Lung Resection and Pulmonary Rehabilitation

Outcomes of Pulmonary Rehabilitation After Lung Resection in Patients With Non-Small Cell Lung Cancer

Lung cancer is the most common cancer in the world and surgical resection remains the gold standard curative treatment in early stage non-small cell lung cancer. However, surgery itself is the direct cause of pulmonary function impairment, which dramatically reduces patients tolerance to exercise and their quality of life. Pulmonary rehabilitation (PR) complements surgical treatment and improves patients' exercise and functional capacity, decreases dyspnea, improves health status.

Our aim is to examine the effectiveness of PR applied after lung resection in patients with lung cancer, 2- To determine whether the respiratory exercise training given to patients who could not participate in the PR program is effective.

Study Overview

• Status: Completed
• Conditions: Lung Cancer; Pulmonary Rehabilitation
• Intervention / Treatment: Other: Exercise

Detailed Description

Pulmonary rehabilitation (PR) is an evidence-based, interdisciplinary, comprehensive exercise program that targets patients with symptomatic chronic respiratory disease. PR integrates exercise and training interventions into a personalized treatment program. PR has become an important component of the general treatment strategy in patients with high-risk surgical diseases such as lung resection. It helps patients return to normal not only physically, but also emotionally and mentally. In patients with lung cancer, preoperative PR increases exercise capacity, decreases post-operative morbidity and mortality. Although it is reported that the PR program applied in the post-operative period increases physical performance and improves the quality of life, referral of patients in need of the PR unit is less than 25%. There is a need to increase the awareness of both pulmonologists and thoracic surgeons about the benefits of the PR program, which is a non-pharmacological and effective intervention.

The investigators have had two objectives in this study. 1- To examine the effectiveness of PR applied after lung resection in patients with lung cancer, 2- To determine whether the respiratory exercise training given to patients who could not participate in the PR program is effective.

An 8-week comprehensive outpatient PR program will applied to half of 66 patients with non-small cell lung cancer who underwent lung resection, and the other half received respiratory exercise training. After the intervention, the results of both groups will compare.

• Study Type: Interventional
• Enrollment (Actual): 66
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • İzmir, Turkey, 35620
    • İlknur Naz Gürşan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients who had undergone surgery for non-small cell lung cancer in the last two years
• Patients who had no chemotherapy or radiotherapy

Exclusion Criteria:

• Patients who were found unsuitable with the cardiology consultation
• Patients with psychiatric problems
• Patients with severe joint diseases
• Reluctant patients

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Pulmonary Rehabilitation Group; An 8-week comprehensive outpatient PR program including respiratory exercises, aerobic and strengthening training	Other: Exercise; Exercise training
Other: Control Group; Respiratory exercises	Other: Exercise; Exercise training

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Exercise Capacity	Six minutes walk test	up to 8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Respiratory Functions	Pulmonary Function Test Pulmonary function test (PFT) which is noninvasive tests that show how well the lungs are working. The tests will measure FEV1; It is the volume of air (in liters) exhaled in the first second during forced exhalation after maximal inspiration. FVC: It s the amount of air that can be forcibly exhaled from your lungs after taking the deepest breath possible, as measured by spirometry FEV1/FVC: It represents the proportion of a person's vital capacity that they are able to expire in the first second of forced expiration (FEV1) to the full, forced vital capacity (FVC).	up to 8 weeks
Dyspnea Sensation	Modified Medical Research Council (MMRC)" dyspnea scale, which consists of 5 items ranging between 1 and 5, to determine the severity of patients' shortness of breath. Higher scores mean a worse outcome.	up to 8 weeks
Disease Specific Quality of Life	St. George's Respiratory Questionnaire (SGRQ) to determine disease-specific quality of life. At this scale, high scores define worsened disease and increased symptoms. Higher scores mean a worse outcome.	up to 8 weeks
Anxiety	Hospital Anxiety and Depression (HAD) Inventory for assessment of anxiety and depression. In this scale; scores of anxiety and depression are calculated separately. The maximum score for both is 21 and high scores correspond to high degree anxiety and depression. Cut-off scores for anxiety and depression were determined as 10/11 and 7/8 respectively.	up to 8 weeks
Depression	Hospital Anxiety and Depression (HAD) Inventory for assessment of anxiety and depression. In this scale; scores of anxiety and depression are calculated separately. The maximum score for both is 21 and high scores correspond to high degree anxiety and depression. Cut-off scores for anxiety and depression were determined as 10/11 and 7/8 respectively.	up to 8 weeks
Body Mass Index	Body mass index is calculated by dividing body mass by the square of length in meters	up to 8 weeks

Collaborators and Investigators

• Sponsor: Izmir Katip Celebi University

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2017
• Primary Completion (Actual): December 1, 2019
• Study Completion (Actual): December 1, 2019

Study Registration Dates

• First Submitted: January 13, 2021
• First Submitted That Met QC Criteria: January 20, 2021
• First Posted (Actual): January 25, 2021

Study Record Updates

• Last Update Posted (Actual): January 25, 2021
• Last Update Submitted That Met QC Criteria: January 20, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: lung cancer; pulmonary rehabilitation; lung surgery
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms
• Other Study ID Numbers: IKC123

Drug and device information, study documents

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