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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02270346
Other study ID # GaziUniversity
Secondary ID
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


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
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