The Effect of Interventional Pulmonary Rehabilitation Exercise With Advanced Lung Cancer.
Primary Purpose
Lung Cancer, Pulmonary Rehabilitation, Exercise
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
pulmonary rehabilitation exercise
Sponsored by

About this trial
This is an interventional supportive care trial for Lung Cancer
Eligibility Criteria
Inclusion Criteria:
- Patients older than 20 years old, diagnosed with advanced lung cancer of stage III and IV lung cancer, and the Eastern Cooperative Oncology Group (ECOG) score of 0 and 1 points.
- Plans to receive treatment or has received treatment, including chemotherapy, targeted therapy, radiation therapy, or combination therapy.
- Those who agree to participate in the research and accept regular follow-up interviews and fill in the written consent form after explaining and explaining the research process and rights in detail.
Exclusion Criteria:
- Those who are unaware or have cognitive impairment who cannot accept the questionnaire interview.
- Unstable angina, arrhythmia, myocardial infarction diagnosis.
- History of epilepsy.
- Heart failure [New York Heart Association, NYHA class IV].
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Experimental group
Control group
Arm Description
Mandatory exercise the lung rehabilitation exercise is divided into three parts: upper and lower limb muscle strength, endurance training and breathing training skills. It lasts for eight weeks of exercise training, and the exercise frequency is: three times a week.
Voluntary exercise the lung rehabilitation exercise is divided into three parts: upper and lower limb muscle strength, endurance training and breathing training skills. It lasts for eight weeks of exercise training, and the exercise frequency is: three times a week.
Outcomes
Primary Outcome Measures
psychological distress
Hospital Anxiety and Depression Scale , HADS .There are 14 items in this scale, including 7 items for anxiety and 7 items for depression. Each item has 4 options and is scored from 0 to 3. The higher the score, the higher the degree of anxiety or depression. Because the question does not contain physical symptoms, but emotional states, it is more likely to avoid false positives caused by cancer symptoms, so it is widely used in emotional evaluation and screening of cancer patients. A score higher than 9 in the anxiety section, or a score higher than 8 in the depression section, or a total score higher than 15 requires clinical attention.
self-efficacy
General Self-Efficacy Scale,GSES.The GSES is a 10-item psychometric scale with scores for each item ranging from 1 (not completely correct) to 4 (including completely correct). Scores range from 10 to 40, with the highest score indicating higher self-efficacy.
quality of life Functional Assessment of Cancer Therapy-Lung
Functional Assessment of Cancer Therapy-Lung,FACT-L.FACT-L, Version 4, is a combination of the 27-item FACT-General (FACT-G) and the 9-item Lung Cancer Subscale (LCS) Items include: physical health status, social/family health status, emotional stability status, Functional health status, additional concerns, lung cancer-related issues, the score ranges from 0 to 4, and the higher the final value, the higher the score on the scale, and the better the quality of life.
Secondary Outcome Measures
6MWT
Six-minute Walking Test
maximum strength training test
maximum strength training test
Full Information
NCT ID
NCT05279521
First Posted
February 16, 2022
Last Updated
March 6, 2022
Sponsor
National Taiwan University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05279521
Brief Title
The Effect of Interventional Pulmonary Rehabilitation Exercise With Advanced Lung Cancer.
Official Title
The Effect of Interventional Pulmonary Rehabilitation Exercise on the Psychological Distress, Self-efficacy, and Quality of Life of Patients With Advanced Lung Cancer.
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
March 20, 2022 (Anticipated)
Primary Completion Date
February 15, 2023 (Anticipated)
Study Completion Date
December 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Taiwan University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study concluded that lung rehabilitation exercise programs can improve the psychological distress, self-efficacy, quality of life, six-minute walk distance, muscle strength, and reduce the number of hospitalizations for patients with advanced lung cancer.
Detailed Description
Lung cancer is the top ten cause of cancer death in Taiwan. Since symptoms in the early stage are insidious, most patients are diagnosed in the advanced stage.
Chemotherapy and radiotherapy are often necessary because most of the advanced stage lung cancer has metastasized and multi-organ involved. The prolonged treatment course and side effects of the chemotherapy and radiotherapy, as long as the low survival rate, all impaired the quality of life. Recent studies have shown that exercise can improve the quality of life of cancer patients; therefore, the purpose of this study is to explore the effects of interventional lung rehabilitation exercises on psychological distress, self-efficacy and quality of life in patients with advanced lung cancer. The research is an interventional study. For the experimental group, lung rehabilitation exercise programs, including endurance training, muscle strength training and breathing training, were given; for the control group, a leaflet for lung rehabilitation exercise were provided. Random allocation software was used to randomly allocate cases to the experimental group and the control group. The patients were enrolled from the ward of the Department of Thoracic Medicine in a teaching hospital in north Taiwan. The estimated number of enrollment was 104. The structured questionnaire was used for data collection and analysis. The questionnaire contained 4 dimensions, including basic demographic characteristics, anxiety and depression scale, self-efficacy scale and quality of life scale. The data were collected at 4 time points; before the intervention (baseline measurement, T1), 4 weeks after the intervention (T2), 6 weeks after the intervention (T3), and 8 weeks after the intervention program (T4). At the same time, the six-minute walking distance and maximum strength training test of each case were measured at the baseline (T1) and 8 weeks after the intervention program (T4). We used the independent sample test,chi square test , Pearson correlation coefficient analysis and single-factor analysis of variance, and the generalized estimation equation for analysis of the psychological distress, self-efficacy, and quality of life between the two groups. This study concluded that lung rehabilitation exercise programs can improve the psychological distress, self-efficacy, quality of life, six-minute walk distance, muscle strength, and reduce the number of hospitalizations for patients with advanced lung cancer.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer, Pulmonary Rehabilitation, Exercise, Lung Adenocarcinoma, Lung Tumor, Lung Neoplasms, Advanced Lung Cancer, Self Efficacy, Quality of Life, Psychological Distress
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
Participant
Allocation
Randomized
Enrollment
104 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Experimental group
Arm Type
Experimental
Arm Description
Mandatory exercise the lung rehabilitation exercise is divided into three parts: upper and lower limb muscle strength, endurance training and breathing training skills. It lasts for eight weeks of exercise training, and the exercise frequency is: three times a week.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Voluntary exercise the lung rehabilitation exercise is divided into three parts: upper and lower limb muscle strength, endurance training and breathing training skills. It lasts for eight weeks of exercise training, and the exercise frequency is: three times a week.
Intervention Type
Behavioral
Intervention Name(s)
pulmonary rehabilitation exercise
Other Intervention Name(s)
exercise
Intervention Description
The lung rehabilitation exercise is divided into three parts: upper and lower limb muscle strength, endurance training and breathing training skills. It lasts for eight weeks of exercise training, and the exercise frequency is: three times a week.
Primary Outcome Measure Information:
Title
psychological distress
Description
Hospital Anxiety and Depression Scale , HADS .There are 14 items in this scale, including 7 items for anxiety and 7 items for depression. Each item has 4 options and is scored from 0 to 3. The higher the score, the higher the degree of anxiety or depression. Because the question does not contain physical symptoms, but emotional states, it is more likely to avoid false positives caused by cancer symptoms, so it is widely used in emotional evaluation and screening of cancer patients. A score higher than 9 in the anxiety section, or a score higher than 8 in the depression section, or a total score higher than 15 requires clinical attention.
Time Frame
The data were collected at 4 time points; before the intervention (baseline measurement, T1), 4 weeks after the intervention (T2), 6 weeks after the intervention (T3), and 8 weeks after the intervention program (T4).
Title
self-efficacy
Description
General Self-Efficacy Scale,GSES.The GSES is a 10-item psychometric scale with scores for each item ranging from 1 (not completely correct) to 4 (including completely correct). Scores range from 10 to 40, with the highest score indicating higher self-efficacy.
Time Frame
The data were collected at 4 time points; before the intervention (baseline measurement, T1), 4 weeks after the intervention (T2), 6 weeks after the intervention (T3), and 8 weeks after the intervention program (T4).
Title
quality of life Functional Assessment of Cancer Therapy-Lung
Description
Functional Assessment of Cancer Therapy-Lung,FACT-L.FACT-L, Version 4, is a combination of the 27-item FACT-General (FACT-G) and the 9-item Lung Cancer Subscale (LCS) Items include: physical health status, social/family health status, emotional stability status, Functional health status, additional concerns, lung cancer-related issues, the score ranges from 0 to 4, and the higher the final value, the higher the score on the scale, and the better the quality of life.
Time Frame
The data were collected at 4 time points; before the intervention (baseline measurement, T1), 4 weeks after the intervention (T2), 6 weeks after the intervention (T3), and 8 weeks after the intervention program (T4).
Secondary Outcome Measure Information:
Title
6MWT
Description
Six-minute Walking Test
Time Frame
baseline (T1) and 8 weeks after the intervention program (T4).
Title
maximum strength training test
Description
maximum strength training test
Time Frame
baseline (T1) and 8 weeks after the intervention program (T4).
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients older than 20 years old, diagnosed with advanced lung cancer of stage III and IV lung cancer, and the Eastern Cooperative Oncology Group (ECOG) score of 0 and 1 points.
Plans to receive treatment or has received treatment, including chemotherapy, targeted therapy, radiation therapy, or combination therapy.
Those who agree to participate in the research and accept regular follow-up interviews and fill in the written consent form after explaining and explaining the research process and rights in detail.
Exclusion Criteria:
Those who are unaware or have cognitive impairment who cannot accept the questionnaire interview.
Unstable angina, arrhythmia, myocardial infarction diagnosis.
History of epilepsy.
Heart failure [New York Heart Association, NYHA class IV].
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Wei-Ling LIU, Postgraduate
Phone
0912768628
Email
m50929g@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Effect of Interventional Pulmonary Rehabilitation Exercise With Advanced Lung Cancer.
We'll reach out to this number within 24 hrs