Physical Fitness of Allogeneic Stem Cell Transplant

NCT ID: NCT07049536

Last Updated: 2026-01-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

17 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-08-30

Study Completion Date

2026-01-15

Brief Summary

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Hematopoietic stem cell transplantation is a treatment used to restore blood cell function in diseases of myeloid and lymphoid origin, which can be malignant or non-malignant. There are two types: autologous transplantation, which uses the patient's own stem cells, and allogeneic transplantation, which uses stem cells from a donor after a high-dose chemotherapy and radiotherapy preparation. This process can lead to complications such as immune reactions, infections, and organ toxicity, affecting the cardiovascular, musculoskeletal, and nervous systems. These complications often reduce physical activity, muscle strength, lung function, and quality of life.

Before transplantation, it is important to assess patients' comorbidities, functional status, and physical fitness to evaluate their ability to tolerate treatment and risk of complications. Low exercise tolerance and impaired physical function are linked to poorer outcomes. Objective tests of physical function provide valuable information about health status. Pre-transplant muscle strength and cardiopulmonary fitness influence post-transplant recovery, so comprehensive assessments are necessary.

Physiotherapy and rehabilitation support patients by preparing them for treatment, maintaining health during therapy, improving physical function after treatment, and enhancing quality of life in palliative care. Exercise improves functional capacity, quality of life, and daily activities, but symptoms like fatigue, pain, breathlessness, and muscle weakness, as well as other barriers, may limit participation.

Physical fitness is the body's ability to perform daily activities efficiently. Reduced fitness leads to frailty and decreased function, which are associated with increased treatment toxicity and mortality. Although the importance of physical fitness before transplantation is recognized, data from objective measurements are limited. Common pre-transplant assessments include lung function tests, walking tests, handgrip strength, and mobility tests.

This study aims to compare the health-related physical fitness of individuals undergoing allogeneic hematopoietic stem cell transplantation with healthy controls.

Detailed Description

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Conditions

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Hematopoietic Stem Cell Transplantation

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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Transplantation Group

Adult patients who underwent hematopoietic stem cell transplantation

Assessment Group

Intervention Type OTHER

Allogeneic Stem Cell Transplant recipients will be evaluated with a supervisor physiotherapist for 2 days between the time they are admitted to the stem cell transplantation unit.

Control Group

Healthy adults

Control Group

Intervention Type OTHER

Adult healthy group with similar sociodemographic characteristics to the evaluation group.

Interventions

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Assessment Group

Allogeneic Stem Cell Transplant recipients will be evaluated with a supervisor physiotherapist for 2 days between the time they are admitted to the stem cell transplantation unit.

Intervention Type OTHER

Control Group

Adult healthy group with similar sociodemographic characteristics to the evaluation group.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Currently receiving treatment in the Adult Bone Marrow Transplantation Unit
* Between 18 and 65 years of age
* Undergoing standard medical treatment including immunosuppressants, antibiotics, and other medications
* Clinically stable, able to walk, and cooperative
* No history of orthopedic, neurological, or cardiac disorders

Exclusion Criteria

* Presence of cognitive impairments
* Orthopedic or neurological diseases that may affect the evaluation of physical fitness tests
* Presence of facial palsy
* Severe visual impairment or visual field defects
* Acute bleeding, hemoglobin level ≤ 8 g/dL, and platelet count ≤ 10,000/mm³
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Istinye University

OTHER

Sponsor Role lead

Responsible Party

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Kubra Koce

Asst. Prof.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Istinye University

Istanbul, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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24-03

Identifier Type: -

Identifier Source: org_study_id

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