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

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.

Study Overview

• Status: Recruiting
• Conditions: Head and Neck Carcinoma
• Intervention / Treatment: Other: Survey Administration; Other: Electronic Health Record Review; Other: Exercise Intervention; Other: Medical Device Usage and Evaluation

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 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.

ARM II: 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.

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Oregon
    • Portland, Oregon, United States, 97239
      • Recruiting
      • OHSU Knight Cancer Institute
      • Contact: Ryan J. Li; Phone Number: 503-494-5355; Email: lry@ohsu.edu
      • Principal Investigator: Ryan J. Li

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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
• Further exclusion criteria may be applied due to conditions that may impact the ability to safely exercise as well as utilize the Fitbit devices:
• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm I (prehabilitation); 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.	Other: Survey Administration; Ancillary studies; Other: Electronic Health Record Review; Ancillary studies; Other: Exercise Intervention; Receive prehabilitation exercise intervention; Other: Medical Device Usage and Evaluation; Wear Fitbits
Active Comparator: Arm II (usual care); 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.	Other: Survey Administration; Ancillary studies; Other: Electronic Health Record Review; Ancillary studies; Other: Medical Device Usage and Evaluation; Wear Fitbits

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post-operative mobility	Will be measured by daily step counts on the Fitbit. 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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post-operative complications	Will be derived from the medical chart, and include pneumonia, DVT, ileus, arrhythmia, wound infection and any events requiring ICU transfer. Descriptive statistics will be used to present the results. A two-sample t-test will be used to analyze continuous variables and Chi-square test will be used for categorical variables.	Up to day of discharge or 14 days post-operatively, whichever is sooner.
Length of stay	Derived from the medical record. Descriptive statistics will be used to present the results. A two-sample t-test will be used to analyze continuous variables and Chi-square test will be used for categorical variables.	From post-operative day 1 until day of discharge or 14 days post-operatively, whichever is sooner.
Depression	Measured with the Patient Health Questionnaire-9 (PHQ-9) to determine level of depression on the day of discharge. This screening instrument measures the frequency of 9 signs and symptoms diagnostic of depression, with answers as not at all, several days, more than half of the days, and nearly every day. Total scores range between 0-27, and can indicate mild (<4), moderate (5-14), or severe (>20) depression. Descriptive statistics will be used to present the results. A two-sample t-test will be used to analyze continuous variables and Chi-square test will be used for categorical variables.	Up to day of discharge or 14 days post-operatively, whichever is sooner.
Health-related quality of life	Measured with the European Organization of Research and Treatment of Cancer Quality of Life Core Questionnaire, version 3.0 (EORTC QLQ C30). A 30-item questionnaire to assess overall quality of life in cancer patients. EORTC QLQ-C30 includes functional scales (physical, cognitive, emotional, and social), global health status, symptom scales (fatigue, pain, nausea/vomiting), and other (dyspnea, appetite loss, insomnia, constipation/diarrhea, and financial difficulties). Most questions use 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions use 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged and transformed to 0-100 scale; higher score equates to better level of physical functioning. Descriptive statistics will be used to present the results. A two-sample t-test will be used to analyze continuous variables and Chi-square test will be used for categorical variables.	Up to day of discharge or 14 days post-operatively, whichever is sooner.
Weight loss	Measured in kg. Weight loss will be determined based on their weight at the time of enrollment at initial pre-operative appointment, compared to their weight on the day of discharge. Descriptive statistics will be used to present the results. A two-sample t-test will be used to analyze continuous variables and Chi-square test will be used for categorical variables.	From time of enrollment to day of discharge or 14 days post-operatively, whichever is sooner.
Average daily pain scores	Measured on a 1-10 Likert scale, during a patient's inpatient, post-operative stay and obtained from the medical record. Descriptive statistics will be used to present the results. A two-sample t-test will be used to analyze continuous variables and Chi-square test will be used for categorical variables.	Up to day of discharge or 14 days post-operatively, whichever is sooner.
Discharge Disposition	Derived from the medical record and may include discharge to home, home with assistance, home with home health, skilled nursing facility, inpatient rehabilitation facility or other facility. Descriptive statistics will be used to present the results. A two-sample t-test will be used to analyze continuous variables and Chi-square test will be used for categorical variables.	At time of discharge or 14 days post-operatively, whichever is sooner.

Collaborators and Investigators

• Sponsor: OHSU Knight Cancer Institute
• Investigators: Principal Investigator: Ryan J Li, OHSU Knight Cancer Institute

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2024
• Primary Completion (Estimated): October 31, 2024
• Study Completion (Estimated): October 31, 2024

Study Registration Dates

• First Submitted: September 28, 2023
• First Submitted That Met QC Criteria: October 5, 2023
• First Posted (Actual): October 12, 2023

Study Record Updates

• Last Update Posted (Actual): March 12, 2024
• Last Update Submitted That Met QC Criteria: March 11, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Head and Neck Neoplasms
• Other Study ID Numbers: STUDY00025357 (Other Identifier: OHSU Knight Cancer Institute); NCI-2023-07171 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No