Skip to main content
OpenTrials
Completed

NCT Number: NCT03007602

Effects of Upper Extremity Aerobic Exercise Training in Hematopoietic Stem Cell Transplantation Recipients

Hematologic malignancy is a tumor of myeloid or lymphatic cells that affects lymph nodes with the involvement of blood, bone marrow or other organs.There are various treatment options for hematological malignancies ranging from follow-up to single or multiple agent chemotherapy, radiotherapy, immunotherapy and autologous or allogeneic hematopoietic stem cell transplantations (HSCT). The general recommendation for patients is to relax and avoid intense exercise, regardless of the devastating consequences of neglecting physical exercise. Patients also go to relaxation by reducing their activity to avoid fatigue, which leads to loss of muscle strength and endurance. As a consequence of all, fatigue, vomiting, weight loss, anemia, depression, decreased aerobic capacity, muscle weakness, decreased physical function and poor quality of life are observed in HSCT recipients. It has been shown that physical exercises improve oxygen consumption, depression and fatigue, cardiorespiratory fitness, muscle strength and physical well-being in patients with hematologic malignancies who are at stages of various treatments. In literature, effects of upper extremity aerobic exercise training have been investigated in patients with spinal cord injury, neuromuscular diseases, claudication, hypertension, multiple sclerosis, heart failure, paraplegic patients and healthy individuals. Results of these studies has shown that upper extremity aerobic exercise training improves walking distance, increases oxygen pulse, muscle strength and endurance of upper extremity. No study was observed to investigate the effects of upper extremity aerobic exercise training on exercise capacity and quality of life in HSCT recipients, as we know. For this reason, our aim is to investigate the effects of upper extremity aerobic exercise training on exercise capacity and quality of life in HSCT recipients.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Gazi University Faculty of Health Sciences Department of Physical Therapy and Rehabilitation

Ankara, Turkey (Türkiye)

About this study

Minimum 30 allogeneic and autologous HSCT recipients (˃100 days past post-transplant status) will be included. Before and after 6-week upper extremity aerobic exercise training, maximal and submaximal exercise capacity, respiratory and peripheral muscle strength, pulmonary functions, physical activity, dyspnea and fatigue perception, anxiety, depression and quality of life were evaluated. Primary outcome measurements were exercise capacity and quality of life , secondary outcomes were respiratory and peripheral muscle strength, pulmonary functions, physical activity, dyspnea and fatigue perception, anxiety and depression.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • being an hematopoietic stem cell transplantation recipient during the intermediate/late post-transplant phase (>100 days),
  • 18-65 years of age
  • under standard medications.

Exclusion criteria

  • having a cognitive disorder,
  • orthopedic or neurological disease with a potential to affect functional capacity,
  • comorbidities such as asthma, chronic obstructive pulmonary disease (COPD), acute infections or pneumonia,
  • problems which may prevent training such as visual problems and mucositis
  • having metastasis to any region (bone etc.)
  • having acute hemorrhage in the intracranial and / or lung and other areas
  • having any contraindication to exercise training

Treatment and study plan

Upper Extremity Aerobic Exercise

Other

Range of maximal heart rate is being followed by a polar band during supervised session each week.

Aerobic exercise is being trained for 30 min-per/day, 3 days/week, 6 weeks. All sessions are being performed by a physiotherapist at cardiopulmonary rehabilitation department.

Primary outcomes

  1. functional exercise capacity evaluation

    Time frame: 6-week

    Evaluated with 6-minute walking test

Secondary outcomes

  1. pulmonary functions test

    Time frame: 6-week

    Evaluated with spirometer

  2. muscle strength

    Time frame: 6-week

    Evaluated with a hand-held dynamometer for peripheral muscles, mouth pressure device for respiratory muscle strength

  3. cough strength

    Time frame: 6-week

    Evaluated with peak flow meter

  4. physical activity level

    Time frame: 6-week

    Evaluated with a metabolic holter

  5. fatigue severity

    Time frame: 6-week

    Evaluated using Fatigue Severity Scale

  6. anxiety and depression perception

    Time frame: 6-week

    Evaluated using Hospital Anxiety and Depression Scale

  7. dyspnea perception

    Time frame: 6-week

    Evaluated using Modified Medical Research Council Dyspnea scale (MMRC) and Modified Borg Scale

  8. quality of life level

    Time frame: 6-week

    evaluated using QOL using European Organization for Research and Treatment of Cancer QOL Questionnaire (EORTCQOL)

  9. maximal exercise capacity evaluation

    Time frame: 6-week

    evaluated using Modified Incremental Shuttle Walk Test

Sponsors and collaborators

Lead sponsor

Gazi University

Other

Registry information

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Jan 2, 2017
Registry last updated
Feb 25, 2021

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.