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Clinical Trials/NCT03352544
NCT03352544
Completed
Not Applicable

Exercise Training in Patients With Severe Mental Illness. The PsychiActive Project

Universidad Pablo de Olavide1 site in 1 country50 target enrollmentMarch 16, 2015

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Exercise Therapy
Sponsor
Universidad Pablo de Olavide
Enrollment
50
Locations
1
Primary Endpoint
Body weight
Status
Completed
Last Updated
7 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
March 16, 2015
End Date
December 23, 2015
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Universidad Pablo de Olavide
Responsible Party
Principal Investigator
Principal Investigator

Javier Bueno-Antequera

Principal Investigator

Universidad Pablo de Olavide

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Body weight

Time Frame: 12 weeks

In kilograms. Using the InBody 770 Body Composition Analyzer (Biospace Ltd, Seoul, Korea)

Blood triglyceride

Time Frame: 12 weeks

In milligram per deciliter. Collected in the morning after an overnight fast

Waist girth

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

Blood glucose

Time Frame: 12 weeks

In milligram per deciliter. Collected in the morning after an overnight fast

Fat mass

Time Frame: 12 weeks

In kilograms. Using the InBody 770 Body Composition Analyzer (Biospace Ltd, Seoul, Korea)

Lean mass

Time Frame: 12 weeks

In kilograms. Using the InBody 770 Body Composition Analyzer (Biospace Ltd, Seoul, Korea)

Hip girth

Time Frame: 12 weeks

In millimeters. Using a measuring tape (Harpenden Anthropometric Tape; Holtain, Dyfed, UK) placed atthe maximum width over the greater trochanters

Blood cholesterol

Time Frame: 12 weeks

In milligram per deciliter. Collected in the morning after an overnight fast

Secondary Outcomes

  • Upper body strength(12 weeks)
  • Upper body flexibility(12 weeks)
  • Dynamic balance(12 weeks)
  • Static balance(12 weeks)
  • Forced vital capacity(12 weeks)
  • Aerobic endurance(12 weeks)
  • Psychopathological symptoms(12 weeks)
  • Anxiety symptoms(12 weeks)
  • Self-Esteem(12 weeks)
  • Smoking(12 weeks)
  • Lower body strength(12 weeks)
  • Lower body flexibility(12 weeks)
  • Quality of life(12 weeks)
  • Health status(12 weeks)
  • Depression symptoms(12 weeks)
  • Physical activity(12 weeks)

Study Sites (1)

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