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Exercise Prehabilitation for Head and Neck Cancer

N/A

Recruiting

Led By Ryan J Li

Research Sponsored by OHSU Knight Cancer Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Be older than 18 years old

Must not have

Planned postoperative admission to the intensive care unit (ICU)

Bony metastases to the spine or extremities

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from post-operative day 1 until day of discharge or 14 days post-operatively, whichever is sooner.

Awards & highlights

No Placebo-Only Group

Summary

This trial looks at how prehabilitation exercise before surgery can help head and neck cancer patients recover better afterwards.

Who is the study for?

This trial is for adults aged 18-89 planning to undergo major head and neck cancer surgery at OHSU, expected to stay for at least 3 days post-op. Participants must understand English, be able to consent, and not require ICU post-op or use assistive walking devices. Those with certain heart conditions, impaired mobility due to falls or metastases, isolation precautions, or cognitive issues affecting technology use cannot join.

What is being tested?

The study tests a pre-surgery exercise program aimed at improving recovery outcomes in head and neck cancer patients. The program includes daily walks, sit-to-stand exercises, and standing therapeutic exercises designed as prehabilitation before their surgical procedure.

What are the potential side effects?

Since the intervention involves an exercise regimen rather than medication or invasive procedures, side effects may include typical exercise-related discomforts such as muscle soreness or fatigue but are generally minimal compared to drug-related side effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am scheduled for major head and neck surgery with tissue reconstruction at OHSU and expected to stay for 3+ days.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am scheduled to stay in the ICU after my surgery.

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My cancer has spread to my bones.

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I do not have cognitive issues affecting my safety or use of technology.

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I need a walker or wheelchair to move around.

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I do not have uncontrolled heart or lung conditions.

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I must stay in my room after surgery due to isolation precautions.

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I have experienced chest pain, dizziness, or fainting during exercise.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from post-operative day 1 until day of discharge or 14 days post-operatively, whichever is sooner.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from post-operative day 1 until day of discharge or 14 days post-operatively, whichever is sooner.

This trial's timeline: 3 weeks for screening, Varies for treatment, and from post-operative day 1 until day of discharge or 14 days post-operatively, whichever is sooner. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Post-operative mobility

Secondary study objectives

Average daily pain scores

Depression

Discharge Disposition

+4 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Arm I (prehabilitation)Experimental Treatment4 Interventions

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 II: Arm II (usual care)Active Control3 Interventions

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.

0 / 8Eligibility criteria met