed among candidates of hematopoietic stem cell transplantation (HSCT). However, impairments in other aspects of physical activity measurement including energy expenditure, physical activity duration, metabolic equivalents of daily task (METs) and lying down duration are still unknown in candidates based on comparison with healthy individuals, which was therefore aimed to investigate in current study.

Condition or disease
Hematopoietic Stem Cell Transplantation

Show Show detailed description

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Study Type : Observational
Actual Enrollment : 94 participants
Observational Model: Case-Control
Time Perspective: Retrospective
Official Title: Physical Activity Level, Pulmonary Functions and Quality of Life in Candidates of Hematopoietic Stem Cell Transplantation and Healthy Individuals: a Cross-sectional Study
Actual Study Start Date : January 2012
Actual Primary Completion Date : November 2014
Actual Study Completion Date : December 2014


Group/Cohort
Candidates of HSCT
Physical activity level using a metabolic holter device, dynamic lung volumes (FEV1, FVC, FEV1/FVC, PEF, FEF25-75%) using a spirometer and quality of life using European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 version 3.0 were objectively evaluated.
Healthy individuals
Physical activity level using a metabolic holter device, dynamic lung volumes (FEV1, FVC, FEV1/FVC, PEF, FEF25-75%) using a spirometer and quality of life using European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 version 3.0 were objectively evaluated.



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


Secondary Outcome Measures :
  1. Evaluation of dynamic lung volumes [ Time Frame: 5 minutes ]
    To assess dynamic lung volumes 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%), a spirometer was used. Guidelines were taken reference for this measurement. These values were recorded as percentages of predicted values.

  2. General quality of life assesment: European Organization for Research and Treatment of Cancer QOL Questionnaire (EORTCQOL) [ Time Frame: 2 minutes ]
    European Organization for Research and Treatment of Cancer QOL Questionnaire C30 version3.0 was used to evaluate quality of life impairment. This is a self-administered questionnaire which consists of five functional subscales along with a social functioning subscale, three symptom subscales with also a fatigue subscale, a global health status subscale, and several single items. All item scores are converted to values from 0 to 100. Higher values show higher health levels in functional and social functioning subscales, a higher quality of life level in global health status subscale, and increased presence of symptoms in both symptom and fatigue subscales.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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. Healthy individuals were recruited from staff in the university and their healthy relatives.
Criteria

Inclusion Criteria for the candidates:

  • being aged between 18 and 65 years, being a candidate for either allogeneic or autologous HSCT before the start of conditioning regimen who were orientated from Bone Marrow Transplantation Unit,
  • having a diagnosis with a hematologic malignancy,
  • being clinically stabile,
  • being functionally mobile
  • receiving optimal standard medical therapy including antibiotics, supplements and other drugs.

Exclusion Criteria for the candidates:

  • having cooperation problems, having orthopedic or neurological disease with a potential to limit daily walking,
  • having comorbidities such as chronic obstructive pulmonary disease, cardiac diseases, acute infections and/or active hemorrhage (with hemoglobin values ≤8 g/L and platelet count ≤10.000 mm3)

Inclusion Criteria for the healthy individuals:

  • being eager to participate to the study
  • being aged between 18 and 65 years,

Exclusion Criteria for the healthy individuals:

  • having any diagnosis of chronic diseases
  • being current smokers
  • being ex-smokers (≥10 pack*years)

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 ClinicalTrials.gov identifier (NCT number): NCT03915210


Sponsors and Collaborators
Gazi University
Investigators
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Study Chair: Gülşah Barğı, PhD Gazi Üniversitesi
Study Director: Meral Boşnak Güçlü, PhD Gazi Üniversitesi
Publications of Results:

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Responsible Party: Meral Boşnak Güçlü, Associate professor, Gazi University
ClinicalTrials.gov Identifier: NCT03915210    
Other Study ID Numbers: GaziUniversity18
First Posted: April 16, 2019    Key Record Dates
Last Update Posted: October 22, 2020
Last Verified: October 2020
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
respiratory function test
quality of life
leisure activities
hematopoietic stem cell transplantation