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Inspiratory Muscle Training Immediately After Lung Transplantation

Primary Purpose

Lung Transplantation, Chronic Lung Disease, Muscle Weakness

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
IMT- Intervention group
IMT- Placebo group
Sponsored by
Ohio State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Lung Transplantation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

Sites / Locations

  • The Ohio State University Wexner Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Sham Comparator

No Intervention

Arm Label

Inspiratory Muscle training- Intervention group

Inspiratory Muscle training - Placebo group

Usual care group

Arm Description

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.

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.

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

Outcomes

Primary Outcome Measures

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.
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.
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.
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

Secondary Outcome Measures

Change in lung function: Pulmonary Function Test
Lung function will be measured in accordance with the guidelines of the American Thoracic Society. The following variables will be analyzed: (a) forced vital capacity (FVC, L) and (b) forced expiratory volume in the first second (FEV1, L).
Change in physical performance
Physical performance test will be evaluated using the Short Physical Performance Battery Test (SPPB) to assess standing balance, walking speed, and chair stands. The corresponding score from each section is determined and compiled for an overall score of 0-12.
Change in lower extremity muscle strength
Quadriceps strength will be measured with a hand-held dynamometer (HHD, Microfet®, Hogan Health Industries, Inc., UT, USA). At least three measurements will be obtained and the higher knee extensor muscle strength value will be used for the analysis.
Change in grip strength
Grip strength will be performed using a digital dynamometer. At least three measurements will be obtained and the highest reproducible value will be taken into analysis and related to reference values.
Change in quality of life
Heath related quality of life will be measured using the SF-36 questionnaire. The 36-Item Short Form Health Survey questionnaire (SF-36) is a very popular instrument for evaluating Health-Related Quality of Life. The SF-36 measures eight scales: physical functioning (PF), role physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role emotional (RE), and mental health (MH).

Full Information

First Posted
March 22, 2022
Last Updated
October 23, 2023
Sponsor
Ohio State University
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1. Study Identification

Unique Protocol Identification Number
NCT05309551
Brief Title
Inspiratory Muscle Training Immediately After Lung Transplantation
Official Title
The Effects of Inspiratory Muscle Training Immediatley After Lung Transplantation: a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 20, 2022 (Actual)
Primary Completion Date
July 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ohio State University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Transplantation, Chronic Lung Disease, Muscle Weakness, Rehabilitation

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Inspiratory Muscle training- Intervention group
Arm Type
Experimental
Arm Description
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.
Arm Title
Inspiratory Muscle training - Placebo group
Arm Type
Sham Comparator
Arm Description
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.
Arm Title
Usual care group
Arm Type
No Intervention
Arm Description
Patients will only participate in standard post-transplant physical therapy.
Intervention Type
Device
Intervention Name(s)
IMT- Intervention group
Other Intervention Name(s)
POWERBreathe Medic Plus®
Intervention Description
The resistive load will be readjusted weekly to reach 50% of maximal inspiratory pressure (MIP).
Intervention Type
Device
Intervention Name(s)
IMT- Placebo group
Other Intervention Name(s)
POWERBreathe Medic Plus®
Intervention Description
The inspiratory resistive load will be adjusted to the minimum value of the device (9 cm H2O) during all inspiratory muscle training sessions.
Primary Outcome Measure Information:
Title
Change in inspiratory muscle strength: Maximal inspiratory pressure (MIP) measured in cmH2O
Description
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.
Time Frame
The groups will be assessed: Before Lung transplantation, at baseline (immediate post-transplant), 8 weeks, 6 and 12 months after LTX
Title
Change in perceived dyspnea: Modified Medical Research Council Dyspnea Scale
Description
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.
Time Frame
The groups will be assessed: Before Lung transplantation, 8 weeks, 6 and 12 months after LTX
Title
Change in fatigue: Fatigue Severity Scale
Description
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.
Time Frame
The groups will be assessed: Before Lung transplantation, 8 weeks, 6 and 12 months after LTX
Title
Change in functional capacity
Description
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
Time Frame
The groups will be assessed: Before Lung transplantation, 8 weeks, 6 and 12 months after LTX
Secondary Outcome Measure Information:
Title
Change in lung function: Pulmonary Function Test
Description
Lung function will be measured in accordance with the guidelines of the American Thoracic Society. The following variables will be analyzed: (a) forced vital capacity (FVC, L) and (b) forced expiratory volume in the first second (FEV1, L).
Time Frame
The groups will be assessed: Before Lung transplantation, 8 weeks, 6 and 12 months after LTX
Title
Change in physical performance
Description
Physical performance test will be evaluated using the Short Physical Performance Battery Test (SPPB) to assess standing balance, walking speed, and chair stands. The corresponding score from each section is determined and compiled for an overall score of 0-12.
Time Frame
The groups will be assessed: Before Lung transplantation, 8 weeks, 6 and 12 months after LTX
Title
Change in lower extremity muscle strength
Description
Quadriceps strength will be measured with a hand-held dynamometer (HHD, Microfet®, Hogan Health Industries, Inc., UT, USA). At least three measurements will be obtained and the higher knee extensor muscle strength value will be used for the analysis.
Time Frame
The groups will be assessed: Before Lung transplantation, 8 weeks, 6 and 12 months after LTX
Title
Change in grip strength
Description
Grip strength will be performed using a digital dynamometer. At least three measurements will be obtained and the highest reproducible value will be taken into analysis and related to reference values.
Time Frame
The groups will be assessed: Before Lung transplantation, 8 weeks, 6 and 12 months after LTX
Title
Change in quality of life
Description
Heath related quality of life will be measured using the SF-36 questionnaire. The 36-Item Short Form Health Survey questionnaire (SF-36) is a very popular instrument for evaluating Health-Related Quality of Life. The SF-36 measures eight scales: physical functioning (PF), role physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role emotional (RE), and mental health (MH).
Time Frame
The groups will be assessed: Before Lung transplantation, 8 weeks, 6 and 12 months after LTX

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: Already participating in a regular IMT program Impaired cognition with inability to follow commands
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Cristiane Meirelles, PT, PhD
Phone
614-685-3564
Email
Cristiane.Meirelles@osumc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cristiane Meirelles, PT, PhD
Organizational Affiliation
School of Health and Rehabilitation Sciences- Physical Therapy Division
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Ohio State University Wexner Medical Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cristiane Meirelles, PT, PhD
Email
Cristiane.Meirelles@osumc.edu

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
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26489835
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Inspiratory Muscle Training Immediately After Lung Transplantation

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