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Trial Title:
An Exercise Prehabilitation Intervention for Improving Mobility and Recovery Outcomes in Patients Undergoing Head and Neck Cancer Surgery
NCT ID:
NCT06079697
Condition:
Head and Neck Carcinoma
Conditions: Official terms:
Head and Neck Neoplasms
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Supportive Care
Masking:
None (Open Label)
Intervention:
Intervention type:
Other
Intervention name:
Electronic Health Record Review
Description:
Ancillary studies
Arm group label:
Arm I (prehabilitation)
Arm group label:
Arm II (usual care)
Intervention type:
Other
Intervention name:
Exercise Intervention
Description:
Receive prehabilitation exercise intervention
Arm group label:
Arm I (prehabilitation)
Intervention type:
Other
Intervention name:
Medical Device Usage and Evaluation
Description:
Wear Fitbits
Arm group label:
Arm I (prehabilitation)
Arm group label:
Arm II (usual care)
Intervention type:
Other
Intervention name:
Survey Administration
Description:
Ancillary studies
Arm group label:
Arm I (prehabilitation)
Arm group label:
Arm II (usual care)
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.
Criteria for 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
Gender:
All
Minimum age:
18 Years
Maximum age:
89 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
OHSU Knight Cancer Institute
Address:
City:
Portland
Zip:
97239
Country:
United States
Status:
Recruiting
Contact:
Last name:
Ryan J. Li
Phone:
503-494-5355
Email:
lry@ohsu.edu
Investigator:
Last name:
Ryan J. Li
Email:
Principal Investigator
Start date:
February 1, 2024
Completion date:
October 31, 2025
Lead sponsor:
Agency:
OHSU Knight Cancer Institute
Agency class:
Other
Source:
OHSU Knight Cancer Institute
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06079697
