Colorectal CancerNCT05290480
Expiratory Muscle Training Versus Incentive Spirometry After Colorectal Surgery
A study testing expiratory muscle training and Insentive spirometry in people with Colorectal Cancer and Pulmonary Rehabilitation, run by Pamukkale University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study was to compare the effects of expiratory muscle training (EMT) and incentive spirometry (IS) in addition to conventional pulmonary rehabilitation after colorectal surgery. Twenty-four individuals (13 male) undergoing colorectal surgery were included. They were randomly divided into two groups. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer, Pulmonary Rehabilitation
- What is being tested?
- expiratory muscle training and Insentive spirometry
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2018to 10 Apr 2019
- 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
- hemodynamically stable
- able to walk independently
- able to walk independently
Who cannot join
- any contraindication for chest physiotherapy (unstable cardiovascular disease, severe pulmonary hypertension, corrected severe hypoxemia, exercise desaturation, rib fractures, subcutaneous emphysema, advanced osteoporosis, thrombocytopenia, effort dyspnea and vertigo)
- any metastases
- severe chronic cardiovascular disease
- candidates for organ transplantation
- abdominal hernia repair
- history of surgery more than one year
- orthopaedic or neurological disease that would prevent independent walking
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Pamukkale University
Denizli, Pamukkale, 20000
About this study
The aim of this study was to compare the effects of expiratory muscle training (EMT) and incentive spirometry (IS) in addition to conventional pulmonary rehabilitation after colorectal surgery. Twenty-four individuals (13 male) undergoing colorectal surgery were included. They were randomly divided into two groups. In addition to conventional chest physiotherapy, group 1 was performed EMT (n=12), group 2 was performed deep breathing exercises with incentive spirometry (IS) in postoperative period. Respiratory muscle strength, functional capacity, levels of movement and independence, and postoperative pulmonary complications (PPC) were evaluated. Length of stay in hospital (LOS) was recorded.
Read the detailed description
The aim of this study was to compare the effects of expiratory muscle training (EMT) and incentive spirometry (IS) in addition to conventional pulmonary rehabilitation after colorectal surgery. Twenty-four individuals (13 male) undergoing colorectal surgery were included. They were randomly divided into two groups. In addition to conventional chest physiotherapy, group 1 was performed EMT (n=12), group 2 was performed deep breathing exercises with incentive spirometry (IS) in postoperative period. Respiratory muscle strength, functional capacity, levels of movement and independence, and postoperative pulmonary complications (PPC) were evaluated. Length of stay in hospital (LOS) was recorded
- Conditions
- Colorectal Cancer, Pulmonary Rehabilitation
- Being tested
- expiratory muscle training, Insentive spirometry
- Keywords
- Colorectal surgery, Expiratory muscle training, Pulmonary rehabilitation
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
expiratory muscle trainingOther
participants performed expiratory muscle training according to their maximum expiratory pressure that measured earlier in addition to conventional chest physiotherapy
Insentive spirometryDevice
participants performed deep breating exercise with insentive spirometry in additional to convantional chest physiotherapy
| Study group | Role | What they receive |
|---|---|---|
| Expiratory muscle training | Experimental | participant performed expiratory muscle training with threshold device Receives: Other: expiratory muscle training |
| Insentive spirometry | Experimental | participant performed deep breathing exercise with insentive spirometry device Receives: Device: Insentive spirometry |
What is being measured
The primary outcome is the main question the study is designed to answer.
Respiratory muscle strength
Maximum expiratory and inspiratory muscle strength
Measured: 2-3 minutes
Postoperative pulmonary complications
any pulmonary complications after colorectal surgery
Measured: 3-7 day
6 Minutes walk test
Physical functional capacity
Measured: 6-10 minutes
'Patient Mobility and Observer Mobility Scale
Indipendence and mobility levels after surgery
Measured: 2-3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2022
- Study start1 Jan 2018
- Primary completion12 Feb 2019
- Study completion10 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pamukkale University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Erhan KIZMAZ, Pamukkale University
- Investigators
- Erhan KIZMAZ, Msc, Principal investigator, Pamukkale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05290480
- Sponsor's protocol ID
- ekizmaz
- Status last verified
- Mar 2022
- First submitted
- 3 Mar 2022
- Last updated
- 22 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Expiratory Muscle Training Versus Incentive Spirometry After Colorectal Surgery
- ClinicalTrials.gov ID
- NCT05290480
- Acronym / sponsor ID
- ekizmaz
- Conditions
- Colorectal Cancer, Pulmonary Rehabilitation
- Keywords
- Colorectal surgery, Expiratory muscle training, Pulmonary rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Pamukkale UniversityUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 12 Feb 2019 (actual)
- Study completion
- 10 Apr 2019 (actual)
- First posted
- 22 Mar 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.
The aim of this study was to compare the effects of expiratory muscle training (EMT) and incentive spirometry (IS) in addition to conventional pulmonary rehabilitation after colorectal surgery. Twenty-four individuals (13 male) undergoing colorectal surgery were included. They were randomly divided into two groups. In addition to conventional chest physiotherapy, group 1 was performed EMT (n=12), group 2 was performed deep breathing exercises with incentive spirometry (IS) in postoperative period. Respiratory muscle strength, functional capacity, levels of movement and independence, and postoperative pulmonary complications (PPC) were evaluated. Length of stay in hospital (LOS) was recorded.
Detailed description
The aim of this study was to compare the effects of expiratory muscle training (EMT) and incentive spirometry (IS) in addition to conventional pulmonary rehabilitation after colorectal surgery. Twenty-four individuals (13 male) undergoing colorectal surgery were included. They were randomly divided into two groups. In addition to conventional chest physiotherapy, group 1 was performed EMT (n=12), group 2 was performed deep breathing exercises with incentive spirometry (IS) in postoperative period. Respiratory muscle strength, functional capacity, levels of movement and independence, and postoperative pulmonary complications (PPC) were evaluated. Length of stay in hospital (LOS) was recorded
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Expiratory muscle training | Experimental | Other: expiratory muscle trainingparticipant performed expiratory muscle training with threshold device |
| Insentive spirometry | Experimental | Device: Insentive spirometryparticipant performed deep breathing exercise with insentive spirometry device |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- hemodynamically stable
- able to walk independently
- able to walk independently
Key exclusion criteria (7 listed)
- any contraindication for chest physiotherapy (unstable cardiovascular disease, severe pulmonary hypertension, corrected severe hypoxemia, exercise desaturation, rib fractures, subcutaneous emphysema, advanced osteoporosis, thrombocytopenia, effort dyspnea and vertigo)
- any metastases
- severe chronic cardiovascular disease
- candidates for organ transplantation
- abdominal hernia repair
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 |
|---|---|---|
| expiratory muscle trainingparticipants performed expiratory muscle training according to their maximum expiratory pressure that measured earlier in addition to conventional chest physiotherapy | Other | Expiratory muscle training |
| Insentive spirometryparticipants performed deep breating exercise with insentive spirometry in additional to convantional chest physiotherapy | Device | Insentive spirometry |
Primary outcome
Respiratory muscle strength
Time frame: 2-3 minutes
Maximum expiratory and inspiratory muscle strength
Postoperative pulmonary complications
Time frame: 3-7 day
any pulmonary complications after colorectal surgery
6 Minutes walk test
Time frame: 6-10 minutes
Physical functional capacity
'Patient Mobility and Observer Mobility Scale
Time frame: 2-3 days
Indipendence and mobility levels after surgery
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 22 Mar 2022.
- Individual participant dataSharing planned: No
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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.
Erhan KIZMAZ, Msc principal investigator
Pamukkale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing expiratory muscle training and Insentive spirometry in people with Colorectal Cancer and Pulmonary Rehabilitation, run by Pamukkale 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 3 inclusion and 7 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 22 Mar 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?
Respiratory muscle strength (time frame: 2-3 minutes). The study lists 4 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 22 Mar 2022.