Therapeutic Resistance Group Exercise Training for Head & Neck Cancer Survivors

NCT02647021 | Completed

• 1 other identifier: HREBA.CC.15-0167
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Head and Neck Neoplasms; Accessory Nerve Injury; Fatigue

Keywords

physical therapy; cancer rehabilitation; exercise

Outcome Measures

Primary Outcomes (1)

• Functional Assessment of Cancer Therapy: Fatigue Scale Questionnaire

  Cancer related fatigue

  change from baseline to 12 weeks.

Secondary Outcomes (13)

• Shoulder range of motion in degrees.

  Change from baseline to one year

• Body mass index

  Change from baseline to 24 weeks.

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

  Change from baseline to 12 weeks.

• Neck Range of Motion in degrees.

  Change from baseline to 12 weeks.

• Upper extremity muscular endurance: number of repetitions performed.

  baseline, 12-weeks, 24-weeks, one year

Other Outcomes (4)

• Physical activity level in minutes per week (average over the previous one month period).

  Change in monthly average physical activity from baseline to one year.

• Cost of programming

  one year

• Exercise Adherence

  Change from baseline to 1 year.

Study Arms (2)

Therapeutic Exercise

ACTIVE COMPARATOR

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

Therapeutic + Lower Body Exercise

EXPERIMENTAL

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; Behavioral: Therapeutic + Lower Body Exercise

Interventions

Therapeutic Exercise BEHAVIORAL

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

Therapeutic + Lower Body Exercise; Therapeutic Exercise

Therapeutic + Lower Body Exercise BEHAVIORAL

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

Therapeutic + Lower Body Exercise

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Alberta: lead
• Cross Cancer Institute: collaborator

Study Sites (1)

University of Alberta/ Cross Cancer Institute

Edmonton, Alberta, T6G 2G4, Canada

Location

MeSH Terms

Conditions

Head and Neck Neoplasms; Accessory Nerve Injuries; Fatigue; Motor Activity

Interventions

Exercise Therapy; Therapeutics

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Accessory Nerve Diseases; Cranial Nerve Diseases; Nervous System Diseases; Cranial Nerve Injuries; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Physical Therapy Modalities

Study Officials

• Margaret L. McNeely, PhD

  University of Alberta

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: December 28, 2015
• First Posted: January 6, 2016
• Study Start: March 31, 2016
• Primary Completion: March 15, 2020
• Study Completion: March 30, 2020
• Last Updated: January 3, 2024

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)