Robotic Surgical ProceduresNCT03636633
The Effect of Inspiratory Muscle Training and Respiratory Physiotherapy on Pulmonary Functions, Respiratory Muscle Strength and Functional Capacity in Patients With Robotic Heart Surgery
A study testing Standard respiratory physiotherapy and Standard respiratory physiotherapy and inspiratory muscle training in people with Robotic Surgical Procedures and Heart Diseases, run by Acibadem University at 1 site in Turkey (Türkiye).
Trial summary
During the past decade, especially with the advancement of technology, major innovations and developments have been observed in the field of surgery. Cardiac surgery is one of the important area of the surgery who renews itself day by day and adds innovations to the nature in terms of patients' comfort. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Robotic Surgical Procedures, Heart Diseases
- What is being tested?
- Standard respiratory physiotherapy and Standard respiratory physiotherapy and inspiratory muscle training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 21 Mar 2018to 21 Feb 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
- Being suitable for robotic cardiac surgery,
- Being hospitalized to have a robotic heart surgery,
- No complications during surgery,
- To be extubated in intensive care unite after surgery ,
- Stable clinical condition,
- To be transferred from ICU to the hospital room on the first day after surgery.
Who cannot join
- Chronic obstructive pulmonary disease,
- Unstable angina,
- Acute decompensated heart failure,
- Acute pericarditis and myocarditis,
- Complex arrhythmia,
- Uncontrolled hypertension,
Show all 9Show fewer
- Serious orthopedic and neurological impairment,
- Uncontrolled diabetes,
- Body Mass Index > 30.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Acıbadem MAA University Maslak Hospital
Istanbul, 34457
About this study
During the past decade, especially with the advancement of technology, major innovations and developments have been observed in the field of surgery. Cardiac surgery is one of the important area of the surgery who renews itself day by day and adds innovations to the nature in terms of patients' comfort. One of the greatest developments in cardiac surgery in this sense is the tendency to reduce the size of the incisions with less interventional procedures. Robotic surgery is getting more and more meaningful in this area. Despite the downsizing of the surgical incisions, postoperative pulmonary complications have not completely disappeared in the robotic cardiac surgery. Major respiratory problems following traditional cardiac surgery are gas exchange problems, atelectasis, decreased coughing force and sputum retention. The effectiveness of respiratory physiotherapy applied after traditional cardiac surgery for the resolution of these complications has been proved by various investigations. Inspiratory muscle training (IMT) has been found to improve autonomic modulation in heart failure patients as well as to increase inspiratory muscle strength in applied patient populations, reduce blood pressure in hypertensive patients, and increase functional capacity in elderly individuals. Considering these benefits, when inspiratory muscle training is given to people with traditional cardiac surgery, respiratory muscle strengths, respiratory functions and functional capacities are increased compared to those not given to these patients. However, although there are complications after robotic cardiac surgery, there are no studies in the literature about respiratory physiotherapy or inspiratory muscle training. Thus, the subject of this study is the comparison of the effects of standard respiratory physiotherapy and standard respiratory physiotherapy plus inspiratory muscle training on the respiratory functions, respiratory muscle strength and functional capacity of the patients with the robotic heart surgery.
- Conditions
- Robotic Surgical Procedures, Heart Diseases
- Being tested
- Standard respiratory physiotherapy, Standard respiratory physiotherapy and inspiratory muscle training
- Keywords
- Robotic Heart Surgery, Inspiratory Muscle Training, Pulmonary Function Test, 6-Minute Walk Test, Respiratory Muscle Strength, Functional Capacity
- Medical subject headings
- Heart Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard respiratory physiotherapyOther
Standard respiratory physiotherapy content; diaphragmatic breathing, pursed lip breathing, segmental breathing, incentive spirometer exercises (Triflo) and coughing techniques.
Standard respiratory physiotherapy and inspiratory muscle trainingOther
Standard respiratory physiotherapy content; diaphragmatic breathing, pursed lip breathing, segmental breathing, incentive spirometer exercises (Triflo) and coughing techniques. Addition to that, threshold IMT device will be used for the training. Training intensity will set at 40% of the maximum inspiratory pressure.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Active comparator | Standard respiratory physiotherapy
Patients in this group will receive standard respiratory physiotherapy two times a day, 7 days a week for 4 weeks. During hospitalization, sessions will be performed by a respiratory physiotherapist. After discharge, other sessions will be performed at home by themselves. Receives: Other: Standard respiratory physiotherapy |
| Training Group | Experimental | Standard respiratory physiotherapy and inspiratory muscle train
In addition to the standard respiratory physiotherapy program, patients in this group will receive 3 sets of inspiratory muscle training with 10 repetitions twice a day for 4 weeks. During hospitalization, sessions will be performed by a respiratory physiotherapist. After discharge, other sessions will be performed at home by themselves. Receives: Other: Standard respiratory physiotherapy and inspiratory muscle training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline Forced Vital Capacity (FVC) at 4 weeks
Measured: Four weeks
Change from baseline Forced Expiratory Volume in 1 second (FEV1) at 4 weeks
Measured: Four weeks
Change from baseline Peak Expiratory Flow (PEF) at 4 weeks
Measured: Four weeks
Change from baseline maximum inspiratory pressure (MIP) at 4 weeks
Measured: Four weeks
Change from baseline maximum expiratory pressure (MEP) at 4 weeks
Measured: Four weeks
Change from baseline distance covered in six-minute walk test (6MWT) at 4 weeks
Measured: Four weeks
Change from baseline carbon monoxide diffusion capacity of the lungs (DLCO) at 4 weeks
Measured: Four weeks
Secondary outcomes (2)
Fatigue Severity Scale
The 9 item scale which measures the severity of fatigue and its effect on a person's activities and lifestyle in patients with a variety of disorders. Assessment type: Patient reported outcomes.The items are scored on a 7 point scale with 1 = strongly disagree and 7= strongly agree.The minimum score = 9 and maximum score possible = 63. Higher the score = greater fatigue severity.
Measured: Four weeks
Fatigue Impact Scale
The fatigue impact scale was developed to assess the symptom of fatigue as part of an underlying chronic disease or condition. Consisting of 40 items, the instrument evaluates the effect of fatigue on three domains of daily life: cognitive functioning, physical functioning, and psychosocial functioning. Respondents are asked to rate the extent to which fatigue has interfered with certain aspects of their day-to-day functioning using a scale that ranges from 0 ("no problem") to 4 ("extreme problem"). Scores are then tallied to produce an overall score with a potential maximum of 160. Subscale scores can also be calculated to give a more nuanced impression of fatigue.
Measured: Four weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2018
- Study start21 Mar 2018
- Primary completion21 Mar 2019
- Study completion21 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Robotic Surgical ProceduresStudies of the same condition, open and under way.
- More trials run by Acibadem 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Acibadem University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aslı İrem Dönmez, Acibadem University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03636633
- Sponsor's protocol ID
- ATADEK-2018-2/55
- Status last verified
- Apr 2022
- First submitted
- 6 Aug 2018
- Last updated
- 29 Apr 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Inspiratory Muscle Training and Respiratory Physiotherapy on Pulmonary Functions, Respiratory Muscle Strength and Functional Capacity in Patients With Robotic Heart Surgery
- ClinicalTrials.gov ID
- NCT03636633
- Acronym / sponsor ID
- ATADEK-2018-2/55
- Conditions
- Robotic Surgical Procedures, Heart Diseases
- Keywords
- Robotic Heart Surgery, Inspiratory Muscle Training, Pulmonary Function Test, 6-Minute Walk Test, Respiratory Muscle Strength, Functional Capacity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Acibadem UniversityUniversity, hospital or other
- Study start
- 21 Mar 2018 (actual)
- Primary completion
- 21 Mar 2019 (actual)
- Study completion
- 21 Feb 2021 (actual)
- First posted
- 17 Aug 2018 (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.
During the past decade, especially with the advancement of technology, major innovations and developments have been observed in the field of surgery. Cardiac surgery is one of the important area of the surgery who renews itself day by day and adds innovations to the nature in terms of patients' comfort. One of the greatest developments in cardiac surgery in this sense is the tendency to reduce the size of the incisions with less interventional procedures. Robotic surgery is getting more and more meaningful in this area. Despite the downsizing of the surgical incisions, postoperative pulmonary complications have not completely disappeared in the robotic cardiac surgery. Major respiratory problems following traditional cardiac surgery are gas exchange problems, atelectasis, decreased coughing force and sputum retention. The effectiveness of respiratory physiotherapy applied after traditional cardiac surgery for the resolution of these complications has been proved by various investigations. Inspiratory muscle training (IMT) has been found to improve autonomic modulation in heart failure patients as well as to increase inspiratory muscle strength in applied patient populations, reduce blood pressure in hypertensive patients, and increase functional capacity in elderly individuals. Considering these benefits, when inspiratory muscle training is given to people with traditional cardiac surgery, respiratory muscle strengths, respiratory functions and functional capacities are increased compared to those not given to these patients. However, although there are complications after robotic cardiac surgery, there are no studies in the literature about respiratory physiotherapy or inspiratory muscle training. Thus, the subject of this study is the comparison of the effects of standard respiratory physiotherapy and standard respiratory physiotherapy plus inspiratory muscle training on the respiratory functions, respiratory muscle strength and functional capacity of the patients with the robotic heart surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | Active comparator | Other: Standard respiratory physiotherapyStandard respiratory physiotherapy Patients in this group will receive standard respiratory physiotherapy two times a day, 7 days a week for 4 weeks. During hospitalization, sessions will be performed by a respiratory physiotherapist. After discharge, other sessions will be performed at home by themselves. |
| Training Group | Experimental | Other: Standard respiratory physiotherapy and inspiratory muscle trainingStandard respiratory physiotherapy and inspiratory muscle train In addition to the standard respiratory physiotherapy program, patients in this group will receive 3 sets of inspiratory muscle training with 10 repetitions twice a day for 4 weeks. During hospitalization, sessions will be performed by a respiratory physiotherapist. After discharge, other sessions will be performed at home by themselves. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Being suitable for robotic cardiac surgery,
- Being hospitalized to have a robotic heart surgery,
- No complications during surgery,
- To be extubated in intensive care unite after surgery ,
- Stable clinical condition,
Key exclusion criteria (9 listed)
- Chronic obstructive pulmonary disease,
- Unstable angina,
- Acute decompensated heart failure,
- Acute pericarditis and myocarditis,
- Complex arrhythmia,
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 |
|---|---|---|
| Standard respiratory physiotherapyStandard respiratory physiotherapy content; diaphragmatic breathing, pursed lip breathing, segmental breathing, incentive spirometer exercises (Triflo) and coughing techniques. | Other | Control Group |
| Standard respiratory physiotherapy and inspiratory muscle trainingStandard respiratory physiotherapy content; diaphragmatic breathing, pursed lip breathing, segmental breathing, incentive spirometer exercises (Triflo) and coughing techniques. Addition to that, threshold IMT device will be used for the training. Training intensity will set at 40% of the maximum inspiratory pressure. | Other | Training Group |
Primary outcome
Change from baseline Forced Vital Capacity (FVC) at 4 weeks
Time frame: Four weeks
Change from baseline Forced Expiratory Volume in 1 second (FEV1) at 4 weeks
Time frame: Four weeks
Change from baseline Peak Expiratory Flow (PEF) at 4 weeks
Time frame: Four weeks
Change from baseline maximum inspiratory pressure (MIP) at 4 weeks
Time frame: Four weeks
Change from baseline maximum expiratory pressure (MEP) at 4 weeks
Time frame: Four weeks
Change from baseline distance covered in six-minute walk test (6MWT) at 4 weeks
Time frame: Four weeks
Change from baseline carbon monoxide diffusion capacity of the lungs (DLCO) at 4 weeks
Time frame: Four weeks
2 secondary outcomes
Fatigue Severity Scale
Time frame: Four weeks
Fatigue Impact Scale
Time frame: Four 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 29 Apr 2022.
- Individual participant dataSharing planned: Undecided
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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 Standard respiratory physiotherapy and Standard respiratory physiotherapy and inspiratory muscle training in people with Robotic Surgical Procedures and Heart Diseases, run by Acibadem University at 1 site in Turkey (Türkiye).
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 6 inclusion and 9 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 29 Apr 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 Turkey (Türkiye). 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?
Change from baseline Forced Vital Capacity (FVC) at 4 weeks (time frame: Four weeks). The study lists 7 primary outcomes in all. 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 29 Apr 2022.