NCT03992235

Brief Summary

The patients who have undergone thoracotomy operation will include in the study. All patients have chest physiotherapy in the intensive care unit. Patients will be randomized and divided into two groups. One group will be given an exercise form with details and photographs of the exercises. No documents will be given to the other group. The program includes breathing exercises, incentive spirometry study, coughing and graded ambulation. After 1 intensive care session, patients are admitted to the service rooms due to routine procedures. The patients will be served in the afternoon and will be questioned whether they are performing their exercises or not.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2024

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

June 18, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 20, 2019

Completed
5.2 years until next milestone

Study Start

First participant enrolled

September 1, 2024

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2024

Completed
Last Updated

September 28, 2023

Status Verified

September 1, 2023

Enrollment Period

Same day

First QC Date

June 18, 2019

Last Update Submit

September 27, 2023

Conditions

Keywords

chest physiotherapyphysiotherapyeducationeducational materialthoracotomychestsurgerylungexercise

Outcome Measures

Primary Outcomes (2)

  • The number of exercises remembered

    The number of remembered exercises will be asked by the patient to show the exercises and recorded by the physiotherapist.

    15 second

  • The number of exercises done correctly

    The number of exercises done correctly will be asked by the patient to show the exercises and recorded by the physiotherapist.

    15 second

Secondary Outcomes (1)

  • Demographic features

    5 second

Study Arms (2)

Study Group

EXPERIMENTAL

Chest physiotherapy + educational material

Other: Chest physiotherapyOther: Educational material

Control group

OTHER

Chest physiotherapy

Other: Chest physiotherapy

Interventions

All patients will receive chest physiotherapy including "Breathing exercise, intensive spirometry use, coughing, ambulation".

Control groupStudy Group

Exercise brochure with photos and explanations

Study Group

Eligibility Criteria

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

You may qualify if:

  • Between 18-70 years
  • Having undergone post-thoracotomy
  • Hemodynamically stable,
  • To be conscious

You may not qualify if:

  • Excessive pain
  • Neurological complications
  • Cardiovascular and musculoskeletal problems that prevent him from exercising
  • Not wanting to be involved 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

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • ESRA PEHLİVAN, PhD

    SBÜ

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: The patients will randomize into 2 group
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ass.Prof, PT, PhD

Study Record Dates

First Submitted

June 18, 2019

First Posted

June 20, 2019

Study Start

September 1, 2024

Primary Completion

September 1, 2024

Study Completion

September 1, 2024

Last Updated

September 28, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations