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

Phase 2

Completed

• Conditions: Head and Neck Neoplasms
• Interventions: Behavioral: Exercise

• Registration Number: NCT00248235
• Lead Sponsor: University of Alberta

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.

Study Timeline

• Study Start: 2005-09
• Study First Submitted: 2005-11-01
• Study First Submitted QC: 2005-11-01
• Study First Posted: 2005-11-03
• Primary Completion: 2008-05
• Study Completion: 2009-01
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-04
• Last Update Posted: 2024-11-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 64

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PRET	Exercise	Progressive Resistance Exercise Training: upper extremity 6-8 exercises
Standard Care	Exercise	Standard Care: physical therapy - range of motion, 6-8 strengthening exercises

Primary Outcome Measures

Name	Time	Method
Pain and dysfunction (baseline, 12 weeks, 6 months, 12 months)	baseline, 12 weeks, 6 months, 12 months
Active and passive range of motion (baseline, 12 weeks)	baseline, 12 weeks
Muscular strength and endurance (baseline, 12 weeks)	baseline, 12 weeks
Quality of life (baseline, 12 weeks, 6 months, 12 months)	baseline, 12 weeks, 6 months, 12 months

Secondary Outcome Measures

Name	Time	Method
Nerve conduction testing (baseline, 12 weeks as indicated)	Baseline
Anxiety, depression and fatigue (baseline, 12 weeks, 6 months, 12 months)	baseline, 12 weeks, 6 months, 12 months
Electromyography (baseline, 12 weeks as indicated)	Baseline

Trial Locations

Locations (1)

Behavioral Medicine Laboratory, University of Alberta; 🇨🇦 Edmonton, Alberta, Canada