Expiratory Muscle Training Versus Incentive Spirometry After Colorectal Surgery

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 Overview

• Status: Completed
• Conditions: Colorectal Cancer; Pulmonary Rehabilitation
• Intervention / Treatment: Other: expiratory muscle training; Device: Insentive spirometry

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 Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Pamukkale
    • Denizli, Pamukkale, Turkey, 20000
      • Pamukkale University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Pamukkale University
• Investigators: Principal Investigator: Erhan KIZMAZ, Msc, Pamukkale University

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2018
• Primary Completion (ACTUAL): February 12, 2019
• Study Completion (ACTUAL): April 10, 2019

Study Registration Dates

• First Submitted: March 3, 2022
• First Submitted That Met QC Criteria: March 13, 2022
• First Posted (ACTUAL): March 22, 2022

Study Record Updates

• Last Update Posted (ACTUAL): March 22, 2022
• Last Update Submitted That Met QC Criteria: March 13, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: Colorectal surgery; Pulmonary rehabilitation; Expiratory muscle training
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms
• Other Study ID Numbers: ekizmaz

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No