Exercise in Severe Mental Illness. The PsychiActive Project

NCT ID: NCT03352544

Last Updated: 2018-09-05

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

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-03-16

Study Completion Date

2015-12-23

Brief Summary

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The purpose of this randomized controlled trial is to study the effects of exercise on body weight, body composition, anthropometric and fasting blood measures, physical fitness, pulmonary function, 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

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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Exercise

Exercise training for 12 weeks (aerobic and resistance training trice a week).

Group Type EXPERIMENTAL

Exercise

Intervention Type BEHAVIORAL

Exercise training for 12 weeks (aerobic and resistance training trice a week)

Usual treatment

Usual treatment during 12 weeks, coinciding with exercise intervention time frame.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Exercise

Exercise training for 12 weeks (aerobic and resistance training trice a week)

Intervention Type BEHAVIORAL

Other Intervention Names

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Exercise training

Eligibility Criteria

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Inclusion Criteria

Patients with severe mental illness established by experienced psychiatrists, aged 18 years or older and stabilized on antipsychotic medication during the last month.

Exclusion Criteria

Patients with clinical instability, co-morbid substance abuse, or evidence of uncontrolled cardiovascular, neuromuscular and endocrine disorders.
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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Javier Bueno-Antequera

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Universidad Pablo de Olavide

Seville, , Spain

Site Status

Countries

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Spain

Other Identifiers

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CTS948AFS17

Identifier Type: -

Identifier Source: org_study_id

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