Feasibility and Effectiveness of a Virtual Group Fitness and Nutrition Intervention in Individuals With Psychosis: A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 4
- 主要终点
- Feasibility of lifestyle intervention
研究概览
简要总结
Individuals with schizophrenia spectrum disorder (SSD) often face unique barriers that limit the development of long-lasting lifestyle changes. In this study, The investigators will investigate the feasibility and impact of a novel lifestyle intervention in individuals with schizophrenia or schizoaffective disorder. The intervention will be composed of group fitness instruction and educational nutrition didactics that will be accessible to participants at-home through remote streaming. The fitness component will consist of weekly group fitness sessions delivered by a certified personal trainer over a virtual interface. The educational nutritional component of this intervention will involve interactive didactic sessions designed to improve knowledge of nutrition and positively change dietary behavior in this population.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Receiving outpatient psychiatric care for early-episode psychosis, schizophrenia, or schizoaffective disorder at Boston Medical Center or the Mass General Hospital
- •Proficient in English
- •Cleared by their primary care provider to perform 30 minutes of aerobic and strength exercise
排除标准
- •Documented history of one of the absolute contraindications to exercise defined in the "Exercise Standards for Testing and Training" by the American Heart Association in our electronic medical record which includes the following:
- •Acute myocardial infarction
- •Ongoing unstable angina
- •Uncontrolled cardiac arrhythmia with hemodynamic compromise
- •Endocarditis
- •Symptomatic severe aortic stenosis
- •Decompensated heart failure
- •Acute pulmonary embolism, pulmonary infarction, or deep vein thrombosis
- •Acute myocarditis or pericarditis
- •Acute aortic dissection
- •Inability to ambulate independently
结局指标
主要结局
Feasibility of lifestyle intervention
时间窗: 22 weeks
Feasibility of the lifestyle intervention will be assessed by the satisfaction level of participants which will be obtained from questions on an investigator developed questionnaire. Higher satisfaction levels will suggest greater feasibility.
Tolerability of group fitness classes
时间窗: 22 weeks
Individual attendance levels will be measured at weekly intervals during group fitness classes. Attendance will be calculated as the total number of attended groups divided by the total number of eligible groups to account for the late enrollment of individuals.
Tolerability of educational nutritional sessions
时间窗: 22 weeks
Individual attendance levels will be measured at weekly intervals during educational nutrition didactic sessions. Attendance will be calculated as the total number of attended groups divided by the total number of eligible groups to account for the late enrollment of individuals.
次要结局
- Change in weight(baseline, 22 weeks)
- Change in physical activity level(baseline, 22 weeks)
- Change in resting heart rate(baseline, 22 weeks)
- Change in self esteem(baseline, 22 weeks)
- Motivation to exercise(22 weeks)
- Change in psychological well being(baseline, 22 weeks)
- Change in psychotic episodes(baseline, 22 weeks)
- Change in nutritional knowledge(baseline, 22 weeks)
- Change in Hemoglobin A1c level (HbA1c)(baseline, 22 weeks)