Exercise TherapyNCT03352544
Exercise in Severe Mental Illness. The PsychiActive Project
A study testing Exercise in people with Exercise Therapy, run by Universidad Pablo de Olavide at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Exercise Therapy
- What is being tested?
- Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteSpain
- Study dates
- 16 Mar 2015to 23 Dec 2015
- 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
- Patients with severe mental illness established by experienced psychiatrists, aged 18 years or older and stabilized on antipsychotic medication during the last month.
Who cannot join
- Patients with clinical instability, co-morbid substance abuse, or evidence of uncontrolled cardiovascular, neuromuscular and endocrine disorders.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Exercise Training in Patients With 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.
- Conditions
- Exercise Therapy
- Being tested
- Exercise
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseBehavioural
Also called Exercise training
Exercise training for 12 weeks (aerobic and resistance training trice a week)
| Study group | Role | What they receive |
|---|---|---|
| Exercise | Experimental | Exercise training for 12 weeks (aerobic and resistance training trice a week). Receives: Behavioral: Exercise |
| Usual treatment | No intervention | Usual treatment during 12 weeks, coinciding with exercise intervention time frame. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body weight
In kilograms. Using the InBody 770 Body Composition Analyzer (Biospace Ltd, Seoul, Korea)
Measured: 12 weeks
Fat mass
In kilograms. Using the InBody 770 Body Composition Analyzer (Biospace Ltd, Seoul, Korea)
Measured: 12 weeks
Lean mass
In kilograms. Using the InBody 770 Body Composition Analyzer (Biospace Ltd, Seoul, Korea)
Measured: 12 weeks
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
Measured: 12 weeks
Hip girth
In millimeters. Using a measuring tape (Harpenden Anthropometric Tape; Holtain, Dyfed, UK) placed atthe maximum width over the greater trochanters
Measured: 12 weeks
Blood glucose
In milligram per deciliter. Collected in the morning after an overnight fast
Measured: 12 weeks
Blood cholesterol
In milligram per deciliter. Collected in the morning after an overnight fast
Measured: 12 weeks
Blood triglyceride
In milligram per deciliter. Collected in the morning after an overnight fast
Measured: 12 weeks
Secondary outcomes (16)
Lower body strength
In number of full stands. Using the 30-second chair stand test
Measured: 12 weeks
Upper body strength
In number of bicep curls. Using the 30-second arm curl test
Measured: 12 weeks
Aerobic endurance
In meters. Using the 6-min walk test
Measured: 12 weeks
Lower body flexibility
In centimeters. Using the chair sit-and-reach test
Measured: 12 weeks
Upper body flexibility
In centimeters. Using the back scratch test
Measured: 12 weeks
Dynamic balance
In seconds. Using the 8-foot up-and-go test
Measured: 12 weeks
Static balance
In seconds. Using the stork balance test
Measured: 12 weeks
Forced vital capacity
In liters. Using spirometry (Spirolab II. Medical International Research, Rome, Italy)
Measured: 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.
Measured: 12 weeks
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.
Measured: 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.
Measured: 12 weeks
Anxiety symptoms
Using the Beck Anxiety Inventory questionnaire. Score range from 0 to 63 points. Higher values represent a higher level of anxiety.
Measured: 12 weeks
Depression symptoms
Using the Beck depression inventory-II questionnaire. Score range from 0 to 63 points. Higher values represent a higher level of depression.
Measured: 12 weeks
Self-Esteem
Using the Rosenberg Self-Esteem Scale. Score range from 10 to 40 points. Higher values represent a higher self-esteem.
Measured: 12 weeks
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.
Measured: 12 weeks
Smoking
Using the Fagerström nicotine dependence questionnaire. Score range from 0 to 10 points. Higher values represent a higher nicotine dependece.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2017
- Study start16 Mar 2015
- Primary completion5 Aug 2015
- Study completion23 Dec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Exercise TherapyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Pablo de Olavide
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Javier Bueno-Antequera, Universidad Pablo de Olavide
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03352544
- Sponsor's protocol ID
- CTS948AFS17
- Status last verified
- Sep 2018
- First submitted
- 10 Nov 2017
- Last updated
- 5 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exercise Training in Patients With Severe Mental Illness. The PsychiActive Project
- ClinicalTrials.gov ID
- NCT03352544
- Acronym / sponsor ID
- CTS948AFS17
- Conditions
- Exercise Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Universidad Pablo de OlavideUniversity, hospital or other
- Study start
- 16 Mar 2015 (actual)
- Primary completion
- 5 Aug 2015 (actual)
- Study completion
- 23 Dec 2015 (actual)
- First posted
- 24 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise | Experimental | Behavioral: ExerciseExercise training for 12 weeks (aerobic and resistance training trice a week). |
| Usual treatment | No intervention | –Usual treatment during 12 weeks, coinciding with exercise intervention time frame. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with severe mental illness established by experienced psychiatrists, aged 18 years or older and stabilized on antipsychotic medication during the last month.
Key exclusion criteria (1 listed)
- Patients with clinical instability, co-morbid substance abuse, or evidence of uncontrolled cardiovascular, neuromuscular and endocrine disorders.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ExerciseAlso: Exercise trainingExercise training for 12 weeks (aerobic and resistance training trice a week) | Behavioural | Exercise |
Primary outcome
Body weight
Time frame: 12 weeks
In kilograms. Using the InBody 770 Body Composition Analyzer (Biospace Ltd, Seoul, Korea)
Fat mass
Time frame: 12 weeks
In kilograms. Using the InBody 770 Body Composition Analyzer (Biospace Ltd, Seoul, Korea)
Lean mass
Time frame: 12 weeks
In kilograms. Using the InBody 770 Body Composition Analyzer (Biospace Ltd, Seoul, Korea)
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
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
Blood glucose
Time frame: 12 weeks
In milligram per deciliter. Collected in the morning after an overnight fast
Blood cholesterol
Time frame: 12 weeks
In milligram per deciliter. Collected in the morning after an overnight fast
Blood triglyceride
Time frame: 12 weeks
In milligram per deciliter. Collected in the morning after an overnight fast
16 secondary outcomes
Lower body strength
Time frame: 12 weeks
Upper body strength
Time frame: 12 weeks
Aerobic endurance
Time frame: 12 weeks
Lower body flexibility
Time frame: 12 weeks
Upper body flexibility
Time frame: 12 weeks
Dynamic balance
Time frame: 12 weeks
Static balance
Time frame: 12 weeks
Forced vital capacity
Time frame: 12 weeks
Health status
Time frame: 12 weeks
Quality of life
Time frame: 12 weeks
Psychopathological symptoms
Time frame: 12 weeks
Anxiety symptoms
Time frame: 12 weeks
Depression symptoms
Time frame: 12 weeks
Self-Esteem
Time frame: 12 weeks
Physical activity
Time frame: 12 weeks
Smoking
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise in people with Exercise Therapy, 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 5 Sep 2018. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body weight (time frame: 12 weeks). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Sep 2018.