The purpose of this randomized controlled trial is to study the feasibility, adherence and effects of two exercise interventions on body weight, body composition, anthropometric and fasting blood measures, physical fitness, quality of life, and lifestyle habits in patients with severe mental illness.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
80
Activity trackers with adaptive weekly step goals, weekly walking groups and coaching.
Activity trackers with adaptive weekly step goals, weekly walking groups, coaching and exercise programme based on exergames (aerobic, resistance and stretching training three weekly group sessions).
Álvaro López Moral
Seville, Andalusia, Spain
RECRUITINGSelf-reported sedentary behavior
In hours per week. Using the Sedentary Behaviour Questionnaire. It asks about amount of time spent doing 11 sedentary behaviours of a usual weekday and weekend day. Time in hours of each behaviour were summed separately for weekdays and weekend days, and time for an average day was calculated as (weekday hours ×5 +weekend day hours × 2)/7. Higher values represent a higher level of sedentary behavior.
Time frame: 12 weeks
Self-reported physical activity
In metabolic equivalent minutes per week. Using the Simple Physical Activity Questionnaire. Higher values represent a higher level of physical activity.
Time frame: 12 weeks
Behavioral Regulation in Exercise
Using the Behavioral Regulation in Exercise Questionnaire. It consists of 24 items1 with a five-point Likert scale, which varied between 1 ("Strongly Disagree") and 4 ("Strongly Agree"). The items were grouped posteriorly into six factors (with four items each). Higher values represent a higher level of motivational continuum of self-determination theory.
Time frame: 12 weeks
Adherence
In percent. Adherence will be evaluated by the percentage of attendance with respect to the total number of minutes of intervention.
Time frame: 12 weeks
Dropout
In percent. Dropout will be study by the percent drop relative to the total subjects began intervention.
Time frame: 12 weeks
Body weight
In kilograms. Using the InBody 770 Body Composition Analyzer (Biospace Ltd, Seoul, Korea)
Time frame: 12 weeks
Fat mass
In kilograms. Using the InBody 770 Body Composition Analyzer (Biospace Ltd, Seoul, Korea)
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Time frame: 12 weeks
Lean mass
In kilograms. Using the InBody 770 Body Composition Analyzer (Biospace Ltd, Seoul, Korea)
Time frame: 12 weeks
Waist circumference
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
Hip circumference
In millimeters. Using a measuring tape (Harpenden Anthropometric Tape; Holtain, Dyfed, UK) placed atthe maximum width over the greater trochanters
Time frame: 12 weeks
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.
Time frame: 12 weeks
Quality of Life
Using the European Quality of Life-5 Dimensions Questionnaire.The descriptive system contains five dimensions of health (mobility, personal care, daily activities, pain / discomfort and anxiety / depression) and each of them has three levels of severity (no problems, some moderate or severe problems and problems). Scores range from 0 to 1 point, with higher scores indicating better quality of life.
Time frame: 12 weeks
Self-Reported Physical Fitness
Using "The International Fitness Scale" (IFIS) questionnaire. The IFIS consists of a Likert-type scale (range 1-5) with five response options (very poor, poor, average, good, and very good) about perceived overall fitness, and its main components are cardiorespiratory fitness, muscular strength, speed-agility, and flexibility. Higher scores indicating better physical fitness.
Time frame: 12 weeks
Lower body strength
In number of full stands. Using the 30-second chair stand test
Time frame: 12 weeks
Upper body strength
In number of bicep curls. Using the 30-second arm curl test.
Time frame: 12 weeks
Handgrip strength
In kilograms. Using a dynamometer (TKK 5401 Grip-D, Takey, Tokyo, Japan)
Time frame: 12 weeks
Cardiorespiratory fitness
In meters. Using the 6-min walk test.
Time frame: 12 weeks
Lower body flexibility
In centimeters. Using the chair sit-and-reach test
Time frame: 12 weeks
Upper body flexibility
In centimeters. Using the back scratch test
Time frame: 12 weeks
Mood
Using the Scale for Mood Assessment. This questionnaire valuates four moods through 16 items divided into four categories: sadness-depression, anxiety, anger/hostility and happiness. Item scores are evaluated with the Likert scales ranging from 0 to 10, higher values represent a higher level of this mood.
Time frame: 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.
Time frame: 12 weeks
Smoking
Using the Fagerström nicotine dependence questionnaire. Score range from 0 to 10 points. Higher values represent a higher nicotine dependece.
Time frame: 12 weeks
Blood glucose
In milligram per deciliter. Collected in the morning after an overnight fast
Time frame: 12 weeks
Blood cholesterol
In milligram per deciliter. Collected in the morning after an overnight fast
Time frame: 12 weeks
Blood triglyceride
In milligram per deciliter. Collected in the morning after an overnight fast
Time frame: 12 weeks