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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05290480
Other study ID # ekizmaz
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 1, 2018
Est. completion date April 10, 2019

Study information

Verified date March 2022
Source Pamukkale University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


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


Recruitment information / eligibility

Status Completed
Enrollment 24
Est. completion date April 10, 2019
Est. primary completion date February 12, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Intervention

Other:
expiratory muscle training
participants performed expiratory muscle training according to their maximum expiratory pressure that measured earlier in addition to conventional chest physiotherapy
Device:
Insentive spirometry
participants performed deep breating exercise with insentive spirometry in additional to convantional chest physiotherapy

Locations

Country Name City State
Turkey Pamukkale University Denizli Pamukkale

Sponsors (1)

Lead Sponsor Collaborator
Pamukkale University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Respiratory muscle strength Maximum expiratory and inspiratory muscle strength 2-3 minutes
Primary Postoperative pulmonary complications any pulmonary complications after colorectal surgery 3-7 day
Primary 6 Minutes walk test Physical functional capacity 6-10 minutes
Primary 'Patient Mobility and Observer Mobility Scale Indipendence and mobility levels after surgery 2-3 days
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