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

May 10, 2016 updated by: University of Alberta, Physical Education

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

64

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G 2H9
        • Behavioral Medicine Laboratory, University of Alberta

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Alberta, Physical Education

Investigators

  • Principal Investigator: Kerry S Courneya, PhD, Professor, Faculty of Physical Education and Recreation, University of Alberta

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2005

Primary Completion (Actual)

May 1, 2008

Study Completion (Actual)

January 1, 2009

Study Registration Dates

First Submitted

November 1, 2005

First Submitted That Met QC Criteria

November 1, 2005

First Posted (Estimate)

November 3, 2005

Study Record Updates

Last Update Posted (Estimate)

May 12, 2016

Last Update Submitted That Met QC Criteria

May 10, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HN-4-0023

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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