Multimodal Prehabilitation to Enhance Functional Recovery After Lung Surgery

Lung Cancer Clinical Trial

Official title:

Multimodal Prehabilitation to Enhance Functional Recovery After Lung Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02938104
• Other study ID #: 14-193-GEN
• Status: Completed
• Phase: N/A
• First received: February 2, 2016
• Last updated: March 20, 2018
• Start date: August 2014
• Est. completion date: September 2017

Study information

• Verified date: March 2018
• Source: McGill University Health Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: September 2017
• Est. primary completion date: September 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lung Cancer

Intervention

Dietary Supplement:
• 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

Behavioral:
• Physical Exercise Program
Physical exercises personalized by a kinesiologist consisting of walking or stationary bike and elastic band exercises.
• Relaxation Techniques
Relaxation techniques consisting of breathing exercises and using a relaxation CD

Locations

Country	Name	City	State
Canada	Montreal General Hospital	Montreal	Quebec

Sponsors (2)

Lead Sponsor	Collaborator
Franco Carli	Immunotec Inc.

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Six-minute walk test	The 6MWT evaluates the ability of an individual to maintain a moderate level of physical activity over a time period reflective of the activities of daily living. Subjects are instructed to walk back and forth, in a 20 m stretch of hallway, for six minutes, at a pace that would make them tired by the end of the walk; encouragement and feedback are given according to published guidelines.	8 weeks after surgery
Secondary	Health-related quality of life	The SF-36 incorporates behavioural functioning, subjective well-being and perceptions of health by assessing, on a 0 to 100 scale, eight health concepts: (1) Physical function (PF) -limitations in physical activities due to health problems; (2) Role physical (RP)-limitations in role activities due to physical health problems; (3) Role emotional (RE) -limitations in usual role activities due to emotional problems; (4) Social functioning (SF) -limitations in social activities due to health problems; (5) Bodily pain (BP)-pain; (6) General health (GH) -general health perceptions; (7) Vitality (VT) -energy and fatigue; and (8) Mental health (MH) -general mental health.	8 weeks after surgery
Secondary	Quality of Life	The FACT-L (functional assessment of cancer therapy lung) and EQ-5D, both validated measures, will be used to assess quality of life.	8 weeks after surgery
Secondary	Physical activity level	Physical activity level will be measured through the Community Health Activities Model Program for Seniors (CHAMPS) questionnaire.	8 weeks after surgery
Secondary	Depression and anxiety	The Hospital Anxiety and Depression Scale (HADS) will be used to assess anxiety and depression.	8 weeks after surgery
Secondary	Nutritional status	Nutritional status will be assessed using body, body weight loss over the preceding three months (>10%), and/or serum albumin < 35 g -1 will define poor nutritional status. Hand grip strength and body impedance will also be measured.	8 weeks after surgery