Perioperative Rehabilitation in Operation for Lung Cancer

Summary

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.

Conditions

• Lung Cancer
• Non Small Cell Lung Cancer

Interventions

BEHAVIORAL

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.

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.

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.

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.

Sponsors & Collaborators

• Centre for Integrated Rehabilitation of Cancer patients, CIRE, Denmark

  collaborator UNKNOWN

• Danish Cancer Society

  collaborator OTHER

• Novo Nordisk A/S

  collaborator INDUSTRY

• University of Copenhagen

  collaborator OTHER

• Copenhagen Centre for Cancer and Health, Denmark.

  collaborator UNKNOWN

• Rigshospitalet, Denmark

  lead OTHER

Principal Investigators

• Jesper Holst Pedersen, MD, DrMSci · Department of Cardiothoracic Surgery RT

• Jette Vibe-Petersen, MD · Copenhagen Centre for Cancer and Health

• Maja Schick Sommer, MHS · Copenhagen Centre for Cancer and Health

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2012-05-31

Primary Completion

2014-10-31

Completion

2015-01-31

Countries

• Denmark

Study Locations