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Lung Cancer (NSCLC)NCT07824778

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

A study testing Exercise Management for Elderly Lung Cancer Patients After Surgery Based on Social Cognitive Theory in people with Lung Cancer (NSCLC), run by Sir Run Run Shaw Hospital at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 60 to 80 weeks
Conditions the study is for
Lung Cancer (NSCLC)
What is being tested?
Exercise Management for Elderly Lung Cancer Patients After Surgery Based on Social Cognitive Theory
Could I receive a placebo?
No, everyone receives an active treatment
How many people
68 participants
Where
1 siteChina
Study dates
1 Apr 2024to 30 Jan 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 60 to 80 weeks
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

China1 site
  • Sir Run Run Shaw Hospital, Zhejiang University School of Medicine

    Hangzhou, Zhejiang, 310016

Other trials in China

About this study

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

Read more

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.

  1. 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

Being tested
Exercise Management for Elderly Lung Cancer Patients After Surgery Based on Social Cognitive Theory
Medical subject headings
Lung Neoplasms, Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

    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;

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

    On the basis of receiving routine care, the intervention group underwent systematic exercise intervention according to the postoperative exercise management program for elderly lung cancer patients. The intervention period was from 1 day before surgery to the 2-week follow-up after discharge. The intervention content included aerobic exercise, resistance exercise, respiratory training, etc. The intervention frequency throughout the process was once every other day. The intervention process was repeatedly reinforced with videos and an exercise guidance manual until the patients mastered it. The exercise guidance manual mainly introduces the necessity and benefits of exercise after lung cancer surgery, including enhancing immunity, improving respiratory function, and preventing complications; explains the preparatory work before and after exercise, such as choosing appropriate time, place, clothing, and diet, as well as how to assess one's own exercise capacity and intensity;

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

    Face-to-face intervention combined with telephone/WeChat remote intervention. During hospitalization, on day 1 before surgery, explain and sign the informed consent form, complete baseline data, add the patient's or family member's WeChat, and collect 6MWT data. After collection, the principal investigator gathers enrolled patients and family members to watch the postoperative exercise guidance video, provide on-the-spot teaching, promptly point out deficiencies, and use the Teach-back method for feedback until they correctly master the movement essentials, instructing family members to accompany and supervise exercise during hospitalization and at home. Give each patient an exercise guidance manual, informing them of exercise methods at different stages, exercise-related precautions, and how to keep exercise records during hospitalization and 2 weeks after discharge. In the postoperative exercise intervention stage, patients exercise according to the program.

Study groups in NCT07824778
Study groupRoleWhat they receive
Exercise Management for Elderly Lung Cancer Patients After Surgery Based on Social Cognitive TheoryExperimentalThe development of this SCT- based exercise program has been described in detail in a previously published protocol. Briefly, participants in the intervention group received the program from one day preoperatively to two weeks post-discharge, with every-other-day sessions (approximately 3-4 times per week). The program operationalized five SCT constructs (self-efficacy, sociocultural/environmental facilitation, goal setting, outcome expectancy, behavioral evaluation) . Standardized rehabilitation materials, including exercise videos accessible via QR codes and a printed exercise manual, were provided to all participants in the intervention group
Receives: Behavioral: Exercise Management for Elderly Lung Cancer Patients After Surgery Based on Social Cognitive Theory
Control groupNo interventionParticipants allocated to the control group received the institution's standard perioperative care for lung cancer surgery, which did not include any structured post-discharge rehabilitation protocol. The in-hospital care pathway was standardized as follows: upon admission, patients received general orientation to the ward environment and basic disease-related education. One day prior to surgery, patients underwent standardized preoperative teaching, which covered surgical procedures and immediate postoperative precautions. During hospitalization, routine postoperative care was provided, including vital sign monitoring, incision care, pain management, and encouragement of early in-bed mobilization as per institutional nursing standards, but without any formal exercise prescription. No structured rehabilitation guidance-whether verbal, written, or supervised-was provided for the period following hospital discharge.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. six-minute walk test (6MWT)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Sep 2026
  2. Study start1 Apr 2024
  3. Primary completion30 Sep 2024
  4. Study completion30 Jan 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
68 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07824778
Sponsor's protocol ID
SRRSH2024-0379
Other IDs
2024KY1119
Status last verified
Apr 2026
First submitted
12 Sep 2026
Last updated
17 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Exercise Management for Elderly Lung Cancer Patients After Surgery Based on Social Cognitive Theory in people with Lung Cancer (NSCLC), run by Sir Run Run Shaw Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2026.

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