Exercise in Severe Mental Illness. The PsychiActive Project 2.0

Exercise Therapy Clinical Trial

Official title:

Feasibility, Adherence and Effects of Two Exercise-based Interventions in Adults With Severe Mental Illness. The PsychiActive Project 2.0

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04337398
• Other study ID #: CTS948AFS20
• Status: Recruiting
• Phase: N/A
• Start date: April 20, 2020
• Est. completion date: October 30, 2020

Study information

• Verified date: April 2020
• Source: Universidad Pablo de Olavide
• Contact: Álvaro López-Moral, MSc
• Phone: 627682636
• Email: alopmor1[@]upo.es
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: October 30, 2020
• Est. primary completion date: May 20, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Clinical diagnosis of psychiatric disorder (ICD-10).

• Stabilized antipsychotic medication during the last month.

Exclusion Criteria:

• Clinical instability.

• Substance abuse.

• Comorbidities contraindicating.

Related Conditions & MeSH terms

• Exercise Therapy
• Mental Disorders
• Severe Mental Illness

Intervention

Behavioral:
• Exercise training for 12 weeks (wearables)
Activity trackers with adaptive weekly step goals, weekly walking groups and coaching.
• Exercise training for 12 weeks (wearables and exergames)
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).

Locations

Country	Name	City	State
Spain	Álvaro López Moral	Sevilla	Andalucia

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	Self-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.	12 weeks
Primary	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.	12 weeks
Primary	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.	12 weeks
Primary	Adherence	In percent. Adherence will be evaluated by the percentage of attendance with respect to the total number of minutes of intervention.	12 weeks
Primary	Dropout	In percent. Dropout will be study by the percent drop relative to the total subjects began intervention.	12 weeks
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 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	12 weeks
Primary	Hip circumference	In millimeters. Using a measuring tape (Harpenden Anthropometric Tape; Holtain, Dyfed, UK) placed atthe maximum width over the greater trochanters	12 weeks
Primary	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
Primary	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.	12 weeks
Primary	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.	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	Handgrip strength	In kilograms. Using a dynamometer (TKK 5401 Grip-D, Takey, Tokyo, Japan)	12 weeks
Secondary	Cardiorespiratory fitness	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	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.	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	Smoking	Using the Fagerström nicotine dependence questionnaire. Score range from 0 to 10 points. Higher values represent a higher nicotine dependece.	12 weeks
Secondary	Blood glucose	In milligram per deciliter. Collected in the morning after an overnight fast	12 weeks
Secondary	Blood cholesterol	In milligram per deciliter. Collected in the morning after an overnight fast	12 weeks
Secondary	Blood triglyceride	In milligram per deciliter. Collected in the morning after an overnight fast	12 weeks