NCT05891340

Brief Summary

The study to be carried out in the Istanbul Faculty of Medicine Department of Anesthesiology was planned as a randomized, prospective study. Patients who will undergo lung resection will be included in the study. Patients were randomized into two groups: Intervention Group includes patients who are rehabilitated preoperatively (prehabilitation), Control Group includes patients who are routinely recommended preoperative exercise, alcohol and smoking cessation. Prehabilitation consists of respiratory muscle exercise and walking is recommended to Intervention Group. Postoperative recovery will be questioned with Quality of Recovery-15 (QoR-15) on the 2nd day and 1st month. The intensive care unit admission, postoperative pulmonary complications and length of hospital stay will be recorded.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P25-P50 for not_applicable lung-cancer

Timeline
Completed

Started Jun 2023

Shorter than P25 for not_applicable lung-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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 25, 2023

Completed
7 days until next milestone

Study Start

First participant enrolled

June 1, 2023

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 6, 2023

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2024

Completed
Last Updated

May 17, 2024

Status Verified

May 1, 2024

Enrollment Period

11 months

First QC Date

May 25, 2023

Last Update Submit

May 16, 2024

Conditions

Keywords

prehabilitationquality of recoverylung resection

Outcome Measures

Primary Outcomes (1)

  • Quality of recovery at postoperative second day

    The primary aim of our study is to compare recovery of patients who have prehabilitation programme and who have not any programme by using QoR-15 questionnaire on the 2nd postoperative day.

    two days

Secondary Outcomes (4)

  • Quality of recovery at postoperative first month

    one month

  • length of intensive care unit stay

    two weeks

  • Length of hospital stay

    one month

  • Postoperative pulmonary complications

    one month

Study Arms (2)

Control

NO INTERVENTION

Preoperative exercise, alcohol and smoking cessation are recommended to patients.

Intervention

ACTIVE COMPARATOR

Respiratory muscle exercise (two times a day) and walking (5000steps/day) are recommended to the patients preoperatively.

Other: Respiratory muscle exerciseOther: Endurance exercise

Interventions

respiratory muscle exercise with inspiratory muscle trainer (two times a day)

Intervention

walking exercise 5000 steps/day

Intervention

Eligibility Criteria

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

You may qualify if:

  • ASA physical status classification system score 1-3 patients
  • Patients who underwent lung resection
  • Patients who agreed to participate in the study and gave written informed consent

You may not qualify if:

  • Re-operation
  • Emergency operations
  • Patients with psychiatric drug use
  • unability for physical exercise

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul Faculty of Medicine

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Breathing Exercises

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsExercise Movement TechniquesPhysical Therapy Modalities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: randomized, prospective
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 25, 2023

First Posted

June 6, 2023

Study Start

June 1, 2023

Primary Completion

April 30, 2024

Study Completion

April 30, 2024

Last Updated

May 17, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

Locations