ClinicalTrials.gg
CompletedNCT03352544Updated Sep 5, 2018

Exercise in Severe Mental Illness. The PsychiActive Project

An interventional study of Exercise in Exercise Therapy, sponsored by Universidad Pablo de Olavide. Completed at 1 site in Spain. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2018-09-05.

Sponsored by Universidad Pablo de Olavide · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 2 years 7 months after the study started (first participant enrolled Mar 2015, registered Nov 2017).
Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Exercise Therapy
03

In context

Lead sponsor

Universidad Pablo de Olavide is the lead sponsor of 6 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

Patients with clinical instability, co-morbid substance abuse, or evidence of uncontrolled cardiovascular, neuromuscular and endocrine disorders.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
50 participants (actual)

Study arms

  • Experimental
    Exercise

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

    Behavioral: Exercise

  • No intervention
    Usual treatment

    Usual treatment during 12 weeks, coinciding with exercise intervention time frame.

Interventions

  • BehavioralExercise

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

    Also known as: Exercise training

06

What researchers measure

Primary outcomes

  1. Body weight

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

    Time frame: 12 weeks

  2. Fat mass

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

    Time frame: 12 weeks

  3. Lean mass

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

    Time frame: 12 weeks

  4. Waist girth

    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

  5. Hip girth

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

    Time frame: 12 weeks

  6. Blood glucose

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

    Time frame: 12 weeks

  7. Blood cholesterol

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

    Time frame: 12 weeks

  8. Blood triglyceride

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

    Time frame: 12 weeks

Secondary outcomes

  1. Lower body strength

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

    Time frame: 12 weeks

  2. Upper body strength

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

    Time frame: 12 weeks

  3. Aerobic endurance

    In meters. Using the 6-min walk test

    Time frame: 12 weeks

  4. Lower body flexibility

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

    Time frame: 12 weeks

  5. Upper body flexibility

    In centimeters. Using the back scratch test

    Time frame: 12 weeks

  6. Dynamic balance

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

    Time frame: 12 weeks

  7. Static balance

    In seconds. Using the stork balance test

    Time frame: 12 weeks

  8. Forced vital capacity

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

    Time frame: 12 weeks

  9. 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

  10. Quality of life

    Using the Tolerability and Quality of Life questionnaire. Score range from 8 to 32 points. Higher lower represent a better quality of life.

    Time frame: 12 weeks

  11. 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

  12. Anxiety symptoms

    Using the Beck Anxiety Inventory questionnaire. Score range from 0 to 63 points. Higher values represent a higher level of anxiety.

    Time frame: 12 weeks

  13. Depression symptoms

    Using the Beck depression inventory-II questionnaire. Score range from 0 to 63 points. Higher values represent a higher level of depression.

    Time frame: 12 weeks

  14. Self-Esteem

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

    Time frame: 12 weeks

  15. Physical activity

    Using the Short form International Physical Activity Questionnaire. In metabolic equivalent minutes per week. Higher values represent a higher level of physical activity.

    Time frame: 12 weeks

  16. 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

07

Study locations

1 site
  • Universidad Pablo de Olavide
    Sevilla, Spain
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Mar 2015 to primary completion in Aug 2015, 4 months.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 10, 2017
First posted
Nov 24, 2017
StartActual
Mar 16, 2015
Primary completionActual
Aug 5, 2015
CompletionActual
Dec 23, 2015
Last update
Sep 5, 2018
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 5, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03352544
Lead sponsor
Universidad Pablo de Olavide
Responsible party
Javier Bueno-Antequera (Principal Investigator, Universidad Pablo de Olavide) — Principal investigator
First posted
Nov 24, 2017
Start date
Mar 16, 2015
Primary completion
Aug 5, 2015
Completion
Dec 23, 2015
Last update
Sep 5, 2018

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2018. You cannot join it, but the record below documents what was studied.

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