Feasibility, Adherence and Effects of Two Exercise-based Interventions in Adults With Severe Mental Illness. The PsychiActive Project 2.0
概览
- 阶段
- 不适用
- 干预措施
- 未指定
- 疾病 / 适应症
- Exercise Therapy
- 发起方
- Universidad Pablo de Olavide
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Lean mass
- 最后更新
- 6年前
概览
简要总结
The purpose of this randomized controlled trial is to study the feasibility, adherence and effects of two exercise interventions on body weight, body composition, anthropometric and fasting blood measures, physical fitness, quality of life, and lifestyle habits in patients with severe mental illness.
研究者
Alvaro López Moral
MSc Sport Sciences
Universidad Pablo de Olavide
入排标准
入选标准
- •Clinical diagnosis of psychiatric disorder (ICD-10).
- •Stabilized antipsychotic medication during the last month.
排除标准
- •Clinical instability.
- •Substance abuse.
- •Comorbidities contraindicating.
结局指标
主要结局
Lean mass
时间窗: 12 weeks
In kilograms. Using the InBody 770 Body Composition Analyzer (Biospace Ltd, Seoul, Korea)
Self-reported sedentary behavior
时间窗: 12 weeks
In hours per week. Using the Sedentary Behaviour Questionnaire. It asks about amount of time spent doing 11 sedentary behaviours of a usual weekday and weekend day. Time in hours of each behaviour were summed separately for weekdays and weekend days, and time for an average day was calculated as (weekday hours ×5 +weekend day hours × 2)/7. Higher values represent a higher level of sedentary behavior.
Behavioral Regulation in Exercise
时间窗: 12 weeks
Using the Behavioral Regulation in Exercise Questionnaire. It consists of 24 items1 with a five-point Likert scale, which varied between 1 ("Strongly Disagree") and 4 ("Strongly Agree"). The items were grouped posteriorly into six factors (with four items each). Higher values represent a higher level of motivational continuum of self-determination theory.
Body weight
时间窗: 12 weeks
In kilograms. Using the InBody 770 Body Composition Analyzer (Biospace Ltd, Seoul, Korea)
Waist circumference
时间窗: 12 weeks
In millimeters. Using a measuring tape (Harpenden Anthropometric Tape; Holtain, Dyfed, UK) placed at the midpoint between the last rib and the iliac crest
Self-reported physical activity
时间窗: 12 weeks
In metabolic equivalent minutes per week. Using the Simple Physical Activity Questionnaire. Higher values represent a higher level of physical activity.
Adherence
时间窗: 12 weeks
In percent. Adherence will be evaluated by the percentage of attendance with respect to the total number of minutes of intervention.
Hip circumference
时间窗: 12 weeks
In millimeters. Using a measuring tape (Harpenden Anthropometric Tape; Holtain, Dyfed, UK) placed atthe maximum width over the greater trochanters
Quality of Life
时间窗: 12 weeks
Using the European Quality of Life-5 Dimensions Questionnaire.The descriptive system contains five dimensions of health (mobility, personal care, daily activities, pain / discomfort and anxiety / depression) and each of them has three levels of severity (no problems, some moderate or severe problems and problems). Scores range from 0 to 1 point, with higher scores indicating better quality of life.
Self-Reported Physical Fitness
时间窗: 12 weeks
Using "The International Fitness Scale" (IFIS) questionnaire. The IFIS consists of a Likert-type scale (range 1-5) with five response options (very poor, poor, average, good, and very good) about perceived overall fitness, and its main components are cardiorespiratory fitness, muscular strength, speed-agility, and flexibility. Higher scores indicating better physical fitness.
Dropout
时间窗: 12 weeks
In percent. Dropout will be study by the percent drop relative to the total subjects began intervention.
Fat mass
时间窗: 12 weeks
In kilograms. Using the InBody 770 Body Composition Analyzer (Biospace Ltd, Seoul, Korea)
Health status
时间窗: 12 weeks
Using the Short Form 36-Item Health Survey questionnaire version 2. Examines eight domains of physical (physical functioning, physical role, body pain, and general health) and mental health status (vitality, social functioning, emotional role, and mental health). The four physical-domains are summarized into a physical component score, and the four mental-domains constitute a mental component score. Scores range from 0 to 100 points, with higher scores indicating better health status.
次要结局
- Upper body flexibility(12 weeks)
- Blood triglyceride(12 weeks)
- Mood(12 weeks)
- Blood cholesterol(12 weeks)
- Psychopathological symptoms(12 weeks)
- Smoking(12 weeks)
- Blood glucose(12 weeks)
- Handgrip strength(12 weeks)
- Cardiorespiratory fitness(12 weeks)
- Lower body flexibility(12 weeks)
- Lower body strength(12 weeks)
- Upper body strength(12 weeks)