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

Not Applicable

Completed

• Conditions: Aerobic Exercise; Hematopoietic Stem Cell Transplantation
• Interventions: Other: Upper Extremity Aerobic Exercise

• Registration Number: NCT03007602
• Lead Sponsor: Gazi University

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.

Study Timeline

• Study Start: 2016-04
• Study First Submitted: 2016-12-16
• Study First Submitted QC: 2016-12-28
• Study First Posted: 2017-01-02
• Primary Completion: 2018-08
• Study Completion: 2018-09
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-24
• Last Update Posted: 2021-02-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment group: aerobic exercise	Upper Extremity Aerobic Exercise	The upper extremity aerobic exercise training with an arm ergometer will be performed in the treatment group so that training intensity will be between 60% and 80% of the maximum heart rate, dyspnea perception will be 3-4 according to Modified Borg Scale and fatigue perception will be 5-6 according to Modified Borg Scale, training duration will be a 6-week.

Primary Outcome Measures

Name	Time	Method
functional exercise capacity evaluation	6-week	Evaluated with 6-minute walking test

Secondary Outcome Measures

Name	Time	Method
physical activity level	6-week	Evaluated with a metabolic holter
muscle strength	6-week	Evaluated with a hand-held dynamometer for peripheral muscles, mouth pressure device for respiratory muscle strength
cough strength	6-week	Evaluated with peak flow meter
fatigue severity	6-week	Evaluated using Fatigue Severity Scale
anxiety and depression perception	6-week	Evaluated using Hospital Anxiety and Depression Scale
dyspnea perception	6-week	Evaluated using Modified Medical Research Council Dyspnea scale (MMRC) and Modified Borg Scale
quality of life level	6-week	evaluated using QOL using European Organization for Research and Treatment of Cancer QOL Questionnaire (EORTCQOL)
pulmonary functions test	6-week	Evaluated with spirometer
maximal exercise capacity evaluation	6-week	evaluated using Modified Incremental Shuttle Walk Test

Trial Locations

Locations (1)

Gazi University Faculty of Health Sciences Department of Physical Therapy and Rehabilitation; 🇹🇷 Ankara, Turkey