Clinical Trials Directory

Trials / Completed

CompletedNCT04554667

Heavy Lifting Strength Training in Head and Neck Cancer Survivors

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

Status
Completed
Phase
Phase 1
Study type
Interventional
Enrollment
9 (actual)
Sponsor
University of Alberta · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

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.

Detailed 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.

Conditions

Interventions

TypeNameDescription
BEHAVIORALExercise InterventionHeavy Lifting Strength Training

Timeline

Start date
2020-11-24
Primary completion
2022-07-31
Completion
2022-07-31
First posted
2020-09-18
Last updated
2022-09-06

Locations

1 site across 1 country: Canada

Source: ClinicalTrials.gov record NCT04554667. Inclusion in this directory is not an endorsement.