Effects of Pulmonary Rehabilitation in Hematopoietic Stem Cell Transplantation Recipients

NCT ID: NCT03625063

Last Updated: 2022-12-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-02-01
• Study Completion Date: 2021-12-30

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.

Detailed Description

According to sample size calculation 20 patients scheduled for hematopoietic stem cell transplantation will be included. Patients scheduled for hematopoietic stem cell transplantation will be evaluated four times; pre-transplantation, post-transplantation, 100th day after transplantation and 1st year after transplantation. Recipients will be randomized into study and control groups. Cardiopulmonary rehabilitation programme includes inspiratory muscle training, upper extremity aerobic exercise, progressive resistance training will be performed study groups. Upper extremity aerobic exercise and progressive resistance training will be performed control groups. Exercise capacity, physical activity, pulmonary functions, respiratory and peripheral muscle strength, respiratory muscle endurance, dyspnea and fatigue perception, depression and quality of life will be evaluated. Primary outcome measurements are exercise capacity and which outcome measures influence survival. Secondary outcomes are respiratory and peripheral muscle strength, respiratory muscle endurance, pulmonary functions, physical activity, dyspnea and fatigue perception, depression and quality of life.

Conditions

Hematopoietic Stem Cell Transplantation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SCREENING
• Blinding Strategy: DOUBLE

Study Groups

Exercise training group

Inspiratory muscle, upper extremity aerobic exercise and progressive resistance trainings

Group Type: ACTIVE_COMPARATOR

Exercise training group

Intervention Type: 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.

Control training group

Upper extremity aerobic exercise and progressive resistance trainings

Group Type: SHAM_COMPARATOR

Control training group

Intervention Type: 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.

Interventions

Exercise training group

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.

Intervention Type: OTHER

Control training group

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• patients scheduled to undergo hematopoietic stem cell transplantation
• under standard medications
• 18-65 years of age

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Gazi University

OTHER

Sponsor Role: lead

Responsible Party

Meral Boşnak Güçlü

Associate professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Selin Bayram, MSc

Role: STUDY_CHAIR

Gazi University

Meral Boşnak Güçlü, Assoc. Prof

Role: STUDY_DIRECTOR

Gazi University

Gülşah Barğı, PhD

Role: PRINCIPAL_INVESTIGATOR

Gazi University

Zeliha Çelik, MSc

Role: PRINCIPAL_INVESTIGATOR

Gazi University

Locations

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

Ankara, Çankaya, Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

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Reference Type: BACKGROUND

PMID: 25068429 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 28220548 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 18264142 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 13130321 (View on PubMed)

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Reference Type: BACKGROUND

PMID: 21116175 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 21545527 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 26135532 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 38158450 (View on PubMed)

Other Identifiers

Gazi University 8

Identifier Type: -

Identifier Source: org_study_id