Back to resultsExpiratory Muscle Training Versus Incentive Spirometry After Colorectal Surgery
Primary Purpose
Colorectal Cancer, Pulmonary Rehabilitation
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
expiratory muscle training
Insentive spirometry
Sponsored by
About this trial
This is an interventional supportive care trial for Colorectal Cancer focused on measuring Colorectal surgery, Expiratory muscle training, Pulmonary rehabilitation
Eligibility Criteria
Inclusion Criteria:
- hemodynamically stable
- able to walk independently
- able to walk independently
Exclusion Criteria:
- 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
Sites / Locations
- Pamukkale University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Expiratory muscle training
Insentive spirometry
Arm Description
participant performed expiratory muscle training with threshold device
participant performed deep breathing exercise with insentive spirometry device
Outcomes
Primary Outcome Measures
Respiratory muscle strength
Maximum expiratory and inspiratory muscle strength
Postoperative pulmonary complications
any pulmonary complications after colorectal surgery
6 Minutes walk test
Physical functional capacity
'Patient Mobility and Observer Mobility Scale
Indipendence and mobility levels after surgery
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05290480
Brief Title
Expiratory Muscle Training Versus Incentive Spirometry After Colorectal Surgery
Official Title
Expiratory Muscle Training Versus Incentive Spirometry After Colorectal Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
January 1, 2018 (Actual)
Primary Completion Date
February 12, 2019 (Actual)
Study Completion Date
April 10, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Pamukkale University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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. 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer, Pulmonary Rehabilitation
Keywords
Colorectal surgery, Expiratory muscle training, Pulmonary rehabilitation
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Masking Description
Treatment and evaluation were performed by two different physiotherapists. The assessing physiotherapist was blind to group allocation.
Allocation
Randomized
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Expiratory muscle training
Arm Type
Experimental
Arm Description
participant performed expiratory muscle training with threshold device
Arm Title
Insentive spirometry
Arm Type
Experimental
Arm Description
participant performed deep breathing exercise with insentive spirometry device
Intervention Type
Other
Intervention Name(s)
expiratory muscle training
Intervention Description
participants performed expiratory muscle training according to their maximum expiratory pressure that measured earlier in addition to conventional chest physiotherapy
Intervention Type
Device
Intervention Name(s)
Insentive spirometry
Intervention Description
participants performed deep breating exercise with insentive spirometry in additional to convantional chest physiotherapy
Primary Outcome Measure Information:
Title
Respiratory muscle strength
Description
Maximum expiratory and inspiratory muscle strength
Time Frame
2-3 minutes
Title
Postoperative pulmonary complications
Description
any pulmonary complications after colorectal surgery
Time Frame
3-7 day
Title
6 Minutes walk test
Description
Physical functional capacity
Time Frame
6-10 minutes
Title
'Patient Mobility and Observer Mobility Scale
Description
Indipendence and mobility levels after surgery
Time Frame
2-3 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
hemodynamically stable
able to walk independently
able to walk independently
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Erhan KIZMAZ, Msc
Organizational Affiliation
Pamukkale University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pamukkale University
City
Denizli
State/Province
Pamukkale
ZIP/Postal Code
20000
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Expiratory Muscle Training Versus Incentive Spirometry After Colorectal Surgery
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