Clinical trial NCT06079697: An Exercise Prehabilitation Intervention for Improving Mobility and Recovery Outcomes in Patients Undergoing Head and Neck Cancer Surgery
Official title: The Effect of Exercise Prehabilitation on Post-Operative Recovery After Head and Neck Cancer Surgery
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Head and Neck Carcinoma
Lead sponsor: OHSU Knight Cancer Institute
Sponsor class: OTHER
First posted: 2023-10-12
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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:

I. To evaluate the adherence rate to and satisfaction with a pre-operative exercise prehabilitation program, which will be evaluated at the end of their inpatient stay.

II. To evaluate the impact of lower extremity free tissue transfer on post-operative recovery after undergoing an exercise prehabilitation program, which will be evaluated at the end of their inpatient stay.

III. To evaluate the impact of the duration of prehabilitation on post-operative outcomes after head and neck cancer surgery, which will be evaluated at the end of their inpatient stay.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients wear a Fitbit or personal wearable device beginning on day 1 and receive the prehabilitation exercise intervention consisting of 2000-4000 steps per day, sit-to-stand training 3 days per week, and standing therapeutic exercises 3 days per week beginning on day 2 for up to 2-5 weeks prior to surgery. Patients continue wearing the Fitbit personal wearable device from post-operative day 1 until hospital discharge or until 14 days post-surgery.

ARM II: Patients wear a Fitbit personal wearable device beginning on day 1 up until day of surgery and then from post-operative day 1 until hospital discharge or until 14 days post-surgery.

Eligibility criteria: 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

Primary outcomes:
measure: Post-operative mobility
timeFrame: Up to day of discharge or 14 days post-operatively, whichever is sooner.
Secondary outcomes:
measure: Post-operative complications
timeFrame: Up to day of discharge or 14 days post-operatively, whichever is sooner.
measure: Length of stay
timeFrame: From post-operative day 1 until day of discharge or 14 days post-operatively, whichever is sooner.
measure: Depression
timeFrame: Up to day of discharge or 14 days post-operatively, whichever is sooner.
measure: Health-related quality of life
timeFrame: Up to day of discharge or 14 days post-operatively, whichever is sooner.
measure: Weight loss
timeFrame: From time of enrollment to day of discharge or 14 days post-operatively, whichever is sooner.
measure: Average daily pain scores
timeFrame: Up to day of discharge or 14 days post-operatively, whichever is sooner.
measure: Discharge Disposition
timeFrame: At time of discharge or 14 days post-operatively, whichever is sooner.
Other outcomes:
Locations:
city: Portland
country: United States
facility: OHSU Knight Cancer Institute
state: Oregon
Study officials:
affiliation: OHSU Knight Cancer Institute
name: Ryan J Li
role: PRINCIPAL_INVESTIGATOR
References: