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.

Study Overview

• Status: Completed
• Conditions: Hematopoietic Stem Cell Transplantation; Aerobic Exercise
• Intervention / Treatment: Other: Upper Extremity Aerobic Exercise

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 Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Ankara, Turkey
    • Gazi University Faculty of Health Sciences Department of Physical Therapy and Rehabilitation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment group: 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.	Other: Upper Extremity Aerobic Exercise; 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.
No Intervention: Control group: deep breathing exercise; Deep breathing exercises combinated with arm movements will be given as a home schedule in the control group. Training duration will be a 6-week.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
functional exercise capacity evaluation	Evaluated with 6-minute walking test	6-week

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Gazi University
• Investigators: Study Director: Meral Boşnak Güçlü, PhD., Gazi University; Study Chair: Gülşah Barğı, MSc., Gazi University; Principal Investigator: Zübeyde Nur Özkurt, PhD., Gazi University; Principal Investigator: Münci Yağcı, PhD., Gazi University

Publications and helpful links

Helpful Links

• 'Best supportive care' has had its day.
• Management of bleeding and of invasive procedures in patients with platelet disorders and/or thrombocytopenia: Guidelines of the Italian Society for Haemostasis and Thrombosis (SISET).
• Aerobic physical exercise for adult patients with haematological malignancies.

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2016
• Primary Completion (Actual): August 1, 2018
• Study Completion (Actual): September 1, 2018

Study Registration Dates

• First Submitted: December 16, 2016
• First Submitted That Met QC Criteria: December 28, 2016
• First Posted (Estimate): January 2, 2017

Study Record Updates

• Last Update Posted (Actual): February 25, 2021
• Last Update Submitted That Met QC Criteria: February 24, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: Depression; fatigue; Aerobic exercise; Quality of Life; exercise capacity; anxiety; Muscle Strength; Hematopoietic stem cell transplantation; pulmonary functions; dyspnea
• Other Study ID Numbers: Gazi-231

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: There is not a plan to make individual participant data but when the statistical analyses of all data are made, all results will be shared.