Inspiratory Muscle Training in Allogeneic Hematopoietic Stem Cell Transplantation Recipients

Allogeneic Hematopoietic Stem Cell Transplantation Clinical Trial

Official title:

Effects of Inspiratory Muscle Training in Allogeneic Hematopoietic Stem Cell Transplantation Recipients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02270346
• Other study ID #: GaziUniversity
• Status: Completed
• Phase: N/A
• First received: October 14, 2014
• Last updated: October 18, 2014
• Start date: March 2012
• Est. completion date: September 2013

Study information

• Verified date: October 2014
• Source: Gazi University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: September 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Allogeneic Hematopoietic Stem Cell Transplantation
• Respiratory Aspiration

Intervention

Device:
• Inspiratory muscle training
Treatment group received inspiratory muscle training using threshold loading device (POWERbreathe Classic, IMT Technologies Ltd. Birmingham, England) at 40% of maximal inspiratory pressure (MIP). The MIP was measured at supervised session each week, and 40% of measured MIP value was the new training workload. The treatment group trained for 30 min-per/day, 7 days/week, for 6 weeks. Six sessions at home and 1 session were performed at department.
• Sham inspiratory muscle training
Control group received sham inspiratory muscle training using threshold loading device (POWERbreathe Classic IMT Technologies Ltd. Birmingham, England) at fixed workload, 5% of MIP. The control group trained for 30 min-per/day, 7 days/week, for 6 weeks. Six sessions at home and 1 session were performed at department.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Gazi University

References & Publications (4)

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. — View 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. — View 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.20 — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Inspiratory and expiratory muscle strength (MIP, MEP)	Mouth pressure device	6 weeks	Yes
Secondary	Fatigue	Fatigue Impact Scale (FIS)	6 weeks	Yes
Secondary	Pulmonary function	Spirometry	6 weeks	Yes
Secondary	Peripheral muscle strength	Hand held dynamometer	6 weeks	Yes
Secondary	Dyspnea	Modified Borg and Modified Medical Research Council (MMRC) dyspnea scales,	6 weeks	Yes
Secondary	Depression	Montgomery Asberg Depression Rating Scale (MADRS)	6 weeks	Yes
Secondary	Quality of life	European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire C-30 version 3.0 (Turkish versions of all scales)	6 weeks	Yes
Secondary	Submaximal exercise capacity	Six-minute walk test (6MWT)	6 weeks	Yes
Secondary	Maximal exercise capacity	Modified incremental shuttle walk test (ISWT)	6 weeks	Yes