A Phase 2/3 interventional study of Exercise in Head and Neck Neoplasms, sponsored by University of Alberta. Completed at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-11-05.
Sponsored by University of Alberta · Phase 2/3, Interventional, and Treatment
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.
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.
2,344 studies on the registry are indexed under Head and Neck Neoplasms; 551 are open to participants now.
This study's enrollment of 64 is above the median of 47 across 1,751 interventional studies indexed under Head and Neck Neoplasms.
Browse Head and Neck Neoplasms studies →University of Alberta is the lead sponsor of 800 studies on the registry; 168 are open to participants now.
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Exclusion Criteria:
Progressive Resistance Exercise Training: upper extremity 6-8 exercises
Behavioral: Exercise
Standard Care: physical therapy - range of motion, 6-8 strengthening exercises
Behavioral: Exercise
Pain and dysfunction (baseline, 12 weeks, 6 months, 12 months)
Time frame: baseline, 12 weeks, 6 months, 12 months
Active and passive range of motion (baseline, 12 weeks)
Time frame: baseline, 12 weeks
Muscular strength and endurance (baseline, 12 weeks)
Time frame: baseline, 12 weeks
Quality of life (baseline, 12 weeks, 6 months, 12 months)
Time frame: baseline, 12 weeks, 6 months, 12 months
Anxiety, depression and fatigue (baseline, 12 weeks, 6 months, 12 months)
Time frame: baseline, 12 weeks, 6 months, 12 months
Nerve conduction testing (baseline, 12 weeks as indicated)
Time frame: Baseline
Electromyography (baseline, 12 weeks as indicated)
Time frame: Baseline
This study is completed, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.
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University of Alberta