Therapeutic Resistance Group Exercise Training for Head & Neck Cancer Survivors

University of Alberta60 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

SINGLE

Enrollment

Conditions

Head and Neck Neoplasms Accessory Nerve Injury Fatigue

Interventions

Therapeutic ExerciseBEHAVIORAL

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

Therapeutic + Lower Body ExerciseBEHAVIORAL

A combined therapeutic exercise program (as per the comparison arm) plus the addition of lower body resistance exercise

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

University of Alberta/ Cross Cancer Institute

Edmonton, Alberta, Canada

Outcomes

Primary Outcomes

Functional Assessment of Cancer Therapy: Fatigue Scale Questionnaire

Cancer related fatigue

Time frame: change from baseline to 12 weeks.

Secondary Outcomes

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

Data from ClinicalTrials.gov

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