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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.
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.
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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Exercise Group | Experimental | 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. |
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| Usual Care Group | No Intervention | 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 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Experimental | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Recruitment rate | Recruitment range: 40 to 60 participants; Higher=better and more available data | Baseline, postintervention (12 weeks), and monitored throughout 12 week study period |
| Adherence to a heavy lifting strength training program | Adherence rate: 0 to 100 percent of exercise sessions; Higher=better | Baseline, postintervention (12 weeks), and monitored throughout 12 week study period |
| Completion of maximal strength testing | 3 repetition maximum testing rate: 0 to 100 percent; Higher=better | Baseline and postintervention (12 weeks) |
| Followup assessment rate | Followup assessment rate: 0 to 100 percent; Higher=better | Postintervention (12 weeks) |
| Safety | Adverse events: minimum: no adverse events, maximum: no maximum. Higher=worse | Baseline, postintervention (12 weeks), and monitored throughout 12 week study period |
| Measure | Description | Time Frame |
|---|---|---|
| Muscular Strength | Assessed via 3 repetition maximum tests on the chest press and leg press machines Minimum: 0 kilograms, Maximum: none. Higher score=better strength | Baseline and Postintervention (12 weeks) |
| Cancer Specific Quality of Life |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Stephanie Ntoukas | Contact | 7804922829 | ntoukas@ualberta.ca |
| Name | Affiliation | Role |
|---|---|---|
| Kerry Courneya | University of Alberta | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alberta | Recruiting | Edmonton | Alberta | Canada |
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| ID | Term |
|---|---|
| D006258 | Head and Neck Neoplasms |
| D000077195 | Squamous Cell Carcinoma of Head and Neck |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D002294 | Carcinoma, Squamous Cell |
| D002277 | Carcinoma |
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Participants and investigators will not be blinded to group assignment given the nature of the intervention.
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Assessed via cancer specific European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire
Minimum: 0 points, Maximum: 100 points. Higher score=better quality of life
| Baseline and Postintervention (12 weeks) |
| Fear of Cancer Recurrence | Assessed via the Fear of Cancer Recurrence Inventory - Short Form Minimum: 0 points, Maximum: 36 points. Higher score=worse fear of cancer recurrence | Baseline and Postintervention (12 weeks) |
| Symptom Burden | Assessed via the revised Edmonton Symptom Assessment System Minimum: 0 points, Maximum: 100 points. Higher score=worse cancer symptoms | Baseline and Postintervention (12 weeks) |
| Perceived Stress | Assessed via the Perceived Stress Scale Minimum: 0 points, Maximum: 56 points. Higher score=worse perceived stress | Baseline and Postintervention (12 weeks) |
| Self-Esteem | Assessed via the Rosenberg Self-Esteem Scale Minimum: 10 points, Maximum: 40 points. Higher score=better self-esteem | Baseline and Postintervention (12 weeks) |
| Sleep Habits | Assessed via the Insomnia Severity Index Minimum: 0 points, Maximum: 28 points. Higher score=worse insomnia | Baseline and Postintervention (12 weeks) |
| Malnutrition Status | Assessed via the Patient Generated Subjective Global Assessment with reference to the Global Leadership Initiative on Malnutrition Minimum: 0 points, Maximum: 36 points. Higher score=worse, high risk of malnutrition 0-1 points: no intervention required at this time. Re-assessment on routine and regular basis during treatment. 2-3 points: patient & family education by dietitian, nurse, or other clinician with pharmacologic intervention as indicated by symptom survey and lab values as appropriate 4-8 points: requires intervention by dietitian, in conjunction with nurse or physician as indicated by symptoms ≥ 9 points: indicates a critical need for improved symptom management and/or nutrient intervention options | Baseline and Postintervention (12 weeks) |
| Swallowing Abilities | Assessed via the MD Anderson Dysphagia Inventory Minimum: 20 points, Maximum: 100 points. Higher score=better swallowing ability | Baseline and Postintervention (12 weeks) |
| Shoulder Range of Motion | Assessed via seated active flexion and abduction using a goniometer Minimum: 150 degrees (18-50 years); 130 degrees (over 50 years), Maximum: none Higher score=better shoulder mobility | Baseline and Postintervention (12 weeks) |
| Body composition | Assessed via bioelectrical impedance analysis (InBody 770) Minimum: none, Maximum: none. Higher score=variable Higher fat free mass score=better Higher fat mass score=worse | Baseline and Postintervention (12 weeks) |
| Handgrip Strength | Assessed via held held dynamometer Minimum: 0 kilograms, Maximum: none. Higher score=better hand grip strength | Baseline and Postintervention (12 weeks) |
| Physical Function | Assessed via the six minute walk test Minimum: 0 metres, Maximum: none. Higher score=better physical function | Baseline and Postintervention (12 weeks) |
| D009375 |
| Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D001519 | Behavior |