Heavy Strength Training in Head and Neck Cancer Survivors
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Experimental.
- Who it may be relevant to
- Registry conditions: Head and Neck Neoplasms, Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma, Head and Neck Carcinoma. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Canada
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Feasibility and Preliminary Efficacy of Heavy Lifting Strength Training Versus Usual Care in Head and Neck Cancer Survivors: A Randomized Controlled Trial
Overview
Despite improvements in treatments, head and neck cancer survivors (HNCS) still endure acute and chronic side effects such as loss of muscular strength, limitations in physical functioning, fatigue, and swallowing difficulties that impact quality of life (QoL) and limit return to work. Light-to-moderate intensity strength training (LMST) has been shown to improve some side effects. Heavy lifting strength training (HLST) may further improve outcomes in some populations, however, only one small pilot study has focused on HNCS. The LIFTING 2 trial will be the first to examine the feasibility and effects of a HLST program versus no exercise in HNCS.
Detailed description
1. Background and Rationale
Despite improvements in treatments, head and neck cancer survivors (HNCS) still endure acute and chronic side effects such as loss of muscular strength, limitations in physical functioning, fatigue, and swallowing difficulties that impact quality of life (QoL) and limit return to work. Light-to-moderate intensity strength training (LMST) has been shown to improve some side effects. Heavy lifting strength training (HLST) may further improve outcomes in some populations, however, only one small pilot study has focused on HNCS. 2. Research Question \& Objectives
The primary aim of the proposed study is to further establish the feasibility of HLST in HNCS which will be based on the eligibility rate, recruitment rate, one-repetition max (3RM) testing rate, HLST program adherence, and follow-up assessment rate. A secondary aim is to provide preliminary evidence of the effects of a HLST program compared to usual care (UC) in HNCS. The primary efficacy outcome will be upper and lower muscular strength assessed by reliable 3-repetition maximum (3RM) tests on the chest press and leg press machines. Secondary efficacy outcomes include physical function, handgrip strength, body composition, QoL, fear of cancer recurrence, symptom burden, pain, anxiety, fatigue, stress, self-esteem, shoulder mobility, sleep, malnutrition status, and swallowing abilities. 3. Methods
This single-centre, two-armed, randomized controlled trial will recruit 60 HNCS ≥1-year posttreatment, and randomly assign them to the HLST group or UC group. For the HLST group, the 12-week exercise intervention will include supervised training 2 days per week. The HLST group will progress to lifting low repetitions of heavy loads at 80-90% of one repetition maximum (1RM), whereas the UC group will not receive any exercise prescription or instruction during the 12-week intervention, but will be offered a 4-week introduction to HLST program and/or referred to a community-based program after the postintervention assessments are complete. Assessments for both groups will occur at baseline and postintervention and include reliable 3RM strength tests, bioelectrical impedance analysis (BIA), Senior's Fitness Test, and validated QoL questionnaires.
Interventions
- Other Experimental
Three primary exercises will be included in the exercise sessions for participants randomized to this group: barbell back squat, bench press, and dead lift The weight will be progressively increased overtime based on participants' perceived exertion and repetitions in reserve. Number of repetitions performed for each exercise will begin at 10 repetitions in weeks 1-2, with gradual progression to lifting heavier loads of 3-5 sets of 1-5 repetitions between weeks 6-12.
Primary outcome measures
- Recruitment rate [Time frame: Baseline, postintervention (12 weeks), and monitored throughout 12 week study period]
- Adherence to a heavy lifting strength training program [Time frame: Baseline, postintervention (12 weeks), and monitored throughout 12 week study period]
- Completion of maximal strength testing [Time frame: Baseline and postintervention (12 weeks)]
- Followup assessment rate [Time frame: Postintervention (12 weeks)]
- Safety [Time frame: Baseline, postintervention (12 weeks), and monitored throughout 12 week study period]
Secondary outcome measures (12)
- Muscular Strength [Time frame: Baseline and Postintervention (12 weeks)]
- Cancer Specific Quality of Life [Time frame: Baseline and Postintervention (12 weeks)]
- Fear of Cancer Recurrence [Time frame: Baseline and Postintervention (12 weeks)]
- Symptom Burden [Time frame: Baseline and Postintervention (12 weeks)]
- Perceived Stress [Time frame: Baseline and Postintervention (12 weeks)]
- Self-Esteem [Time frame: Baseline and Postintervention (12 weeks)]
- Sleep Habits [Time frame: Baseline and Postintervention (12 weeks)]
- Malnutrition Status [Time frame: Baseline and Postintervention (12 weeks)]
- Swallowing Abilities [Time frame: Baseline and Postintervention (12 weeks)]
- Shoulder Range of Motion [Time frame: Baseline and Postintervention (12 weeks)]
- Body composition [Time frame: Baseline and Postintervention (12 weeks)]
- Handgrip Strength [Time frame: Baseline and Postintervention (12 weeks)]
Eligibility criteria
Inclusion criteria
- males and females, 18 years of age and older
- any head and neck cancer subtype, stage, and treatment type
- at least 1-year posttreatment with adequate shoulder range of motion (must meet minimum cutpoints for active flexion and abduction to be eligible)
- no unmanaged medical conditions, alcohol, or drug abuse
- approved for exercise by oncologist and a certified exercise physiologist or kinesiologist
- ability to understand and communicate in English
Exclusion criteria
- has met the Canadian Physical Activity strength training guidelines within the past one-month: at least two days per week of muscle and bone strength training activities using major muscle groups
- currently involved in a different exercise trial or clinical drug trial
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Other
Study locations
Canada · 1 center
- University of Alberta — Edmonton
Identifiers
NCT: NCT06289049 · HREBA.CC-24-0021