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Completed

NCT Number: NCT00248235

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Behavioral Medicine Laboratory, University of Alberta

Edmonton, Alberta, T6G 2H9, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Exercise

Behavioral

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Alberta

Other

Registry information

Official study title

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

Important dates

Study start
2005
Primary completion
2008
Study completion
2009
First posted
Nov 3, 2005
Registry last updated
Nov 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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