Exercise in Severe Mental Illness. The PsychiActive Project 2.0

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

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.

Study Overview

• Status: Unknown
• Conditions: Exercise Therapy; Severe Mental Illness
• Intervention / Treatment: Behavioral: Exercise training for 12 weeks (wearables); Behavioral: Exercise training for 12 weeks (wearables and exergames)

• Study Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Andalucia
    • Sevilla, Andalucia, Spain, 41702
      • Recruiting
      • Álvaro López Moral
      • Contact: Álvaro López, MSc; Phone Number: +34 627682635; Email: alopmor1@upo.es

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Wearables; Adults with several mental illness	Behavioral: Exercise training for 12 weeks (wearables); Activity trackers with adaptive weekly step goals, weekly walking groups and coaching.; Other Names: Xiaomi MiBand4
Experimental: Wearables and exergames; Adults with several mental illness	Behavioral: Exercise training for 12 weeks (wearables and exergames); 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).; Other Names: Xiaomi MiBand4 and Xbox 360 Kinect

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Universidad Pablo de Olavide
• Investigators: Principal Investigator: Diego Munguía-Izquierdo, PhD, Universidad Pablo de Olavide

Study record dates

Study Major Dates

• Study Start (Anticipated): April 20, 2020
• Primary Completion (Anticipated): May 20, 2020
• Study Completion (Anticipated): October 30, 2020

Study Registration Dates

• First Submitted: March 31, 2020
• First Submitted That Met QC Criteria: April 3, 2020
• First Posted (Actual): April 7, 2020

Study Record Updates

• Last Update Posted (Actual): April 7, 2020
• Last Update Submitted That Met QC Criteria: April 3, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Keywords: Adherence; Exercise; Wearables; Severe Mental Illness; Exergames; Activity Trackers
• Additional Relevant MeSH Terms: Mental Disorders
• Other Study ID Numbers: CTS948AFS20

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No