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Physical Deteriorations in Allo-HSCT.

Completed
Conditions
Stem Cell Transplantation
Registration Number
NCT03606005
Lead Sponsor
Gazi University
Brief Summary

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.

Detailed Description

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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
144
Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
6-minute walk test (6-MWT)10 minutes

Submaximal exercise capacity was evaluated with this test.

Secondary Outcome Measures
NameTimeMethod
Pulmonary function test5 minutes

Pulmonary functions were evaluated using a spirometry.

Dyspnea scale2 minutes

Severity of dyspnea during daily living activities was evaluated using Modified Medical Research Council (MMRC) dyspnea scale. Dyspnea is graded between zero (absence of dyspnea during strenuous exercise) to four (presence of dyspnea during all daily living activities). Minimal clinically important difference (MCID) is 1 U for MMRC dyspnea scale.

Physical activity measurement3 days

For this evaluation, a metabolic holter was used.

Quality of life Scale2 minutes

European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 version3.0 (EORTC QLQ-C30) was used to evaluate aspects of quality of life impairment. Self-administered questionnaire incorporates five functional scales including social functioning subscale, three symptom scales including fatigue subscale, a global health status and several single items. All item scores are transformed to 0-100. Higher values represent higher functional/healthy level in functional scales, a higher quality of life level in global health status and increased presence of symptoms in symptom scales.

Trial Locations

Locations (1)

Gazi University Faculty of Health Science Department of Physiotherapy and Rehabilitation

🇹🇷

Ankara, Turkey

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