NCT05290480

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable colorectal-cancer

Timeline
Completed

Started Jan 2018

Shorter than P25 for not_applicable colorectal-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2018

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 12, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 10, 2019

Completed
2.9 years until next milestone

First Submitted

Initial submission to the registry

March 3, 2022

Completed
19 days until next milestone

First Posted

Study publicly available on registry

March 22, 2022

Completed
Last Updated

March 22, 2022

Status Verified

March 1, 2022

Enrollment Period

1.1 years

First QC Date

March 3, 2022

Last Update Submit

March 13, 2022

Conditions

Colorectal CancerPulmonary Rehabilitation

Keywords

Colorectal surgeryExpiratory muscle trainingPulmonary rehabilitation

Outcome Measures

Primary Outcomes (4)

  • 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

Study Arms (2)

Expiratory muscle training

EXPERIMENTAL

participant performed expiratory muscle training with threshold device

Other: expiratory muscle training

Insentive spirometry

EXPERIMENTAL

participant performed deep breathing exercise with insentive spirometry device

Device: Insentive spirometry

Interventions

expiratory muscle trainingOTHER

participants performed expiratory muscle training according to their maximum expiratory pressure that measured earlier in addition to conventional chest physiotherapy

Expiratory muscle training
Insentive spirometryDEVICE

participants performed deep breating exercise with insentive spirometry in additional to convantional chest physiotherapy

Insentive spirometry

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • hemodynamically stable
  • able to walk independently
  • able to walk independently

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pamukkale University

Denizli, Pamukkale, 20000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Study Officials

  • Erhan KIZMAZ, Msc

    Pamukkale University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Masking Details
Treatment and evaluation were performed by two different physiotherapists. The assessing physiotherapist was blind to group allocation.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
research assistant

Study Record Dates

First Submitted

March 3, 2022

First Posted

March 22, 2022

Study Start

January 1, 2018

Primary Completion

February 12, 2019

Study Completion

April 10, 2019

Last Updated

March 22, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)