An Exercise Prehabilitation Intervention for Improving Mobility and Recovery Outcomes in Patients Undergoing Head and Neck Cancer Surgery

NCT ID: NCT06079697

Last Updated: 2025-12-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 52 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-02-01
• Study Completion Date: 2025-07-15

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.

Conditions

Head and Neck Carcinoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Arm I (prehabilitation)

Patients wear a Fitbit or a 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 or personal wearable device from post-operative day 1 until hospital discharge or until 14 days post-surgery.

Group Type: EXPERIMENTAL

Electronic Health Record Review

Intervention Type: OTHER

Ancillary studies

Exercise Intervention

Intervention Type: OTHER

Receive prehabilitation exercise intervention

Medical Device Usage and Evaluation

Intervention Type: OTHER

Wear Fitbits

Survey Administration

Intervention Type: OTHER

Ancillary studies

Arm II (usual care)

Patients wear a Fitbit or 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.

Group Type: ACTIVE_COMPARATOR

Electronic Health Record Review

Intervention Type: OTHER

Ancillary studies

Medical Device Usage and Evaluation

Intervention Type: OTHER

Wear Fitbits

Survey Administration

Intervention Type: OTHER

Ancillary studies

Interventions

Electronic Health Record Review

Ancillary studies

Intervention Type: OTHER

Exercise Intervention

Receive prehabilitation exercise intervention

Intervention Type: OTHER

Medical Device Usage and Evaluation

Wear Fitbits

Intervention Type: OTHER

Survey Administration

Ancillary studies

Intervention Type: OTHER

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
• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 89 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

OHSU Knight Cancer Institute

OTHER

Sponsor Role: lead

Responsible Party

Ryan Li, MD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ryan J Li

Role: PRINCIPAL_INVESTIGATOR

OHSU Knight Cancer Institute

Locations

OHSU Knight Cancer Institute

Portland, Oregon, United States

Countries

United States

Other Identifiers

NCI-2023-07171

Identifier Type: REGISTRY

Identifier Source: secondary_id

STUDY00025357

Identifier Type: OTHER

Identifier Source: secondary_id

STUDY00025357

Identifier Type: -

Identifier Source: org_study_id