Exercise in Severe Mental Illness. The PsychiActive Project 2.0

NCT04337398 | Unknown

• 1 other identifier: CTS948AFS20
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Exercise Therapy; Severe Mental Illness

Keywords

Exercise; Severe Mental Illness; Adherence; Wearables; Activity Trackers; Exergames

Outcome Measures

Primary Outcomes (13)

• 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 Outcomes (12)

• Lower body strength

  12 weeks

• Upper body strength

  12 weeks

• Handgrip strength

  12 weeks

• Cardiorespiratory fitness

  12 weeks

• Lower body flexibility

  12 weeks

Study Arms (2)

Wearables

EXPERIMENTAL

Adults with several mental illness

Behavioral: Exercise training for 12 weeks (wearables)

Wearables and exergames

EXPERIMENTAL

Adults with several mental illness

Behavioral: Exercise training for 12 weeks (wearables and exergames)

Interventions

Exercise training for 12 weeks (wearables) BEHAVIORAL

Activity trackers with adaptive weekly step goals, weekly walking groups and coaching.

Also known as: Xiaomi MiBand4

Wearables

Exercise training for 12 weeks (wearables and exergames) BEHAVIORAL

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).

Also known as: Xiaomi MiBand4 and Xbox 360 Kinect

Wearables and exergames

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Universidad Pablo de Olavide: lead

Study Sites (1)

Álvaro López Moral

Seville, Andalusia, 41702, Spain

RECRUITING

MeSH Terms

Conditions

Mental Disorders; Motor Activity

Interventions

Exercise; Exergaming

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Diego Munguía-Izquierdo, PhD

  Universidad Pablo de Olavide

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Álvaro López-Moral, MSc

CONTACT

627682636; alopmor1@upo.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MSc Sport Sciences

Study Record Dates

• First Submitted: March 31, 2020
• First Posted: April 7, 2020
• Study Start: April 20, 2020
• Primary Completion: May 20, 2020
• Study Completion: October 30, 2020
• Last Updated: April 7, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)