Clinical trial NCT02270346: Inspiratory Muscle Training in Allogeneic Hematopoietic Stem Cell Transplantation Recipients
Official title: Effects of Inspiratory Muscle Training in Allogeneic Hematopoietic Stem Cell Transplantation Recipients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Allogeneic Hematopoietic Stem Cell Transplantation
Keywords: Allogeneic HSCT, Inspiratory Muscle Training, Exercise Capacity
Lead sponsor: Gazi University
Sponsor class: OTHER
First posted: 2014-10-21
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Allogeneic hematopoietic stem cell transplantation (allo-HSCT) causes various toxic effects in many body tissues, organs and systems such as immune, cardiovascular, pulmonary, gastrointestinal, neuroendocrine and musculoskeletal systems, liver, kidneys and skin.Available limited numbers of studies showed that inspiratory muscle weakness in allo-HSCT candidates and recipients. Although meta-analysis, systematic reviews and studies demonstrated beneficial effects of inspiratory muscle training on several outcomes in different disease groups; chronic obstructive pulmonary disease, bronchiectasis and heart failure, no published paper reported the effects of IMT in allo-HSC recipients.

Detailed description: Thirty-eight allo-HSCT recipients (˃100 days past post-transplant status) were included. Before and after 6-week IMT, maximal and submaximal exercise capacity, respiratory and peripheral muscle strength, pulmonary functions, dyspnea and fatigue perception, depression and quality of life were evaluated. Primary outcome measurement was respiratory muscle strength, secondary outcomes were exercise capacity, dyspnea, peripheral muscle strength, quality of life, fatigue and depression.

Eligibility criteria: Inclusion Criteria:

* Allo-HSC recipients (˃100 days past post-transplant status),
* 18-65 years of age,
* Under standard medications

Exclusion Criteria:

* Having cognitive disorder, orthopedic problem or neurological disease that were affecting functional capacity,
* Additional heart and lung diseases such as asthma, chronic obstructive pulmonary disease, acute infections or pneumonia,
* Problems prevented performing assessment and training such as visual problems and mucositis

Primary outcomes:
measure: Inspiratory and expiratory muscle strength (MIP, MEP)
timeFrame: 6 weeks
Secondary outcomes:
measure: Fatigue
timeFrame: 6 weeks
measure: Pulmonary function
timeFrame: 6 weeks
measure: Peripheral muscle strength
timeFrame: 6 weeks
measure: Dyspnea
timeFrame: 6 weeks
measure: Depression
timeFrame: 6 weeks
measure: Quality of life
timeFrame: 6 weeks
measure: Submaximal exercise capacity
timeFrame: 6 weeks
measure: Maximal exercise capacity
timeFrame: 6 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Gazi University
name: Gülşah Barğı, MSc.
role: STUDY_CHAIR
affiliation: Gazi University
name: Meral Boşnak Güçlü, PhD.
role: STUDY_DIRECTOR
affiliation: Gazi University
name: Zeynep Arıbaş, MSc.
role: PRINCIPAL_INVESTIGATOR
affiliation: Gazi University
name: Zeynep Şahika Akı, MD, PhD.
role: PRINCIPAL_INVESTIGATOR
affiliation: Gazi University
name: Gülsan Türköz Sucak, MD, PhD.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Dimeo FC, Tilmann MH, Bertz H, Kanz L, Mertelsmann R, Keul J. Aerobic exercise in the rehabilitation of cancer patients after high dose chemotherapy and autologous peripheral stem cell transplantation. Cancer. 1997 May 1;79(9):1717-22.
citation: Ferrell B, Grant M, Schmidt GM, Rhiner M, Whitehead C, Fonbuena P, Forman SJ. The meaning of quality of life for bone marrow transplant survivors. Part 1. The impact of bone marrow transplant on quality of life. Cancer Nurs. 1992 Jun;15(3):153-60.
citation: White AC, Terrin N, Miller KB, Ryan HF. Impaired respiratory and skeletal muscle strength in patients prior to hematopoietic stem-cell transplantation. Chest. 2005 Jul;128(1):145-52. doi: 10.1378/chest.128.1.145.
citation: 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.
citation: 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.