Thoracic SurgeryEMI HiPoNCT03158402
Preoperative Inspiratory Muscle Training Effects on the Perioperative Inflammatory Reaction in Cardiac Surgery.
A study testing Prehabilitation with inspiratory muscle training in people with Thoracic Surgery and Prehabilitation, run by University Hospital, Angers at 1 site in France.
Trial summary
This study evaluates the impact of preoperative high-intensity inspiratory muscle training (IMThi) before cardiac surgery on perioperative inflammatory response. Half participants will receive high intensity inspiratory muscle training and the others a sham inspiratory muscle therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thoracic Surgery, Prehabilitation, Respiratory Therapy
- What is being tested?
- Prehabilitation with inspiratory muscle training
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 14 Feb 2018to 8 Jan 2021
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Waiting for thoracic surgery with valve replacement
- Preoperative surgeon consultation between 3 and 6 weeks before surgery
Who cannot join
- Patient with antecedent of lung surgery
- Patient with neuromuscular or neurovascular disease
- Non anticipated surgery with a time between surgeon consultation and surgery inferior to 3 weeks.
- Inhability to do the preoperative exercises
Trial locations and contacts
1 site in 1 country.
About this study
Official title: High Intensity Preoperative Inspiratory Muscle Training (IMTHi) Effects on the Perioperative Inflammatory Reaction in Cardiac Surgery With an Associated Biocollection.
This study evaluates the impact of preoperative high-intensity inspiratory muscle training (IMThi) before cardiac surgery on perioperative inflammatory response. Half participants will receive high intensity inspiratory muscle training and the others a sham inspiratory muscle therapy.
- Conditions
- Thoracic Surgery, Prehabilitation, Respiratory Therapy
- Being tested
- Prehabilitation with inspiratory muscle training
- Keywords
- Inspiratory muscle training, Systemic Inflammatory Response Syndrome
- Medical subject headings
- Systemic Inflammatory Response Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prehabilitation with inspiratory muscle trainingOther
3 to 6 weeks of two times a day inspiratory muscle training at 80% of the Maximum Inspiratory Pressure.
| Study group | Role | What they receive |
|---|---|---|
| sham IMT | Sham comparator | Preoperative Inspiratory muscle training at low intensity (15% Pimax) which is considered as a no effect training. Receives: Other: Prehabilitation with inspiratory muscle training |
| Hi Intensity IMT | Experimental | High intensity muscle training in the preoperative period at 80% of the maximal inspiratory muscle pressure. Receives: Other: Prehabilitation with inspiratory muscle training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Preoperative STNFr1 level
Post training and preoperative Serum concentration of the SRNFr1 cytokine.
Measured: Outcome is evaluated at the training initiation and re evaluated 24hours before the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2017
- Study start14 Feb 2018
- Primary completion12 Jun 2019
- Study completion8 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Thoracic SurgeryStudies of the same condition, open and under way.
- More trials run by University Hospital, AngersThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03158402
- Sponsor's protocol ID
- 2017-A00216-47
- Acronym
- EMI HiPo
- Status last verified
- Jan 2023
- First submitted
- 16 May 2017
- Last updated
- 19 Jan 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Furon Y, Dang Van S, Blanchard S, Saulnier P, Baufreton C. Effects of high-intensity inspiratory muscle training on systemic inflammatory response in cardiac surgery - A randomized clinical trial. Physiother Theory Pract. 2024 Apr;40(4):778-788. doi: 10.1080/09593985.2022.2163212. Epub 2023 Jan 13.
PubMed 36637368
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High Intensity Preoperative Inspiratory Muscle Training (IMTHi) Effects on the Perioperative Inflammatory Reaction in Cardiac Surgery With an Associated Biocollection.
- ClinicalTrials.gov ID
- NCT03158402
- Acronym / sponsor ID
- EMI HiPo / 2017-A00216-47
- Conditions
- Thoracic Surgery, Prehabilitation, Respiratory Therapy
- Keywords
- Inspiratory muscle training, Systemic Inflammatory Response Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University Hospital, AngersOther government
- Study start
- 14 Feb 2018 (actual)
- Primary completion
- 12 Jun 2019 (actual)
- Study completion
- 8 Jan 2021 (actual)
- First posted
- 18 May 2017 (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 study evaluates the impact of preoperative high-intensity inspiratory muscle training (IMThi) before cardiac surgery on perioperative inflammatory response. Half participants will receive high intensity inspiratory muscle training and the others a sham inspiratory muscle therapy.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| sham IMT | Sham comparator | Other: Prehabilitation with inspiratory muscle trainingPreoperative Inspiratory muscle training at low intensity (15% Pimax) which is considered as a no effect training. |
| Hi Intensity IMT | Experimental | Other: Prehabilitation with inspiratory muscle trainingHigh intensity muscle training in the preoperative period at 80% of the maximal inspiratory muscle pressure. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Waiting for thoracic surgery with valve replacement
- Preoperative surgeon consultation between 3 and 6 weeks before surgery
Key exclusion criteria (4 listed)
- Patient with antecedent of lung surgery
- Patient with neuromuscular or neurovascular disease
- Non anticipated surgery with a time between surgeon consultation and surgery inferior to 3 weeks.
- Inhability to do the preoperative exercises
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 |
|---|---|---|
| Prehabilitation with inspiratory muscle training3 to 6 weeks of two times a day inspiratory muscle training at 80% of the Maximum Inspiratory Pressure. | Other | Hi Intensity IMT, sham IMT |
Primary outcome
Preoperative STNFr1 level
Time frame: Outcome is evaluated at the training initiation and re evaluated 24hours before the surgery
Post training and preoperative Serum concentration of the SRNFr1 cytokine.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2023.
- Results publication: PubMed 36637368Furon Y, Dang Van S, Blanchard S, Saulnier P, Baufreton C. Effects of high-intensity inspiratory muscle training on systemic inflammatory response in cardiac surgery - A randomized clinical trial. Physiother Theory Pract. 2024 Apr;40(4):778-788. doi: 10.1080/09593985.2022.2163212. Epub 2023 Jan 13.
Related trials for Thoracic Surgery
RecruitingPhase 3
Immunotherapy After Surgery for People Who Have No Remaining Cancer Cells After Standard Treatment for Early-Stage Non-Small Cell Lung Cancer, INSIGHT Trial
Lung Non-Small Cell Carcinoma, Stage II Lung Cancer AJCC v8
Active, not recruitingPhase 2
A Phase II Study of Neoadjuvant Sotorasib in Combination With Cisplatin or Carboplatin and Pemetrexed for Surgically Resectable Stage IIA-IIIB Non-Squamous Non-Small Cell Lung Cancer With a KRAS p.G12C Mutation
Lung Cancer
Not yet recruiting
TBLC vs NIVATS in Interstitial Lung Disease
Interstitial Lung Diseases (ILD)
RecruitingPhase 3
Evaluation of the Safety and Efficacy of Abenacianine (VGT-309) to Identify Cancer in Subjects Undergoing Surgery for Cancer in the Lung
Lung Cancer, Lung Metastases
Recruiting
Treatment in Thoracic Aortic Aneurysm: Surgery vs Surveillance
Ascending Aortic Aneurysm Enlargement, Ascending Aorta Aneurysm
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prehabilitation with inspiratory muscle training in people with Thoracic Surgery and Prehabilitation, run by University Hospital, Angers at 1 site in France.
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 4 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: finished, as of the sponsor's last update on 19 Jan 2023. 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 France. 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. Some participants in this study may receive a placebo. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Preoperative STNFr1 level (time frame: Outcome is evaluated at the training initiation and re evaluated 24hours before the surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03158402, which also lists 1 linked publication.
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 19 Jan 2023.