Skip to main content
OpenTrials
Completed

NCT Number: NCT03606005

Physical Deteriorations in Allo-HSCT.

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Gazi University Faculty of Health Science Department of Physiotherapy and Rehabilitation

Ankara, 06010, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

for recipients:

  • 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

Exclusion criteria

for recipients:

  • 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

Inclusion criteria

for healthy individuals:

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

Exclusion criteria

for healthy individuals:

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

Treatment and study plan

Primary outcomes

  1. 6-minute walk test (6-MWT)

    Time frame: 10 minutes

    Submaximal exercise capacity was evaluated with this test.

Secondary outcomes

  1. Pulmonary function test

    Time frame: 5 minutes

    Pulmonary functions were evaluated using a spirometry.

  2. Dyspnea scale

    Time frame: 2 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.

  3. Physical activity measurement

    Time frame: 3 days

    For this evaluation, a metabolic holter was used.

  4. Quality of life Scale

    Time frame: 2 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.

Sponsors and collaborators

Lead sponsor

Gazi University

Other

Registry information

Official study title

Deteriorations in Dyspnea, Exercise Capacity, Physical Activity and Quality of Life of Allogeneic Hematopoietic Stem Cell Transplantation Survivors Versus Healthy Individuals: a Retrospective, Cross Sectional Study

Important dates

Study start
2012
Primary completion
2017
Study completion
2018
First posted
Jul 30, 2018
Registry last updated
May 28, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.