Multimodal Prehabilitation to Enhance Functional Recovery After Lung Surgery

NCT02938104 | Completed

• 1 other identifier: 14-193-GEN
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Health-related quality of life

  8 weeks after surgery

• Quality of Life

  8 weeks after surgery

• Physical activity level

  8 weeks after surgery

• Depression and anxiety

  8 weeks after surgery

• Nutritional status

  8 weeks after surgery

Study Arms (2)

Prehabilitation

EXPERIMENTAL

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; Behavioral: Physical Exercise Program; Behavioral: Relaxation Techniques

Rehabilitation

ACTIVE COMPARATOR

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; Behavioral: Physical Exercise Program; Behavioral: Relaxation Techniques

Interventions

Whey Protein Isolate Powder 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

Prehabilitation; Rehabilitation

Physical Exercise Program BEHAVIORAL

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

Prehabilitation; Rehabilitation

Relaxation Techniques BEHAVIORAL

Relaxation techniques consisting of breathing exercises and using a relaxation CD

Prehabilitation; Rehabilitation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Franco Carli: lead
• Immunotec Inc.: collaborator

Study Sites (1)

Montreal General Hospital

Montreal, Quebec, H3A 1A1, Canada

Location

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Relaxation Therapy

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Franco Carli, MD

  Montreal General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: February 2, 2016
• First Posted: October 19, 2016
• Study Start: August 1, 2014
• Primary Completion: September 1, 2017
• Study Completion: September 1, 2017
• Last Updated: March 22, 2018

Record last verified: 2018-03

Locations

CA (1)