The Impact of Inspiratory Muscle Strength Training and Personalized Exercise Prescription on Metabolism, Cardiovascular Function, and Cardiorespiratory Fitness in Lymphoma Survivors
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 1
- 试验地点
- 4
- 主要终点
- Session Attendance per Participant
研究概览
简要总结
High-resistance inspiratory muscle strength training (IMST) is a time-efficient (~5 minutes/day) form of exercise that employs an affordable, handheld device which impedes inspiratory breathing to train the diaphragm and accessory respiratory muscles and has demonstrated improvements in both cardiovascular health (9 mmHg reduction in systolic blood pressure, 45% improvement in vascular endothelial function) and improve exercise tolerance (12% increase in treadmill exercise time) in generally healthy midlife/older adults. Therefore, this approach may circumvent preventative hurdles to exercise, and augment the effects of exercise for capable survivors.
详细描述
Cancer survivorship has been steadily improving as a result of earlier detection and improved therapies. Behind cancer recurrence, the primary cause of morbidity and mortality among survivors stems from the onset of cardiovascular disease that arises in part due to cardiotoxic chemo and radiation therapies. The increased risk of cardiovascular disease is particularly high in specific survivor populations, such as lymphoma survivors. Although exercise has been demonstrated to improve both recovery after cancer therapy and quality of life, both physical and logistical hurdles may prohibit certain patients from accessing this intervention. High-resistance inspiratory muscle strength training (IMST) is a time-efficient (~5 minutes/day) form of exercise that employs an affordable, handheld device which impedes inspiratory breathing to train the diaphragm and accessory respiratory muscles and has demonstrated improvements in both cardiovascular health (9 mmHg reduction in systolic blood pressure, 45% improvement in vascular endothelial function) and improve exercise tolerance (12% increase in treadmill exercise time) in generally healthy midlife/older adults. Therefore, this approach may circumvent preventative hurdles to exercise, and augment the effects of exercise for capable survivors.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Single (Care Provider)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 - 80
- •Primary cancer diagnosis of lymphoma
- •Able and willing to participate in a supervised exercise program at the Anschutz Health and Wellness Center
- •Provides a signed physician exercise clearance form
- •SBP > 120 mmHg
- •Completion of curative cancer treatment over 12 months prior (individuals on maintenance therapy will be included)
- •Possession of a smartphone compatible with the IMST training application (available on both Android and Apple).
排除标准
- •oSecond active cancer diagnosis
- •oPlanned active cancer treatment or change in current treatment in the next 6 months
- •Severe obesity (BMI >; 40 kg/m2) or underweight (BMI <18.5 kg/m2)
- •Unstable weight (>; 3 kg change in body mass in last 3 months)
- •Significant metabolic disorder (e.g. diabetes type II)
- •Uncontrolled thyroid disease
- •Recent changes in hypertensive medication (within last 3 months)
- •Any medical condition that would impact the safety of, or participation in, an exercise program, including:
- •Significant pulmonary conditions such as chronic obstructive pulmonary disease, emphysema, or interstitial lung disease
- •Known cardiovascular disease, significant hypertension (>180/120), or a recent cardiac event (within past 6 months)
- •Orthopedic conditions such as advanced osteoarthritis, mobility-limiting amputations or chronic injuries, or mobility-limiting acute orthopedic injuries
- •Advanced rheumatoid arthritis or chronic widespread pain conditions such as fibromyalgia
结局指标
主要结局
Session Attendance per Participant
时间窗: 5 months
Adherence to 75% of the program will be deemed acceptable
Total Participants Recruited
时间窗: 2 years
Count of number of participants recruited into the study
Total Participants Completing the Intervention
时间窗: 2 years
Adherence to 75% of the program will be deemed acceptable
Valid Assessments per Participant
时间窗: 5 months
Adherence to 75% of the program will be deemed acceptable
Enrolled Participants per Month
时间窗: 2 years
Average number of participants enrolled per month of the study
Systolic Blood Pressure
时间窗: 5 months
Resting systolic blood pressure, collected in triplicate
次要结局
- Cardiorespiratory Fitness (CRF) will be assessed via estimated VO2max(5 months)
- Godin Leisure Time Physical Activity Questionnaire(5 months)
- Molecular Markers - Acetylcholine-stimulated basal reactive oxygen species production(5 months)
- Metabolomics analyses will be performed on blood samples(5 months)
- Hospital Anxiety and Depression Scale (HADS)(5 months)
- Molecular Markers - Acetylcholine-stimulated production of nitric oxide(5 months)
- Physical function primarily assessed by the 6MWT(5 months)
- Functional Assessment of Cancer Therapy - General (FACT-G, assessing quality of life)(5 months)
- Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue)(5 months)
- Cardiac risk factors will be collected from medical history forms(5 months)