Exercise in Severe Mental Illness. The PsychiActive Project 2.0

Not Applicable

• Conditions: Exercise Therapy; Severe Mental Illness
• Interventions: Behavioral: Exercise training for 12 weeks (wearables and exergames); Behavioral: Exercise training for 12 weeks (wearables)

• Registration Number: NCT04337398
• Lead Sponsor: Universidad Pablo de Olavide

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-03-31
• Status Verified: 2020-04
• Study First Submitted QC: 2020-04-03
• Last Update Submitted: 2020-04-03
• Study First Posted: 2020-04-07
• Last Update Posted: 2020-04-07
• Study Start: 2020-04-20
• Primary Completion: 2020-05-20
• Study Completion: 2020-10-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• Clinical diagnosis of psychiatric disorder (ICD-10).
• Stabilized antipsychotic medication during the last month.

Exclusion Criteria

• Clinical instability.
• Substance abuse.
• Comorbidities contraindicating.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Wearables and exergames	Exercise training for 12 weeks (wearables and exergames)	Adults with several mental illness
Wearables	Exercise training for 12 weeks (wearables)	Adults with several mental illness

Primary Outcome Measures

Name	Time	Method
Lean mass	12 weeks	In kilograms. Using the InBody 770 Body Composition Analyzer (Biospace Ltd, Seoul, Korea)
Self-reported sedentary behavior	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	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	12 weeks	In kilograms. Using the InBody 770 Body Composition Analyzer (Biospace Ltd, Seoul, Korea)
Waist circumference	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	12 weeks	In metabolic equivalent minutes per week. Using the Simple Physical Activity Questionnaire. Higher values represent a higher level of physical activity.
Adherence	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	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	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	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	12 weeks	In percent. Dropout will be study by the percent drop relative to the total subjects began intervention.
Fat mass	12 weeks	In kilograms. Using the InBody 770 Body Composition Analyzer (Biospace Ltd, Seoul, Korea)
Health status	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.

Secondary Outcome Measures

Name	Time	Method
Blood triglyceride	12 weeks	In milligram per deciliter. Collected in the morning after an overnight fast
Mood	12 weeks	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.
Blood cholesterol	12 weeks	In milligram per deciliter. Collected in the morning after an overnight fast
Psychopathological symptoms	12 weeks	Using the Brief Symptom Inventory-18 questionnaire. Score range from 0 to 72 points. Higher values represent a higher psychopathological severity.
Smoking	12 weeks	Using the Fagerström nicotine dependence questionnaire. Score range from 0 to 10 points. Higher values represent a higher nicotine dependece.
Blood glucose	12 weeks	In milligram per deciliter. Collected in the morning after an overnight fast
Handgrip strength	12 weeks	In kilograms. Using a dynamometer (TKK 5401 Grip-D, Takey, Tokyo, Japan)
Cardiorespiratory fitness	12 weeks	In meters. Using the 6-min walk test.
Lower body flexibility	12 weeks	In centimeters. Using the chair sit-and-reach test
Lower body strength	12 weeks	In number of full stands. Using the 30-second chair stand test
Upper body strength	12 weeks	In number of bicep curls. Using the 30-second arm curl test.
Upper body flexibility	12 weeks	In centimeters. Using the back scratch test

Trial Locations

Locations (1)

Álvaro López Moral; 🇪🇸 Sevilla, Andalucia, Spain