Multimodal Prehabilitation to Enhance Functional Recovery After Lung Surgery

Franco Carli

Status: Completed

Conditions: Lung Cancer

Treatments: Dietary Supplement: Whey Protein Isolate Powder; Behavioral: Relaxation Techniques; Behavioral: Physical Exercise Program

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02938104

14-193-GEN

Details and patient eligibility

About

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.

Full 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).

Enrollment: 120 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 2 patient groups

Prehabilitation

Experimental group

Description:

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

Treatment:

Dietary Supplement: Whey Protein Isolate Powder

Behavioral: Physical Exercise Program

Behavioral: Relaxation Techniques

Rehabilitation

Active Comparator group

Description:

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.

Treatment:

Dietary Supplement: Whey Protein Isolate Powder

Behavioral: Physical Exercise Program

Behavioral: Relaxation Techniques