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Multimodal Prehabilitation to Enhance Functional Recovery After Lung Surgery

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ClinicalTrials.gov Identifier: NCT02938104
Recruitment Status : Completed
First Posted : October 19, 2016
Last Update Posted : March 22, 2018
Sponsor:
Collaborator:
Immunotec Inc.
Information provided by (Responsible Party):
Franco Carli, McGill University Health Center

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.

Condition or disease Intervention/treatment Phase
Lung Cancer Dietary Supplement: Whey Protein Isolate Powder Behavioral: Physical Exercise Program Behavioral: Relaxation Techniques Not Applicable

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).


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Multimodal Prehabilitation to Enhance Functional Recovery After Lung Surgery
Study Start Date : August 2014
Actual Primary Completion Date : September 2017
Actual Study Completion Date : September 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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
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.

Behavioral: Relaxation Techniques
Relaxation techniques consisting of breathing exercises and using a relaxation CD

Active Comparator: 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.
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.

Behavioral: Relaxation Techniques
Relaxation techniques consisting of breathing exercises and using a relaxation CD




Primary Outcome Measures :
  1. Six-minute walk test [ Time Frame: 8 weeks after surgery ]
    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.


Secondary Outcome Measures :
  1. Health-related quality of life [ Time Frame: 8 weeks after surgery ]
    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.

  2. Quality of Life [ Time Frame: 8 weeks after surgery ]
    The FACT-L (functional assessment of cancer therapy lung) and EQ-5D, both validated measures, will be used to assess quality of life.

  3. Physical activity level [ Time Frame: 8 weeks after surgery ]
    Physical activity level will be measured through the Community Health Activities Model Program for Seniors (CHAMPS) questionnaire.

  4. Depression and anxiety [ Time Frame: 8 weeks after surgery ]
    The Hospital Anxiety and Depression Scale (HADS) will be used to assess anxiety and depression.

  5. Nutritional status [ Time Frame: 8 weeks after surgery ]
    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02938104


Locations
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Canada, Quebec
Montreal General Hospital
Montreal, Quebec, Canada, H3A 1A1
Sponsors and Collaborators
Franco Carli
Immunotec Inc.
Investigators
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Principal Investigator: Franco Carli, MD Montreal General Hospital

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Responsible Party: Franco Carli, MD, McGill University Health Center
ClinicalTrials.gov Identifier: NCT02938104     History of Changes
Other Study ID Numbers: 14-193-GEN
First Posted: October 19, 2016    Key Record Dates
Last Update Posted: March 22, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided