Heavy Lifting Strength Training in Head and Neck Cancer Survivors

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

9 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-11-24

Study Completion Date

2022-07-31

Brief Summary

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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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Detailed Description

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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.

Conditions

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Cancer of Head and Neck

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Single arm, safety and feasibility trial.

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Exercise Intervention

Single exercise arm

Group Type EXPERIMENTAL

Exercise Intervention

Intervention Type BEHAVIORAL

Heavy Lifting Strength Training

Interventions

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Exercise Intervention

Heavy Lifting Strength Training

Intervention Type BEHAVIORAL

Eligibility Criteria

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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