Exercise in Severe Mental Illness. The PsychiActive Project 2.0

Study Overview
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Brief Summary
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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.

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

Conditions
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Exercise Therapy, Severe Mental Illness

Intervention / Treatment
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* Behavioral: Exercise training for 12 weeks (wearables)
* Behavioral: Exercise training for 12 weeks (wearables and exergames)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinical diagnosis of psychiatric disorder (ICD-10). Stabilized antipsychotic medication during the last month. Exclusion Criteria: Clinical instability. Substance abuse. Comorbidities contraindicating.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Wearables<br>Adults with several mental illness | Behavioral: Exercise training for 12 weeks (wearables)<br>* Activity trackers with adaptive weekly step goals, weekly walking groups and coaching.<br>* Other names: Xiaomi MiBand4;|
| Experimental: Wearables and exergames<br>Adults with several mental illness | Behavioral: Exercise training for 12 weeks (wearables and exergames)<br>* Activity trackers with adaptive weekly step goals, weekly walking groups, coaching and exercise programme based on exergames (aerobic, resistance and stretching training three weekly group sessions).<br>* Other names: Xiaomi MiBand4 and Xbox 360 Kinect;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Self-reported sedentary behavior | 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. | 12 weeks | 
| Self-reported physical activity | In metabolic equivalent minutes per week. Using the Simple Physical Activity Questionnaire. Higher values represent a higher level of physical activity. | 12 weeks | 
| Behavioral Regulation in Exercise | 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. | 12 weeks | 
| Adherence | In percent. Adherence will be evaluated by the percentage of attendance with respect to the total number of minutes of intervention. | 12 weeks | 
| Dropout | In percent. Dropout will be study by the percent drop relative to the total subjects began intervention. | 12 weeks | 
| Body weight | In kilograms. Using the InBody 770 Body Composition Analyzer (Biospace Ltd, Seoul, Korea) | 12 weeks | 
| Fat mass | In kilograms. Using the InBody 770 Body Composition Analyzer (Biospace Ltd, Seoul, Korea) | 12 weeks | 
| Lean mass | In kilograms. Using the InBody 770 Body Composition Analyzer (Biospace Ltd, Seoul, Korea) | 12 weeks | 
| Waist circumference | In millimeters. Using a measuring tape (Harpenden Anthropometric Tape; Holtain, Dyfed, UK) placed at the midpoint between the last rib and the iliac crest | 12 weeks | 
| Hip circumference | In millimeters. Using a measuring tape (Harpenden Anthropometric Tape; Holtain, Dyfed, UK) placed atthe maximum width over the greater trochanters | 12 weeks | 
| Health status | 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. | 12 weeks | 
| Quality of Life | 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. | 12 weeks | 
| Self-Reported Physical Fitness | 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. | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lower body strength | In number of full stands. Using the 30-second chair stand test | 12 weeks | 
| Upper body strength | In number of bicep curls. Using the 30-second arm curl test. | 12 weeks | 
| Handgrip strength | In kilograms. Using a dynamometer (TKK 5401 Grip-D, Takey, Tokyo, Japan) | 12 weeks | 
| Cardiorespiratory fitness | In meters. Using the 6-min walk test. | 12 weeks | 
| Lower body flexibility | In centimeters. Using the chair sit-and-reach test | 12 weeks | 
| Upper body flexibility | In centimeters. Using the back scratch test | 12 weeks | 
| Mood | Using the Scale for Mood Assessment. This questionnaire valuates four moods through 16 items divided into four categories: sadness-depression, anxiety, anger/hostility and happiness. Item scores are evaluated with the Likert scales ranging from 0 to 10, higher values represent a higher level of this mood. | 12 weeks | 
| Psychopathological symptoms | Using the Brief Symptom Inventory-18 questionnaire. Score range from 0 to 72 points. Higher values represent a higher psychopathological severity. | 12 weeks | 
| Smoking | Using the Fagerström nicotine dependence questionnaire. Score range from 0 to 10 points. Higher values represent a higher nicotine dependece. | 12 weeks | 
| Blood glucose | In milligram per deciliter. Collected in the morning after an overnight fast | 12 weeks | 
| Blood cholesterol | In milligram per deciliter. Collected in the morning after an overnight fast | 12 weeks | 
| Blood triglyceride | In milligram per deciliter. Collected in the morning after an overnight fast | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Adherence, Exercise, Severe Mental Illness, Wearables, Activity Trackers, Exergames