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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2005 by University of Alberta, Physical Education.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
University of Alberta, Physical Education
ClinicalTrials.gov Identifier:
NCT00248235
First received: November 1, 2005
Last updated: January 31, 2007
Last verified: September 2005
  Purpose

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 Intervention Phase
Head and Neck Neoplasms
Behavioral: Exercise
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Treatment
Official Title: Randomized Controlled Trial of Progressive Resistance Exercise Training for Spinal Accessory Neurapraxia/ Neurectomy in Head and Neck Cancer Survivors

Resource links provided by NLM:


Further study details as provided by University of Alberta, Physical Education:

Primary Outcome Measures:
  • Pain and dysfunction (baseline, 12 weeks, 6 months, 12 months)
  • Active and passive range of motion (baseline, 12 weeks)
  • Muscular strength and endurance (baseline, 12 weeks)
  • Quality of life (baseline, 12 weeks, 6 months, 12 months)

Secondary Outcome Measures:
  • Anxiety, depression and fatigue (baseline, 12 weeks, 6 months, 12 months)
  • Nerve conduction testing (baseline, 12 weeks as indicated)
  • Electromyography (baseline, 12 weeks as indicated)

Estimated Enrollment: 64
Study Start Date: September 2005
Estimated Study Completion Date: September 2005
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00248235

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

Publications:
ClinicalTrials.gov Identifier: NCT00248235     History of Changes
Other Study ID Numbers: HN-4-0023
Study First Received: November 1, 2005
Last Updated: January 31, 2007
Health Authority: Canada: Health Canada

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

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

ClinicalTrials.gov processed this record on July 26, 2014