Effects of Pulmonary Rehabilitation in Hematopoietic Stem Cell Transplantation Recipients

NCT03625063 | Completed

• 1 other identifier: Gazi University 8
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Stem cell transplantation is a process in which stem cells are harvested from either a patient's or donor's bone morrow or peripheral blood for intravenous infusion. Hematopoietic stem cell transplantation is a treatment with a high curative potential that may benefit a great number of patients with hematological, oncological, immunologic and hereditary diseases. In contrast, there are significant risks of chronic and acute complications due to conditioning regimens and immunosuppression, toxicity infections, graft versus host disease (GVHD) and inactivity including being bedridden. Patients undergoing hematopoietic stem cell transplantation are exposed to risk factors due to chemotherapy, whole body radiation, high dose corticosteroids, treatment-related inactivity, transplantation and GVHD-related muscle damage. Direct toxicity of the cardiovascular and musculoskeletal system (left ventricular dysfunction, pulmonary fibrosis) in relation to hematopoietic stem cell transplantation and secondary indirect physiological consequences of treatment such as exercise intolerance, sarcopenia are seen. In literature, there are few studies showing that aerobic exercise and resistance training applied during and after the transplantation process has positive effects on muscle strength and endurance, fatigue, functional performance, quality of life and physical activity. It has been shown in the literature that inspiratory muscle training in allogeneic hematopoietic stem cell transplant recipients increases functional exercise capacity, inspiratory and expiratory muscle strength, and reduces effort dyspnea perception, but the effects of inspiratory muscle training during transplantation have not been investigated. There are no studies showing long-term follow-up of comprehensive cardiopulmonary rehabilitation program during hematopoietic stem cell transplantation and which of these outcome measures are survival effect. Therefore, the investigators aimed to investigate the effect of cardiopulmonary rehabilitation on hematopoietic stem cell transplantation in terms of exercise capacity, respiratory and peripheral muscle strength, respiratory muscle endurance, respiratory function, physical activity level, fatigue, depression and quality of life effects and the effect of these outcome measures on survival.

Conditions

Hematopoietic Stem Cell Transplantation

Keywords

exercise capacity; physical activity; respiratory muscle strength; respiratory muscle endurance

Outcome Measures

Primary Outcomes (1)

• Maximal exercise capacity

  Maximal exercise capacity will be evaluated symptom limited cardiopulmonary exercise testing. Oxygen consumption will be measured by cardiopulmonary exercise test. The cardiopulmonary exercise test will be performed on the treadmill at a progressively increasing speed and grade.

  Second day

Secondary Outcomes (10)

• Respiratory muscle strength

  First day

• Respiratory muscle endurance

  First day

• Peripheral muscle strength

  First day

• Pulmonary functions contains dynamic lung volumes

  First day

• Physical activity

  First day

Study Arms (2)

Exercise training group

ACTIVE COMPARATOR

Inspiratory muscle, upper extremity aerobic exercise and progressive resistance trainings

Other: Exercise training group

Control training group

SHAM COMPARATOR

Upper extremity aerobic exercise and progressive resistance trainings

Other: Control training group

Interventions

Exercise training group OTHER

All exercise program will be applied during supervised session by a physiotherapist. Range of maximal heart rate will be screened by heart rate monitor during supervised session each day at patient's room. Inspiratory muscle training (threshold loading device (Threshold®- Inspiratory Muscle Trainer) at 20-30% of maximal inspiratory pressure (MIP)), upper extremity aerobic exercise training (arm ergometer, at 60-80% of maximum heart rate, dyspnea perception at 3-4 level as well as fatigue perception at 5-6 level according to Modified Borg Scale) and progressive resistance training (shoulder flexors, shoulder abduction and knee extensors at 4-6 level according to modified Borg scale) will be performed in the treatment group during acute hematopoietic stem cell transplantation process.

Exercise training group

Control training group OTHER

All exercise program will be applied during supervised session by a physiotherapist. Range of maximal heart rate will be screened by heart rate monitor during supervised session each day in patient's room.Upper extremity aerobic exercise training (arm ergometer, at 60-80% of maximum heart rate, dyspnea perception at 3-4 level as well as fatigue perception at 5-6 level according to Modified Borg Scale) and progressive resistance training (shoulder flexors, shoulder abduction and knee extensors at 4-6 level according to modified Borg scale) except inspiratory muscle training will be performed in the control group during acute hematopoietic stem cell transplantation process.

Control training group

Eligibility Criteria

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

You may qualify if:

• patients scheduled to undergo hematopoietic stem cell transplantation
• under standard medications
• years of age

You may not qualify if:

• orthopedic or neurological disease with a potential to affect functional capacity,
• comorbidities such as asthma, chronic obstructive pulmonary disease (COPD), acute infections or pneumonia,
• have problems that can prevent evaluation,
• take treatment other than standard medications during transplantation,
• 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, Çankaya, 06580, Turkey (Türkiye)

Location

Related Publications (8)

• Kelsey CR, Scott JM, Lane A, Schwitzer E, West MJ, Thomas S, Herndon JE 2nd, Michalski MG, Horwitz ME, Hennig T, Jones LW. Cardiopulmonary exercise testing prior to myeloablative allo-SCT: a feasibility study. Bone Marrow Transplant. 2014 Oct;49(10):1330-6. doi: 10.1038/bmt.2014.159. Epub 2014 Jul 28.

  PMID: 25068429 BACKGROUND

• Morishita S, Kaida K, Yamauchi S, Wakasugi T, Ikegame K, Ogawa H, Domen K. Relationship of physical activity with physical function and health-related quality of life in patients having undergone allogeneic haematopoietic stem-cell transplantation. Eur J Cancer Care (Engl). 2017 Jul;26(4). doi: 10.1111/ecc.12669. Epub 2017 Feb 21.

  PMID: 28220548 BACKGROUND

• Kovalszki A, Schumaker GL, Klein A, Terrin N, White AC. Reduced respiratory and skeletal muscle strength in survivors of sibling or unrelated donor hematopoietic stem cell transplantation. Bone Marrow Transplant. 2008 Jun;41(11):965-9. doi: 10.1038/bmt.2008.15. Epub 2008 Feb 11.

  PMID: 18264142 BACKGROUND

• Mello M, Tanaka C, Dulley FL. Effects of an exercise program on muscle performance in patients undergoing allogeneic bone marrow transplantation. Bone Marrow Transplant. 2003 Oct;32(7):723-8. doi: 10.1038/sj.bmt.1704227.

  PMID: 13130321 BACKGROUND

• Hacker ED, Larson J, Kujath A, Peace D, Rondelli D, Gaston L. Strength training following hematopoietic stem cell transplantation. Cancer Nurs. 2011 May-Jun;34(3):238-49. doi: 10.1097/NCC.0b013e3181fb3686.

  PMID: 21116175 BACKGROUND

• Baumann FT, Zopf EM, Nykamp E, Kraut L, Schule K, Elter T, Fauser AA, Bloch W. Physical activity for patients undergoing an allogeneic hematopoietic stem cell transplantation: benefits of a moderate exercise intervention. Eur J Haematol. 2011 Aug;87(2):148-56. doi: 10.1111/j.1600-0609.2011.01640.x.

  PMID: 21545527 BACKGROUND

• Bargi G, Guclu MB, Aribas Z, Aki SZ, Sucak GT. Inspiratory muscle training in allogeneic hematopoietic stem cell transplantation recipients: a randomized controlled trial. Support Care Cancer. 2016 Feb;24(2):647-659. doi: 10.1007/s00520-015-2825-3. Epub 2015 Jul 2.

  PMID: 26135532 BACKGROUND

• Bayram S, Bargi G, Celik Z, Bosnak Guclu M. Effects of pulmonary rehabilitation in hematopoietic stem cell transplantation recipients: a randomized controlled study. Support Care Cancer. 2023 Dec 30;32(1):72. doi: 10.1007/s00520-023-08236-x.

  PMID: 38158450 DERIVED

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Selin Bayram, MSc

  Gazi University

  STUDY CHAIR

• Meral Boşnak Güçlü, Assoc. Prof

  Gazi University

  STUDY DIRECTOR

• Gülşah Barğı, PhD

  Gazi University

  PRINCIPAL INVESTIGATOR

• Zeliha Çelik, MSc

  Gazi University

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: July 19, 2018
• First Posted: August 10, 2018
• Study Start: February 1, 2018
• Primary Completion: August 30, 2021
• Study Completion: December 30, 2021
• Last Updated: December 8, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)