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

Hematopoietic Stem Cell Transplantation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03007602
• Other study ID #: Gazi-231
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Aerobic Exercise
• Hematopoietic Stem Cell Transplantation

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

External Links

•   'Best supportive care' has had its day.
•   Aerobic physical exercise for adult patients with haematological malignancies.
•   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).