Exercise in Severe Mental Illness. The PsychiActive Project

Overview

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.

Full Title of Study: “Exercise Training in Patients With Severe Mental Illness. The PsychiActive Project”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Outcomes Assessor)
  • Study Primary Completion Date: August 5, 2015

Interventions

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

Arms, Groups and Cohorts

  • Experimental: Exercise
    • Exercise training for 12 weeks (aerobic and resistance training trice a week).
  • No Intervention: Usual treatment
    • Usual treatment during 12 weeks, coinciding with exercise intervention time frame.

Clinical Trial Outcome Measures

Primary Measures

  • Body weight
    • Time Frame: 12 weeks
    • In kilograms. Using the InBody 770 Body Composition Analyzer (Biospace Ltd, Seoul, Korea)
  • 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)
  • 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
  • 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 glucose
    • Time Frame: 12 weeks
    • In milligram per deciliter. Collected in the morning after an overnight fast
  • Blood cholesterol
    • Time Frame: 12 weeks
    • In milligram per deciliter. Collected in the morning after an overnight fast
  • Blood triglyceride
    • Time Frame: 12 weeks
    • In milligram per deciliter. Collected in the morning after an overnight fast

Secondary Measures

  • Lower body strength
    • Time Frame: 12 weeks
    • In number of full stands. Using the 30-second chair stand test
  • Upper body strength
    • Time Frame: 12 weeks
    • In number of bicep curls. Using the 30-second arm curl test
  • Aerobic endurance
    • Time Frame: 12 weeks
    • In meters. Using the 6-min walk test
  • Lower body flexibility
    • Time Frame: 12 weeks
    • In centimeters. Using the chair sit-and-reach test
  • Upper body flexibility
    • Time Frame: 12 weeks
    • In centimeters. Using the back scratch test
  • Dynamic balance
    • Time Frame: 12 weeks
    • In seconds. Using the 8-foot up-and-go test
  • Static balance
    • Time Frame: 12 weeks
    • In seconds. Using the stork balance test
  • Forced vital capacity
    • Time Frame: 12 weeks
    • In liters. Using spirometry (Spirolab II. Medical International Research, Rome, Italy)
  • 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.
  • Quality of life
    • Time Frame: 12 weeks
    • Using the Tolerability and Quality of Life questionnaire. Score range from 8 to 32 points. Higher lower represent a better quality of life.
  • 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.
  • Anxiety symptoms
    • Time Frame: 12 weeks
    • Using the Beck Anxiety Inventory questionnaire. Score range from 0 to 63 points. Higher values represent a higher level of anxiety.
  • Depression symptoms
    • Time Frame: 12 weeks
    • Using the Beck depression inventory-II questionnaire. Score range from 0 to 63 points. Higher values represent a higher level of depression.
  • Self-Esteem
    • Time Frame: 12 weeks
    • Using the Rosenberg Self-Esteem Scale. Score range from 10 to 40 points. Higher values represent a higher self-esteem.
  • Physical activity
    • Time Frame: 12 weeks
    • Using the Short form International Physical Activity Questionnaire. In metabolic equivalent minutes per week. Higher values represent a higher level of physical activity.
  • 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.

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Universidad Pablo de Olavide
  • Provider of Information About this Clinical Study
    • Principal Investigator: Javier Bueno-Antequera, Principal Investigator – Universidad Pablo de Olavide

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