Exercise in Severe Mental Illness. The PsychiActive Project 2.0

NCT ID: NCT04337398

Last Updated: 2020-04-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-04-20

Study Completion Date

2020-10-30

Brief Summary

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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

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Conditions

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Exercise Therapy Severe Mental Illness

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Wearables

Adults with several mental illness

Group Type EXPERIMENTAL

Exercise training for 12 weeks (wearables)

Intervention Type BEHAVIORAL

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

Wearables and exergames

Adults with several mental illness

Group Type EXPERIMENTAL

Exercise training for 12 weeks (wearables and exergames)

Intervention Type 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).

Interventions

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Exercise training for 12 weeks (wearables)

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

Intervention Type 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).

Intervention Type BEHAVIORAL

Other Intervention Names

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Xiaomi MiBand4 Xiaomi MiBand4 and Xbox 360 Kinect

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Clinical instability.
* Substance abuse.
* Comorbidities contraindicating.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universidad Pablo de Olavide

OTHER

Sponsor Role lead

Responsible Party

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Alvaro López Moral

MSc Sport Sciences

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Diego Munguía-Izquierdo, PhD

Role: PRINCIPAL_INVESTIGATOR

Universidad Pablo de Olavide

Locations

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Álvaro López Moral

Seville, Andalusia, Spain

Site Status RECRUITING

Countries

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Spain

Central Contacts

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Álvaro López-Moral, MSc

Role: CONTACT

627682636 ext. +34

Facility Contacts

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Álvaro López, MSc

Role: primary

627682635 ext. +34

Other Identifiers

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CTS948AFS20

Identifier Type: -

Identifier Source: org_study_id

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