Randomized Controlled Trial of Progressive Resistance Exercise Training for Spinal Accessory Neurapraxia/ Neurectomy in Head and Neck Cancer Survivors
18 Years
N/A
Both
Head and Neck Neoplasms
Trial Information
Randomized Controlled Trial of Progressive Resistance Exercise Training for Spinal Accessory Neurapraxia/ Neurectomy in Head and Neck Cancer Survivors
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.
Inclusion Criteria:
1. 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
2. Surgical treatment includes radical neck dissection, modified radical neck dissection
and other variants of functional/selective neck dissection
3. Karnofsky Performance Status greater than or equal to 60%
4. No evidence of residual cancer in the neck and no distant (M0) metastasis
5. Participants must have completed their head and neck cancer treatment
Exclusion Criteria:
1. A history of shoulder or neck pathology unrelated to cancer treatment
2. Serious co-morbid medical illness or psychiatric illness
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment
Outcome Measure:
Pain and dysfunction (baseline, 12 weeks, 6 months, 12 months)
Principal Investigator
Kerry S Courneya, PhD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Professor, Faculty of Physical Education and Recreation, University of Alberta
Authority:
Canada: Health Canada
Study ID:
HN-4-0023
NCT ID:
NCT00248235
Start Date:
September 2005
Completion Date:
September 2005
Related Keywords:
- Head and Neck Neoplasms
- exercise
- rehabilitation
- head and neck neoplasms
- Neoplasms
- Head and Neck Neoplasms
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