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CompletedNCT03007602Updated Feb 25, 2021

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

An interventional study of Upper Extremity Aerobic Exercise in Hematopoietic Stem Cell Transplantation and Aerobic Exercise, sponsored by Gazi University. Completed at 1 site in Turkey. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2021-02-25.

Sponsored by Gazi University · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Registered 8 months after the study started (first participant enrolled Apr 2016, registered Dec 2016).
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Hematopoietic Stem Cell Transplantation
  • Aerobic Exercise

Keywords

  • Hematopoietic stem cell transplantation
  • Aerobic exercise
  • Quality of Life
  • Muscle Strength
  • Depression
  • exercise capacity
  • dyspnea
  • anxiety
  • fatigue
  • pulmonary functions
03

In context

Lead sponsor

Gazi University is the lead sponsor of 531 studies on the registry; 99 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
30 participants (actual)

Study arms

  • 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

  • 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.

Interventions

  • OtherUpper 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.

06

What researchers measure

Primary outcomes

  1. functional exercise capacity evaluation

    Evaluated with 6-minute walking test

    Time frame: 6-week

Secondary outcomes

  1. pulmonary functions test

    Evaluated with spirometer

    Time frame: 6-week

  2. muscle strength

    Evaluated with a hand-held dynamometer for peripheral muscles, mouth pressure device for respiratory muscle strength

    Time frame: 6-week

  3. cough strength

    Evaluated with peak flow meter

    Time frame: 6-week

  4. physical activity level

    Evaluated with a metabolic holter

    Time frame: 6-week

  5. fatigue severity

    Evaluated using Fatigue Severity Scale

    Time frame: 6-week

  6. anxiety and depression perception

    Evaluated using Hospital Anxiety and Depression Scale

    Time frame: 6-week

  7. dyspnea perception

    Evaluated using Modified Medical Research Council Dyspnea scale (MMRC) and Modified Borg Scale

    Time frame: 6-week

  8. quality of life level

    evaluated using QOL using European Organization for Research and Treatment of Cancer QOL Questionnaire (EORTCQOL)

    Time frame: 6-week

  9. maximal exercise capacity evaluation

    evaluated using Modified Incremental Shuttle Walk Test

    Time frame: 6-week

07

Study locations

1 site
  • Gazi University Faculty of Health Sciences Department of Physical Therapy and Rehabilitation
    Ankara, Turkey
08

References and documents

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 25, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03007602
Lead sponsor
Gazi University
Responsible party
Meral Boşnak Güçlü (Associate professor, Gazi University) — Principal investigator
First posted
Jan 2, 2017
Start date
Apr 2016
Primary completion
Aug 2018
Completion
Sep 2018
Last update
Feb 25, 2021

Study contacts

Gülşah Barğı, MSc.
study chair · Gazi University
Meral Boşnak Güçlü, PhD.
study director · Gazi University
Zübeyde Nur Özkurt, PhD.
principal investigator · Gazi University
Münci Yağcı, PhD.
principal investigator · Gazi University

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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