Feasibility and Preliminary Efficacy of Heavy Lifting Strength Training Versus Usual Care in Head and Neck Cancer Survivors: A Randomized Controlled Trial
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- University of Alberta
- Enrollment
- 37
- Locations
- 1
- Primary Endpoint
- Followup assessment rate
Study Overview
Brief Summary
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
- 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- None
Masking Description
Participants and investigators will not be blinded to group assignment given the nature of the intervention.
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Exercise Group
The exercise intervention will consist of 24 supervised, heavy lifting strength training exercise sessions over a 12 week period. The exercise frequency will be two times per week. Main exercises will consist of barbell back squat, bench press, and dead lift.
Intervention: Experimental (Other)
Usual Care Group
Participants randomized to the usual care group will be asked to continue will their typical daily routine during the 12 week study period, and not begin any new exercise program to increase their exercise levels from baseline. They will not receive any information or education regarding exercise. After the postintervention assessments, participants in the usual care group will be offered a 4-week introduction to heavy lifting strength training program and/or referred to a community-based exercise program
Outcomes
Primary Outcomes
Followup assessment rate
Time Frame: Postintervention (12 weeks)
Followup assessment rate: 0 to 100 percent; Higher=better
Recruitment rate
Time Frame: Baseline, postintervention (12 weeks), and monitored throughout 12 week study period
Recruitment range: 40 to 60 participants; Higher=better and more available data
Adherence to a heavy lifting strength training program
Time Frame: Baseline, postintervention (12 weeks), and monitored throughout 12 week study period
Adherence rate: 0 to 100 percent of exercise sessions; Higher=better
Completion of maximal strength testing
Time Frame: Baseline and postintervention (12 weeks)
3 repetition maximum testing rate: 0 to 100 percent; Higher=better
Safety
Time Frame: Baseline, postintervention (12 weeks), and monitored throughout 12 week study period
Adverse events: minimum: no adverse events, maximum: no maximum. Higher=worse
Secondary Outcomes
- Handgrip Strength(Baseline and Postintervention (12 weeks))
- Cancer Specific Quality of Life(Baseline and Postintervention (12 weeks))
- Symptom Burden(Baseline and Postintervention (12 weeks))
- Muscular Strength(Baseline and Postintervention (12 weeks))
- Fear of Cancer Recurrence(Baseline and Postintervention (12 weeks))
- Perceived Stress(Baseline and Postintervention (12 weeks))
- Self-Esteem(Baseline and Postintervention (12 weeks))
- Sleep Habits(Baseline and Postintervention (12 weeks))
- Malnutrition Status(Baseline and Postintervention (12 weeks))
- Swallowing Abilities(Baseline and Postintervention (12 weeks))
- Shoulder Range of Motion(Baseline and Postintervention (12 weeks))
- Body composition(Baseline and Postintervention (12 weeks))
- Physical Function(Baseline and Postintervention (12 weeks))