Universidad Pablo de Olavide
Seville, Spain
NCT Number: NCT03352544
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.
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Notify Me18 year–65 year
All sexes
Interventional
Not applicable
Seville, Spain
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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.
Exercise training for 12 weeks (aerobic and resistance training trice a week)
Other names: Exercise training
Time frame: 12 weeks
In kilograms. Using the InBody 770 Body Composition Analyzer (Biospace Ltd, Seoul, Korea)
Time frame: 12 weeks
In kilograms. Using the InBody 770 Body Composition Analyzer (Biospace Ltd, Seoul, Korea)
Time frame: 12 weeks
In kilograms. Using the InBody 770 Body Composition Analyzer (Biospace Ltd, Seoul, Korea)
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
Time frame: 12 weeks
In millimeters. Using a measuring tape (Harpenden Anthropometric Tape; Holtain, Dyfed, UK) placed atthe maximum width over the greater trochanters
Time frame: 12 weeks
In milligram per deciliter. Collected in the morning after an overnight fast
Time frame: 12 weeks
In milligram per deciliter. Collected in the morning after an overnight fast
Time frame: 12 weeks
In milligram per deciliter. Collected in the morning after an overnight fast
Time frame: 12 weeks
In number of full stands. Using the 30-second chair stand test
Time frame: 12 weeks
In number of bicep curls. Using the 30-second arm curl test
Time frame: 12 weeks
In meters. Using the 6-min walk test
Time frame: 12 weeks
In centimeters. Using the chair sit-and-reach test
Time frame: 12 weeks
In centimeters. Using the back scratch test
Time frame: 12 weeks
In seconds. Using the 8-foot up-and-go test
Time frame: 12 weeks
In seconds. Using the stork balance test
Time frame: 12 weeks
In liters. Using spirometry (Spirolab II. Medical International Research, Rome, Italy)
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.
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.
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.
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.
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.
Time frame: 12 weeks
Using the Rosenberg Self-Esteem Scale. Score range from 10 to 40 points. Higher values represent a higher self-esteem.
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.
Time frame: 12 weeks
Using the Fagerström nicotine dependence questionnaire. Score range from 0 to 10 points. Higher values represent a higher nicotine dependece.
Universidad Pablo de Olavide
Other
Exercise Training in Patients With Severe Mental Illness. The PsychiActive Project
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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