Physical Deteriorations in Allo-HSCT.

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

144 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-03-31

Study Completion Date

2018-10-31

Brief Summary

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Limited number of studies reported impairments in physical activity, exercise capacity and quality of life of allogeneic hematopoietic stem cell transplantation (allogeneic-HSCT) recipients. However, comparison of dyspnea, exercise capacity, physical activity level and quality of life in allogeneic-HSCT recipients versus age-gender matched healthy individuals have not been known so far.To compare dyspnea, submaximal exercise capacity, physical activity level and quality of life in allogeneic-HSCT recipients with healthy individuals.

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Detailed Description

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Hematopoietic stem cell transplantation (HSCT) is a prevalent curative treatment approach for a large variety of diseases affecting hematopoietic systems. More than 50.000 HSCT are implemented all over the world annually. Despite having complex aspect, allogeneic-HSCT also serves as an important chance of survival and cure for patients with hematological malignancies. Allogeneic-HSCT recipients have at least 2-year survival rate, yet long term complications such as chronic health conditions, life-threatening diseases, musculoskeletal and cardiopulmonary disorders may occur in recipients following HSCT due to general state of immunosuppression and medications. Besides pulmonary complications existed in 30-50% of HSCT recipients, pulmonary infiltrates especially after allogeneic HSCT is an ongoing challenge for recipients. All toxic treatments received to cure hematological malignancies including HSCT and various complications seen after HSCT may induce muscle weakness, decreased submaximal exercise capacity and oxygen consumption via impaired skeletal muscle oxygenation in most allogeneic-HSCT long-term survivors. Therefore, European Society for Blood and Marrow Transplantation Group recommends that allied health-care professionals should take part in team for a successful dynamic process of allogeneic-HSCT.

Limited number of studies reported impairments in exercise capacity, physical activity and quality of life in allogeneic-HSCT recipients. However it is not known that to what extent dyspnea, exercise capacity, physical activity and quality of life impair in allogeneic recipients who were over 100 days status post transplantation versus age-gender matched healthy individuals so far. Therefore aspiration of current study was comparison of dyspnea, submaximal exercise capacity, physical activity level and quality of life in allogeneic-HSCT recipients with healthy individuals.

Conditions

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Stem Cell Transplantation

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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Group 1: Allogeneic-HSCT recipients

Dyspnea \[Modified Medical Research Council dyspnea scale (MMRC)\], submaximal exercise capacity \[6-minute walk test (6-MWT)\], physical activity level \[metabolic holter\], quality of life \[European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTCQOL)\] and pulmonary functions \[spirometry\] were evaluated in allogeneic-HSCT recipients (.Vital signs, dyspnea and fatigue perception \[Modified Borg Scale\] were recorded as pre-post measurements of 6-MWT.

No interventions assigned to this group

Group 2: Healthy individuals

Healthy individuals were selected from individuals without known and diagnosed any chronic diseases. Similar measurements were applicated in healthy individuals.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* between ages of 18 and 70
* under standard medical treatment including immunosuppressive, antibiotics and other drugs
* underwent allogeneic HSCT who were at minimum 100 days status post-transplantation

* being 18-70 years of age
* being individuals without known and diagnosed any chronic diseases

Exclusion Criteria

* having cognitive disorder, orthopedic or neurological disease with a potential to affect assessment of exercise capacity,
* having comorbidities such as asthma, chronic obstructive pulmonary disease (COPD), acute respiratory or other infections,
* having problems like visual and mucositis which may prevent measurements,
* acute hemorrhage anywhere in the body,
* hemoglobin value less than 8 g/L and platelet count less than 10.000 mm3

* being current smokers
* being ex-smokers (≥5 packyears).

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes