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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00248235
Recruitment Status : Completed
First Posted : November 3, 2005
Last Update Posted : May 12, 2016
Information provided by (Responsible Party):
University of Alberta, Physical Education

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Head and Neck Neoplasms Behavioral: Exercise Phase 2 Phase 3

Detailed Description:
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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized Controlled Trial of Progressive Resistance Exercise Training for Spinal Accessory Neurapraxia/ Neurectomy in Head and Neck Cancer Survivors
Study Start Date : September 2005
Actual Primary Completion Date : May 2008
Actual Study Completion Date : January 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: PRET
Progressive Resistance Exercise Training: upper extremity 6-8 exercises
Behavioral: Exercise
Active Comparator: Standard Care
Standard Care: physical therapy - range of motion, 6-8 strengthening exercises
Behavioral: Exercise

Primary Outcome Measures :
  1. Pain and dysfunction (baseline, 12 weeks, 6 months, 12 months) [ Time Frame: baseline, 12 weeks, 6 months, 12 months ]
  2. Active and passive range of motion (baseline, 12 weeks) [ Time Frame: baseline, 12 weeks ]
  3. Muscular strength and endurance (baseline, 12 weeks) [ Time Frame: baseline, 12 weeks ]
  4. Quality of life (baseline, 12 weeks, 6 months, 12 months) [ Time Frame: baseline, 12 weeks, 6 months, 12 months ]

Secondary Outcome Measures :
  1. Anxiety, depression and fatigue (baseline, 12 weeks, 6 months, 12 months) [ Time Frame: baseline, 12 weeks, 6 months, 12 months ]
  2. Nerve conduction testing (baseline, 12 weeks as indicated) [ Time Frame: Baseline ]
  3. Electromyography (baseline, 12 weeks as indicated) [ Time Frame: Baseline ]

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00248235

Canada, Alberta
Behavioral Medicine Laboratory, University of Alberta
Edmonton, Alberta, Canada, T6G 2H9
Sponsors and Collaborators
University of Alberta, Physical Education
Principal Investigator: Kerry S Courneya, PhD Professor, Faculty of Physical Education and Recreation, University of Alberta

Responsible Party: University of Alberta, Physical Education Identifier: NCT00248235     History of Changes
Other Study ID Numbers: HN-4-0023
First Posted: November 3, 2005    Key Record Dates
Last Update Posted: May 12, 2016
Last Verified: May 2016

Keywords provided by University of Alberta, Physical Education:
head and neck neoplasms

Additional relevant MeSH terms:
Head and Neck Neoplasms
Neoplasms by Site