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| Name | Class |
|---|---|
| Cross Cancer Institute | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Therapeutic Exercise | Active Comparator | Therapeutic Exercise Program (standard care) will include:
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| Therapeutic + Lower Body Exercise | Experimental | The Therapeutic Exercise Program (standard care) will include:
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Therapeutic Exercise | Behavioral | A specialized therapeutic exercise program to address neck and shoulder dysfunction due to spinal accessory nerve damage. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Functional Assessment of Cancer Therapy: Fatigue Scale Questionnaire | Cancer related fatigue | change from baseline to 12 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Shoulder range of motion in degrees. | Active and passive glenohumeral joint range of motion using standard 12 inch goniometer. | Change from baseline to one year |
| Body mass index | Derived from height and weight of the participant. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Change in monthly average physical activity from baseline to one year. |
| Cost of programming |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Margaret L. McNeely, PhD | University of Alberta | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alberta/ Cross Cancer Institute | Edmonton | Alberta | T6G 2G4 | Canada |
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| ID | Term |
|---|---|
| D006258 | Head and Neck Neoplasms |
| D061227 | Accessory Nerve Injuries |
| D005221 | Fatigue |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D020436 | Accessory Nerve Diseases |
| D003389 | Cranial Nerve Diseases |
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| ID | Term |
|---|---|
| D005081 | Exercise Therapy |
| D013812 | Therapeutics |
| ID | Term |
|---|---|
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
| D005791 | Patient Care |
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| Therapeutic + Lower Body Exercise | Behavioral | A combined therapeutic exercise program (as per the comparison arm) plus the addition of lower body resistance exercise |
|
| 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. | Change from baseline to 12 weeks. |
| Neck Range of Motion in degrees. | Measures of neck flexion, side flexion, rotations and extension using myrin goniometer. | 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. | baseline, 12-weeks, 24-weeks, one year |
| Lower extremity flexibility in centimetres. | Sit and reach test | Change from baseline to 12-weeks. |
| Functional capacity | 6 minute walk test | Change from baseline to 24 weeks. |
| Neck Dissection Impairment Index | Neck dissection related quality of life | 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. | Change from baseline to 12-weeks. |
| 1 repetition maximum leg press in pounds | The maximal amount of weight that can be moved with proper | 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. | Change from baseline to 12 weeks. |
| 30 second sit to stand (optional: in lieu of leg press) | number of repetitions performed in 30 seconds | 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. | Baseline to 12-weeks. |
costs to programming, institution and participants |
| one year |
| Exercise Adherence | Adherence to exercise programming: attendance at supervised exercise sessions and self-directed sessions over the 1 year period. | Change from baseline to 1 year. |
| Functional Assessment of Cancer Therapy Fatigue Scale at one year. | Cancer-related fatigue. | Change from baseline to 1 year. |
| D009422 |
| Nervous System Diseases |
| D020209 | Cranial Nerve Injuries |
| D006259 | Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001519 | Behavior |
| D026741 |
| Physical Therapy Modalities |