Skip to main content
OpenTrials
Completed

NCT Number: NCT02647021

Therapeutic Resistance Group Exercise Training for Head & Neck Cancer Survivors

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Alberta/ Cross Cancer Institute

Edmonton, Alberta, T6G 2G4, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Therapeutic Exercise

Behavioral

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

Therapeutic + Lower Body Exercise

Behavioral

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

Primary outcomes

  1. Functional Assessment of Cancer Therapy: Fatigue Scale Questionnaire

    Time frame: change from baseline to 12 weeks.

    Cancer related fatigue

Secondary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of Alberta

Other

Collaborators

  • Cross Cancer Institute

Registry information

Official study title

Evaluating Outcomes From a Combined Supervised Therapeutic and Physical Exercise Program for Post-surgical Head and Neck Cancer Survivors: A Randomized Controlled Trial

Acronym: TARGET

Important dates

Study start
2016
Primary completion
2020
Study completion
2020
First posted
Jan 6, 2016
Registry last updated
Jan 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.