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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
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

Study 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.Check my eligibility
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.See study design
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
Select...
I am scheduled for major head and neck surgery with tissue reconstruction at OHSU and expected to stay for 3+ days.

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.
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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Post-operative mobility
Secondary outcome measures
Average daily pain scores
Depression
Discharge Disposition
+4 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Arm I (prehabilitation)Experimental Treatment4 Interventions
Patients wear a Fitbit 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 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 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.

Find a Location

Who is running the clinical trial?

OHSU Knight Cancer InstituteLead Sponsor
230 Previous Clinical Trials
2,090,686 Total Patients Enrolled
Ryan J LiPrincipal InvestigatorOHSU Knight Cancer Institute
3 Previous Clinical Trials
162 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Do I qualify as a potential participant in this medical experiment?

"Eligibility criteria for this trial necessitates that prospective participants have head and neck cancers and are aged between 18 to 89. In total, 40 people may be accepted into the clinical study."

Answered by AI

Is the age limit for this trial restricted to individuals under 35?

"To be included in this trial, applicants must have an age bracket between 18 and 89. There are also 16 trials currently open for those under the legal age of consent and 409 for patients above the retirement age of 65."

Answered by AI

Are there vacant slots for participants in this trial?

"As of the most recent update to clinicaltrials.gov, this medical research is no longer looking for participants; however, 414 other studies are currently enrolling patients. Initially posted on October 31st 2023 and last edited on October 5th 2023, this trial has since concluded its recruitment period."

Answered by AI
~27 spots leftby Oct 2024