Validation and Impact of Cardiorespiratory Fitness in Severe Mental Illness - the Heart in Mind Project
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 75
- 试验地点
- 2
- 主要终点
- Validation of the revised Ekblom-Bak submaximal cycle-ergometer fitness test
研究概览
简要总结
This project aims to evaluate feasibility, validity and clinically applicability to systematically measure fitness in patients with severe mental illness.
The research project is a validation study using a cross-sectional design. The project will include 50 people with severe mental illness and 25 healthy controls without present or previous mental illness. The protocol includes a baseline visit where three different ways of measure fitness will be carried out, and a 14-day period of physical activity monitoring.
详细描述
BACKGROUND Cardiorespiratory fitness (CRF) is a strong independent predictor of cardiovascular disease (CVD) and all-cause mortality in the general population. However, CRF is rarely considered or measured in psychiatric populations, despite people with severe mental illness (SMI) is a high-risk population of CVD and may suffer from premature death of up to 15-20 years.
AIM The aim of this project is to evaluate the feasibility, validity, and clinical relevance of CRF assessment in patients with SMI.
POPULATION 50 people with severe mental illness in treatment with antipsychotic medications and 25 healthy controls without present or previous mental illness matched for sex, age, and BMI will be included in the study.
METHODS This is a validation study with a cross-sectional design. The study includes a ~3 hour baseline visit and 14 days of physical activity monitoring.
Baseline Visit (D0) Physical health, body composition, vital signs, and non-exercise VO2max estimation by seismocardiography (SCG) will be carried out initially. Afterwards, psychopathology, substance use, and cognition will be assessed during an interview. Questionnaires regarding physical activity, fitness, quality of life, body image and self-esteem, and sleep will be completed by the participants.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •18-45 years
- •Diagnosis within schizophrenia spectrum or affective disorders (i.e. F2.x or F3.x according to ICD-10 classification)
- •current antipsychotic treatment for more than one month on a regular daily dose
- •Able to give informed consent.
排除标准
- •Clinical or laboratory evidence of uncompensated medical disease
- •Unstable psychiatric disorder
- •Acute suicidal risk
- •Planned hospitalization within the study period.
研究组 & 干预措施
Patients
Adults with severe mental illness in treatment with antipsychotic medications
Healthy controls
Adults without present or previous mental illness, and no first-degree relatives with present or previous mental illness, matched to the patient group for gender, age, and BMI.
结局指标
主要结局
Validation of the revised Ekblom-Bak submaximal cycle-ergometer fitness test
时间窗: At baseline visit (D0)
The revised Ekblom-Bak submaximal cycle-ergometer fitness test (EBsub) will be carried out to estimate VO2max and validated against measured VO2max during a cardiopulmonary exercise test (CPET) including calculation of coefficient variation, limits of agreement, mean absolute percentage error, linear regression analyses for obtaining R-squared values and standard errors of the estimate, and Bland-Altman plotting. VO2max will be assessed during an incremental cycle protocol until exhaustion conforming to the state-of-the-art CPET. Oxygen consumption and carbon dioxide excretion rates will be measured using a "breath-by-breath" analysing system coupled to a fitted silicone mask, strapped around the participants head, covering nose and mouth (Vyntus CPX, Jaeger). VO2max will be defined as the average of the three highest oxygen consumption measurements. VO2max will be estimated with the EBsub conforming to the developing authors guidelines.
Estimated VO2max
时间窗: At baseline visit (D0)
The revised Ekblom-Bak submaximal cycle-ergometer fitness test (EBsub) will be carried out to estimate VO2max and validated against measured VO2max during a cardiopulmonary exercise test (CPET) including calculation of coefficient variation, limits of agreement, mean absolute percentage error, linear regression analyses for obtaining R-squared values and standard errors of the estimate, and Bland-Altman plotting. VO2max will be assessed during an incremental cycle protocol until exhaustion conforming to the state-of-the-art CPET. Oxygen consumption and carbon dioxide excretion rates will be measured using a "breath-by-breath" analysing system coupled to a fitted silicone mask, strapped around the participants head, covering nose and mouth (Vyntus CPX, Jaeger). VO2max will be defined as the average of the three highest oxygen consumption measurements. VO2max will be estimated with the EBsub conforming to the developing authors guidelines.
次要结局
- Validation of non-exercise VO2max estimation by seismocardiography(At baseline visit (D0))
- Non-exercise estimated VO2max(At baseline visit (D0))
研究者
Bjorn H. Ebdrup
Professor and consultant psychiatrist
University of Copenhagen