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

Sponsor

Gazi University (Other)

Overall Status

Completed

CT.gov ID

NCT03007602

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hematopoietic Stem Cell Transplantation Aerobic Exercise	Other: Upper Extremity Aerobic Exercise	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

30 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Supportive Care

Official Title:

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

Actual Study Start Date :

Apr 1, 2016

Actual Primary Completion Date :

Aug 1, 2018

Actual Study Completion Date :

Sep 1, 2018

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

functional exercise capacity evaluation [6-week]
Evaluated with 6-minute walking test

Secondary Outcome Measures

pulmonary functions test [6-week]
Evaluated with spirometer
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
physical activity level [6-week]
Evaluated with a metabolic holter
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)
maximal exercise capacity evaluation [6-week]
evaluated using Modified Incremental Shuttle Walk Test

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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