NCT06079697

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

The Effect of Exercise Prehabilitation on Post-Operative Recovery After Head and Neck Cancer Surgery

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 52 (actual)
• Sponsor: OHSU Knight Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years – 89 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
OTHER	Electronic Health Record Review	Ancillary studies
OTHER	Exercise Intervention	Receive prehabilitation exercise intervention
OTHER	Medical Device Usage and Evaluation	Wear Fitbits
OTHER	Survey Administration	Ancillary studies

Timeline

• Start date: 2024-02-01
• Primary completion: 2025-07-15
• Completion: 2025-07-15
• First posted: 2023-10-12
• Last updated: 2025-12-12

Locations

1 site across 1 country: United States