Exercise in Severe Mental Illness. The PsychiActive Project 2.0

April 3, 2020 updated by: Alvaro López Moral, Universidad Pablo de Olavide

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

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
80

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Álvaro López-Moral, MSc
  • Phone Number: +34 627682636
  • Email: alopmor1@upo.es

Study Locations

  • Spain
    • Andalucia
      • Sevilla, Andalucia, Spain, 41702
        • Recruiting
        • Álvaro López Moral
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Self-reported sedentary behavior
Time Frame: 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.
12 weeks
Self-reported physical activity
Time Frame: 12 weeks
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
Time Frame: 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.
12 weeks
Adherence
Time Frame: 12 weeks
In percent. Adherence will be evaluated by the percentage of attendance with respect to the total number of minutes of intervention.
12 weeks
Dropout
Time Frame: 12 weeks
In percent. Dropout will be study by the percent drop relative to the total subjects began intervention.
12 weeks
Body weight
Time Frame: 12 weeks
In kilograms. Using the InBody 770 Body Composition Analyzer (Biospace Ltd, Seoul, Korea)
12 weeks
Fat mass
Time Frame: 12 weeks
In kilograms. Using the InBody 770 Body Composition Analyzer (Biospace Ltd, Seoul, Korea)
12 weeks
Lean mass
Time Frame: 12 weeks
In kilograms. Using the InBody 770 Body Composition Analyzer (Biospace Ltd, Seoul, Korea)
12 weeks
Waist circumference
Time Frame: 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
12 weeks
Hip circumference
Time Frame: 12 weeks
In millimeters. Using a measuring tape (Harpenden Anthropometric Tape; Holtain, Dyfed, UK) placed atthe maximum width over the greater trochanters
12 weeks
Health status
Time Frame: 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.
12 weeks
Quality of Life
Time Frame: 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.
12 weeks
Self-Reported Physical Fitness
Time Frame: 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.
12 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Lower body strength
Time Frame: 12 weeks
In number of full stands. Using the 30-second chair stand test
12 weeks
Upper body strength
Time Frame: 12 weeks
In number of bicep curls. Using the 30-second arm curl test.
12 weeks
Handgrip strength
Time Frame: 12 weeks
In kilograms. Using a dynamometer (TKK 5401 Grip-D, Takey, Tokyo, Japan)
12 weeks
Cardiorespiratory fitness
Time Frame: 12 weeks
In meters. Using the 6-min walk test.
12 weeks
Lower body flexibility
Time Frame: 12 weeks
In centimeters. Using the chair sit-and-reach test
12 weeks
Upper body flexibility
Time Frame: 12 weeks
In centimeters. Using the back scratch test
12 weeks
Mood
Time Frame: 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.
12 weeks
Psychopathological symptoms
Time Frame: 12 weeks
Using the Brief Symptom Inventory-18 questionnaire. Score range from 0 to 72 points. Higher values represent a higher psychopathological severity.
12 weeks
Smoking
Time Frame: 12 weeks
Using the Fagerström nicotine dependence questionnaire. Score range from 0 to 10 points. Higher values represent a higher nicotine dependece.
12 weeks
Blood glucose
Time Frame: 12 weeks
In milligram per deciliter. Collected in the morning after an overnight fast
12 weeks
Blood cholesterol
Time Frame: 12 weeks
In milligram per deciliter. Collected in the morning after an overnight fast
12 weeks
Blood triglyceride
Time Frame: 12 weeks
In milligram per deciliter. Collected in the morning after an overnight fast
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Universidad Pablo de Olavide

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Diego Munguía-Izquierdo, PhD, Universidad Pablo de Olavide

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 20, 2020

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 20, 2020

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 30, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 31, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 3, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 7, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 7, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 3, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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