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Therapeutic Resistance Group Exercise Training for Head & Neck Cancer Survivors (TARGET)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02647021
Recruitment Status : Active, not recruiting
First Posted : January 6, 2016
Last Update Posted : April 29, 2019
Sponsor:
Collaborator:
Cross Cancer Institute
Information provided by (Responsible Party):
Margie McNeely, University of Alberta

Brief 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.

Condition or disease Intervention/treatment Phase
Head and Neck Neoplasms Accessory Nerve Injury Fatigue Behavioral: Therapeutic Exercise Behavioral: Therapeutic + Lower Body Exercise Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Evaluating Outcomes From a Combined Supervised Therapeutic and Physical Exercise Program for Post-surgical Head and Neck Cancer Survivors: A Randomized Controlled Trial
Actual Study Start Date : March 31, 2016
Estimated Primary Completion Date : March 1, 2020
Estimated Study Completion Date : September 30, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Therapeutic Exercise

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
A specialized therapeutic exercise program to address neck and shoulder dysfunction due to spinal accessory nerve damage.

Experimental: Therapeutic + Lower Body 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
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




Primary Outcome Measures :
  1. Functional Assessment of Cancer Therapy: Fatigue Scale Questionnaire [ Time Frame: change from baseline to 12 weeks. ]
    Cancer related fatigue


Secondary Outcome Measures :
  1. Shoulder range of motion in degrees. [ Time Frame: Change from baseline to one year ]
    Active and passive glenohumeral joint range of motion using standard 12 inch goniometer.

  2. Body mass index [ Time Frame: Change from baseline to 24 weeks. ]
    Derived from height and weight of the participant.

  3. 1 repetition maximum (1RM) strength for seated row in pounds. [ 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.

  4. Neck Range of Motion in degrees. [ Time Frame: Change from baseline to 12 weeks. ]
    Measures of neck flexion, side flexion, rotations and extension using myrin goniometer.

  5. Upper extremity muscular endurance: number of repetitions performed. [ Time Frame: baseline, 12-weeks, 24-weeks, one year ]
    Maximal repetitions to fatigue based on 50% of 1 repetition maximum strength for seated row.

  6. Lower extremity flexibility in centimetres. [ Time Frame: Change from baseline to 12-weeks. ]
    Sit and reach test

  7. Functional capacity [ Time Frame: Change from baseline to 24 weeks. ]
    6 minute walk test

  8. Neck Dissection Impairment Index [ Time Frame: Change from baseline to one year. ]
    Neck dissection related quality of life

  9. Grip strength in pounds. [ Time Frame: Change from baseline to 12-weeks. ]
    Maximal grip strength: composite score of both hands. Best of three attempts for each side.

  10. 1 repetition maximum leg press in pounds [ Time Frame: Change from baseline to 12 weeks. ]
    The maximal amount of weight that can be moved with proper

  11. 1 repetition maximum chest press in pounds. [ Time Frame: Change from baseline to 12 weeks. ]
    The maximal amount of weight that can be pushed with proper form.

  12. 30 second sit to stand (optional: in lieu of leg press) [ Time Frame: Change from baseline to 12 weeks. ]
    number of repetitions performed in 30 seconds

  13. Functional Assessment of Cancer Therapy Questionnaire Trial Outcome Index [ Time Frame: Baseline to 12-weeks. ]
    The composite score of physical, functional and fatigue subscales of the questionnaire.


Other Outcome Measures:
  1. Physical activity level in minutes per week (average over the previous one month period). [ Time Frame: Change in monthly average physical activity from baseline to one year. ]
    Godin Leisure Time Questionnaire: minutes of mild, moderate and strenuous exercise.

  2. Cost of programming [ Time Frame: one year ]
    costs to programming, institution and participants

  3. Exercise Adherence [ 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.

  4. Functional Assessment of Cancer Therapy Fatigue Scale at one year. [ Time Frame: Change from baseline to 1 year. ]
    Cancer-related fatigue.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Squamous cell carcinoma/ thyroid cancer/ melanoma or lymphoma involving: oral cavity, oropharynx, larynx or hypopharynx, or lymph nodes in the neck region
  • Surgical treatment includes radical neck dissection, modified radical neck dissection and other variants of functional/selective neck dissection
  • Karnofsky Performance Status greater than or equal to 60%
  • No evidence of residual cancer in the neck and no distant (M0) metastasis. Potential participants with symptoms suggestive of distant metastasis (M1) must have appropriate investigations (e.g. bone scan) to rule these out.
  • Participants must have completed their head and neck/ thyroid/ melanoma/ lymphoma cancer treatment (minimum 4 weeks post treatment)
  • Pre-participation Screening: Prior to participation in the exercise program, potential participants will complete general and cancer-specific Physical Activity Readiness Questionnaires (PAR-Q+) to determine appropriateness for the exercise program. Physician consent and approval for supervised exercise will be required prior to enrollment.

Exclusion Criteria:

  • A participant will be ineligible if they present with medical illness or psychiatric illness, which, in the opinion of the investigators, would impact his/her ability to participate in exercise or interfere with follow-up.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02647021


Locations
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Canada, Alberta
University of Alberta/ Cross Cancer Institute
Edmonton, Alberta, Canada, T6G 2G4
Sponsors and Collaborators
University of Alberta
Cross Cancer Institute
Investigators
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Principal Investigator: Margaret L. McNeely, PhD University of Alberta

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Responsible Party: Margie McNeely, Associate Professor, University of Alberta
ClinicalTrials.gov Identifier: NCT02647021    
Other Study ID Numbers: HREBA.CC.15-0167
First Posted: January 6, 2016    Key Record Dates
Last Update Posted: April 29, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Margie McNeely, University of Alberta:
physical therapy
cancer rehabilitation
exercise
Additional relevant MeSH terms:
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Head and Neck Neoplasms
Accessory Nerve Injuries
Fatigue
Neoplasms by Site
Neoplasms
Signs and Symptoms
Accessory Nerve Diseases
Cranial Nerve Diseases
Nervous System Diseases
Cranial Nerve Injuries
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries