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

Sponsor

Halime Sinem Barutçu (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05794607

Collaborator

(none)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Tele-pulmonary Rehabilitation Lung Cancer Lung Resection	Other: Rehabilitation group	N/A

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.

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.
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 Design

Study Type:

Interventional

Anticipated Enrollment :

36 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Patients who will undergo lung surgery for lung cancerPatients who will undergo lung surgery for lung cancer

Masking:

Single (Investigator)

Primary Purpose:

Supportive Care

Official Title:

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

Anticipated Study Start Date :

Apr 1, 2023

Anticipated Primary Completion Date :

Apr 1, 2024

Anticipated Study Completion Date :

Dec 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
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.
No Intervention: Control group

Arm

Intervention/Treatment

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.

No Intervention: Control group

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

55 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Halime Sinem Barutçu

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Halime Sinem Barutçu, Physical Therapist, Dr. Lutfi Kirdar Kartal Training and Research Hospital

ClinicalTrials.gov Identifier:

NCT05794607

Other Study ID Numbers:

DrLutfiKirdarPT

First Posted:

Apr 3, 2023

Last Update Posted:

Apr 3, 2023

Last Verified:

Mar 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Apr 3, 2023