NCT03726541

Brief Summary

Physiotherapy will be applied to the patients who undergo thoracotomy operation after 24 hours of intensive care stay. Physiotherapy program includes breathing exercises, incentive spirometer training, ambulation. Oxygen saturation, heart rate and blood pressure values will be recorded before and after the training session. Changes in the follow-up parameters will be discussed.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
72

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2018

Shorter than P25 for not_applicable

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 30, 2018

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 31, 2018

Completed
1 day until next milestone

Study Start

First participant enrolled

November 1, 2018

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2018

Completed
Last Updated

March 7, 2019

Status Verified

March 1, 2019

Enrollment Period

2 months

First QC Date

October 30, 2018

Last Update Submit

March 6, 2019

Conditions

Outcome Measures

Primary Outcomes (3)

  • Change from baseline oxygen saturation

    The hearth rate response will be measured before and after exercise training with pulse oximeter.

    30 minutes

  • Change from baseline hearth rate response.

    The hearth rate response will be measured before and after exercise training with intensive care ECG

    30 minutes

  • Change from baseline systolic and diastolic blood pressure response.

    Blood pressure will be measured before and after exercise training with monometer from the arm

    30 minutes

Study Arms (1)

Early physiotherapy group

EXPERIMENTAL

breathing exercise incentive spirometry training ambulation coughing

Other: physiotherapy

Interventions

Physiotherapy program includes breathing exercises, incisive spirometer study, grade ambulation. Oxygen saturation, heart rate and blood pressure values will be recorded before and after the session. Changes in the follow-up parameters will be discussed.

Early physiotherapy group

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Between 18-75 age
  • Hemodynamically stable
  • Being conscious

You may not qualify if:

  • Excessive pain
  • Neurological complications
  • Posttraumatic and musculoskeletal problems to prevent exercise
  • Do not want to be included in the study
  • Fever above 38 degrees

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yedikule Chest Disease Hospital

Istanbul, Zeytinburnu, 34200, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Lung Diseases

Interventions

Physical Therapy Modalities

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

TherapeuticsRehabilitation

Study Officials

  • Arif Balcı

    Saglik Bilimleri Universitesi

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

October 30, 2018

First Posted

October 31, 2018

Study Start

November 1, 2018

Primary Completion

December 30, 2018

Study Completion

December 30, 2018

Last Updated

March 7, 2019

Record last verified: 2019-03

Locations