Pulmonary AtelectasisNCT04566172
Preoperative Optimization to Improve Functional Status
A study testing Inspiratory Muscle Training (IMT) in people with Pulmonary Atelectasis and Pneumonia, Ventilator-Associated, run by Johns Hopkins University at 1 site in United States.
Trial summary
This is a pilot study to obtain preliminary information on the usability and efficacy of a pre-habilitation program. The investigators will recruit up to 100 patients. The two specific aims of this study are to conduct an initial pilot study with the following goals: 1. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Pulmonary Atelectasis, Pneumonia, Ventilator-Associated
- What is being tested?
- Inspiratory Muscle Training (IMT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2024to 1 Mar 2027
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Undergoing thoracic or upper abdominal surgery with an estimated date of surgery between 2-10 weeks after enrollment
- Age>65 y/o
Who cannot join
- Impaired cognition that would limit participation in the program
- History of spontaneous pneumothorax
- Any other physician judgement
Trial locations and contacts
1 site in 1 country.
United States1 site
The Johns Hopkins University
Baltimore, Maryland, 21287
About this study
This is a pilot study to obtain preliminary information on the usability and efficacy of a pre-habilitation program. The investigators will recruit up to 100 patients.
The two specific aims of this study are to conduct an initial pilot study with the following goals:
- To obtain information on feasibility and utilization of the program
- To determine whether participation in the program improves a patient's Maximal Inspiratory Pressure
Read the detailed description
Participants will engage in a pre-habilitation program prior to surgery at home, that includes using an inspiratory muscle training (IMT) device that will strengthen the muscles of breathing. Participants will keep a log of training. The Maximum Inspiratory Pressure will be measured at baseline and prior to surgery.
- Being tested
- Inspiratory Muscle Training (IMT)
- Medical subject headings
- Pulmonary Atelectasis, Pneumonia, Ventilator-Associated
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inspiratory Muscle Training (IMT)Behavioural
Also called IMT
Participants will receive an inspiratory muscle training that they will do leading up to the day of their surgery.
| Study group | Role | What they receive |
|---|---|---|
| Prehabilitation program | Experimental | Patient undergoing thoracic or upper abdominal surgery as part of their regular medical care will be approached. Participants will receive a prehabilitation program that includes an inspiratory muscle training that they will do leading up to the day of their surgery. Receives: Behavioral: Inspiratory Muscle Training (IMT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Inspiratory muscle training compliance as assessed by daily logs
The primary outcome variable will be compliance with >70% of inspiratory muscle training. Patients will be instructed to follow the prescribed program daily from the day consent is obtained until the day of surgery. Patients will complete a daily log of breathing exercises.
Measured: Up to 10 Weeks
Secondary outcomes (5)
Number of attempted inspiratory muscle training as assessed by percent days the program was attempted
Secondary feasibility outcome variables will be compliance (percent days the program was attempted). Patients will complete a daily log of breathing exercises and document the completion of each breathing exercise. The amount of days to be measured will be the number of days from consent to the day of surgery.
Measured: Up to 10 Weeks
Number of completed inspiratory muscle training as assessed by percent days with full compliance
Secondary feasibility outcome variables will be compliance (percent days with full compliance). Patients will complete a daily log of breathing exercises and document the completion of each breathing exercise. The amount of days to be measured will be the number of days from consent to the day of surgery.
Measured: Up to 10 Weeks
Change in maximum inspiratory pressure
The change in maximum inspiratory pressure will be determined by comparing the baseline maximum inspiratory pressure to the maximum inspiratory pressure on the day of surgery to assess the efficacy of the inspiratory muscle training.
Measured: Baseline and on the day of surgery, up to 10 weeks from enrollment
Interest in Using Program for Future Surgeries as assessed by a likert scale
The patient's willingness to use this program for future surgeries will be measured using the Likert scale 1 to 5. Higher scores mean more willingness to use program for future surgeries.
Measured: Day of Surgery, up to 10 weeks from enrollment
Overall Satisfaction with the Program as assessed by a likert scale
The patient's satisfaction with the program will be measure using the Likert scale 1 to 5. Higher scores mean better satisfaction.
Measured: Day of Surgery, up to 10 weeks from enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2020
- Study start1 Nov 2024 (estimated)
- Primary completion1 Oct 2026 (estimated)
- Study completion1 Mar 2027 (estimated)
Why it stopped: Unable to begin the study due to COVID-19 restrictions. Once restrictions were lifted, funding was no longer available.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary AtelectasisStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All participants will receive the same intervention.
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Charles Brown, MD, Principal investigator, Johns Hopkins Univesity School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04566172
- Sponsor's protocol ID
- IRB00227450
- Status last verified
- May 2024
- First submitted
- 22 Sep 2020
- Last updated
- 21 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be available to other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preoperative Optimization to Improve Functional Status
- ClinicalTrials.gov ID
- NCT04566172
- Acronym / sponsor ID
- IRB00227450
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Unable to begin the study due to COVID-19 restrictions. Once restrictions were lifted, funding was no longer available.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Study start
- 1 Nov 2024 (estimated)
- Primary completion
- 1 Oct 2026 (estimated)
- Study completion
- 1 Mar 2027 (estimated)
- First posted
- 28 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a pilot study to obtain preliminary information on the usability and efficacy of a pre-habilitation program. The investigators will recruit up to 100 patients.
The two specific aims of this study are to conduct an initial pilot study with the following goals:
- To obtain information on feasibility and utilization of the program
- To determine whether participation in the program improves a patient's Maximal Inspiratory Pressure
Detailed description
Participants will engage in a pre-habilitation program prior to surgery at home, that includes using an inspiratory muscle training (IMT) device that will strengthen the muscles of breathing. Participants will keep a log of training. The Maximum Inspiratory Pressure will be measured at baseline and prior to surgery.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All participants will receive the same intervention.
| Arm | Type | Receives |
|---|---|---|
| Prehabilitation program | Experimental | Behavioral: Inspiratory Muscle Training (IMT)Patient undergoing thoracic or upper abdominal surgery as part of their regular medical care will be approached. Participants will receive a prehabilitation program that includes an inspiratory muscle training that they will do leading up to the day of their surgery. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- Undergoing thoracic or upper abdominal surgery with an estimated date of surgery between 2-10 weeks after enrollment
- Age>65 y/o
Key exclusion criteria (3 listed)
- Impaired cognition that would limit participation in the program
- History of spontaneous pneumothorax
- Any other physician judgement
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Inspiratory Muscle Training (IMT)Also: IMTParticipants will receive an inspiratory muscle training that they will do leading up to the day of their surgery. | Behavioural | Prehabilitation program |
Primary outcome
Overall Inspiratory muscle training compliance as assessed by daily logs
Time frame: Up to 10 Weeks
The primary outcome variable will be compliance with >70% of inspiratory muscle training. Patients will be instructed to follow the prescribed program daily from the day consent is obtained until the day of surgery. Patients will complete a daily log of breathing exercises.
5 secondary outcomes
Number of attempted inspiratory muscle training as assessed by percent days the program was attempted
Time frame: Up to 10 Weeks
Number of completed inspiratory muscle training as assessed by percent days with full compliance
Time frame: Up to 10 Weeks
Change in maximum inspiratory pressure
Time frame: Baseline and on the day of surgery, up to 10 weeks from enrollment
Interest in Using Program for Future Surgeries as assessed by a likert scale
Time frame: Day of Surgery, up to 10 weeks from enrollment
Overall Satisfaction with the Program as assessed by a likert scale
Time frame: Day of Surgery, up to 10 weeks from enrollment
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2024.
- Individual participant dataSharing planned: No. Individual participant data will not be available to other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Charles Brown, MD principal investigator
Johns Hopkins Univesity School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Inspiratory Muscle Training (IMT) in people with Pulmonary Atelectasis and Pneumonia, Ventilator-Associated, run by Johns Hopkins University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 21 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Inspiratory muscle training compliance as assessed by daily logs (time frame: Up to 10 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 May 2024.