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Completed

NCT Number: NCT03352544

Exercise in Severe Mental Illness. The PsychiActive Project

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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Key information

Conditions

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universidad Pablo de Olavide

Seville, Spain

Who can participate

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.

Treatment and study plan

Exercise

Behavioral

Exercise training for 12 weeks (aerobic and resistance training trice a week)

Other names: Exercise training

Primary outcomes

  1. Body weight

    Time frame: 12 weeks

    In kilograms. Using the InBody 770 Body Composition Analyzer (Biospace Ltd, Seoul, Korea)

  2. Fat mass

    Time frame: 12 weeks

    In kilograms. Using the InBody 770 Body Composition Analyzer (Biospace Ltd, Seoul, Korea)

  3. Lean mass

    Time frame: 12 weeks

    In kilograms. Using the InBody 770 Body Composition Analyzer (Biospace Ltd, Seoul, Korea)

  4. Waist girth

    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

  5. Hip girth

    Time frame: 12 weeks

    In millimeters. Using a measuring tape (Harpenden Anthropometric Tape; Holtain, Dyfed, UK) placed atthe maximum width over the greater trochanters

  6. Blood glucose

    Time frame: 12 weeks

    In milligram per deciliter. Collected in the morning after an overnight fast

  7. Blood cholesterol

    Time frame: 12 weeks

    In milligram per deciliter. Collected in the morning after an overnight fast

  8. Blood triglyceride

    Time frame: 12 weeks

    In milligram per deciliter. Collected in the morning after an overnight fast

Secondary outcomes

  1. Lower body strength

    Time frame: 12 weeks

    In number of full stands. Using the 30-second chair stand test

  2. Upper body strength

    Time frame: 12 weeks

    In number of bicep curls. Using the 30-second arm curl test

  3. Aerobic endurance

    Time frame: 12 weeks

    In meters. Using the 6-min walk test

  4. Lower body flexibility

    Time frame: 12 weeks

    In centimeters. Using the chair sit-and-reach test

  5. Upper body flexibility

    Time frame: 12 weeks

    In centimeters. Using the back scratch test

  6. Dynamic balance

    Time frame: 12 weeks

    In seconds. Using the 8-foot up-and-go test

  7. Static balance

    Time frame: 12 weeks

    In seconds. Using the stork balance test

  8. Forced vital capacity

    Time frame: 12 weeks

    In liters. Using spirometry (Spirolab II. Medical International Research, Rome, Italy)

  9. Health status

    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.

  10. Quality of life

    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.

  11. Psychopathological symptoms

    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.

  12. Anxiety symptoms

    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.

  13. Depression symptoms

    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.

  14. Self-Esteem

    Time frame: 12 weeks

    Using the Rosenberg Self-Esteem Scale. Score range from 10 to 40 points. Higher values represent a higher self-esteem.

  15. Physical activity

    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.

  16. Smoking

    Time frame: 12 weeks

    Using the Fagerström nicotine dependence questionnaire. Score range from 0 to 10 points. Higher values represent a higher nicotine dependece.

Sponsors and collaborators

Lead sponsor

Universidad Pablo de Olavide

Other

Registry information

Official study title

Exercise Training in Patients With Severe Mental Illness. The PsychiActive Project

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Nov 24, 2017
Registry last updated
Sep 5, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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