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

NCT06079697 | Completed

• 2 other identifiers: STUDY00025357NCI-2023-07171
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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.

Conditions

Head and Neck Carcinoma

Outcome Measures

Primary Outcomes (1)

• Post-operative mobility

  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.

  Up to day of discharge or 14 days post-operatively, whichever is sooner.

Secondary Outcomes (7)

• Post-operative complications

  Up to day of discharge or 14 days post-operatively, whichever is sooner.

• 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.

• 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.

Study Arms (2)

Arm I (prehabilitation)

EXPERIMENTAL

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.

Other: Electronic Health Record Review; Other: Exercise Intervention; Other: Medical Device Usage and Evaluation; Other: Survey Administration

Arm II (usual care)

ACTIVE COMPARATOR

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.

Other: Electronic Health Record Review; Other: Medical Device Usage and Evaluation; Other: Survey Administration

Interventions

Medical Device Usage and Evaluation OTHER

Wear Fitbits

Arm I (prehabilitation); Arm II (usual care)

Survey Administration OTHER

Ancillary studies

Arm I (prehabilitation); Arm II (usual care)

Electronic Health Record Review OTHER

Ancillary studies

Arm I (prehabilitation); Arm II (usual care)

Exercise Intervention OTHER

Receive prehabilitation exercise intervention

Arm I (prehabilitation)

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• OHSU Knight Cancer Institute: lead

Study Sites (1)

OHSU Knight Cancer Institute

Portland, Oregon, 97239, United States

Location

Study Officials

• Ryan J Li

  OHSU Knight Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 28, 2023
• First Posted: October 12, 2023
• Study Start: February 1, 2024
• Primary Completion: July 15, 2025
• Study Completion: July 15, 2025
• Last Updated: December 12, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)