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Clinical Trials/NCT04568564
NCT04568564
Completed
Not Applicable

Telerehabilitation of Reduced Physiotherapy Service in SARS-CoV-2 Pandemic Process in Lung Surgery Patients

Istanbul Medipol University Hospital1 site in 1 country40 target enrollmentOctober 1, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Lung Cancer
Sponsor
Istanbul Medipol University Hospital
Enrollment
40
Locations
1
Primary Endpoint
Major complication rate
Status
Completed
Last Updated
last year

Overview

Brief Summary

In this study, providing access to physiotherapy applications by telerehabilitation method and the effectiveness of this application will be examined for patients who have undergone lung surgery in the early postoperative period during the pandemic process in which social isolation continues.

Detailed Description

* Patients who meet the inclusion criteria and agree to participate in the study will be included in the study. * Patients diagnosed with lung cancer and underwent thoracotomy will be randomly divided into Telerehabilitation Group (TGR) and Control (KG) groups. * Before the operation, enlightened and signed consent will be obtained from the cases, the first evaluations of the patients in both groups will be made and the first exercise training will be given to the telerehabilitation group. * The study group will be followed up every day during their hospitalizations and the final tests of both groups will be made before discharge. Long-term follow-up will be carried out in the 1st month and 3rd month after discharge.

Registry
clinicaltrials.gov
Start Date
October 1, 2020
End Date
December 1, 2024
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Istanbul Medipol University Hospital
Responsible Party
Principal Investigator
Principal Investigator

esra pehlivan

Principal investigator

Saglik Bilimleri Universitesi

Eligibility Criteria

Inclusion Criteria

  • Having a smart phone and capable of making video calls,
  • Planned to be operated with thoracotomy or videothoracoscope,
  • Staged between IA and IIIB with clinical staging,
  • With proven lung tumor (If AC diagnosis is not confirmed after frozen or wedge, the patient will be excluded from the study),
  • Patients with no cardiac disease (ASA II or better) that affects their quality of life.

Exclusion Criteria

  • Having a cardiac disease that affects the quality of life,
  • Serious cognitive problems and presence of psychiatric diseases,
  • Presence of physical limitations (vision, hearing impairment, orthopedic problems).

Outcomes

Primary Outcomes

Major complication rate

Time Frame: Up to 3 months

Major complication rates such as postoperative fever, infection, and hemorrhage will be documented.

Secondary Outcomes

  • Visual analog scale(Up to 3 months)
  • Diffusion Capacity(Change from baseline to 1 and 3 months)
  • Lung V/Q Scintigraphy(Change from baseline to 1 and 3 months)
  • Procalcitonin (PCT)(Up to 3 months)
  • C-Reactive Protein (CRP)(Up to 3 months)
  • Ferritin(Up to 3 months)
  • D'dimer test(Up to 3 months)
  • Partial Oxigen Pressure (PaO2)(Up to 3 months)
  • The six-minute walking test(Up to 3 months)
  • Duration of tube thoracostomy drainage(Up to 3 months)
  • Forced expiratory volume one second (FEV1)(Up to 3 months)
  • Modified Medical Research Council Dyspnea Scale(Up to 3 months)
  • Forced vital capacity (FVC)(Up to 3 months)
  • Lung Capacities(Change from baseline to 1 and 3 months)
  • Lactate dehydrogenase(Up to 3 months)
  • Partial Carbon monoxide Pressure (PaCO2)(Up to 3 months)
  • Arterial blood oxygen saturation level (SaO2)(Up to 3 months)
  • Anxiety inventory(Up to 3 months)

Study Sites (1)

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