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

NCT03007602 | Completed

• 1 other identifier: Gazi-231
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• functional exercise capacity evaluation

  Evaluated with 6-minute walking test

  6-week

Secondary Outcomes (9)

• pulmonary functions test

  6-week

• muscle strength

  6-week

• cough strength

  6-week

• physical activity level

  6-week

• fatigue severity

  6-week

Study Arms (2)

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.

Other: Upper Extremity Aerobic Exercise

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.

Interventions

Upper Extremity Aerobic Exercise OTHER

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.

Treatment group: aerobic exercise

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• being an hematopoietic stem cell transplantation recipient during the intermediate/late post-transplant phase (\>100 days),
• years of age
• under standard medications.

You may not qualify if:

• 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

Sponsors & Collaborators

• Gazi University: lead

Study Sites (1)

Gazi University Faculty of Health Sciences Department of Physical Therapy and Rehabilitation

Ankara, Turkey (Türkiye)

Location

Related Links

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

MeSH Terms

Conditions

Depression; Dyspnea; Anxiety Disorders; Fatigue

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Study Officials

• Gülşah Barğı, MSc.

  Gazi University

  STUDY CHAIR

• Meral Boşnak Güçlü, PhD.

  Gazi University

  STUDY DIRECTOR

• Zübeyde Nur Özkurt, PhD.

  Gazi University

  PRINCIPAL INVESTIGATOR

• Münci Yağcı, PhD.

  Gazi University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: December 16, 2016
• First Posted: January 2, 2017
• Study Start: April 1, 2016
• Primary Completion: August 1, 2018
• Study Completion: September 1, 2018
• Last Updated: February 25, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)