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

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ClinicalTrials.gov Identifier: NCT03007602
Recruitment Status : Completed
First Posted : January 2, 2017
Last Update Posted : October 9, 2018
Sponsor:
Information provided by (Responsible Party):
Meral Boşnak Güçlü, 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.

Condition or disease Intervention/treatment Phase
Hematopoietic Stem Cell Transplantation Aerobic Exercise Other: Upper Extremity Aerobic Exercise Not Applicable

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  (Clinical Trial)
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 : April 2016
Actual Primary Completion Date : August 2018
Actual Study Completion Date : September 2018

Resource links provided by the National Library of Medicine


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.



Primary Outcome Measures :
  1. functional exercise capacity evaluation [ Time Frame: 6-week ]
    Evaluated with 6-minute walking test


Secondary Outcome Measures :
  1. pulmonary functions test [ Time Frame: 6-week ]
    Evaluated with spirometer

  2. muscle strength [ Time Frame: 6-week ]
    Evaluated with a hand-held dynamometer for peripheral muscles, mouth pressure device for respiratory muscle strength

  3. cough strength [ Time Frame: 6-week ]
    Evaluated with peak flow meter

  4. physical activity level [ Time Frame: 6-week ]
    Evaluated with a metabolic holter

  5. fatigue severity [ Time Frame: 6-week ]
    Evaluated using Fatigue Severity Scale

  6. anxiety and depression perception [ Time Frame: 6-week ]
    Evaluated using Hospital Anxiety and Depression Scale

  7. dyspnea perception [ Time Frame: 6-week ]
    Evaluated using Modified Medical Research Council Dyspnea scale (MMRC) and Modified Borg Scale

  8. quality of life level [ Time Frame: 6-week ]
    evaluated using QOL using European Organization for Research and Treatment of Cancer QOL Questionnaire (EORTCQOL)

  9. maximal exercise capacity evaluation [ Time Frame: 6-week ]
    evaluated using Modified Incremental Shuttle Walk Test



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03007602


Locations
Turkey
Gazi University Faculty of Health Sciences Department of Physical Therapy and Rehabilitation
Ankara, Turkey
Sponsors and Collaborators
Gazi University
Investigators
Study Chair: Gülşah Barğı, MSc. Gazi University
Study Director: Meral Boşnak Güçlü, PhD. Gazi University
Principal Investigator: Zübeyde Nur Özkurt, PhD. Gazi University
Principal Investigator: Münci Yağcı, PhD. Gazi University

Additional Information:
Responsible Party: Meral Boşnak Güçlü, Associate professor, Gazi University
ClinicalTrials.gov Identifier: NCT03007602     History of Changes
Other Study ID Numbers: Gazi-231
First Posted: January 2, 2017    Key Record Dates
Last Update Posted: October 9, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
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.

Keywords provided by Meral Boşnak Güçlü, Gazi University:
Hematopoietic stem cell transplantation
Aerobic exercise
Quality of Life
Muscle Strength
Depression
exercise capacity
dyspnea
anxiety
fatigue
pulmonary functions