University of Alberta/ Cross Cancer Institute
Edmonton, Alberta, T6G 2G4, Canada
NCT Number: NCT02647021
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.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Edmonton, Alberta, T6G 2G4, Canada
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
A specialized therapeutic exercise program to address neck and shoulder dysfunction due to spinal accessory nerve damage.
A combined therapeutic exercise program (as per the comparison arm) plus the addition of lower body resistance exercise
Time frame: change from baseline to 12 weeks.
Cancer related fatigue
Time frame: Change from baseline to one year
Active and passive glenohumeral joint range of motion using standard 12 inch goniometer.
Time frame: Change from baseline to 24 weeks.
Derived from height and weight of the participant.
Time frame: Change from baseline to 12 weeks.
The maximal amount weight that can be pulled (seated row) and pushed (vertical bench) with proper form.
Time frame: Change from baseline to 12 weeks.
Measures of neck flexion, side flexion, rotations and extension using myrin goniometer.
Time frame: baseline, 12-weeks, 24-weeks, one year
Maximal repetitions to fatigue based on 50% of 1 repetition maximum strength for seated row.
Time frame: Change from baseline to 12-weeks.
Sit and reach test
Time frame: Change from baseline to 24 weeks.
6 minute walk test
Time frame: Change from baseline to one year.
Neck dissection related quality of life
Time frame: Change from baseline to 12-weeks.
Maximal grip strength: composite score of both hands. Best of three attempts for each side.
Time frame: Change from baseline to 12 weeks.
The maximal amount of weight that can be moved with proper
Time frame: Change from baseline to 12 weeks.
The maximal amount of weight that can be pushed with proper form.
Time frame: Change from baseline to 12 weeks.
number of repetitions performed in 30 seconds
Time frame: Baseline to 12-weeks.
The composite score of physical, functional and fatigue subscales of the questionnaire.
Time frame: Change in monthly average physical activity from baseline to one year.
Godin Leisure Time Questionnaire: minutes of mild, moderate and strenuous exercise.
Time frame: one year
costs to programming, institution and participants
Time frame: Change from baseline to 1 year.
Adherence to exercise programming: attendance at supervised exercise sessions and self-directed sessions over the 1 year period.
Time frame: Change from baseline to 1 year.
Cancer-related fatigue.
University of Alberta
Other
Evaluating Outcomes From a Combined Supervised Therapeutic and Physical Exercise Program for Post-surgical Head and Neck Cancer Survivors: A Randomized Controlled Trial
Acronym: TARGET
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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