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Physical Functions in Allogeneic-HSCT Candidates

17 april 2019 bijgewerkt door: Meral Boşnak Güçlü, Gazi University

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.

Studie Overzicht

Toestand

Voltooid

Gedetailleerde beschrijving

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.

Studietype

Observationeel

Inschrijving (Werkelijk)

49

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar tot 65 jaar (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

NVT

Geslachten die in aanmerking komen voor studie

Allemaal

Bemonsteringsmethode

Niet-waarschijnlijkheidssteekproef

Studie Bevolking

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.

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Observatiemodellen: Case-control
  • Tijdsperspectieven: Retrospectief

Cohorten en interventies

Groep / Cohort
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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Physical activity measurement
Tijdsspanne: during a total of 48 hours
Physical activity levels of candidates were assessed with a metabolic holter device.
during a total of 48 hours

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
inspiratoire en expiratoire spierkracht (MIP, MEP)
Tijdsspanne: 5-10 minuten
De ademhalingsspierkracht werd geëvalueerd met een monddrukapparaat
5-10 minuten
Quadriceps femoris spierkracht
Tijdsspanne: 5 minuten
Perifere spierkracht werd geëvalueerd met een hand-held dynamometer
5 minuten
Pulmonary function assessment
Tijdsspanne: 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.
5 minutes
Six-minute walk test
Tijdsspanne: 10 minutes
Six-minute walk test was used to evaluate exercise capacity of candidates with reference to American Thoracic Society criteria.
10 minutes

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Onderzoekers

  • Hoofdonderzoeker: Gülsan Türköz Sucak, PhD., Medikalpark hastanesi

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

1 januari 2017

Primaire voltooiing (Werkelijk)

1 december 2018

Studie voltooiing (Werkelijk)

1 februari 2019

Studieregistratiedata

Eerst ingediend

11 april 2019

Eerst ingediend dat voldeed aan de QC-criteria

12 april 2019

Eerst geplaatst (Werkelijk)

16 april 2019

Updates van studierecords

Laatste update geplaatst (Werkelijk)

19 april 2019

Laatste update ingediend die voldeed aan QC-criteria

17 april 2019

Laatst geverifieerd

1 april 2019

Meer informatie

Termen gerelateerd aan deze studie

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

Nee

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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