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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03007602
Other study ID # Gazi-231
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 2016
Est. completion date September 2018

Study information

Verified date February 2021
Source Gazi University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date September 2018
Est. primary completion date August 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
Turkey Gazi University Faculty of Health Sciences Department of Physical Therapy and Rehabilitation Ankara

Sponsors (1)

Lead Sponsor Collaborator
Gazi University

Country where clinical trial is conducted

Turkey, 

Outcome

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