Back to resultsTherapeutic Resistance Group Exercise Training for Head & Neck Cancer Survivors (TARGET)
Primary Purpose
Head and Neck Neoplasms, Accessory Nerve Injury, Fatigue
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Therapeutic Exercise
Therapeutic + Lower Body Exercise
Sponsored by
About this trial
This is an interventional supportive care trial for Head and Neck Neoplasms focused on measuring physical therapy, cancer rehabilitation, exercise
Eligibility 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.
Sites / Locations
- University of Alberta/ Cross Cancer Institute
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Therapeutic Exercise
Therapeutic + Lower Body Exercise
Arm Description
Therapeutic Exercise Program (standard care) will include: Neck range of motion and strengthening, and posture retraining. Shoulder specific progressive resistance exercise program that focuses on spinal accessory nerve dysfunction and rehabilitation of trapezius muscle function.
The Therapeutic Exercise Program (standard care) will include: Neck range of motion and strengthening, and posture retraining. 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. a personalized program of lower extremity resistance exercises core strengthening exercises
Outcomes
Primary Outcome Measures
Functional Assessment of Cancer Therapy: Fatigue Scale Questionnaire
Cancer related fatigue
Secondary Outcome Measures
Shoulder range of motion in degrees.
Active and passive glenohumeral joint range of motion using standard 12 inch goniometer.
Body mass index
Derived from height and weight of the participant.
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.
Neck Range of Motion in degrees.
Measures of neck flexion, side flexion, rotations and extension using myrin goniometer.
Upper extremity muscular endurance: number of repetitions performed.
Maximal repetitions to fatigue based on 50% of 1 repetition maximum strength for seated row.
Lower extremity flexibility in centimetres.
Sit and reach test
Functional capacity
6 minute walk test
Neck Dissection Impairment Index
Neck dissection related quality of life
Grip strength in pounds.
Maximal grip strength: composite score of both hands. Best of three attempts for each side.
1 repetition maximum leg press in pounds
The maximal amount of weight that can be moved with proper
1 repetition maximum chest press in pounds.
The maximal amount of weight that can be pushed with proper form.
30 second sit to stand (optional: in lieu of leg press)
number of repetitions performed in 30 seconds
Functional Assessment of Cancer Therapy Questionnaire Trial Outcome Index
The composite score of physical, functional and fatigue subscales of the questionnaire.
Full Information
NCT ID
NCT02647021
First Posted
December 28, 2015
Last Updated
June 27, 2020
Sponsor
University of Alberta
Collaborators
Cross Cancer Institute
1. Study Identification
Unique Protocol Identification Number
NCT02647021
Brief Title
Therapeutic Resistance Group Exercise Training for Head & Neck Cancer Survivors
Acronym
TARGET
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
March 31, 2016 (Actual)
Primary Completion Date
March 15, 2020 (Actual)
Study Completion Date
March 30, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alberta
Collaborators
Cross Cancer Institute
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Neoplasms, Accessory Nerve Injury, Fatigue
Keywords
physical therapy, cancer rehabilitation, exercise
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Therapeutic Exercise
Arm Type
Active Comparator
Arm Description
Therapeutic Exercise Program (standard care) will include:
Neck range of motion and strengthening, and posture retraining.
Shoulder specific progressive resistance exercise program that focuses on spinal accessory nerve dysfunction and rehabilitation of trapezius muscle function.
Arm Title
Therapeutic + Lower Body Exercise
Arm Type
Experimental
Arm Description
The Therapeutic Exercise Program (standard care) will include:
Neck range of motion and strengthening, and posture retraining.
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.
a personalized program of lower extremity resistance exercises
core strengthening exercises
Intervention Type
Behavioral
Intervention Name(s)
Therapeutic Exercise
Intervention Description
A specialized therapeutic exercise program to address neck and shoulder dysfunction due to spinal accessory nerve damage.
Intervention Type
Behavioral
Intervention Name(s)
Therapeutic + Lower Body Exercise
Intervention Description
A combined therapeutic exercise program (as per the comparison arm) plus the addition of lower body resistance exercise
Primary Outcome Measure Information:
Title
Functional Assessment of Cancer Therapy: Fatigue Scale Questionnaire
Description
Cancer related fatigue
Time Frame
change from baseline to 12 weeks.
Secondary Outcome Measure Information:
Title
Shoulder range of motion in degrees.
Description
Active and passive glenohumeral joint range of motion using standard 12 inch goniometer.
Time Frame
Change from baseline to one year
Title
Body mass index
Description
Derived from height and weight of the participant.
Time Frame
Change from baseline to 24 weeks.
Title
1 repetition maximum (1RM) strength for seated row in pounds.
Description
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.
Title
Neck Range of Motion in degrees.
Description
Measures of neck flexion, side flexion, rotations and extension using myrin goniometer.
Time Frame
Change from baseline to 12 weeks.
Title
Upper extremity muscular endurance: number of repetitions performed.
Description
Maximal repetitions to fatigue based on 50% of 1 repetition maximum strength for seated row.
Time Frame
baseline, 12-weeks, 24-weeks, one year
Title
Lower extremity flexibility in centimetres.
Description
Sit and reach test
Time Frame
Change from baseline to 12-weeks.
Title
Functional capacity
Description
6 minute walk test
Time Frame
Change from baseline to 24 weeks.
Title
Neck Dissection Impairment Index
Description
Neck dissection related quality of life
Time Frame
Change from baseline to one year.
Title
Grip strength in pounds.
Description
Maximal grip strength: composite score of both hands. Best of three attempts for each side.
Time Frame
Change from baseline to 12-weeks.
Title
1 repetition maximum leg press in pounds
Description
The maximal amount of weight that can be moved with proper
Time Frame
Change from baseline to 12 weeks.
Title
1 repetition maximum chest press in pounds.
Description
The maximal amount of weight that can be pushed with proper form.
Time Frame
Change from baseline to 12 weeks.
Title
30 second sit to stand (optional: in lieu of leg press)
Description
number of repetitions performed in 30 seconds
Time Frame
Change from baseline to 12 weeks.
Title
Functional Assessment of Cancer Therapy Questionnaire Trial Outcome Index
Description
The composite score of physical, functional and fatigue subscales of the questionnaire.
Time Frame
Baseline to 12-weeks.
Other Pre-specified Outcome Measures:
Title
Physical activity level in minutes per week (average over the previous one month period).
Description
Godin Leisure Time Questionnaire: minutes of mild, moderate and strenuous exercise.
Time Frame
Change in monthly average physical activity from baseline to one year.
Title
Cost of programming
Description
costs to programming, institution and participants
Time Frame
one year
Title
Exercise Adherence
Description
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.
Title
Functional Assessment of Cancer Therapy Fatigue Scale at one year.
Description
Cancer-related fatigue.
Time Frame
Change from baseline to 1 year.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Margaret L. McNeely, PhD
Organizational Affiliation
University of Alberta
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alberta/ Cross Cancer Institute
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2G4
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
No
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Therapeutic Resistance Group Exercise Training for Head & Neck Cancer Survivors
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