Exercise in Severe Mental Illness. The PsychiActive Project

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

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.

Study Overview

• Status: Completed
• Conditions: Exercise Therapy
• Intervention / Treatment: Behavioral: Exercise

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Sevilla, Spain
    • Universidad Pablo de Olavide

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Exercise; Exercise training for 12 weeks (aerobic and resistance training trice a week).	Behavioral: Exercise; Exercise training for 12 weeks (aerobic and resistance training trice a week); Other Names: Exercise training
No Intervention: Usual treatment; Usual treatment during 12 weeks, coinciding with exercise intervention time frame.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Blood glucose	In milligram per deciliter. Collected in the morning after an overnight fast	12 weeks
Blood cholesterol	In milligram per deciliter. Collected in the morning after an overnight fast	12 weeks
Blood triglyceride	In milligram per deciliter. Collected in the morning after an overnight fast	12 weeks
Waist girth	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 girth	In millimeters. Using a measuring tape (Harpenden Anthropometric Tape; Holtain, Dyfed, UK) placed atthe maximum width over the greater trochanters	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Lower body strength	In number of full stands. Using the 30-second chair stand test	12 weeks
Lower body flexibility	In centimeters. Using the chair sit-and-reach test	12 weeks
Upper body flexibility	In centimeters. Using the back scratch test	12 weeks
Psychopathological symptoms	Using the Brief Symptom Inventory-18 questionnaire. Score range from 0 to 72 points. Higher values represent a higher psychopathological severity.	12 weeks
Smoking	Using the Fagerström nicotine dependence questionnaire. Score range from 0 to 10 points. Higher values represent a higher nicotine dependece.	12 weeks
Upper body strength	In number of bicep curls. Using the 30-second arm curl test	12 weeks
Aerobic endurance	In meters. Using the 6-min walk test	12 weeks
Dynamic balance	In seconds. Using the 8-foot up-and-go test	12 weeks
Static balance	In seconds. Using the stork balance test	12 weeks
Forced vital capacity	In liters. Using spirometry (Spirolab II. Medical International Research, Rome, Italy)	12 weeks
Quality of life	Using the Tolerability and Quality of Life questionnaire. Score range from 8 to 32 points. Higher lower represent a better quality of life.	12 weeks
Anxiety symptoms	Using the Beck Anxiety Inventory questionnaire. Score range from 0 to 63 points. Higher values represent a higher level of anxiety.	12 weeks
Depression symptoms	Using the Beck depression inventory-II questionnaire. Score range from 0 to 63 points. Higher values represent a higher level of depression.	12 weeks
Self-Esteem	Using the Rosenberg Self-Esteem Scale. Score range from 10 to 40 points. Higher values represent a higher self-esteem.	12 weeks
Physical activity	Using the Short form International Physical Activity Questionnaire. In metabolic equivalent minutes per week. Higher values represent a higher level of physical activity.	12 weeks

Collaborators and Investigators

• Sponsor: Universidad Pablo de Olavide

Study record dates

Study Major Dates

• Study Start (Actual): March 16, 2015
• Primary Completion (Actual): August 5, 2015
• Study Completion (Actual): December 23, 2015

Study Registration Dates

• First Submitted: November 10, 2017
• First Submitted That Met QC Criteria: November 22, 2017
• First Posted (Actual): November 24, 2017

Study Record Updates

• Last Update Posted (Actual): September 5, 2018
• Last Update Submitted That Met QC Criteria: September 3, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders
• Other Study ID Numbers: CTS948AFS17

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No