Investigation of the Effectiveness of Tele-pulmonary Rehabilitation After Lung Resection

As a result of the review in the literature, no study was found in which tele-pulmonary rehabilitation was applied after physiotherapist-supervised lung resection via video conferencing.

Therefore, in this study, it was planned to investigate the effectiveness of tele-pulmonary rehabilitation in patients diagnosed with lung cancer and undergoing lung resection.

Study Overview

• Status: Not yet recruiting
• Conditions: Lung Cancer; Lung Resection; Tele-pulmonary Rehabilitation
• Intervention / Treatment: Other: Rehabilitation group

Detailed Description

Research; It was planned as a prospective and randomized controlled study. The research universe is Istanbul Kartal Dr. Lütfi Kırdar City Hospital Chest Surgery Clinic will consist of cases with a preliminary diagnosis of lung cancer. The sample of the study, on the other hand, will consist of patients who agreed to participate in the study and who met the inclusion criteria, who were planned for lung resection.

1. Study group (n=18); The treatment features of the tele-pulmonary rehabilitation group via videoconferencing are; Within the scope of the tele-pulmonary rehabilitation program, an exercise program consisting of lower-upper extremity strengthening training and flexibility training, breathing exercises training (diaphragmatic breathing, thoracic expansion exercises and forced expiration) and aerobic exercise training will be created before discharge, exercise session will be followed. Re-evaluation will be done after 8 weeks.Exercise intensity will be planned as 2 days a week with supervision and 1 day without supervision, 3 days a week in total. Exercise safety will be ensured by taking the severity of shortness of breath of the patients as a reference.
2. Control group (n=18); Patients in the tele-pulmonary rehabilitation control group will be given respiratory and aerobic exercise advice before discharge. Re-evaluation will be done after 8 weeks.

• Study Type: Interventional
• Enrollment (Anticipated): 36
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 55 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Male and female patients aged 55-75 years diagnosed with lung cancer
• Patients who underwent lobectomy, segmentectomy, bilobectomy, and pneumonectomy by either VATS or thoracotomy surgeries
• Patients who can use phones and make video calls

Exclusion Criteria:

• Patients with heart failure or atrial fibrillation
• Patients with acute infection at the time of assessment
• Patients who have had myocardial infarction in the last six months
• Patients with any comorbidities such as uncontrolled diabetes mellitus and/or hypertension
• Patients with any problem that would limit physical activity

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control group
Experimental: Study group	Other: Rehabilitation group; The intervention group will be given strength training to improve muscle strength and flexibility, and aerobic exercise training to improve exercise capacity with function.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Functional exercises capacity	A 6-minute walk test will be performed to determine functional exercise capacity.	8 weeks
Pulmonary function test	Pulmonary function test will be made in accordance with ats criteria	8 weeks
Peripheral muscle strength	Peripheral muscle strength will be done with 'Lafayette' device	8 weeks
Upper extremity normal range of motion	Upper extremity normal range of motion will be measured with a manual goniometer	8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anxiety and depression	Hospital anxiety and depression scale (HAD scale); It will be used to measure and evaluate patients' anxiety and depression scales.	8 weeks
Determination of quality of life	EORTC QLQ-C30; This scale is a widely used quality of life scale in cancer patients all over the world.	8 weeks
Cognitive functions	Mini mental state test; will be used to evaluate postoperative cognitive dysfunction.	8 weeks

Collaborators and Investigators

• Sponsor: Halime Sinem Barutçu

Study record dates

Study Major Dates

• Study Start (Anticipated): April 1, 2023
• Primary Completion (Anticipated): April 1, 2024
• Study Completion (Anticipated): December 1, 2024

Study Registration Dates

• First Submitted: March 16, 2023
• First Submitted That Met QC Criteria: March 30, 2023
• First Posted (Actual): April 3, 2023

Study Record Updates

• Last Update Posted (Actual): April 3, 2023
• Last Update Submitted That Met QC Criteria: March 30, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: DrLutfiKirdarPT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No