Therapeutic Resistance Group Exercise Training for Head & Neck Cancer Survivors

Fatigue Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02647021
• Other study ID #: HREBA.CC.15-0167
• Status: Completed
• Phase: N/A
• Start date: March 31, 2016
• Est. completion date: March 30, 2020

Study information

• Verified date: December 2023
• Source: University of Alberta
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: March 30, 2020
• Est. primary completion date: March 15, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 OR radiation therapy to lymph node regions

• Presenting with shoulder and/ or neck dysfunction related to cancer treatment

• 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.

Related Conditions & MeSH terms

• Accessory Nerve Injuries
• Accessory Nerve Injury
• Fatigue
• Head and Neck Neoplasms

Intervention

Behavioral:
• Therapeutic Exercise
A specialized therapeutic exercise program to address neck and shoulder dysfunction due to spinal accessory nerve damage.
• Therapeutic + Lower Body Exercise
A combined therapeutic exercise program (as per the comparison arm) plus the addition of lower body resistance exercise

Locations

Country	Name	City	State
Canada	University of Alberta/ Cross Cancer Institute	Edmonton	Alberta

Sponsors (2)

Lead Sponsor	Collaborator
University of Alberta	Cross Cancer Institute

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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.
Other	Cost of programming	costs to programming, institution and participants	one year
Other	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.
Other	Functional Assessment of Cancer Therapy Fatigue Scale at one year.	Cancer-related fatigue.	Change from baseline to 1 year.
Primary	Functional Assessment of Cancer Therapy: Fatigue Scale Questionnaire	Cancer related fatigue	change from baseline to 12 weeks.
Secondary	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
Secondary	Body mass index	Derived from height and weight of the participant.	Change from baseline to 24 weeks.
Secondary	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.
Secondary	Neck Range of Motion in degrees.	Measures of neck flexion, side flexion, rotations and extension using myrin goniometer.	Change from baseline to 12 weeks.
Secondary	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
Secondary	Lower extremity flexibility in centimetres.	Sit and reach test	Change from baseline to 12-weeks.
Secondary	Functional capacity	6 minute walk test	Change from baseline to 24 weeks.
Secondary	Neck Dissection Impairment Index	Neck dissection related quality of life	Change from baseline to one year.
Secondary	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.
Secondary	1 repetition maximum leg press in pounds	The maximal amount of weight that can be moved with proper	Change from baseline to 12 weeks.
Secondary	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.
Secondary	30 second sit to stand (optional: in lieu of leg press)	number of repetitions performed in 30 seconds	Change from baseline to 12 weeks.
Secondary	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.