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临床试验/NCT04144127
NCT04144127已完成不适用

A Soccer-based Lifestyle Intervention vs mHealth-based Physical Activity Intervention to Improve Bone Health and Metabolic Health in Prostate Cancer Survivors

Emory University2 个研究点 分布在 1 个国家目标入组 3 人开始时间: 2019年10月25日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
3
试验地点
2
主要终点
Lumbar Spine Bone Mineral Density (BMD)

研究概览

简要总结

This study seeks to directly test the implementation feasibility of a soccer-based and lifestyle education intervention to determine the effects on bone health, body composition, mental health, functional and cardiometabolic status among prostate cancer survivors.

详细描述

Prostate cancer (PCa) is the most common cancer in men in the U.S. and in other industrialized countries. The lifetime probability of PCa in males is one in nine, and it has a high economic burden, with costs expected to rise. Modern tailored treatment approaches, including androgen deprivation therapy (ADT), have resulted in longer life expectancy, but also longer treatment periods, which lead to significant adverse side effects. These often include decreased bone mineral density (BMD), increased risk of fractures, low functional capacity, loss of lean body mass (LBM), increased fat mass, insulin resistance, psychological distress and pain. Of particular concern is a sharp decline in bone health, with systemic bone loss caused by PCa-produced osteoclastogenic cytokines and drug interventions. Independent of disease stage, fractures in PCa patients are predictors of survival. In addition, concomitant physical inactivity and stress during and after treatment predispose PCa patients to elevated risk of deconditioning, BMD loss, cardiovascular and metabolic disease morbidity and mortality.

Exercise-based lifestyle interventions aimed at counteracting treatment-induced adverse effects have been shown to be safe and effective in improving bone, functional and cardiometabolic health for patients with PCa. However, men, in general, are harder to engage in physical activity (PA) and lifestyle interventions. As an alternative to traditional exercise programs, recreational team sports provide a unique environment that may lead to increased physical activity participation and motivation to engage in other lifestyle changes. More than any other sport, recreational soccer (RS) has been shown to be a successful health intervention in patients with, or at risk of chronic diseases, including PCa.

Leveraging the growing enthusiasm around soccer in Atlanta and the U.S. may lead to increased interest, participation, retention and engagement in lifestyle change programming among PCa survivors. Therefore, this study seeks to directly test the implementation feasibility of a soccer-based lifestyle change intervention to determine the effect on bone health, body composition, mental health, functional and cardiometabolic status among PCa survivors.

Participants will be offered an intensive intervention including RS programming and lifestyle education. The group will receive RS, consisting of conditioning drills and games, adapted to the population during 60-minute sessions twice per week. The researchers will evaluate health outcomes at baseline and after 3 months of the intervention.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 79 Years(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • men aged 18-79 years
  • PCa survivors that had at least 6 months of hormone therapy (i.e. ADT with testosterone lowering agents) within the past 10 years
  • not engaged in soccer practice or other exercise or lifestyle intervention program for the past 12 months
  • availability of smartphone to receive text messages
  • treating Oncologist clearance
  • ability to read in English or Spanish and provide informed consent

排除标准

  • BMI > 40 kg/m^2
  • resting BP ≥170/100 at screening or uncontrolled hypertension
  • any mobility issues or exercise program contraindications
  • a recent (i.e., within 12 months) myocardial infarction, diagnosis of congestive heart disease, other active cancer
  • bone or organ metastases
  • chemotherapy within past 6 months
  • therapies and diseases of bone unrelated to PCa e.g. systemic glucocorticoids, bisphosphonates, teriparatide, denosumab, osteomalacia; osteosarcoma; Paget's disease; systemic lupus erythematosus; inflammatory bowel diseases, rheumatoid arthritis; thyroid/parathyroid disorder or mental illness
  • not coronavirus disease 2019 (COVID-19) vaccinated

结局指标

主要结局

Lumbar Spine Bone Mineral Density (BMD)

时间窗: Baseline, 3 months post-intervention

Bone mineral density will be measured by dual x-ray absorptiometry (DXA) scan at the lumbar spine (L2-L4). Decreased BMD a is associated with an increased risk of fractures.

次要结局

  • Total Hip BMD(Baseline, 3 months post-intervention)
  • Osteocalcin Level(Baseline, 3 months post-intervention)
  • C-terminal Telopeptide of Collagen (CTx)(Baseline, 3 months post-intervention)
  • Weight(Baseline, 3 months post-intervention)
  • Body Mass Index (BMI)(Baseline, 3 months post-intervention)
  • Waist Circumference(Baseline, 3 months post-intervention)
  • Lean Body Mass(Baseline, 3 months post-intervention)
  • Resting Heart Rate(Baseline, 3 months post-intervention)
  • Behavioral Regulation in Exercise Questionnaire-2 (BREQ-2) Score(Baseline, 3 months post-intervention)
  • Dietary Intake(Baseline, 3 months post-intervention)
  • Percentage of Body Fat(Baseline, 3 months post-intervention)
  • Systolic Blood Pressure(Baseline, 3 months post-intervention)
  • Diastolic Blood Pressure(Baseline, 3 months post-intervention)
  • Aerobic Capacity(Baseline, 3 months post-intervention)
  • Muscle Strength(Baseline, 3 months post-intervention)
  • Number of Participants Smoking Cigarettes(Baseline, 3 months post-intervention)
  • Sleep Time(Baseline, 3 months post-intervention)
  • Alcohol Habits(Baseline, 3 months post-intervention)
  • Weekly Steps(Baseline, 3 months post-intervention)
  • SF-12 Health Survey Score(Baseline, 3 months post-intervention)
  • Center for Epidemiologic Studies Depression Scale (CESD) Score(Baseline, 3 months post-intervention)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Roberto Felipe Lobelo

Associate Professor

Emory University

研究点 (2)

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