Exercise in Severe Mental Illness. The PsychiActive Project

Study Overview
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Brief Summary
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The purpose of this randomized controlled trial is to study the effects of exercise on body weight, body composition, anthropometric and fasting blood measures, physical fitness, pulmonary function, quality of life, and lifestyle habits in patients with severe mental illness.

Official Title
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Exercise Training in Patients With Severe Mental Illness. The PsychiActive Project

Conditions
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Exercise Therapy

Intervention / Treatment
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* Behavioral: Exercise


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with severe mental illness established by experienced psychiatrists, aged 18 years or older and stabilized on antipsychotic medication during the last month. Exclusion Criteria: Patients with clinical instability, co-morbid substance abuse, or evidence of uncontrolled cardiovascular, neuromuscular and endocrine disorders.

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: Exercise<br>Exercise training for 12 weeks (aerobic and resistance training trice a week). | Behavioral: Exercise<br>* Exercise training for 12 weeks (aerobic and resistance training trice a week)<br>* Other names: Exercise training;|
| No Intervention: Usual treatment<br>Usual treatment during 12 weeks, coinciding with exercise intervention time frame. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 girth | 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 girth | In millimeters. Using a measuring tape (Harpenden Anthropometric Tape; Holtain, Dyfed, UK) placed atthe maximum width over the greater trochanters | 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 | 

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 | 
| Aerobic endurance | 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 | 
| Dynamic balance | In seconds. Using the 8-foot up-and-go test | 12 weeks | 
| Static balance | In seconds. Using the stork balance test | 12 weeks | 
| Forced vital capacity | In liters. Using spirometry (Spirolab II. Medical International Research, Rome, Italy) | 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 Tolerability and Quality of Life questionnaire. Score range from 8 to 32 points. Higher lower represent a better quality of life. | 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 | 
| Anxiety symptoms | Using the Beck Anxiety Inventory questionnaire. Score range from 0 to 63 points. Higher values represent a higher level of anxiety. | 12 weeks | 
| Depression symptoms | Using the Beck depression inventory-II questionnaire. Score range from 0 to 63 points. Higher values represent a higher level of depression. | 12 weeks | 
| Self-Esteem | Using the Rosenberg Self-Esteem Scale. Score range from 10 to 40 points. Higher values represent a higher self-esteem. | 12 weeks | 
| Physical activity | Using the Short form International Physical Activity Questionnaire. In metabolic equivalent minutes per week. Higher values represent a higher level of physical activity. | 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 |