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Inspiratory Muscle Training for Lung Transplant Recovery

N/A

Recruiting

Led By Cristiane Meirelles, PT, PhD

Research Sponsored by Ohio State University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Able to ambulate pre-transplant (not bed/wheelchair bound) with or without assistive device

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up the groups will be assessed: before lung transplantation, 8 weeks, 6 and 12 months after ltx

Awards & highlights

Study Summary

This trial will test whether inspiratory muscle training, in addition to standard physical therapy, can help improve respiratory muscle recovery, reduce dyspnea, and fatigue, and improve overall functional status in patients who have had a lung transplant.

Who is the study for?

This trial is for people waiting for a lung transplant who can walk (even with help) and understand the study. They shouldn't have cognitive issues that make it hard to follow instructions or already be doing inspiratory muscle training.Check my eligibility

What is being tested?

The study tests if using an inspiratory muscle trainer right after a lung transplant helps patients breathe better, feel less tired, and improve their daily activities compared to those who only get standard physical therapy.See study design

What are the potential side effects?

Since this trial involves non-invasive breathing exercises, side effects are minimal but may include temporary increased fatigue or discomfort from the use of the training device.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I can walk by myself or with help from a device.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ the groups will be assessed: before lung transplantation, at baseline (immediate post-transplant), 8 weeks, 6 and 12 months after ltx

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~the groups will be assessed: before lung transplantation, at baseline (immediate post-transplant), 8 weeks, 6 and 12 months after ltx

This trial's timeline: 3 weeks for screening, Varies for treatment, and the groups will be assessed: before lung transplantation, at baseline (immediate post-transplant), 8 weeks, 6 and 12 months after ltx for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in fatigue: Fatigue Severity Scale

Change in functional capacity

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

+1 more

Secondary outcome measures

Change in grip strength

Change in lower extremity muscle strength

Change in lung function: Pulmonary Function Test

+2 more

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Placebo Group

Group I: Inspiratory Muscle training- Intervention groupExperimental Treatment1 Intervention

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.

Group II: Usual care groupActive Control1 Intervention

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

Group III: Inspiratory Muscle training - Placebo groupPlacebo Group1 Intervention

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.

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Ohio State UniversityLead Sponsor

830 Previous Clinical Trials

505,654 Total Patients Enrolled

Cristiane Meirelles, PT, PhDPrincipal InvestigatorSchool of Health and Rehabilitation Sciences- Physical Therapy Division

Media Library

Inspiratory Muscle training- Intervention group Clinical Trial Eligibility Overview. Trial Name: NCT05309551 — N/A

Rehabilitation Research Study Groups: Inspiratory Muscle training- Intervention group, Inspiratory Muscle training - Placebo group, Usual care group

Rehabilitation Clinical Trial 2023: Inspiratory Muscle training- Intervention group Highlights & Side Effects. Trial Name: NCT05309551 — N/A

Inspiratory Muscle training- Intervention group 2023 Treatment Timeline for Medical Study. Trial Name: NCT05309551 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the extent of recruitment for this clinical trial?

"Affirmative. Clinicaltrials.gov provides evidence that recruitment for this clinical trial has commenced, starting from April 20th 2022 and last updated on July 26th 2022. 90 participants are needed at a single location to complete the study."

Answered by AI

Are there any openings left for participants in this research?

"Clinicaltrials.gov states that this trial is presently enrolling participants, with the first posting occurring on April 20th 2022 and a subsequent update released July 26th of the same year."

Answered by AI

What beneficial effects are expected to result from this medical research?

"This clinical trial's primary aim is to assess the alteration in inspiratory muscle strength (Maximal Inspiratory Pressure, measured in cmH2O) over a period of approximately 8 weeks, 6 months and 12 months post-lung transplantation. Secondary objectives include measuring changes in lower extremity muscle strength with a hand-held dynamometer, lung function via Pulmonary Function Test variables such as Forced Vital Capacity and Forced Expiratory Volume as well as Health-Related Quality of Life through SF-36 questionnaire scales like Physical Functioning, Role Physical and Mental health."

Answered by AI

Recent research and studies

Pneumonologia i Alergologia PolskaJournal

Effects of Pulmonary Rehabilitation on Fatigue Severity Scale in Patients with Lung Disease

Talwar, Arunabh, Sonu Sahni, Sarah John, Sameer Verma, José Cárdenas-Garcia, and Nina Kohn. 2014. “Effects of Pulmonary Rehabilitation on Fatigue Severity Scale in Patients with Lung Disease”. Pneumonologia I Alergologia Polska. VM Media SP. zo.o VM Group SK. doi:10.5603/piap.2014.0070.

European Journal of Cardio-Thoracic SurgeryJournal

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

Brocki, Barbara Cristina, Jan Jesper Andreasen, Daniel Langer, Domingos Savio R. Souza, and Elisabeth Westerdahl. 2015. “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”. European Journal of Cardio-thoracic Surgery. Oxford University Press (OUP). doi:10.1093/ejcts/ezv359.

Journal of Thoracic DiseaseJournal

Aerobic and Breathing Exercises Improve Dyspnea, Exercise Capacity and Quality of Life in Idiopathic Pulmonary Fibrosis Patients: Systematic Review and Meta-analysis

Hanada, Masatoshi, Karina Tamy Kasawara, Sunita Mathur, Dmitry Rozenberg, Ryo Kozu, S. Ahmed Hassan, and W. Darlene Reid. 2020. “Aerobic and Breathing Exercises Improve Dyspnea, Exercise Capacity and Quality of Life in Idiopathic Pulmonary Fibrosis Patients: Systematic Review and Meta-analysis”. Journal of Thoracic Disease. AME Publishing Company. doi:10.21037/jtd.2019.12.27.

Critical CareJournal