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

Head and Neck Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06079697
• Other study ID #: STUDY00025357
• Secondary ID: NCI-2023-07171ST
• Status: Recruiting
• Phase: N/A
• Start date: February 1, 2024
• Est. completion date: October 31, 2024

Study information

• Verified date: May 2024
• Source: OHSU Knight Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: October 31, 2024
• Est. primary completion date: October 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 89 Years

Eligibility

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

Related Conditions & MeSH terms

• Head and Neck Carcinoma
• Head and Neck Neoplasms

Intervention

Other:
• Electronic Health Record Review
Ancillary studies
• Exercise Intervention
Receive prehabilitation exercise intervention
• Medical Device Usage and Evaluation
Wear Fitbits
• Survey Administration
Ancillary studies

Locations

Country	Name	City	State
United States	OHSU Knight Cancer Institute	Portland	Oregon

Sponsors (1)

Lead Sponsor	Collaborator
OHSU Knight Cancer Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.