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NCT Number: NCT07824778

Construction and Application Research of a Multidisciplinary Combined Exercise Management Program for Elderly Lung Cancer Patients After Surgery Based on Social Cognitive Theory

Informed Consent Form

Protocol Title: Construction and Application Research of a Multidisciplinary Combined Exercise Management Program for Elderly Lung Cancer Patients After Surgery Based on Social Cognitive Theory

Version Number: V1.0

Version Date: April 1, 2024

Dear Subject:

We invite you to participate in the study titled "Construction and Application Research of a Multidisciplinary Combined Exercise Management Program for Elderly Lung Cancer Patients After Surgery Based on Social Cognitive Theory," which has been reviewed and approved by the Ethics Committee of Sir Run Run Shaw Hospital, Zhejiang University School of Medicine.

This informed consent form will provide you with some information to help you decide whether to participate in this clinical study. Your participation in this study is entirely voluntary, and your decision will not affect your normal rights and treatment at this hospital. If you choose to participate in this study, our research team will make every effort to ensure your safety and rights throughout the research process.

Please read carefully. If you have any questions, please ask the researcher responsible for this study.

I. Research Background, Significance, and Objectives:

1.1 Background and Significance

With the extension of average life expectancy, the number of elderly lung cancer patients has also increased, with patients over 65 years old accounting for more than 50%. Elderly patients often have other diseases, low organ function, decreased cardiopulmonary function after surgery, and poor tissue repair capacity and immune function, making them more susceptible to complications such as atelectasis, pulmonary infection, and respiratory failure. Studies have shown that moderate exercise can reduce the risk of lung cancer, improve cardiopulmonary function and fatigue, increase muscle endurance and quality of life, shorten hospital stay, and reduce the incidence, mortality, and complication rates of lung cancer. The American College of Sports Medicine (ACSM) and the American Cancer Society recommend a total exercise volume of 150 minutes of moderate-intensity exercise or 75 minutes of high-intensity exercise per week, or an equivalent combination. Studies have shown that nearly two-thirds of cancer patients do not meet the recommended exercise volume and face risks of cardiovascular disease, diabetes, and premature death after surgery. Several countries, including the United Kingdom and Australia, have conducted exercise-related studies in patients undergoing lung cancer surgery. However, there is limited research on postoperative exercise intervention for the special population of elderly lung cancer patients both domestically and internationally, and there is a lack of postoperative exercise guidance and postoperative exercise management guidelines. Therefore, it is urgent to develop an exercise management program for this population.

1.2 Research Objectives

This study aims to provide strong theoretical support for clinical medical staff to standardly guide postoperative exercise in elderly lung cancer patients, and also provides a template for the best evidence clinical application for other studies.

II. Research Process:

This study is a single-center clinical study. The expected number of subjects participating at this center is 68. If you agree to participate in this study, you need to sign this informed consent form. Afterward, we will conduct inclusion and exclusion criteria assessment. If you meet the inclusion criteria and do not meet the exclusion criteria, you will be enrolled in this study and have a 1/2 chance of being assigned to the control group or the intervention group. The intervention period is from 1 day before surgery to 2 weeks after discharge. During hospitalization, a rehabilitation physician and a respiratory therapy physician will jointly conduct a risk assessment, supervise, and guide the intervention for you. The intervention includes aerobic exercise, resistance exercise, respiratory training, etc. The intervention frequency ranges from 1-2 times per day to 1-4 times per week. It will be repeatedly reinforced in combination with authoritative exercise guidance videos until you have mastered it. The main part of the exercise guidance video is the specific exercise program, including the exercise methods you can choose, the duration of each exercise session, the weekly exercise frequency, and the exercise intensity. Corresponding demonstration videos and pictures of movements will be provided according to the exercise method you choose, so that you can practice at home. At discharge, you need to join the postoperative rehabilitation group. We will send the intervention guidance videos to the group, and you can save the videos to your mobile phone for reference at any time. At discharge, the rehabilitation physician will provide you with a paper or electronic exercise program for 2 weeks after discharge according to your condition. You w

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Key information

Conditions

Lung Cancer (NSCLC) Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

60 week–80 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sir Run Run Shaw Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310016, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patients diagnosed with lung cancer by pathological examination according to the "Chinese Standards for Diagnosis and Treatment of Primary Lung Cancer (2015 Edition)" and requiring surgical treatment.

Age ≥60 years, with normal or mildly impaired preoperative pulmonary function.

Clear consciousness, no cognitive impairment or communication barriers; the patient or family member owns a smartphone and can use WeChat normally.

Voluntarily participate in this study and sign the informed consent form after understanding the research objectives, methods, and risks.

Exclusion criteria

① Non-first lung surgery.

History of heart, lung, or cerebral infarction diseases, including unstable angina or myocardial infarction within 1 month, worsening heart failure, acute deep vein thrombosis, pulmonary embolism, myocarditis, or endocarditis; patients with concurrent coronary heart disease, heart failure, or COPD; patients with moderate or severe preoperative pulmonary ventilation impairment; patients with preoperative PICC or arm port placement, or a history of other malignant tumor surgery or chemotherapy; patients with post-hip or knee joint surgery or gout, joint dysfunction, or other conditions affecting exercise capacity; patients with other exercise contraindications.

Resting heart rate exceeding 120 beats/min, systolic blood pressure exceeding 180 mmHg, diastolic blood pressure exceeding 100 mmHg, or uncontrolled arterial hypertension.

Patients with mental illness, cognitive impairment, minors, pregnant women, illiterate individuals, etc. Vulnerable groups that may be involved in this study include elderly individuals and illiterate individuals.

Treatment and study plan

Exercise Management for Elderly Lung Cancer Patients After Surgery Based on Social Cognitive Theory

Behavioral

The team members include the principal investigator, 2 thoracic surgery specialist nurses, 2 rehabilitation medicine physicians, and 1 respiratory therapy physician. First, the principal investigator, rehabilitation medicine physicians, and respiratory therapy physician are responsible for filming videos on respiratory training, shoulder function exercises, and resistance exercise, as well as producing the exercise guidance manual. Second, the principal investigator and rehabilitation medicine physicians provide intervention program training to team members. The training content mainly includes content related to the exercise management program, including the standardized operation of the 6MWT, the use of the Borg Rating of Perceived Exertion scale, and the correct implementation of the exercise intervention program. For example: first, screening and assessment are conducted before exercise to determine the patient's physical condition and exercise capacity;

Primary outcomes

six-minute walk test (6MWT)

Time frame: pre-intervention (T0, one day before surgery), during intervention (T1, day of chest tube removal), and post-intervention (T2, two weeks after discharge)

Sponsors and collaborators

Lead sponsor

Sir Run Run Shaw Hospital

Other

Registry information

Important dates

Study start: 2024
Primary completion: 2024
Study completion: 2025
First posted: Sep 17, 2026
Registry last updated: Sep 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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