Inspiratory Muscle Training Immediately After Lung Transplantation

NCT05309551 | Active Not Recruiting FDA Device

• 1 other identifier: 2021H0310
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

Following lung transplantation (LTX), patients may exhibit respiratory and skeletal muscle weakness that will affect exercise capacity, increase dyspnea and fatigue, limit activities of daily living (ADL) and decrease quality of life. Inspiratory muscle training (IMT) has been extensively studied in a variety of non-LTX populations and research has shown that IMT improves exercise capacity, diaphragmatic thickness, and reduced dyspnea during activities of daily living and improved quality of life in patients with advanced lung disease. The aim of this randomized controlled study is to investigate the benefits of providing inspiratory muscle training via use of an inspiratory muscle trainer device in addition to standard physical therapy in the acute phase of rehabilitation following LTX. Patients targeted for enrollment will be those with any type of advanced lung disease requiring LTX with the objective of demonstrating improvements in respiratory muscle recovery, perceived dyspnea, severity of fatigue, and overall functional status following the transplant procedure.

Conditions

Lung Transplantation; Chronic Lung Disease; Muscle Weakness; Rehabilitation

Outcome Measures

Primary Outcomes (4)

• Change in inspiratory muscle strength: Maximal inspiratory pressure (MIP) measured in cmH2O

  Inspiratory muscle strength will be measured as maximal inspiratory pressure (MIP) using a POWERbreathe® KH2, International Ltd; UK. The MIP is defined as the greatest negative pressure sustained for at least one second by each patient. The patient will be verbally encouraged to perform three to five inspiratory maneuvers at maximal intensity. The maximum value will be used for the analysis.

  The groups will be assessed: Before Lung transplantation, at baseline (immediate post-transplant), 8 weeks, 6 and 12 months after LTX

• Change in perceived dyspnea: Modified Medical Research Council Dyspnea Scale

  Modified Medical Research Council Dyspnea Scale (mMRC) will measure dyspnea perceptions during the activities of daily living. A score from 0-4 is used to classify the impact of dyspnea on physical function in patients with respiratory limitations. 0 represents a person who suffers from dyspnea only with strenuous exercise. 4 represents a person who are too breathless to leave the house, or breathless when dressing.

  The groups will be assessed: Before Lung transplantation, 8 weeks, 6 and 12 months after LTX

• Change in fatigue: Fatigue Severity Scale

  Fatigue Severity Scale (FSS) evaluates fatigue using a nine-item, self-scored questionnaire, which with a visual ranking format ranging from one to seven that quantifies patient-perceived fatigue. Higher composite scores indicate more severe fatigue. An average score of less than 2.8 indicates no fatigue, and more than 6.1 indicates chronic fatigue syndrome.

  The groups will be assessed: Before Lung transplantation, 8 weeks, 6 and 12 months after LTX

• Change in functional capacity

  Functional capacity will be estimated using the 6-minute walk test according to the American Thoracic Society guidelines. Before and after the test, oxygen saturation (SpO2), heart rate, Modified Dyspnea Borg Scale and walking distance will be recorded

  The groups will be assessed: Before Lung transplantation, 8 weeks, 6 and 12 months after LTX

Secondary Outcomes (5)

• Change in lung function: Pulmonary Function Test

  The groups will be assessed: Before Lung transplantation, 8 weeks, 6 and 12 months after LTX

• Change in physical performance

  The groups will be assessed: Before Lung transplantation, 8 weeks, 6 and 12 months after LTX

• Change in lower extremity muscle strength

  The groups will be assessed: Before Lung transplantation, 8 weeks, 6 and 12 months after LTX

• Change in grip strength

  The groups will be assessed: Before Lung transplantation, 8 weeks, 6 and 12 months after LTX

• Change in quality of life

  The groups will be assessed: Before Lung transplantation, 8 weeks, 6 and 12 months after LTX

Study Arms (3)

Inspiratory Muscle training- Intervention group

EXPERIMENTAL

Along with standard post-transplant physical therapy, the intervention group will begin daily respiratory exercise training utilizing the IMT trainer device (POWERbreathe Medic Plus®) with weekly incremental increases in respiratory load. Patients will be asked to use the IMT device twice per day, 7 days per week, for 8 weeks.

Device: IMT- Intervention group

Inspiratory Muscle training - Placebo group

SHAM COMPARATOR

Along with standard post-transplant physical therapy, the placebo group will begin daily respiratory exercise training utilizing the IMT trainer device (POWERbreathe Medic Plus®) with no increase of respiratory load. Patients will be asked to use the IMT device twice per day, 7 days per week, for 8 weeks.

Device: IMT- Placebo group

Usual care group

NO INTERVENTION

Patients will only participate in standard post-transplant physical therapy.

Interventions

IMT- Intervention group DEVICE

The resistive load will be readjusted weekly to reach 50% of maximal inspiratory pressure (MIP).

Also known as: POWERBreathe Medic Plus®

Inspiratory Muscle training- Intervention group

IMT- Placebo group DEVICE

The inspiratory resistive load will be adjusted to the minimum value of the device (9 cm H2O) during all inspiratory muscle training sessions.

Also known as: POWERBreathe Medic Plus®

Inspiratory Muscle training - Placebo group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participant has personally signed and dated informed consent form indicating understanding of all pertinent aspects of the study
• Active on the waiting list for lung transplantation
• Able to ambulate pre-transplant (not bed/wheelchair bound) with or without assistive device

You may not qualify if:

• Already participating in a regular IMT program
• Impaired cognition with inability to follow commands

Sponsors & Collaborators

• Ohio State University: lead

Study Sites (1)

The Ohio State University Wexner Medical Center

Columbus, Ohio, 43210, United States

Location

Related Publications (12)

• Brocki BC, Andreasen JJ, Langer D, Souza DS, Westerdahl E. Postoperative inspiratory muscle training in addition to breathing exercises and early mobilization improves oxygenation in high-risk patients after lung cancer surgery: a randomized controlled trial. Eur J Cardiothorac Surg. 2016 May;49(5):1483-91. doi: 10.1093/ejcts/ezv359. Epub 2015 Oct 20.

  PMID: 26489835 BACKGROUND

• Hanada M, Kasawara KT, Mathur S, Rozenberg D, Kozu R, Hassan SA, Reid WD. Aerobic and breathing exercises improve dyspnea, exercise capacity and quality of life in idiopathic pulmonary fibrosis patients: systematic review and meta-analysis. J Thorac Dis. 2020 Mar;12(3):1041-1055. doi: 10.21037/jtd.2019.12.27.

  PMID: 32274173 BACKGROUND

• Bissett B, Gosselink R, van Haren FMP. Respiratory Muscle Rehabilitation in Patients with Prolonged Mechanical Ventilation: A Targeted Approach. Crit Care. 2020 Mar 24;24(1):103. doi: 10.1186/s13054-020-2783-0.

  PMID: 32204719 BACKGROUND

• Hoffman M, Augusto VM, Eduardo DS, Silveira BMF, Lemos MD, Parreira VF. Inspiratory muscle training reduces dyspnea during activities of daily living and improves inspiratory muscle function and quality of life in patients with advanced lung disease. Physiother Theory Pract. 2021 Aug;37(8):895-905. doi: 10.1080/09593985.2019.1656314. Epub 2019 Aug 20.

  PMID: 31429627 BACKGROUND

• Spruit MA, Singh SJ, Garvey C, ZuWallack R, Nici L, Rochester C, Hill K, Holland AE, Lareau SC, Man WD, Pitta F, Sewell L, Raskin J, Bourbeau J, Crouch R, Franssen FM, Casaburi R, Vercoulen JH, Vogiatzis I, Gosselink R, Clini EM, Effing TW, Maltais F, van der Palen J, Troosters T, Janssen DJ, Collins E, Garcia-Aymerich J, Brooks D, Fahy BF, Puhan MA, Hoogendoorn M, Garrod R, Schols AM, Carlin B, Benzo R, Meek P, Morgan M, Rutten-van Molken MP, Ries AL, Make B, Goldstein RS, Dowson CA, Brozek JL, Donner CF, Wouters EF; ATS/ERS Task Force on Pulmonary Rehabilitation. An official American Thoracic Society/European Respiratory Society statement: key concepts and advances in pulmonary rehabilitation. Am J Respir Crit Care Med. 2013 Oct 15;188(8):e13-64. doi: 10.1164/rccm.201309-1634ST.

  PMID: 24127811 BACKGROUND

• Evans JA, Whitelaw WA. The assessment of maximal respiratory mouth pressures in adults. Respir Care. 2009 Oct;54(10):1348-59.

  PMID: 19796415 BACKGROUND

• ATS Committee on Proficiency Standards for Clinical Pulmonary Function Laboratories. ATS statement: guidelines for the six-minute walk test. Am J Respir Crit Care Med. 2002 Jul 1;166(1):111-7. doi: 10.1164/ajrccm.166.1.at1102. No abstract available.

  PMID: 12091180 BACKGROUND

• Bernabeu-Mora R, Medina-Mirapeix F, Llamazares-Herran E, Garcia-Guillamon G, Gimenez-Gimenez LM, Sanchez-Nieto JM. The Short Physical Performance Battery is a discriminative tool for identifying patients with COPD at risk of disability. Int J Chron Obstruct Pulmon Dis. 2015 Dec 3;10:2619-26. doi: 10.2147/COPD.S94377. eCollection 2015.

  PMID: 26664110 BACKGROUND

• Bestall JC, Paul EA, Garrod R, Garnham R, Jones PW, Wedzicha JA. Usefulness of the Medical Research Council (MRC) dyspnoea scale as a measure of disability in patients with chronic obstructive pulmonary disease. Thorax. 1999 Jul;54(7):581-6. doi: 10.1136/thx.54.7.581.

  PMID: 10377201 BACKGROUND

• Talwar A, Sahni S, John S, Verma S, Cardenas-Garcia J, Kohn N. Effects of pulmonary rehabilitation on Fatigue Severity Scale in patients with lung disease. Pneumonol Alergol Pol. 2014;82(6):534-40. doi: 10.5603/PiAP.2014.0070.

  PMID: 25339563 BACKGROUND

• Dowman L, McDonald CF, Hill CJ, Lee A, Barker K, Boote C, Glaspole I, Goh N, Southcott A, Burge A, Ndongo R, Martin A, Holland AE. Reliability of the hand held dynamometer in measuring muscle strength in people with interstitial lung disease. Physiotherapy. 2016 Sep;102(3):249-55. doi: 10.1016/j.physio.2015.10.002. Epub 2015 Oct 22.

  PMID: 26596172 BACKGROUND

• Singer JP, Chen J, Blanc PD, Leard LE, Kukreja J, Chen H. A thematic analysis of quality of life in lung transplant: the existing evidence and implications for future directions. Am J Transplant. 2013 Apr;13(4):839-850. doi: 10.1111/ajt.12174. Epub 2013 Feb 22.

  PMID: 23432992 BACKGROUND

MeSH Terms

Conditions

Muscle Weakness

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Study Officials

• Cristiane Meirelles, PT, PhD

  School of Health and Rehabilitation Sciences- Physical Therapy Division

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor-Clinical

Study Record Dates

• First Submitted: March 22, 2022
• First Posted: April 4, 2022
• Study Start: April 20, 2022
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: December 18, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)