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

NCT ID: NCT00248235

Last Updated: 2024-11-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 64 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-09-30
• Study Completion Date: 2009-01-31

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.

Conditions

Head and Neck Neoplasms

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

PRET

Progressive Resistance Exercise Training: upper extremity 6-8 exercises

Group Type: EXPERIMENTAL

Exercise

Intervention Type: BEHAVIORAL

Standard Care

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

Group Type: ACTIVE_COMPARATOR

Exercise

Intervention Type: BEHAVIORAL

Interventions

Exercise

Intervention Type: BEHAVIORAL

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Alberta

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kerry S Courneya, PhD

Role: PRINCIPAL_INVESTIGATOR

Professor, Faculty of Physical Education and Recreation, University of Alberta

Locations

Behavioral Medicine Laboratory, University of Alberta

Edmonton, Alberta, Canada

Countries

Canada

References

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.

Reference Type: BACKGROUND

PMID: 15162353 (View on PubMed)

Other Identifiers

HN-4-0023

Identifier Type: -

Identifier Source: org_study_id