NCT02647021

Therapeutic Resistance Group Exercise Training for Head & Neck Cancer Survivors

Evaluating Outcomes From a Combined Supervised Therapeutic and Physical Exercise Program for Post-surgical Head and Neck Cancer Survivors: A Randomized Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: University of Alberta · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The investigators will conduct a randomized controlled trial examining 12-week, 24-week and one year outcomes from a combined therapeutic and physical exercise program that aims to bridge head-and-neck cancer survivors from acute care rehabilitation services to community-based exercise programming.

Detailed description

Participants will be stratified by early (within 18 months of surgery) and late (\> 18 months of surgery) and randomized on a one-on-one basis to (1) a supervised therapeutic exercise program for the neck and shoulder (serving as standard care) or (2) a combined therapeutic and lower body resistance exercise program. The randomization sequence will be generated by staff in the Rehabilitation Research Centre at Corbett Hall and placed in sealed opaque envelopes. The exercise program will be offered in a group setting. Participants will exercise 2 times per week for a 10-week session and will have the option to continue for an additional 10-week maintenance session. The primary outcome for the study will be quality of life as measured by the Functional Assessment of Cancer Therapy (FACT)-Fatigue Scale at 12-weeks. At each measurement point following the baseline assessment, including the 12-week and 24-week and one year follow-ups, an Independent Assessor will perform the objective fitness measurements. The Independent Assessor will also administer the Neck Dissection Impairment Questionnaire and the FACT-Fatigue quality of life questionnaires. The Physical Activity Adherence Diary will be collected by a Research Coordinator at each follow-up visit.

Conditions

• Head and Neck Neoplasms
• Accessory Nerve Injury
• Fatigue

Interventions

Type	Name	Description
BEHAVIORAL	Therapeutic Exercise	A specialized therapeutic exercise program to address neck and shoulder dysfunction due to spinal accessory nerve damage.
BEHAVIORAL	Therapeutic + Lower Body Exercise	A combined therapeutic exercise program (as per the comparison arm) plus the addition of lower body resistance exercise

Timeline

• Start date: 2016-03-31
• Primary completion: 2020-03-15
• Completion: 2020-03-30
• First posted: 2016-01-06
• Last updated: 2024-01-03

Locations

1 site across 1 country: Canada