Exercise in Severe Mental Illness. The PsychiActive Project

Exercise Therapy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03352544
• Other study ID #: CTS948AFS17
• Status: Completed
• Phase: N/A
• Start date: March 16, 2015
• Est. completion date: December 23, 2015

Study information

• Verified date: September 2018
• Source: Universidad Pablo de Olavide
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: December 23, 2015
• Est. primary completion date: August 5, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Exercise Therapy
• Mental Disorders

Intervention

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

Locations

Country	Name	City	State
Spain	Universidad Pablo de Olavide	Sevilla

Sponsors (1)

Lead Sponsor	Collaborator
Universidad Pablo de Olavide

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Body weight	In kilograms. Using the InBody 770 Body Composition Analyzer (Biospace Ltd, Seoul, Korea)	12 weeks
Primary	Fat mass	In kilograms. Using the InBody 770 Body Composition Analyzer (Biospace Ltd, Seoul, Korea)	12 weeks
Primary	Lean mass	In kilograms. Using the InBody 770 Body Composition Analyzer (Biospace Ltd, Seoul, Korea)	12 weeks
Primary	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
Primary	Hip girth	In millimeters. Using a measuring tape (Harpenden Anthropometric Tape; Holtain, Dyfed, UK) placed atthe maximum width over the greater trochanters	12 weeks
Primary	Blood glucose	In milligram per deciliter. Collected in the morning after an overnight fast	12 weeks
Primary	Blood cholesterol	In milligram per deciliter. Collected in the morning after an overnight fast	12 weeks
Primary	Blood triglyceride	In milligram per deciliter. Collected in the morning after an overnight fast	12 weeks
Secondary	Lower body strength	In number of full stands. Using the 30-second chair stand test	12 weeks
Secondary	Upper body strength	In number of bicep curls. Using the 30-second arm curl test	12 weeks
Secondary	Aerobic endurance	In meters. Using the 6-min walk test	12 weeks
Secondary	Lower body flexibility	In centimeters. Using the chair sit-and-reach test	12 weeks
Secondary	Upper body flexibility	In centimeters. Using the back scratch test	12 weeks
Secondary	Dynamic balance	In seconds. Using the 8-foot up-and-go test	12 weeks
Secondary	Static balance	In seconds. Using the stork balance test	12 weeks
Secondary	Forced vital capacity	In liters. Using spirometry (Spirolab II. Medical International Research, Rome, Italy)	12 weeks
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Self-Esteem	Using the Rosenberg Self-Esteem Scale. Score range from 10 to 40 points. Higher values represent a higher self-esteem.	12 weeks
Secondary	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
Secondary	Smoking	Using the Fagerström nicotine dependence questionnaire. Score range from 0 to 10 points. Higher values represent a higher nicotine dependece.	12 weeks