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

Primary Purpose

Head and Neck Neoplasms

Status
Completed
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
Exercise
Sponsored by
University of Alberta, Physical Education
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Head and Neck Neoplasms focused on measuring exercise, rehabilitation, head and neck neoplasms

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Behavioral Medicine Laboratory, University of Alberta

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

PRET

Standard Care

Arm Description

Progressive Resistance Exercise Training: upper extremity 6-8 exercises

Standard Care: physical therapy - range of motion, 6-8 strengthening exercises

Outcomes

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)

Full Information

First Posted
November 1, 2005
Last Updated
May 10, 2016
Sponsor
University of Alberta, Physical Education
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1. Study Identification

Unique Protocol Identification Number
NCT00248235
Brief Title
Resistance Exercise Training for the Shoulder and Neck Following Surgery for Head and Neck Cancer
Official Title
Randomized Controlled Trial of Progressive Resistance Exercise Training for Spinal Accessory Neurapraxia/ Neurectomy in Head and Neck Cancer Survivors
Study Type
Interventional

2. Study Status

Record Verification Date
May 2016
Overall Recruitment Status
Completed
Study Start Date
September 2005 (undefined)
Primary Completion Date
May 2008 (Actual)
Study Completion Date
January 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Alberta, Physical Education

4. Oversight

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Neoplasms
Keywords
exercise, rehabilitation, head and neck neoplasms

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
64 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PRET
Arm Type
Experimental
Arm Description
Progressive Resistance Exercise Training: upper extremity 6-8 exercises
Arm Title
Standard Care
Arm Type
Active Comparator
Arm Description
Standard Care: physical therapy - range of motion, 6-8 strengthening exercises
Intervention Type
Behavioral
Intervention Name(s)
Exercise
Primary Outcome Measure Information:
Title
Pain and dysfunction (baseline, 12 weeks, 6 months, 12 months)
Time Frame
baseline, 12 weeks, 6 months, 12 months
Title
Active and passive range of motion (baseline, 12 weeks)
Time Frame
baseline, 12 weeks
Title
Muscular strength and endurance (baseline, 12 weeks)
Time Frame
baseline, 12 weeks
Title
Quality of life (baseline, 12 weeks, 6 months, 12 months)
Time Frame
baseline, 12 weeks, 6 months, 12 months
Secondary Outcome Measure Information:
Title
Anxiety, depression and fatigue (baseline, 12 weeks, 6 months, 12 months)
Time Frame
baseline, 12 weeks, 6 months, 12 months
Title
Nerve conduction testing (baseline, 12 weeks as indicated)
Time Frame
Baseline
Title
Electromyography (baseline, 12 weeks as indicated)
Time Frame
Baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kerry S Courneya, PhD
Organizational Affiliation
Professor, Faculty of Physical Education and Recreation, University of Alberta
Official's Role
Principal Investigator
Facility Information:
Facility Name
Behavioral Medicine Laboratory, University of Alberta
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2H9
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
15162353
Citation
McNeely ML, Parliament M, Courneya KS, Seikaly H, Jha N, Scrimger R, Hanson J. A pilot study of a randomized controlled trial to evaluate the effects of progressive resistance exercise training on shoulder dysfunction caused by spinal accessory neurapraxia/neurectomy in head and neck cancer survivors. Head Neck. 2004 Jun;26(6):518-30. doi: 10.1002/hed.20010.
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Resistance Exercise Training for the Shoulder and Neck Following Surgery for Head and Neck Cancer

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