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Pulmonary Rehabılıtatıon Wıth Non-Small Lung Cancer

Primary Purpose

Lung Cancer, Lung Cancer, Small Cell

Status
Not yet recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Pulmonary Rehabilitation
Sponsored by
Hasan Kalyoncu University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lung Cancer focused on measuring Lung Cancer, Pulmonary Rehabilitation, Aerobic Exercise, Physiotherapy and Rehabilitation, Oncological Rehabilitation

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept 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.

Sites / Locations

  • Hasan Kalyoncu Univercity

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Pulmonary Rehabilitation

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Physical Activity Level
Physical Activity is going to be assess by Physical Activity Questionnaire to determine change from baseline.

Full Information

First Posted
February 25, 2022
Last Updated
April 1, 2022
Sponsor
Hasan Kalyoncu University
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1. Study Identification

Unique Protocol Identification Number
NCT05320458
Brief Title
Pulmonary Rehabılıtatıon Wıth Non-Small Lung Cancer
Official Title
Pulmonary Rehabılıtatıon After Chemotherapy In Patıents Wıth Non-Small Lung Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
May 2, 2022 (Anticipated)
Primary Completion Date
July 1, 2022 (Anticipated)
Study Completion Date
September 2, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hasan Kalyoncu University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.
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. 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. 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer, Lung Cancer, Small Cell
Keywords
Lung Cancer, Pulmonary Rehabilitation, Aerobic Exercise, Physiotherapy and Rehabilitation, Oncological Rehabilitation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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.
Masking
None (Open Label)
Allocation
N/A
Enrollment
11 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Pulmonary Rehabilitation
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Pulmonary Rehabilitation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Chance from baseline in posture analysis score
Description
Posture score is going to be assess by posture analysis form to determine change from baseline.
Time Frame
8 week
Secondary Outcome Measure Information:
Title
Physical Activity Level
Description
Physical Activity is going to be assess by Physical Activity Questionnaire to determine change from baseline.
Time Frame
8 week

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Deniz Kocamaz, PhD
Phone
05375735837
Email
deniz.erdankocamaz@hku.edu.tr
Facility Information:
Facility Name
Hasan Kalyoncu Univercity
City
Gaziantep
Country
Turkey

12. IPD Sharing Statement

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Pulmonary Rehabılıtatıon Wıth Non-Small Lung Cancer

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