Inspiratory Muscle Training in Allogeneic Hematopoietic Stem Cell Transplantation Recipients

NCT02270346 | Completed

• 1 other identifier: GaziUniversity
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Allogeneic Hematopoietic Stem Cell Transplantation

Keywords

Allogeneic HSCT, Inspiratory Muscle Training, Exercise Capacity

Outcome Measures

Primary Outcomes (1)

• Inspiratory and expiratory muscle strength (MIP, MEP)

  Mouth pressure device

  6 weeks

Secondary Outcomes (8)

• Fatigue

  6 weeks

• Pulmonary function

  6 weeks

• Peripheral muscle strength

  6 weeks

• Dyspnea

  6 weeks

• Depression

  6 weeks

Study Arms (2)

Treatment group

ACTIVE COMPARATOR

Intervention: Treatment group received inspiratory muscle training (IMT) using POWERbreathe Classic threshold loading device.

Device: Inspiratory muscle training

Control group

SHAM COMPARATOR

Sham: Control group received sham inspiratory muscle training (IMT) using POWERbreathe Classic threshold loading device .

Device: Sham inspiratory muscle training

Interventions

Inspiratory muscle training DEVICE

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.

Treatment group

Sham inspiratory muscle training DEVICE

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.

Control 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:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Gazi University: lead

Related Publications (5)

• 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.

  PMID: 9128987 RESULT

• 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.

  PMID: 1611601 RESULT

• 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.

  PMID: 16002928 RESULT

• 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 RESULT

• 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 DERIVED

Study Officials

• Gülşah Barğı, MSc.

  Gazi University

  STUDY CHAIR

• Meral Boşnak Güçlü, PhD.

  Gazi University

  STUDY DIRECTOR

• Zeynep Arıbaş, MSc.

  Gazi University

  PRINCIPAL INVESTIGATOR

• Zeynep Şahika Akı, MD, PhD.

  Gazi University

  PRINCIPAL INVESTIGATOR

• Gülsan Türköz Sucak, MD, PhD.

  Gazi University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. Prof.

Study Record Dates

• First Submitted: October 14, 2014
• First Posted: October 21, 2014
• Study Start: March 1, 2012
• Primary Completion: June 1, 2013
• Study Completion: September 1, 2013
• Last Updated: October 21, 2014

Record last verified: 2014-10