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临床试验/NCT04337398
NCT04337398
Unknown
不适用

Feasibility, Adherence and Effects of Two Exercise-based Interventions in Adults With Severe Mental Illness. The PsychiActive Project 2.0

Universidad Pablo de Olavide1 个研究点 分布在 1 个国家目标入组 80 人2020年4月20日

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.

注册库
clinicaltrials.gov
开始日期
2020年4月20日
结束日期
2020年10月30日
最后更新
6年前
研究类型
Interventional
研究设计
Parallel
性别
All

研究者

发起方
Universidad Pablo de Olavide
责任方
Principal Investigator
主要研究者

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)

研究点 (1)

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