NCT04568564

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable lung-cancer

Timeline
Completed

Started Oct 2020

Typical duration 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 18, 2020

Completed
11 days until next milestone

First Posted

Study publicly available on registry

September 29, 2020

Completed
2 days until next milestone

Study Start

First participant enrolled

October 1, 2020

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

April 8, 2025

Status Verified

April 1, 2025

Enrollment Period

4.2 years

First QC Date

September 18, 2020

Last Update Submit

April 6, 2025

Conditions

Keywords

exercisevideoconferencelung cancersurgerypostoperativechest physiotherapytelerehabilitation

Outcome Measures

Primary Outcomes (1)

  • Major complication rate

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

    Up to 3 months

Secondary Outcomes (18)

  • The six-minute walking test

    Up to 3 months

  • Modified Medical Research Council Dyspnea Scale

    Up to 3 months

  • Visual analog scale

    Up to 3 months

  • Duration of tube thoracostomy drainage

    Up to 3 months

  • Forced expiratory volume one second (FEV1)

    Up to 3 months

  • +13 more secondary outcomes

Study Arms (2)

Telerehabilitation Group (TG)

EXPERIMENTAL

Patients diagnosed with lung cancer and underwent thoracotomy

Other: Breathing exercise, intensive spirometry use, supported cough, progressive mobilisation and ambulation

Control group (CG)

ACTIVE COMPARATOR

Patients diagnosed with lung cancer and underwent thoracotomy

Other: Exercise booklet

Interventions

The exercise program includes breathing exercises (chest-abdominal-lateral basal breathing; 10 repetitions), use of intensive spirometry (20 repetitions) and assisted coughing. Apart from this, a progressive mobilization program will be applied considering patient tolerance and hemodynamic parameters, starting after the patient is taken to the service room. The teleconference exercise call will be continued from the postop 1st day until discharge, twice a day.

Telerehabilitation Group (TG)

Patients will be interviewed by videoconferencing method at least 1 day before the operation, their first evaluation will be taken and an exercise booklet will be given.

Control group (CG)

Eligibility Criteria

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul University-Cerrahpaşa, Cerrahpaşa Faculty of Medicine Thoracic Surgery Clinic

Istanbul, 34668, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Lung NeoplasmsMotor Activity

Interventions

Breathing ExercisesWalking

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesBehavior

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsExercise Movement TechniquesPhysical Therapy ModalitiesLocomotionMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaExerciseMotor Activity

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Randomized controlled trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

September 18, 2020

First Posted

September 29, 2020

Study Start

October 1, 2020

Primary Completion

December 1, 2024

Study Completion

December 1, 2024

Last Updated

April 8, 2025

Record last verified: 2025-04

Locations