Expiratory Muscle Training Versus Incentive Spirometry After Colorectal Surgery

• Sponsor: Pamukkale University (Other)
• Overall Status: Completed
• CT.gov ID: NCT05290480
• Collaborator: (none)
• Enrollment: 24
• Location: 1
• Arms: 2
• Actual Duration (Months): 15.2
• Patients Per Site Per Month: 1.6

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Colorectal Cancer; Pulmonary Rehabilitation	Other: expiratory muscle training; Device: Insentive spirometry	N/A

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

• Study Type: Interventional
• Actual Enrollment: 24 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Investigator)
• Masking Description: Treatment and evaluation were performed by two different physiotherapists. The assessing physiotherapist was blind to group allocation.
• Primary Purpose: Supportive Care
• Official Title: Expiratory Muscle Training Versus Incentive Spirometry After Colorectal Surgery
• Actual Study Start Date: Jan 1, 2018
• Actual Primary Completion Date: Feb 12, 2019
• Actual Study Completion Date: Apr 10, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Expiratory muscle training participant performed expiratory muscle training with threshold device	Other: expiratory muscle training; participants performed expiratory muscle training according to their maximum expiratory pressure that measured earlier in addition to conventional chest physiotherapy
Experimental: Insentive spirometry participant performed deep breathing exercise with insentive spirometry device	Device: Insentive spirometry; participants performed deep breating exercise with insentive spirometry in additional to convantional chest physiotherapy

Outcome Measures

Primary Outcome Measures

1. Respiratory muscle strength [2-3 minutes]

   Maximum expiratory and inspiratory muscle strength

2. Postoperative pulmonary complications [3-7 day]

   any pulmonary complications after colorectal surgery

3. 6 Minutes walk test [6-10 minutes]

   Physical functional capacity

4. 'Patient Mobility and Observer Mobility Scale [2-3 days]

   Indipendence and mobility levels after surgery

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pamukkale University	Denizli	Pamukkale	Turkey	20000

Sponsors and Collaborators

• Pamukkale University

Investigators

• Principal Investigator: Erhan KIZMAZ, Msc, Pamukkale University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Erhan KIZMAZ, research assistant, Pamukkale University
• ClinicalTrials.gov Identifier: NCT05290480
• Other Study ID Numbers: ekizmaz
• First Posted: Mar 22, 2022
• Last Update Posted: Mar 22, 2022
• Last Verified: Mar 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Erhan KIZMAZ, research assistant, Pamukkale University: Colorectal surgery; Expiratory muscle training; Pulmonary rehabilitation
• Additional relevant MeSH terms: Colorectal Neoplasms

Study Results

No Results Posted as of Mar 22, 2022