Inspiratory Muscle TrainingNCT05239819
The Cardiopulmonary Effects and Diaphragm Function of Complete Inspiratory Muscle Training in Patients With Upper Abdominal Surgery
A study testing Inspiratory muscle training and Regulated care and education in people with Inspiratory Muscle Training and Postoperative Pulmonary Complications, run by National Cheng Kung University at 1 site in Taiwan.
Trial summary
Upper abdominal surgical treatment may have reduced respiratory muscle function and mucociliary clearance, which might be a consequence of postoperative pulmonary complications (PPCs). Read more about this study
- Who is it for?
- Ages 20 to 85 years
- Conditions the study is for
- Inspiratory Muscle Training, Postoperative Pulmonary Complications, Respiratory Muscle Function
- What is being tested?
- Inspiratory muscle training and Regulated care and education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Apr 2019to 1 Dec 2020
- 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 20 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≧20 years old with upper abdominal surgery,
- American Society of Anesthesiologists; ASA) I-IV
- body Mass Index; BMI≥ 18
- able to follow exercise protocol. T
Who cannot join
- history of prior abdominal surgery
- high risk of exercise contraindications (e.g. severe cardiac or cardiovascular disease), 3) American Society of Anesthesiologists; ASA) V-IV
- 4) unable to follow exercise protocol 5) severe organ failure
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Fully Engaged Inspiratory Muscle Training Reduces Postoperative Pulmonary Complications Rate and Increased Respiratory Muscle Function in Patients With Upper Abdominal Surgery: a Randomized Controlled Trial
Upper abdominal surgical treatment may have reduced respiratory muscle function and mucociliary clearance, which might be a consequence of postoperative pulmonary complications (PPCs). The threshold inspiratory muscle training (IMT) may serve as an effective modality to improve respiratory muscle strength and endurance in patients. However, whether this training could help patients with upper abdominal surgery remain to be determined.
- Conditions
- Inspiratory Muscle Training, Postoperative Pulmonary Complications, Respiratory Muscle Function, Abdominal Surgery
- Being tested
- Inspiratory muscle training, Regulated care and education
- Keywords
- inspiratory muscle training, postoperative pulmonary complications, respiratory muscle function, abdominal surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inspiratory muscle trainingBehavioural
The initial training intensity of the preoperative threshold IMT trainer (DofinTM, Breathing Strength Builder, Taiwan) was moderate to high intensity (≥50% of MIP), which was according to the patient's baseline level and increased by 5-10% per week. The frequency is 25-30 minutes each time, twice a day and five days per week for at least two weeks. The participants would receive at least 10 times training sessions before surgery
Regulated care and educationBehavioural
Regulated care and education will be applied
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | We conducted a fully engaged inspiratory muscle training (IMT) program. The exercise group received the intervention threshold IMT from preoperative to postoperative undergoing upper abdominal surgery. The IMT was started before 3 weeks of operation and surveyed in the followed 4 weeks. Receives: Behavioral: Inspiratory muscle training |
| Usual care group | Active comparator | The Usual care group will receive regulated education. Receives: Behavioral: Regulated care and education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Pulmonary complications rate
According to the definition of PPCs on European Perioperative Clinical Outcome 2015
Measured: Change from baseline (0 week) to follow up (4 weeks)
Respiratory muscles strength
MIP and MEP are done by measuring the upper airway pressure
Measured: Change from baseline (0 week) to follow up (4 weeks)
Diaphragm mobilit
Diaphragm ultrasonography
Measured: Change from baseline (0 week) to follow up (4 weeks)
Secondary outcomes (1)
Quality of life score
The World Health Organization Quality of Life Briefing
Measured: Change from baseline (0 week) to follow up (4 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2022
- Study start1 Apr 2019
- Primary completion1 Dec 2020
- Study completion1 Dec 2020
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 Inspiratory Muscle TrainingStudies of the same condition, open and under way.
- 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
- Model description
- The study population will be randomized and separated in two groups, Intervention and Usual care group.
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cheng Kung University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kun-Ling Tsai, National Cheng Kung University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05239819
- Sponsor's protocol ID
- B-BR-108-012
- Status last verified
- Feb 2022
- First submitted
- 4 Feb 2022
- Last updated
- 15 Feb 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD sharing plan will be decided after summarized data being published
Publications
Huang YT, Lin YJ, Hung CH, Cheng HC, Yang HL, Kuo YL, Chu PM, Tsai YF, Tsai KL. The fully engaged inspiratory muscle training reduces postoperative pulmonary complications rate and increased respiratory muscle function in patients with upper abdominal surgery: a randomized controlled trial. Ann Med. 2022 Dec;54(1):2222-2232. doi: 10.1080/07853890.2022.2106511.
PubMed 35942800
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Fully Engaged Inspiratory Muscle Training Reduces Postoperative Pulmonary Complications Rate and Increased Respiratory Muscle Function in Patients With Upper Abdominal Surgery: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05239819
- Acronym / sponsor ID
- B-BR-108-012
- Conditions
- Inspiratory Muscle Training, Postoperative Pulmonary Complications, Respiratory Muscle Function, Abdominal Surgery
- Keywords
- inspiratory muscle training, postoperative pulmonary complications, respiratory muscle function, abdominal surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- National Cheng Kung UniversityUniversity, hospital or other
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 1 Dec 2020 (actual)
- Study completion
- 1 Dec 2020 (actual)
- First posted
- 15 Feb 2022 (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.
Upper abdominal surgical treatment may have reduced respiratory muscle function and mucociliary clearance, which might be a consequence of postoperative pulmonary complications (PPCs). The threshold inspiratory muscle training (IMT) may serve as an effective modality to improve respiratory muscle strength and endurance in patients. However, whether this training could help patients with upper abdominal surgery remain to be determined.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The study population will be randomized and separated in two groups, Intervention and Usual care group.
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: Inspiratory muscle trainingWe conducted a fully engaged inspiratory muscle training (IMT) program. The exercise group received the intervention threshold IMT from preoperative to postoperative undergoing upper abdominal surgery. The IMT was started before 3 weeks of operation and surveyed in the followed 4 weeks. |
| Usual care group | Active comparator | Behavioral: Regulated care and educationThe Usual care group will receive regulated education. |
Who may qualify
- Ages
- 20 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- ≧20 years old with upper abdominal surgery,
- American Society of Anesthesiologists; ASA) I-IV
- body Mass Index; BMI≥ 18
- able to follow exercise protocol. T
Key exclusion criteria (3 listed)
- history of prior abdominal surgery
- high risk of exercise contraindications (e.g. severe cardiac or cardiovascular disease), 3) American Society of Anesthesiologists; ASA) V-IV
- 4) unable to follow exercise protocol 5) severe organ failure
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 trainingThe initial training intensity of the preoperative threshold IMT trainer (DofinTM, Breathing Strength Builder, Taiwan) was moderate to high intensity (≥50% of MIP), which was according to the patient's baseline level and increased by 5-10% per week. The frequency is 25-30 minutes each time, twice a day and five days per week for at least two weeks. The participants would receive at least 10 times training sessions before surgery | Behavioural | Intervention group |
| Regulated care and educationRegulated care and education will be applied | Behavioural | Usual care group |
Primary outcome
Postoperative Pulmonary complications rate
Time frame: Change from baseline (0 week) to follow up (4 weeks)
According to the definition of PPCs on European Perioperative Clinical Outcome 2015
Respiratory muscles strength
Time frame: Change from baseline (0 week) to follow up (4 weeks)
MIP and MEP are done by measuring the upper airway pressure
Diaphragm mobilit
Time frame: Change from baseline (0 week) to follow up (4 weeks)
Diaphragm ultrasonography
1 secondary outcome
Quality of life score
Time frame: Change from baseline (0 week) to follow up (4 weeks)
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 15 Feb 2022.
- Derived from this study: PubMed 35942800Huang YT, Lin YJ, Hung CH, Cheng HC, Yang HL, Kuo YL, Chu PM, Tsai YF, Tsai KL. The fully engaged inspiratory muscle training reduces postoperative pulmonary complications rate and increased respiratory muscle function in patients with upper abdominal surgery: a randomized controlled trial. Ann Med. 2022 Dec;54(1):2222-2232. doi: 10.1080/07853890.2022.2106511.
- Individual participant dataSharing planned: No. IPD sharing plan will be decided after summarized data being published
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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.
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 Inspiratory muscle training and Regulated care and education in people with Inspiratory Muscle Training and Postoperative Pulmonary Complications, run by National Cheng Kung University at 1 site in Taiwan.
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 4 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: finished, as of the sponsor's last update on 15 Feb 2022. 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 Taiwan. 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 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?
Postoperative Pulmonary complications rate (time frame: Change from baseline (0 week) to follow up (4 weeks)). The study lists 3 primary outcomes in all. 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 NCT05239819, 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 15 Feb 2022.