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Completed

NCT Number: NCT04554667

Heavy Lifting Strength Training in Head and Neck Cancer Survivors

The LIFTING trial will examine the feasibility and safety of a heavy lifting strength training (HLST) program in head and neck cancer survivors (HNCS) at least 1 years post surgical neck dissection. The trial will determine whether this training style is safe and feasible in HNCS. Physical and psychosocial changes will also be reported.

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Key information

Conditions

Cancer of Head and Neck Behavior Head and Neck Neoplasms Motor Activity Neoplasms Neoplasms by Site

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

University of Alberta

Edmonton, Alberta, T6G 2H9, Canada

About this study

RATIONALE Despite improvements in treatments, HNCS still endure numerous acute and chronic side effects. Strength training has been shown to manage some of these side effects but most interventions have involved light-to-moderate resistance training programs. HLST may produce better outcomes but it is unknown if such a weight training program is feasible and safe for HNCS.

OBJECTIVE The primary aim of this proposed study is to examine the feasibility and safety of a HLST program in HNCS at least 1 year post-surgical neck dissection.

METHODS This single arm feasibility study will recruit 15-20 HNCS to complete the HLST program 2 times per week. The primary feasibility outcomes will include the eligibility rate (with reasons for ineligibility), recruitment rate (with reasons for refusal), 1 repetition maximum testing rate (with reasons for not completing the test), program adherence (including attendance, dose modifications, and progression), and follow-up assessment rate (with reasons for drop out). The primary efficacy outcome will be strength gains from baseline. Secondary efficacy outcomes will include physical functioning, quality of life, fear of cancer recurrence, pain, body composition, anxiety, fatigue, stress, shoulder mobility, self-esteem, sleep, and motivation to engage in a HLST program.

SIGNIFICANCE Weight training is an effective intervention in HNCS but the optimal weight training prescription is unknown. If heavy weight training is deemed safe and feasible in HNCS, it can be compared to light-to-moderate load weight training to determine if it is a better prescription for improving outcomes that are important to HNCS.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • previously diagnosed with any subtype and stage of head and neck cancer
  • at least one year post surgical neck dissection for head and neck cancer and showing full shoulder range of motion or recovery of the spinal accessory nerve
  • adults ages 18 and older
  • no unmanaged medical conditions, alcohol, and drug abuse
  • approved for a heavy lifting strength training program by the treating surgeon and a certified exercise physiologist
  • ability to understand and communicate in English

Exclusion criteria

  • having comorbidities or uncontrolled medical conditions that their referred clinicians indicate as inappropriate to participate in exercise

Treatment and study plan

Exercise Intervention

Behavioral

Heavy Lifting Strength Training

Primary outcomes

  1. Recruitment Rate

    Time frame: Over 12 weeks

    Recruitment rate (with reasons for refusal).

    Recruitment minimum: 15 participants Recruitment maximum: 20 participants Higher number= better and more data

  2. Muscular Strength

    Time frame: Changes from baseline to 12 weeks

    Change in muscular strength from baseline to postintervention with be assessed using maximal strength tests.

    Minimum: none Maximum: none Higher score= better strength

  3. Program Adherence

    Time frame: Over 12 weeks

    Program adherence minimum: 80% Program adherence maximum: 100% Higher score= better adherence

Secondary outcomes

  1. Physical functioning

    Time frame: Changes from baseline to 12 weeks

    Assessed using the Neck Dissection Impairment Index (NDII) and maximum strength tests.

    Minimum: 40 Maximum: 100 Higher score= worse impairment

  2. Fear of cancer recurrence

    Time frame: Changes from baseline to 12 weeks

    Assessed using the Fear of Cancer Recurrence Inventory (FCRI)

    Minimum: 0 Maximum: 36 Higher score= worse fear of cancer recurrence

  3. Post Traumatic Growth after cancer

    Time frame: Changes from baseline to 12 weeks

    How cancer has changed an individual's life will be assessed using the Post Traumatic Growth Inventory (PTGI)

    Minimum: 0 Maximum: 105 Higher score= better (positive) post traumatic growth transformation

  4. Waist to hip ratio (body composition)

    Time frame: Changes from baseline to 12 weeks

    Assessed using waist to hip ratio (WHR) measure.

    Minimum WHR: none Maximum WHR: none Higher score WHR= worse body composition

  5. Anxiety

    Time frame: Changes from baseline to 12 weeks

    Assessed using the Spielberger State Trait Anxiety Inventory (STAI)

    Minimum: 20 Maximum: 80 Higher score= worse anxiety

  6. Fatigue

    Time frame: Changes from baseline to 12 weeks

    Assessed using the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) questionnaire

    Minimum: 0 Maximum: 52 Higher score=worse fatigue

  7. Stress

    Time frame: Changes from baseline to 12 weeks

    Assessed using the Perceived Stress Scale (PSS)

    Minimum: 0 Maximum: 56 Higher score=worse perceived stress

  8. Shoulder Mobility

    Time frame: Changes from baseline to 12 weeks

    Changes in shoulder mobility

    Minimum: 150 degrees (18-50 years); 130 degrees (over 50 years) Maximum: none Higher score= better mobility

  9. Self-Esteem

    Time frame: Changes from baseline to 12 weeks

    Changes in level of self-esteem assessed using Rosenberg Self-Esteem (RSE) scale

    Minimum: 10 Maximum: 40 Higher score= better self-esteem

  10. Sleep

    Time frame: Changes from baseline to 12 weeks

    Changes in sleep patterns assessed using the insomnia severity index (ISI)

    Minimum: 0 Maximum: 28 Higher score= worse insomnia

  11. Motivation

    Time frame: Changes from baseline to 12 weeks

    Questions based on the theory of planned behaviour

    Minimum: 7 Maximum: 35 Higher score= better motivation

  12. Cancer specific quality of life

    Time frame: Changes from baseline to 12 weeks

    Assessed using the Functional Assessment of Cancer Therapy-Head and Neck (FACT-H&N Symptom Index)

    Minimum: 0 Maximum: 40 Higher score= worse head and neck cancer symptoms

  13. Cancer Symptom Burden

    Time frame: Changes from baseline to 12 weeks

    Assessed using the revised Edmonton Symptom Assessment System (ESAS-r)

    Minimum: 0 Maximum: 100 Higher score= worse cancer symptoms

  14. Height

    Time frame: Changes from baseline to 12 weeks

    Assessed using standing height without shoes.

    Minimum height: none Maximum height: none Taller: not specifically better or worse

  15. Weight

    Time frame: Changes from baseline to 12 weeks

    Assessed using a digital scale without shoes.

    Minimum weight: none Maximum weight: none Higher weight: typically worse, but depends on other factors (ie. height, muscle mass, overall health status)

Sponsors and collaborators

Lead sponsor

University of Alberta

Other

Registry information

Official study title

Feasibility and Safety of Heavy Lifting Strength Training in Head and Neck Cancer Survivors Post-Surgical Neck Dissection

Acronym: LIFTING

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Sep 18, 2020
Registry last updated
Sep 6, 2022

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.

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