Pulmonary Rehabılıtatıon Wıth Non-Small Lung Cancer

Sponsor

Hasan Kalyoncu University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05320458

Collaborator

(none)

Enrollment

Location

Arm

Anticipated Duration (Months)

2.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The aim of our study is to investigate the effects of pulmonary rehabilitation on respiratory tests and quality of life in patients with early and locally advanced NSCLC who received chemotherapy regardless of whether the investigators had undergone surgical treatment.

Condition or Disease	Intervention/Treatment	Phase
Lung Cancer Lung Cancer, Small Cell	Other: Pulmonary Rehabilitation	N/A

Detailed Description

Patients with lung cancer often have concomitant lung and heart comorbidities that limit their cancer treatment options. For example, in the last prevalence study that included patients with newly diagnosed lung cancer, 73% of whom were men and 53% were women, there was clinically significant COPD. This patient population has shortness of breath, decreased physical capacity, low muscle condiction, and poor exercise tolerance.

Pulmonary rehabilitation is an intervention that has a scientific basis and is used systematically, aiming to optimize individual daily functions and health-related quality of life in patients with morbidity due to chronic diseases measured by clinical or physiological methods.

The effectiveness of pulmonary rehabilitation is well known in the treatment of patients with COPD and in the perioperative lung transplant preparation period. Studies lead to a significant increase in preoperative pulmonary rehabilitation exercise capacity, dyspnea and health-related quality of life.

This study was conducted with outpatients who were diagnosed with small cell lung cancer between 2021-2022, who were approved by the oncologist and physical therapist to participate in a physiotherapy and rehabilitation program. Permission for the study was obtained from the Non-Interventional Local Ethics Committee (decision dated 20.11.2018 and numbered 2018/34). The study was conducted in accordance with the Helsinki Declaration of Patient Rights. Individuals were informed about the study and a written informed consent form was signed by the individuals who volunteered to participate.

Participants Thirty patients aged 18-65 years in remission were included in the study. Surgery, adjuvant chemotherapy and radiotherapy processes of all patients included in the study were completed. Patients with suspected pregnancy, diagnosis of diabetes mellitus, patients in metastatic period, and patients with acute/chronic infection were excluded from the study.

Evaluation The patients' age, gender, height and body weight, medical history and family history information, education status, income level, smoking (pack/year), place of residence, admission to the emergency department in the last year, number of hospital admissions and hospitalizations, and medication used The information was recorded from the patients and their files. Participation of individuals in regular physical activity was questioned. In addition, pre- and post-treatment pain was evaluated using the visual analog scale (VAS).

The evaluations applied to the patients in our study;

Posture Analysis
Normal Joint Movement and Evaluation of Muscle Shortness
Muscle Test
Six Minute Walking Test
Physical Activity Level
Dyspnea Severity
Quality of Life
Fatigue Evaluation

Applied Treatments;

Respiratory Exercises
Walking Training
Aerobic exercise training

Study Design

Study Type:

Interventional

Anticipated Enrollment :

11 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

Single group 30 individuals were included in the study. Surgery, adjuvant chemotherapy and radiotherapy processes of all patients included in the study were completed. Patients between the ages of 18-65 and in remission period were included in the study. Patients with suspected pregnancy, diabetes mellitus, metastatic patients, and patients with acute and chronic infections were excluded from the study.Single group 30 individuals were included in the study. Surgery, adjuvant chemotherapy and radiotherapy processes of all patients included in the study were completed. Patients between the ages of 18-65 and in remission period were included in the study. Patients with suspected pregnancy, diabetes mellitus, metastatic patients, and patients with acute and chronic infections were excluded from the study.

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Pulmonary Rehabılıtatıon After Chemotherapy In Patıents Wıth Non-Small Lung Cancer

Anticipated Study Start Date :

May 2, 2022

Anticipated Primary Completion Date :

Jul 1, 2022

Anticipated Study Completion Date :

Sep 2, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Pulmonary Rehabilitation Pulmonary rehabilitation program will be applied 3 days a week at 40-60% of submaximal heart rate for a total of 8 weeks. Diaphragmatic breathing, pursed lips and segmental breathing exercises will be applied to the patients in the presence of a physiotherapist. Walking and aerobic exercise training will be given.	Other: Pulmonary Rehabilitation 1-Pulmonary Rehabilitation: Pulmonary rehabilitation program was applied at 40-60% of submaximal heart rate, 3 days a week for a total of 8 weeks. Diaphragmatic breathing, pursed lip breathing and segmental breathing exercises were practiced with the patients in the company of a physiotherapist. Walking and aerobic exercise training was given.

Arm

Intervention/Treatment

Experimental: Pulmonary Rehabilitation

Pulmonary rehabilitation program will be applied 3 days a week at 40-60% of submaximal heart rate for a total of 8 weeks. Diaphragmatic breathing, pursed lips and segmental breathing exercises will be applied to the patients in the presence of a physiotherapist. Walking and aerobic exercise training will be given.

Other: Pulmonary Rehabilitation

1-Pulmonary Rehabilitation: Pulmonary rehabilitation program was applied at 40-60% of submaximal heart rate, 3 days a week for a total of 8 weeks. Diaphragmatic breathing, pursed lip breathing and segmental breathing exercises were practiced with the patients in the company of a physiotherapist. Walking and aerobic exercise training was given.

Outcome Measures

Primary Outcome Measures

Chance from baseline in posture analysis score [8 week]
Posture score is going to be assess by posture analysis form to determine change from baseline.

Secondary Outcome Measures

Physical Activity Level [8 week]
Physical Activity is going to be assess by Physical Activity Questionnaire to determine change from baseline.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

Between the ages of 18-65, must be in remission.
Surgery, adjuvant chemotherapy and radiotherapy processes must be completed.

Exclusion Criteria:

Those with suspected pregnancy
Diabetes mellitus diagnosis
Patients in the metastatic period
Patients with a diagnosis of acute/chronic infection were excluded from the study.