Back to resultsExercise in Severe Mental Illness. The PsychiActive Project
Primary Purpose
Exercise Therapy
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Exercise
Sponsored by
About this trial
This is an interventional treatment trial for Exercise Therapy
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.
Sites / Locations
- Universidad Pablo de Olavide
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Exercise
Usual treatment
Arm Description
Exercise training for 12 weeks (aerobic and resistance training trice a week).
Usual treatment during 12 weeks, coinciding with exercise intervention time frame.
Outcomes
Primary Outcome Measures
Body weight
In kilograms. Using the InBody 770 Body Composition Analyzer (Biospace Ltd, Seoul, Korea)
Fat mass
In kilograms. Using the InBody 770 Body Composition Analyzer (Biospace Ltd, Seoul, Korea)
Lean mass
In kilograms. Using the InBody 770 Body Composition Analyzer (Biospace Ltd, Seoul, Korea)
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
Hip girth
In millimeters. Using a measuring tape (Harpenden Anthropometric Tape; Holtain, Dyfed, UK) placed atthe maximum width over the greater trochanters
Blood glucose
In milligram per deciliter. Collected in the morning after an overnight fast
Blood cholesterol
In milligram per deciliter. Collected in the morning after an overnight fast
Blood triglyceride
In milligram per deciliter. Collected in the morning after an overnight fast
Secondary Outcome Measures
Lower body strength
In number of full stands. Using the 30-second chair stand test
Upper body strength
In number of bicep curls. Using the 30-second arm curl test
Aerobic endurance
In meters. Using the 6-min walk test
Lower body flexibility
In centimeters. Using the chair sit-and-reach test
Upper body flexibility
In centimeters. Using the back scratch test
Dynamic balance
In seconds. Using the 8-foot up-and-go test
Static balance
In seconds. Using the stork balance test
Forced vital capacity
In liters. Using spirometry (Spirolab II. Medical International Research, Rome, Italy)
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.
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.
Psychopathological symptoms
Using the Brief Symptom Inventory-18 questionnaire. Score range from 0 to 72 points. Higher values represent a higher psychopathological severity.
Anxiety symptoms
Using the Beck Anxiety Inventory questionnaire. Score range from 0 to 63 points. Higher values represent a higher level of anxiety.
Depression symptoms
Using the Beck depression inventory-II questionnaire. Score range from 0 to 63 points. Higher values represent a higher level of depression.
Self-Esteem
Using the Rosenberg Self-Esteem Scale. Score range from 10 to 40 points. Higher values represent a higher self-esteem.
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.
Smoking
Using the Fagerström nicotine dependence questionnaire. Score range from 0 to 10 points. Higher values represent a higher nicotine dependece.
Full Information
NCT ID
NCT03352544
First Posted
November 10, 2017
Last Updated
September 3, 2018
Sponsor
Universidad Pablo de Olavide
1. Study Identification
Unique Protocol Identification Number
NCT03352544
Brief Title
Exercise in Severe Mental Illness. The PsychiActive Project
Official Title
Exercise Training in Patients With Severe Mental Illness. The PsychiActive Project
Study Type
Interventional
2. Study Status
Record Verification Date
September 2018
Overall Recruitment Status
Completed
Study Start Date
March 16, 2015 (Actual)
Primary Completion Date
August 5, 2015 (Actual)
Study Completion Date
December 23, 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad Pablo de Olavide
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Exercise Therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Exercise
Arm Type
Experimental
Arm Description
Exercise training for 12 weeks (aerobic and resistance training trice a week).
Arm Title
Usual treatment
Arm Type
No Intervention
Arm Description
Usual treatment during 12 weeks, coinciding with exercise intervention time frame.
Intervention Type
Behavioral
Intervention Name(s)
Exercise
Other Intervention Name(s)
Exercise training
Intervention Description
Exercise training for 12 weeks (aerobic and resistance training trice a week)
Primary Outcome Measure Information:
Title
Body weight
Description
In kilograms. Using the InBody 770 Body Composition Analyzer (Biospace Ltd, Seoul, Korea)
Time Frame
12 weeks
Title
Fat mass
Description
In kilograms. Using the InBody 770 Body Composition Analyzer (Biospace Ltd, Seoul, Korea)
Time Frame
12 weeks
Title
Lean mass
Description
In kilograms. Using the InBody 770 Body Composition Analyzer (Biospace Ltd, Seoul, Korea)
Time Frame
12 weeks
Title
Waist girth
Description
In millimeters. Using a measuring tape (Harpenden Anthropometric Tape; Holtain, Dyfed, UK) placed at the midpoint between the last rib and the iliac crest
Time Frame
12 weeks
Title
Hip girth
Description
In millimeters. Using a measuring tape (Harpenden Anthropometric Tape; Holtain, Dyfed, UK) placed atthe maximum width over the greater trochanters
Time Frame
12 weeks
Title
Blood glucose
Description
In milligram per deciliter. Collected in the morning after an overnight fast
Time Frame
12 weeks
Title
Blood cholesterol
Description
In milligram per deciliter. Collected in the morning after an overnight fast
Time Frame
12 weeks
Title
Blood triglyceride
Description
In milligram per deciliter. Collected in the morning after an overnight fast
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Lower body strength
Description
In number of full stands. Using the 30-second chair stand test
Time Frame
12 weeks
Title
Upper body strength
Description
In number of bicep curls. Using the 30-second arm curl test
Time Frame
12 weeks
Title
Aerobic endurance
Description
In meters. Using the 6-min walk test
Time Frame
12 weeks
Title
Lower body flexibility
Description
In centimeters. Using the chair sit-and-reach test
Time Frame
12 weeks
Title
Upper body flexibility
Description
In centimeters. Using the back scratch test
Time Frame
12 weeks
Title
Dynamic balance
Description
In seconds. Using the 8-foot up-and-go test
Time Frame
12 weeks
Title
Static balance
Description
In seconds. Using the stork balance test
Time Frame
12 weeks
Title
Forced vital capacity
Description
In liters. Using spirometry (Spirolab II. Medical International Research, Rome, Italy)
Time Frame
12 weeks
Title
Health status
Description
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.
Time Frame
12 weeks
Title
Quality of life
Description
Using the Tolerability and Quality of Life questionnaire. Score range from 8 to 32 points. Higher lower represent a better quality of life.
Time Frame
12 weeks
Title
Psychopathological symptoms
Description
Using the Brief Symptom Inventory-18 questionnaire. Score range from 0 to 72 points. Higher values represent a higher psychopathological severity.
Time Frame
12 weeks
Title
Anxiety symptoms
Description
Using the Beck Anxiety Inventory questionnaire. Score range from 0 to 63 points. Higher values represent a higher level of anxiety.
Time Frame
12 weeks
Title
Depression symptoms
Description
Using the Beck depression inventory-II questionnaire. Score range from 0 to 63 points. Higher values represent a higher level of depression.
Time Frame
12 weeks
Title
Self-Esteem
Description
Using the Rosenberg Self-Esteem Scale. Score range from 10 to 40 points. Higher values represent a higher self-esteem.
Time Frame
12 weeks
Title
Physical activity
Description
Using the Short form International Physical Activity Questionnaire. In metabolic equivalent minutes per week. Higher values represent a higher level of physical activity.
Time Frame
12 weeks
Title
Smoking
Description
Using the Fagerström nicotine dependence questionnaire. Score range from 0 to 10 points. Higher values represent a higher nicotine dependece.
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Universidad Pablo de Olavide
City
Sevilla
Country
Spain
12. IPD Sharing Statement
Learn more about this trial
Exercise in Severe Mental Illness. The PsychiActive Project
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