Heavy Strength Training in Head and Neck Cancer Survivors
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Experimental.
- Кому может быть актуально
- Состояния в реестре: Head and Neck Neoplasms, Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma, Head and Neck Carcinoma. Базовые параметры: от 18 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Канада
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Не всё понятно в терминах? Прочитайте наш гид для пациентов →
Официальное название
Feasibility and Preliminary Efficacy of Heavy Lifting Strength Training Versus Usual Care in Head and Neck Cancer Survivors: A Randomized Controlled Trial
Обзор
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.
Подробное описание
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.
Вмешательства
- Другое 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.
Первичные конечные точки
- Recruitment rate [Срок оценки: Baseline, postintervention (12 weeks), and monitored throughout 12 week study period]
- Adherence to a heavy lifting strength training program [Срок оценки: Baseline, postintervention (12 weeks), and monitored throughout 12 week study period]
- Completion of maximal strength testing [Срок оценки: Baseline and postintervention (12 weeks)]
- Followup assessment rate [Срок оценки: Postintervention (12 weeks)]
- Safety [Срок оценки: Baseline, postintervention (12 weeks), and monitored throughout 12 week study period]
Вторичные конечные точки (12)
- Muscular Strength [Срок оценки: Baseline and Postintervention (12 weeks)]
- Cancer Specific Quality of Life [Срок оценки: Baseline and Postintervention (12 weeks)]
- Fear of Cancer Recurrence [Срок оценки: Baseline and Postintervention (12 weeks)]
- Symptom Burden [Срок оценки: Baseline and Postintervention (12 weeks)]
- Perceived Stress [Срок оценки: Baseline and Postintervention (12 weeks)]
- Self-Esteem [Срок оценки: Baseline and Postintervention (12 weeks)]
- Sleep Habits [Срок оценки: Baseline and Postintervention (12 weeks)]
- Malnutrition Status [Срок оценки: Baseline and Postintervention (12 weeks)]
- Swallowing Abilities [Срок оценки: Baseline and Postintervention (12 weeks)]
- Shoulder Range of Motion [Срок оценки: Baseline and Postintervention (12 weeks)]
- Body composition [Срок оценки: Baseline and Postintervention (12 weeks)]
- Handgrip Strength [Срок оценки: Baseline and Postintervention (12 weeks)]
Критерии участия
Критерии включения
- 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
Критерии исключения
- 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
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Параллельные группы
- Маскирование
- Открытое
- Основная цель
- Другое
Центры проведения
Канада · 1 центр
- University of Alberta — Edmonton
Идентификаторы
NCT: NCT06289049 · HREBA.CC-24-0021