An interventional study of Therapeutic Exercise and Therapeutic + Lower Body Exercise in Head and Neck Neoplasms, Accessory Nerve Injury and Fatigue, sponsored by University of Alberta. Completed at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-01-03.
Sponsored by University of Alberta · Not applicable, Interventional, and Supportive care
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.
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.
2,344 studies on the registry are indexed under Head and Neck Neoplasms; 551 are open to participants now.
This study's enrollment of 60 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.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Therapeutic Exercise Program (standard care) will include: 1. Neck range of motion and strengthening, and posture retraining. 2. Shoulder specific progressive resistance exercise program that focuses on spinal accessory nerve dysfunction and rehabilitation of trapezius muscle function.
Behavioral: Therapeutic Exercise
The Therapeutic Exercise Program (standard care) will include: 1. Neck range of motion and strengthening, and posture retraining. 2. Shoulder specific progressive resistance exercise program that focuses on spinal accessory nerve dysfunction and rehabilitation of trapezius muscle function. The Resistance Exercise component will target 6-8 muscle groups of the lower extremities and core including gluteal, quadriceps, hamstrings, abdominals, and gastrocnemius muscles. A progressive introduction of exercises will occur over the first 3 weeks. 1. a personalized program of lower extremity resistance exercises 2. core strengthening exercises
Behavioral: Therapeutic Exercise · Behavioral: Therapeutic + Lower Body Exercise
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
Functional Assessment of Cancer Therapy: Fatigue Scale Questionnaire
Cancer related fatigue
Time frame: change from baseline to 12 weeks.
Shoulder range of motion in degrees.
Active and passive glenohumeral joint range of motion using standard 12 inch goniometer.
Time frame: Change from baseline to one year
Body mass index
Derived from height and weight of the participant.
Time frame: Change from baseline to 24 weeks.
1 repetition maximum (1RM) strength for seated row in pounds.
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.
Neck Range of Motion in degrees.
Measures of neck flexion, side flexion, rotations and extension using myrin goniometer.
Time frame: Change from baseline to 12 weeks.
Upper extremity muscular endurance: number of repetitions performed.
Maximal repetitions to fatigue based on 50% of 1 repetition maximum strength for seated row.
Time frame: baseline, 12-weeks, 24-weeks, one year
Lower extremity flexibility in centimetres.
Sit and reach test
Time frame: Change from baseline to 12-weeks.
Functional capacity
6 minute walk test
Time frame: Change from baseline to 24 weeks.
Neck Dissection Impairment Index
Neck dissection related quality of life
Time frame: Change from baseline to one year.
Grip strength in pounds.
Maximal grip strength: composite score of both hands. Best of three attempts for each side.
Time frame: Change from baseline to 12-weeks.
1 repetition maximum leg press in pounds
The maximal amount of weight that can be moved with proper
Time frame: Change from baseline to 12 weeks.
1 repetition maximum chest press in pounds.
The maximal amount of weight that can be pushed with proper form.
Time frame: Change from baseline to 12 weeks.
30 second sit to stand (optional: in lieu of leg press)
number of repetitions performed in 30 seconds
Time frame: Change from baseline to 12 weeks.
Functional Assessment of Cancer Therapy Questionnaire Trial Outcome Index
The composite score of physical, functional and fatigue subscales of the questionnaire.
Time frame: Baseline to 12-weeks.
Physical activity level in minutes per week (average over the previous one month period).
Godin Leisure Time Questionnaire: minutes of mild, moderate and strenuous exercise.
Time frame: Change in monthly average physical activity from baseline to one year.
Cost of programming
costs to programming, institution and participants
Time frame: one year
Exercise Adherence
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.
Functional Assessment of Cancer Therapy Fatigue Scale at one year.
Cancer-related fatigue.
Time frame: Change from baseline to 1 year.
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Dec 2023. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University of Alberta