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Heavy Lifting Strength Training in Head and Neck Cancer Survivors (LIFTING)

U

University of Alberta

Status and phase

Completed
Phase 1

Conditions

Cancer of Head and Neck

Treatments

Behavioral: Exercise Intervention

Study type

Interventional

Funder types

Other

Identifiers

NCT04554667
20-0169

Details and patient eligibility

About

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.

Full description

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.

Enrollment

9 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Supportive Care

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

9 participants in 1 patient group

Exercise Intervention
Experimental group
Description:
Single exercise arm
Treatment:
Behavioral: Exercise Intervention

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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