Multimodal Prehabilitation to Enhance Functional Recovery After Lung Surgery

NCT ID: NCT02938104

Last Updated: 2018-03-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-08-31
• Study Completion Date: 2017-09-30

Brief Summary

The investigators propose a randomized controlled study in patients undergoing lung resection for cancer to compare the impact of multimodal intervention composed of exercise, nutritional supplement and psychological well-being on functional exercise capacity. One group (rehabilitation group) will receive the multimodal intervention after surgery for 8 weeks; the other will start 4 weeks before surgery and continue for 8 weeks postop (prehabilitation group). In this case, both groups will be exposed to the program, which will be available to both groups postoperatively. One of the two groups will start this program 4 weeks before surgery and continue for 8 weeks postoperatively, and the other will start once they leave the hospital and continue for 8 weeks postoperatively.

Detailed Description

Interventions

The multidisciplinary program is composed of 3 elements: exercise, nutritional supplements and psychological coping strategies

Exercise program

Patients will be seen by a kinesiologist for a period of 1 hour and he/she will assess patients' mobility and capacity to undertake exercise, will prepare a personalized program and will explain and monitor the exercise program. Patients will be instructed on how to conduct aerobic exercise in the lab and at home, by either walking or cycling initially at 50% of the calculated heart rate reserve for 20 min three times per week, and this will be increased in stepwise increments by 10% each week, if tolerable.

Muscular resistance training will be also carried out 3 times a week to avoid muscle soreness. Persons will be instructed to do push-up, sit-ups, and standing strides (lunges) until volitional fatigue increasing this number to reach 12 repetitions. The resistance chosen for strengthening of biceps, deltoids and quadriceps will be based on what the person can lift to reach volitional fatigue with 8 repetitions.

Psychological program

It is expected that patients undergoing surgery for cancer are anxious with some component of depression. Since both anxiety and depression can influence the motivation to carry out social and functional activities, psychological strategies can be put in place to help patients to cope with the stress of surgery and disease. For this reason patients will be seen by a trained psychologist. Patients will receive a total of 1.5 hours of psychological intervention in the first session and more sessions if necessary.

In the first preoperative session, the first hour will address the patient's anxieties, coping strategies, and post-operative expectations, with the goal of optimizing psychological well-being & ways of coping with surgery. The importance of the patient's active participation in the healing process will also be discussed. The last thirty minutes will be devoted to teaching relaxation techniques and breathing exercises. Patients will be given a relaxation CD to take home for practice.

Nutritional supplementation

The nutritional status of patients affected by lung cancer is directly influenced by the presence of cancer, which impacts on all aspects of intermediary (protein, carbohydrate, lipid, trace element, vitamin) metabolism, and by other factors such as age, adjuvant cancer therapy and stage of the disease. The greater sensitivity of protein catabolism to nutritional support, in particular to amino acids, could have important implications for the nutritional management of these patients during the period of catabolic stress, with particular emphasis on substrate utilization and energy requirement.

The patients' nutritional status and dietary intake will be assessed by the nutritionist. Percentage of lean body mass and fat percentage will be measured. All patients will receive a daily dietary supplement known as whey protein (Immunocal, Immunotec ©). Special precautions will be considered if patients have specific medical conditions (e.g. diabetes).

Conditions

Lung Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Prehabilitation

Immediately after randomization, until surgery and to be continued for 8 weeks after surgery, patients in this arm will:

1. Receive a personalized physical exercise program

2. Receive nutritional counselling with whey protein isolate powder

3. Receive relaxation techniques

Group Type: EXPERIMENTAL

Whey Protein Isolate Powder

Intervention Type: DIETARY_SUPPLEMENT

Nutritional counselling is given to patients to ensure their daily proteins and energy requirements are met. Whey Protein Isolate Posder (Immunocal) is provided.

Immunocal (1.5g/kg PO (by mouth) per day in daily doses

Physical Exercise Program

Intervention Type: BEHAVIORAL

Physical exercises personalized by a kinesiologist consisting of walking or stationary bike and elastic band exercises.

Relaxation Techniques

Intervention Type: BEHAVIORAL

Relaxation techniques consisting of breathing exercises and using a relaxation CD

Rehabilitation

Patients in this arm will receive the same personalized physical exercise program, nutritional intervention and relaxation techniques as patient in the other arm but to be started after surgery.

Group Type: ACTIVE_COMPARATOR

Whey Protein Isolate Powder

Intervention Type: DIETARY_SUPPLEMENT

Nutritional counselling is given to patients to ensure their daily proteins and energy requirements are met. Whey Protein Isolate Posder (Immunocal) is provided.

Immunocal (1.5g/kg PO (by mouth) per day in daily doses

Physical Exercise Program

Intervention Type: BEHAVIORAL

Physical exercises personalized by a kinesiologist consisting of walking or stationary bike and elastic band exercises.

Relaxation Techniques

Intervention Type: BEHAVIORAL

Relaxation techniques consisting of breathing exercises and using a relaxation CD

Interventions

Whey Protein Isolate Powder

Nutritional counselling is given to patients to ensure their daily proteins and energy requirements are met. Whey Protein Isolate Posder (Immunocal) is provided.

Immunocal (1.5g/kg PO (by mouth) per day in daily doses

Intervention Type: DIETARY_SUPPLEMENT

Physical Exercise Program

Physical exercises personalized by a kinesiologist consisting of walking or stationary bike and elastic band exercises.

Intervention Type: BEHAVIORAL

Relaxation Techniques

Relaxation techniques consisting of breathing exercises and using a relaxation CD

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• aged 18 and above
• referred electively for resection of malignant, non-metastasized lung lesion

Exclusion Criteria

• persons with American Society of Anesthesiologists (ASA) health status class 4-5
• persons with co-morbid medical, physical, and mental abnormalities (e.g. dementia, disabling orthopedic and neuromuscular disease, psychosis), cardiac abnormalities, severe end-organ disease such as cardia failure, COPD, renal failure, sepsis, morbid obesity, anemia, and other conditions interfering with the ability to perform exercise at home or to complete testing procedures
• poor English or French comprehension

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Immunotec Inc.

INDUSTRY

Sponsor Role: collaborator

Franco Carli

OTHER

Sponsor Role: lead

Responsible Party

Franco Carli

MD

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Franco Carli, MD

Role: PRINCIPAL_INVESTIGATOR

Montreal General Hospital

Locations

Montreal General Hospital

Montreal, Quebec, Canada

Countries

Canada

Other Identifiers

14-193-GEN

Identifier Type: -

Identifier Source: org_study_id