Resistance Exercise Training for the Shoulder and Neck Following Surgery for Head and Neck Cancer

Study Overview
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Brief Summary
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The purpose of this study is to investigate the effect of a progressive therapeutic exercise program on specific physical and functional deficits in the neck and shoulder region occurring as a result of head and neck cancer treatment.

Detailed Description
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We will be conducting a randomized controlled trial to evaluate the effects of progressive resistance exercise training (PRET) on shoulder and neck dysfunction due to spinal accessory neurapraxia/ neurectomy in patients with head and neck cancer. Sixty-four head and neck cancer survivors will be randomly assigned to PRET or standard care. Participants assigned to the PRET group will exercise 3 times per week for 12 weeks. The goal of the exercise program will be to enhance scapular stability, and improve mobility and strength of the upper extremity. The resistance exercise program will be progressive in terms of the number of sets and repetitions performed, as well as amount lifted, depending on baseline strength levels and overall performance status. The primary outcomes for the study include pain and dysfunction, active and passive range of motion measures, strength and endurance testing, and quality of life. Nerve conduction testing and electromyography will be performed to assess/ monitor the status of the spinal accessory nerve and trapezius muscle function respectively.

Official Title
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Randomized Controlled Trial of Progressive Resistance Exercise Training for Spinal Accessory Neurapraxia/ Neurectomy in Head and Neck Cancer Survivors

Conditions
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Head and Neck Neoplasms

Intervention / Treatment
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* Behavioral: Exercise


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Squamous cell carcinoma of the oral cavity, oropharynx, larynx or hypopharynx OR squamous cell carcinoma metastatic to the neck from unknown primary site; probable occult mucosal origin in the head and neck Surgical treatment includes radical neck dissection, modified radical neck dissection and other variants of functional/selective neck dissection Karnofsky Performance Status greater than or equal to 60% No evidence of residual cancer in the neck and no distant (M0) metastasis Participants must have completed their head and neck cancer treatment Exclusion Criteria: A history of shoulder or neck pathology unrelated to cancer treatment Serious co-morbid medical illness or psychiatric illness

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PRET<br>Progressive Resistance Exercise Training: upper extremity 6-8 exercises | Behavioral: Exercise<br> <br> |
| Active Comparator: Standard Care<br>Standard Care: physical therapy - range of motion, 6-8 strengthening exercises | Behavioral: Exercise<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain and dysfunction (baseline, 12 weeks, 6 months, 12 months) |  | baseline, 12 weeks, 6 months, 12 months | 
| Active and passive range of motion (baseline, 12 weeks) |  | baseline, 12 weeks | 
| Muscular strength and endurance (baseline, 12 weeks) |  | baseline, 12 weeks | 
| Quality of life (baseline, 12 weeks, 6 months, 12 months) |  | baseline, 12 weeks, 6 months, 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anxiety, depression and fatigue (baseline, 12 weeks, 6 months, 12 months) |  | baseline, 12 weeks, 6 months, 12 months | 
| Nerve conduction testing (baseline, 12 weeks as indicated) |  | Baseline | 
| Electromyography (baseline, 12 weeks as indicated) |  | Baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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exercise, rehabilitation, head and neck neoplasms