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Clinical Trials/NCT03007602
NCT03007602CompletedNot Applicable

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

Gazi University1 site in 1 country30 target enrollmentStarted: April 1, 2016Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
30
Locations
1
Primary Endpoint
functional exercise capacity evaluation

Study Overview

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.

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
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Supportive Care
Masking
Single (Participant)

Eligibility Criteria

Ages
18 Years to 65 Years (Adult, Older Adult)
Sex
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

  • •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

Arms & Interventions

Treatment group: aerobic exercise

Experimental

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.

Intervention: Upper Extremity Aerobic Exercise (Other)

Control group: deep breathing exercise

No Intervention

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.

Outcomes

Primary Outcomes

functional exercise capacity evaluation

Time Frame: 6-week

Evaluated with 6-minute walking test

Secondary Outcomes

  • physical activity level(6-week)
  • muscle strength(6-week)
  • cough strength(6-week)
  • fatigue severity(6-week)
  • anxiety and depression perception(6-week)
  • dyspnea perception(6-week)
  • quality of life level(6-week)
  • pulmonary functions test(6-week)
  • maximal exercise capacity evaluation(6-week)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Meral Boşnak Güçlü

Associate professor

Gazi University

Study Sites (1)

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