Perioperative Rehabilitation in Operation for Lung Cancer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-05-31

Study Completion Date

2015-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Background: Improved surgical techniques combined with effective adjuvant chemotherapy, has led to a better survival in individuals with NSCLC. The treatment of NSCLC and other cancer diseases are after all still complex and potentially lethal.

Study aim: The rationale for the study PROLUCA is to identify the optimal timing of exercise to improve recovery after surgery in patients operated for lunge cancer with focus on physical capacity and quality of life.

Who can participate? Patients above 18 years and diagnosed with lung cancer and referred for operation. Participation in this study is not possible if the participants by a doctor are advised not to do strenuous exercise.

What does the study involve? The intervention consists of a combination of (1) exercise before surgery and (2) exercise after surgery for lung cancer.

1. Exercise before surgery is a home-based exercise program is individually designed and must be performed for at least 30 minutes every day until surgery. The home-based exercise program varies in length due to number of days until surgery, and the intention is not exceed 14 days.
2. The exercise initiated two weeks and 6 weeks after surgery consists of a 12 weeks rehabilitation program and three individual counseling sessions. Special needs in terms of smoking cessation, nutritional counseling or patient education, this is also offered. The exercise consists of individually prepared supervised strength - and fitness exercise in a team, two sessions of 60 minutes/week.

What interventions will be compared? A home-based post-operative exercise program, combined with exercise initiated two weeks after surgery, will be compared with usual care (exercise initiated six weeks after surgery).

Will all participants receive the same treatment?

By draw it is decided which of the 4 groups the participants will attend to in the study:

* Group 1: Home-based exercise before surgery and rehabilitation initiated as early as two weeks after surgery
* Group 2: Home-based exercise before surgery and rehabilitation initiated six weeks after surgery
* Group 3: Rehabilitation initiated as early as two weeks after surgery
* Group 4: Rehabilitation initiated six weeks after surgery (Usual practice as control group) What are the possible benefits and risks of participating? There are no risks or side- effects of participating other than muscle soreness and exercise is beneficial when it comes to recover from an operation from lung cancer.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Postoperative Rehabilitation in Operation for LUng CAncer (PROLUCA)

NCT02439073

Lung Cancer

UNKNOWN NA

Lung Rehabilitation in Treating Patients With Chronic Obstructive Pulmonary Disease Who Are Undergoing Surgery for Lung Cancer

NCT00363428

Lung Cancer Perioperative/Postoperative Complications Pulmonary Complications +1 more

COMPLETED NA

Pulmonary Rehabilitation Before Lung Cancer Resection

NCT01682850

Lung Cancer COPD Chronic Obstructive Lung Disease +1 more

COMPLETED NA

Effect of Pulmonary Rehabilitation on Surgical Outcomes in the Cancer Setting

NCT00618553

Lung Cancer

ACTIVE_NOT_RECRUITING PHASE2

Effectiveness of a Preoperative Pulmonary Rehabilitation Program in Patients Awaiting Lung Resection

NCT01963923

Lung Cancer

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Lung Cancer Non Small Cell Lung Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Caregivers Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1. Experimental

Home-based exercise pre surgery and postoperative exercise in a team initiated two weeks after surgery.

Group Type EXPERIMENTAL

Experimental: 1. Experimental

Intervention Type BEHAVIORAL

Home-based exercise pre surgery and postoperative exercise in a team initiated two weeks after surgery. Intervention consists of:

1. Preoperative home-based exercise program - cardiovascular exercise of moderate-vigorous intensity for at least 30 minutes every day until surgery.
2. Postoperative rehabilitation: A supervised 12-week rehabilitation program containing 24 group-based exercise sessions, three individual counseling sessions and smoking cessation, nutritional counseling or patient education, this is offered too.The cardiorespiratory intensity is at \~50-60% of individual HRmax for the first four weeks and increases to moderate-high intensity at \~70-90% of individually determined HRmax. The intensity of the strength exercise program is at \~60-80% of 1 RM.

2. Experimental

Home-based exercise pre surgery and postoperative exercise in a team initiated six weeks after surgery.

Group Type EXPERIMENTAL

Experimental: 2. Experimental

Intervention Type BEHAVIORAL

Home-based exercise pre surgery and postoperative exercise in a team initiated six weeks after surgery. Intervention consists of:

1. Preoperative home-based exercise program - cardiovascular exercise of moderate-vigorous intensity for at least 30 minutes every day until surgery.
2. Postoperative rehabilitation: A supervised 12-week rehabilitation program containing 24 group-based exercise sessions, three individual counseling sessions and smoking cessation, nutritional counseling or patient education, this is offered too.The cardiorespiratory intensity is at \~50-60% of individual HRmax for the first four weeks and increases to moderate-high intensity at \~70-90% of individually determined HRmax. The intensity of the strength exercise program is at \~60-80% of 1 RM.

3. Experimental

Exercise in a team initiated two weeks after surgery.

Group Type EXPERIMENTAL

Experimental: 3. Experimental

Intervention Type BEHAVIORAL

Early postoperative exercise in a team initiated two weeks after surgery. Intervention consists of:

Postoperative rehabilitation: A supervised 12-week rehabilitation program containing 24 group-based exercise sessions, three individual counseling sessions and smoking cessation, nutritional counseling or patient education, this is offered too.The cardiorespiratory intensity is at \~50-60% of individual HRmax for the first four weeks and increases to moderate-high intensity at \~70-90% of individually determined HRmax. The intensity of the strength exercise program is at \~60-80% of 1 RM.

4. Usual care

Exercise in a team initiated six weeks after surgery.

Group Type OTHER

Other: 4. Usual care

Intervention Type BEHAVIORAL

Exercise in a team initiated six weeks after surgery consisting of a supervised 12-week rehabilitation program containing 24 group-based exercise sessions, three individual counseling sessions, and three group-based lessons in health-promoting behavior. If the participants have special needs in terms of smoking cessation, nutritional counseling or patient education, this is offered too.

The cardiorespiratory intensity is at \~50-60% of individual HRmax for the first four weeks. The next eight weeks the intensity increases to moderate-high intensity at \~70-90% of individually determined HRmax. The intensity of the strength exercise program is at \~60-80% of 1 RM.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Experimental: 1. Experimental

Home-based exercise pre surgery and postoperative exercise in a team initiated two weeks after surgery. Intervention consists of:

1. Preoperative home-based exercise program - cardiovascular exercise of moderate-vigorous intensity for at least 30 minutes every day until surgery.
2. Postoperative rehabilitation: A supervised 12-week rehabilitation program containing 24 group-based exercise sessions, three individual counseling sessions and smoking cessation, nutritional counseling or patient education, this is offered too.The cardiorespiratory intensity is at \~50-60% of individual HRmax for the first four weeks and increases to moderate-high intensity at \~70-90% of individually determined HRmax. The intensity of the strength exercise program is at \~60-80% of 1 RM.

Intervention Type BEHAVIORAL

Experimental: 2. Experimental

Home-based exercise pre surgery and postoperative exercise in a team initiated six weeks after surgery. Intervention consists of:

1. Preoperative home-based exercise program - cardiovascular exercise of moderate-vigorous intensity for at least 30 minutes every day until surgery.
2. Postoperative rehabilitation: A supervised 12-week rehabilitation program containing 24 group-based exercise sessions, three individual counseling sessions and smoking cessation, nutritional counseling or patient education, this is offered too.The cardiorespiratory intensity is at \~50-60% of individual HRmax for the first four weeks and increases to moderate-high intensity at \~70-90% of individually determined HRmax. The intensity of the strength exercise program is at \~60-80% of 1 RM.

Intervention Type BEHAVIORAL

Experimental: 3. Experimental

Early postoperative exercise in a team initiated two weeks after surgery. Intervention consists of:

Postoperative rehabilitation: A supervised 12-week rehabilitation program containing 24 group-based exercise sessions, three individual counseling sessions and smoking cessation, nutritional counseling or patient education, this is offered too.The cardiorespiratory intensity is at \~50-60% of individual HRmax for the first four weeks and increases to moderate-high intensity at \~70-90% of individually determined HRmax. The intensity of the strength exercise program is at \~60-80% of 1 RM.

Intervention Type BEHAVIORAL

Other: 4. Usual care

Exercise in a team initiated six weeks after surgery consisting of a supervised 12-week rehabilitation program containing 24 group-based exercise sessions, three individual counseling sessions, and three group-based lessons in health-promoting behavior. If the participants have special needs in terms of smoking cessation, nutritional counseling or patient education, this is offered too.

The cardiorespiratory intensity is at \~50-60% of individual HRmax for the first four weeks. The next eight weeks the intensity increases to moderate-high intensity at \~70-90% of individually determined HRmax. The intensity of the strength exercise program is at \~60-80% of 1 RM.

Intervention Type BEHAVIORAL

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Preoperative and early postoperative rehabilitation Preoperative and late postoperative rehabilitation Early postoperative rehabilitation alone Usual care

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Performance status 0-2 (WHO)
* Living in the City of Copenhagen or surrounding Municipalities
* Ability to read and understand Danish
* Approval by primary surgeon