The Effect of Exercise Prehabilitation on Post-Operative Recovery After Head and Neck Cancer Surgery
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- OHSU Knight Cancer Institute
- Enrollment
- 52
- Locations
- 2
- Primary Endpoint
- Post-operative mobility
Study Overview
Brief Summary
This clinical trial evaluates a prehabilitation exercise intervention for improving mobility and recovery outcomes in patients undergoing surgery for head and neck cancer. Prehabilitation focuses on optimizing health before surgery in order to improve outcomes after surgery. Prehabilitation may include aspects of nutrition, exercise, mental health, or a combination of these. Exercise has been proven to improve anxiety, depression, fatigue, health related quality of life, and physical function among patients undergoing cancer treatment, as well as cancer survivors. The prehabilitation exercise intervention being studied includes a daily walking program, sit-to-stand training, and standing therapeutic exercises before patients undergo surgery. Receiving this prehabilitation exercise intervention prior to surgery may improve mobility and recovery outcomes in patients after surgery for head and neck cancer.
Detailed Description
PRIMARY OBJECTIVE:
I. To evaluate the impact of an exercise prehabilitation program on post-operative outcomes after head and neck cancer surgery.
SECONDARY OBJECTIVE:
I. To evaluate the impact of an exercise prehabilitation program on post-operative weight loss, depression and discharge disposition after head and neck cancer surgery.
EXPLORATORY OBJECTIVES:
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 89 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Older than 18 years of age and younger than 89 years of age. Both men and women and members of all races and ethnic groups may be included
- •Planned to undergo major head and neck cancer surgery with free tissue transfer reconstruction at Oregon Health and Science University (OHSU) with the Department of Otolaryngology-Head and Neck Surgery with an expected length of stay (LOS) of 3 days or more
- •Ability to understand and the willingness to sign a written informed consent document
Exclusion Criteria
- •Non-English speaking
- •Planned postoperative admission to the intensive care unit (ICU)
- •Social or psychiatric conditions that may interfere with compliance
- •Further exclusion criteria may be applied due to conditions that may impact the ability to safely exercise as well as utilize the Fitbit devices:
- •Symptoms of or ongoing work-up for unstable angina, uncontrolled tachyarrhythmias, decompensated heart failure, severe aortic stenosis, hypertrophic obstructive cardiomyopathy, uncontrolled hypertension (HTN), uncontrolled pulmonary HTN or uncontrolled asthma
- •History of chest pain, dizziness or syncope with exercise
- •Bony metastases to the spine or extremities
- •Falls in the last year
- •Cognitive impairments limiting safety or ability to use technology
- •Impaired mobility requiring the use of assistive devices, such as use of a walker or wheelchair at baseline
- •Isolation precautions, as they would not be allowed to ambulate on a patient floor post-operatively
Outcomes
Primary Outcomes
Post-operative mobility
Time Frame: Up to day of discharge or 14 days post-operatively, whichever is sooner.
Will be measured by daily step counts on the Fitbit or personal wearable device. Descriptive summaries of continuous data will include the sample size, group mean, standard deviation, median, and range. Confidence intervals will be included as appropriate. The primary endpoint of daily post-operative step counts will be compared using two sample t-tests between the intervention and control groups.
Secondary Outcomes
- Length of stay(From post-operative day 1 until day of discharge or 14 days post-operatively, whichever is sooner.)
- Depression(Up to day of discharge or 14 days post-operatively, whichever is sooner.)
- Post-operative complications(Up to day of discharge or 14 days post-operatively, whichever is sooner.)
- Discharge Disposition(At time of discharge or 14 days post-operatively, whichever is sooner.)
- Health-related quality of life(Up to day of discharge or 14 days post-operatively, whichever is sooner.)
- Weight loss(From time of enrollment to day of discharge or 14 days post-operatively, whichever is sooner.)
- Average daily pain scores(Up to day of discharge or 14 days post-operatively, whichever is sooner.)
Investigators
Ryan Li, MD
Principal Investigator
OHSU Knight Cancer Institute