Exercise in Severe Mental Illness. The PsychiActive Project
- Conditions
- Exercise Therapy
- Interventions
- Behavioral: Exercise
- Registration Number
- NCT03352544
- Lead Sponsor
- Universidad Pablo de Olavide
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 50
Patients with severe mental illness established by experienced psychiatrists, aged 18 years or older and stabilized on antipsychotic medication during the last month.
Patients with clinical instability, co-morbid substance abuse, or evidence of uncontrolled cardiovascular, neuromuscular and endocrine disorders.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Exercise Exercise Exercise training for 12 weeks (aerobic and resistance training trice a week).
- Primary Outcome Measures
Name Time Method Body weight 12 weeks In kilograms. Using the InBody 770 Body Composition Analyzer (Biospace Ltd, Seoul, Korea)
Blood triglyceride 12 weeks In milligram per deciliter. Collected in the morning after an overnight fast
Waist girth 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
Blood glucose 12 weeks In milligram per deciliter. Collected in the morning after an overnight fast
Fat mass 12 weeks In kilograms. Using the InBody 770 Body Composition Analyzer (Biospace Ltd, Seoul, Korea)
Lean mass 12 weeks In kilograms. Using the InBody 770 Body Composition Analyzer (Biospace Ltd, Seoul, Korea)
Hip girth 12 weeks In millimeters. Using a measuring tape (Harpenden Anthropometric Tape; Holtain, Dyfed, UK) placed atthe maximum width over the greater trochanters
Blood cholesterol 12 weeks In milligram per deciliter. Collected in the morning after an overnight fast
- Secondary Outcome Measures
Name Time Method Upper body strength 12 weeks In number of bicep curls. Using the 30-second arm curl test
Upper body flexibility 12 weeks In centimeters. Using the back scratch test
Dynamic balance 12 weeks In seconds. Using the 8-foot up-and-go test
Static balance 12 weeks In seconds. Using the stork balance test
Forced vital capacity 12 weeks In liters. Using spirometry (Spirolab II. Medical International Research, Rome, Italy)
Aerobic endurance 12 weeks In meters. Using the 6-min walk test
Psychopathological symptoms 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 12 weeks Using the Beck Anxiety Inventory questionnaire. Score range from 0 to 63 points. Higher values represent a higher level of anxiety.
Self-Esteem 12 weeks Using the Rosenberg Self-Esteem Scale. Score range from 10 to 40 points. Higher values represent a higher self-esteem.
Smoking 12 weeks Using the Fagerström nicotine dependence questionnaire. Score range from 0 to 10 points. Higher values represent a higher nicotine dependece.
Lower body strength 12 weeks In number of full stands. Using the 30-second chair stand test
Lower body flexibility 12 weeks In centimeters. Using the chair sit-and-reach test
Quality of life 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.
Health status 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.
Depression symptoms 12 weeks Using the Beck depression inventory-II questionnaire. Score range from 0 to 63 points. Higher values represent a higher level of depression.
Physical activity 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.
Trial Locations
- Locations (1)
Universidad Pablo de Olavide
🇪🇸Sevilla, Spain