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Exercise in Severe Mental Illness. The PsychiActive Project 2.0

Primary Purpose

Exercise Therapy, Severe Mental Illness

Status
Unknown status
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Exercise training for 12 weeks (wearables)
Exercise training for 12 weeks (wearables and exergames)
Sponsored by
Universidad Pablo de Olavide
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Exercise Therapy focused on measuring Exercise, Severe Mental Illness, Adherence, Wearables, Activity Trackers, Exergames

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

  • Álvaro López MoralRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Wearables

Wearables and exergames

Arm Description

Adults with several mental illness

Adults with several mental illness

Outcomes

Primary Outcome Measures

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.
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.
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.
Adherence
In percent. Adherence will be evaluated by the percentage of attendance with respect to the total number of minutes of intervention.
Dropout
In percent. Dropout will be study by the percent drop relative to the total subjects began intervention.
Body weight
In kilograms. Using the InBody 770 Body Composition Analyzer (Biospace Ltd, Seoul, Korea)
Fat mass
In kilograms. Using the InBody 770 Body Composition Analyzer (Biospace Ltd, Seoul, Korea)
Lean mass
In kilograms. Using the InBody 770 Body Composition Analyzer (Biospace Ltd, Seoul, Korea)
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
Hip circumference
In millimeters. Using a measuring tape (Harpenden Anthropometric Tape; Holtain, Dyfed, UK) placed atthe maximum width over the greater trochanters
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.
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.
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.

Secondary Outcome Measures

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

Full Information

First Posted
March 31, 2020
Last Updated
April 3, 2020
Sponsor
Universidad Pablo de Olavide
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1. Study Identification

Unique Protocol Identification Number
NCT04337398
Brief Title
Exercise in Severe Mental Illness. The PsychiActive Project 2.0
Official Title
Feasibility, Adherence and Effects of Two Exercise-based Interventions in Adults With Severe Mental Illness. The PsychiActive Project 2.0
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Unknown status
Study Start Date
April 20, 2020 (Anticipated)
Primary Completion Date
May 20, 2020 (Anticipated)
Study Completion Date
October 30, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad Pablo de Olavide

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Exercise Therapy, Severe Mental Illness
Keywords
Exercise, Severe Mental Illness, Adherence, Wearables, Activity Trackers, Exergames

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Wearables
Arm Type
Experimental
Arm Description
Adults with several mental illness
Arm Title
Wearables and exergames
Arm Type
Experimental
Arm Description
Adults with several mental illness
Intervention Type
Behavioral
Intervention Name(s)
Exercise training for 12 weeks (wearables)
Other Intervention Name(s)
Xiaomi MiBand4
Intervention Description
Activity trackers with adaptive weekly step goals, weekly walking groups and coaching.
Intervention Type
Behavioral
Intervention Name(s)
Exercise training for 12 weeks (wearables and exergames)
Other Intervention Name(s)
Xiaomi MiBand4 and Xbox 360 Kinect
Intervention Description
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).
Primary Outcome Measure Information:
Title
Self-reported sedentary behavior
Description
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.
Time Frame
12 weeks
Title
Self-reported physical activity
Description
In metabolic equivalent minutes per week. Using the Simple Physical Activity Questionnaire. Higher values represent a higher level of physical activity.
Time Frame
12 weeks
Title
Behavioral Regulation in Exercise
Description
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.
Time Frame
12 weeks
Title
Adherence
Description
In percent. Adherence will be evaluated by the percentage of attendance with respect to the total number of minutes of intervention.
Time Frame
12 weeks
Title
Dropout
Description
In percent. Dropout will be study by the percent drop relative to the total subjects began intervention.
Time Frame
12 weeks
Title
Body weight
Description
In kilograms. Using the InBody 770 Body Composition Analyzer (Biospace Ltd, Seoul, Korea)
Time Frame
12 weeks
Title
Fat mass
Description
In kilograms. Using the InBody 770 Body Composition Analyzer (Biospace Ltd, Seoul, Korea)
Time Frame
12 weeks
Title
Lean mass
Description
In kilograms. Using the InBody 770 Body Composition Analyzer (Biospace Ltd, Seoul, Korea)
Time Frame
12 weeks
Title
Waist circumference
Description
In millimeters. Using a measuring tape (Harpenden Anthropometric Tape; Holtain, Dyfed, UK) placed at the midpoint between the last rib and the iliac crest
Time Frame
12 weeks
Title
Hip circumference
Description
In millimeters. Using a measuring tape (Harpenden Anthropometric Tape; Holtain, Dyfed, UK) placed atthe maximum width over the greater trochanters
Time Frame
12 weeks
Title
Health status
Description
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.
Time Frame
12 weeks
Title
Quality of Life
Description
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.
Time Frame
12 weeks
Title
Self-Reported Physical Fitness
Description
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.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Lower body strength
Description
In number of full stands. Using the 30-second chair stand test
Time Frame
12 weeks
Title
Upper body strength
Description
In number of bicep curls. Using the 30-second arm curl test.
Time Frame
12 weeks
Title
Handgrip strength
Description
In kilograms. Using a dynamometer (TKK 5401 Grip-D, Takey, Tokyo, Japan)
Time Frame
12 weeks
Title
Cardiorespiratory fitness
Description
In meters. Using the 6-min walk test.
Time Frame
12 weeks
Title
Lower body flexibility
Description
In centimeters. Using the chair sit-and-reach test
Time Frame
12 weeks
Title
Upper body flexibility
Description
In centimeters. Using the back scratch test
Time Frame
12 weeks
Title
Mood
Description
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.
Time Frame
12 weeks
Title
Psychopathological symptoms
Description
Using the Brief Symptom Inventory-18 questionnaire. Score range from 0 to 72 points. Higher values represent a higher psychopathological severity.
Time Frame
12 weeks
Title
Smoking
Description
Using the Fagerström nicotine dependence questionnaire. Score range from 0 to 10 points. Higher values represent a higher nicotine dependece.
Time Frame
12 weeks
Title
Blood glucose
Description
In milligram per deciliter. Collected in the morning after an overnight fast
Time Frame
12 weeks
Title
Blood cholesterol
Description
In milligram per deciliter. Collected in the morning after an overnight fast
Time Frame
12 weeks
Title
Blood triglyceride
Description
In milligram per deciliter. Collected in the morning after an overnight fast
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Clinical diagnosis of psychiatric disorder (ICD-10). Stabilized antipsychotic medication during the last month. Exclusion Criteria: Clinical instability. Substance abuse. Comorbidities contraindicating.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Álvaro López-Moral, MSc
Phone
627682636
Ext
+34
Email
alopmor1@upo.es
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Diego Munguía-Izquierdo, PhD
Organizational Affiliation
Universidad Pablo de Olavide
Official's Role
Principal Investigator
Facility Information:
Facility Name
Álvaro López Moral
City
Sevilla
State/Province
Andalucia
ZIP/Postal Code
41702
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Álvaro López, MSc
Phone
627682635
Ext
+34
Email
alopmor1@upo.es

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Exercise in Severe Mental Illness. The PsychiActive Project 2.0

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