The Effect of Interventional Pulmonary Rehabilitation Exercise With Advanced Lung Cancer.
1 other identifier
interventional
104
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable lung-cancer
Started Mar 2022
Typical duration for not_applicable lung-cancer
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 16, 2022
CompletedFirst Posted
Study publicly available on registry
March 15, 2022
CompletedStudy Start
First participant enrolled
March 20, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 15, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 30, 2024
CompletedMarch 15, 2022
February 1, 2022
11 months
February 16, 2022
March 6, 2022
Conditions
Outcome Measures
Primary Outcomes (3)
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.
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).
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.
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).
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.
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 Outcomes (2)
6MWT
baseline (T1) and 8 weeks after the intervention program (T4).
maximum strength training test
baseline (T1) and 8 weeks after the intervention program (T4).
Study Arms (2)
Experimental group
EXPERIMENTALMandatory 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.
Control group
NO INTERVENTIONVoluntary 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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 \[New York Heart Association, NYHA class IV\].
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 16, 2022
First Posted
March 15, 2022
Study Start
March 20, 2022
Primary Completion
February 15, 2023
Study Completion
December 30, 2024
Last Updated
March 15, 2022
Record last verified: 2022-02
Data Sharing
- IPD Sharing
- Will not share