Clinical trial NCT03007602: Effects of Upper Extremity Aerobic Exercise Training in Hematopoietic Stem Cell Transplantation Recipients
Official title: Effects of Upper Extremity Aerobic Exercise Training in Hematopoietic Stem Cell Transplantation Recipients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hematopoietic Stem Cell Transplantation
Aerobic Exercise
Keywords: Hematopoietic stem cell transplantation
Aerobic exercise
Quality of Life
Muscle Strength
Depression
exercise capacity
dyspnea
anxiety
fatigue
pulmonary functions
Lead sponsor: Gazi University
Sponsor class: OTHER
First posted: 2017-01-02
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: functional exercise capacity evaluation
timeFrame: 6-week
Secondary outcomes:
measure: pulmonary functions test
timeFrame: 6-week
measure: muscle strength
timeFrame: 6-week
measure: cough strength
timeFrame: 6-week
measure: physical activity level
timeFrame: 6-week
measure: fatigue severity
timeFrame: 6-week
measure: anxiety and depression perception
timeFrame: 6-week
measure: dyspnea perception
timeFrame: 6-week
measure: quality of life level
timeFrame: 6-week
measure: maximal exercise capacity evaluation
timeFrame: 6-week
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Gazi University Faculty of Health Sciences Department of Physical Therapy and Rehabilitation
Study officials:
affiliation: Gazi University
name: Gülşah Barğı, MSc.
role: STUDY_CHAIR
affiliation: Gazi University
name: Meral Boşnak Güçlü, PhD.
role: STUDY_DIRECTOR
affiliation: Gazi University
name: Zübeyde Nur Özkurt, PhD.
role: PRINCIPAL_INVESTIGATOR
affiliation: Gazi University
name: Münci Yağcı, PhD.
role: PRINCIPAL_INVESTIGATOR
References: