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Exercise TherapyNCT04337398

Exercise in Severe Mental Illness. The PsychiActive Project 2.0

A study testing Exercise training for 12 weeks (wearables) and Exercise training for 12 weeks (wearables and exergames) in people with Exercise Therapy and Severe Mental Illness, run by Universidad Pablo de Olavide at 1 site in Spain.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Exercise Therapy, Severe Mental Illness
What is being tested?
Exercise training for 12 weeks (wearables) and Exercise training for 12 weeks (wearables and exergames)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
1 siteSpain
Study dates
20 Apr 2020to 30 Oct 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Clinical diagnosis of psychiatric disorder (ICD-10).
  • Stabilized antipsychotic medication during the last month.

Who cannot join

  • Clinical instability.
  • Substance abuse.
  • Comorbidities contraindicating.

Trial locations and contacts

1 site in 1 country.

Álvaro López-Moral, MSc contact

627682636 ext. +34

alopmor1@upo.es

Spain1 site, 1 recruiting

  • Álvaro López Moral

    Seville, Andalusia, 41702

    Álvaro López, MSc, 627682635 ext. +34, alopmor1@upo.es

    Recruiting

Other trials in Spain

About this study

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

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.

Being tested
Exercise training for 12 weeks (wearables), Exercise training for 12 weeks (wearables and exergames)
Keywords
Exercise, Severe Mental Illness, Adherence, Wearables, Activity Trackers, Exergames
Medical subject headings
Mental Disorders, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Exercise training for 12 weeks (wearables)Behavioural

    Also called Xiaomi MiBand4

    Activity trackers with adaptive weekly step goals, weekly walking groups and coaching.

  • Exercise training for 12 weeks (wearables and exergames)Behavioural

    Also called Xiaomi MiBand4 and Xbox 360 Kinect

    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).

Study groups in NCT04337398
Study groupRoleWhat they receive
WearablesExperimentalAdults with several mental illness
Receives: Behavioral: Exercise training for 12 weeks (wearables)
Wearables and exergamesExperimentalAdults with several mental illness
Receives: Behavioral: Exercise training for 12 weeks (wearables and exergames)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 12 weeks

  2. 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.

    Measured: 12 weeks

  3. 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.

    Measured: 12 weeks

  4. Adherence

    In percent. Adherence will be evaluated by the percentage of attendance with respect to the total number of minutes of intervention.

    Measured: 12 weeks

  5. Dropout

    In percent. Dropout will be study by the percent drop relative to the total subjects began intervention.

    Measured: 12 weeks

  6. Body weight

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

    Measured: 12 weeks

  7. Fat mass

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

    Measured: 12 weeks

  8. Lean mass

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

    Measured: 12 weeks

  9. 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

    Measured: 12 weeks

  10. Hip circumference

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

    Measured: 12 weeks

  11. 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.

    Measured: 12 weeks

  12. 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.

    Measured: 12 weeks

  13. 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.

    Measured: 12 weeks

Secondary outcomes (12)

  1. Lower body strength

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

    Measured: 12 weeks

  2. Upper body strength

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

    Measured: 12 weeks

  3. Handgrip strength

    In kilograms. Using a dynamometer (TKK 5401 Grip-D, Takey, Tokyo, Japan)

    Measured: 12 weeks

  4. Cardiorespiratory fitness

    In meters. Using the 6-min walk test.

    Measured: 12 weeks

  5. Lower body flexibility

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

    Measured: 12 weeks

  6. Upper body flexibility

    In centimeters. Using the back scratch test

    Measured: 12 weeks

  7. 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.

    Measured: 12 weeks

  8. Psychopathological symptoms

    Using the Brief Symptom Inventory-18 questionnaire. Score range from 0 to 72 points. Higher values represent a higher psychopathological severity.

    Measured: 12 weeks

  9. Smoking

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

    Measured: 12 weeks

  10. Blood glucose

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

    Measured: 12 weeks

  11. Blood cholesterol

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

    Measured: 12 weeks

  12. Blood triglyceride

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

    Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Apr 2020
  2. Study start20 Apr 2020 (estimated)
  3. Primary completion20 May 2020 (estimated)
  4. Study completion30 Oct 2020 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
80 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04337398
Sponsor's protocol ID
CTS948AFS20
Status last verified
Apr 2020
First submitted
31 Mar 2020
Last updated
7 Apr 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Exercise training for 12 weeks (wearables) and Exercise training for 12 weeks (wearables and exergames) in people with Exercise Therapy and Severe Mental Illness, run by Universidad Pablo de Olavide at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 7 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Álvaro López-Moral, MSc (627682636 ext. +34, alopmor1@upo.es), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Self-reported sedentary behavior (time frame: 12 weeks). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04337398.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2020.

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