SchizophreniaE-SNCT03953664
The Effects of Three Different Modalities of Exercise in Patients With Schizophrenia
A study testing Experimental-Exercise training in people with Schizophrenia, run by Cardenal Herrera University at 1 site in Spain.
Trial summary
Exercise has been shown to improve health in patients with schizophrenia. However, it remains unclear which modality of exercise reports better benefits. Aim: To compare the effects of different modalities of exercise training on psychological and physiological variables in schizophrenia. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- Experimental-Exercise training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteSpain
- Study dates
- 14 Jan 2020to 1 Apr 2021
- 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
- Diagnosis of Schizophrenia
- Age between 18-65 years
Who cannot join
- Patients with other mental diseases
- Patients with mental disabilities
- Patients who present motor or behavioral pathologies that prevent the realization of the exercise training.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of Three Different Modalities of Exercise Training (Aerobic, Strength, Aerobic-strength) on Psychological and Physiological Correlates in Schizophrenia: a Randomized Clinical Trial
Exercise has been shown to improve health in patients with schizophrenia. However, it remains unclear which modality of exercise reports better benefits.
Aim: To compare the effects of different modalities of exercise training on psychological and physiological variables in schizophrenia.
Read the detailed description
Exercise has been shown to improve psychological, physiological, and biological correlates in patients with schizophrenia. However, it remains unclear which modality of exercise reports better health benefits.
Aim: To compare the effects of three different modalities of exercise (aerobic, strength, aerobic-strength) on psychological and physiological variables in patients with schizophrenia.
Design: Randomized clinical trial
- Conditions
- Schizophrenia
- Being tested
- Experimental-Exercise training
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental-Exercise trainingOther
Each session lass 60 minutes, during which time 20 minutes are allocated for warming up and cooling down (stretching) and 40 minutes are allocated to strength or/and aerobic training exercises.
| Study group | Role | What they receive |
|---|---|---|
| Experimental-Strength training | Experimental | Each session lass 60 minutes, during which time 20 minutes are allocated for warming up and cooling down (stretching) and 40 minutes are allocated to strength training exercise involving the major muscle groups. Receives: Other: Experimental-Exercise training |
| Experimental-Aerobic training | Experimental | Each session lass 60 minutes, during which time 20 minutes are allocated for warming up and cooling down (stretching) and 40 minutes are allocated to brisk walking. Receives: Other: Experimental-Exercise training |
| Experimental-Strength/Aerobic training | Experimental | Each session lass 60 minutes, during which time 20 minutes are allocated for warming up and cooling down (stretching), 15 minutes are allocated to brisk walking and 25 minutes are allocated to strength training involving the major muscle groups. Receives: Other: Experimental-Exercise training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Positive and Negative Syndrome Scale (PANSS)
Symptoms of schizophrenia are measured according to the subscale scores and total score on the PANSS which consists of 30 items scored from 1 (Absent) to 7 (Extreme). Scores range from 30 to 210, with higher scores indicating more symptoms.
Measured: 16 weeks
Secondary outcomes (2)
World Health Organization Quality of Life-Short version (WHOQOL-BREF)
The WHOQOL-BREF contains 24 questions covering 4 domains plus two questions related to overall quality of life and satisfaction with health. Highes scores represent higher quality of life.
Measured: 16 weeks
Body Mass Index (BMI)
The BMI is defined as the body mass divided by the square of the body height.
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2019
- Study start14 Jan 2020
- Primary completion1 Apr 2021
- Study completion1 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies 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
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cardenal Herrera University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Juan F. Lisón Párraga, Dr, Cardenal Herrera University
- Investigators
- JF Lisón, PhD, Study director, Cardenal Herrera University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03953664
- Sponsor's protocol ID
- UNIVERSITY CARDENAL HERRERA-22
- Acronym
- E-S
- Status last verified
- Jun 2021
- First submitted
- 15 May 2019
- Last updated
- 29 Jun 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual deidentified participant data will be available to other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Three Different Modalities of Exercise Training (Aerobic, Strength, Aerobic-strength) on Psychological and Physiological Correlates in Schizophrenia: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03953664
- Acronym / sponsor ID
- E-S / UNIVERSITY CARDENAL HERRERA-22
- Conditions
- Schizophrenia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Cardenal Herrera UniversityUniversity, hospital or other
- Study start
- 14 Jan 2020 (actual)
- Primary completion
- 1 Apr 2021 (actual)
- Study completion
- 1 Apr 2021 (actual)
- First posted
- 16 May 2019 (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.
Exercise has been shown to improve health in patients with schizophrenia. However, it remains unclear which modality of exercise reports better benefits.
Aim: To compare the effects of different modalities of exercise training on psychological and physiological variables in schizophrenia.
Detailed description
Exercise has been shown to improve psychological, physiological, and biological correlates in patients with schizophrenia. However, it remains unclear which modality of exercise reports better health benefits.
Aim: To compare the effects of three different modalities of exercise (aerobic, strength, aerobic-strength) on psychological and physiological variables in patients with schizophrenia.
Design: Randomized clinical trial
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Experimental-Strength training | Experimental | Other: Experimental-Exercise trainingEach session lass 60 minutes, during which time 20 minutes are allocated for warming up and cooling down (stretching) and 40 minutes are allocated to strength training exercise involving the major muscle groups. |
| Experimental-Aerobic training | Experimental | Other: Experimental-Exercise trainingEach session lass 60 minutes, during which time 20 minutes are allocated for warming up and cooling down (stretching) and 40 minutes are allocated to brisk walking. |
| Experimental-Strength/Aerobic training | Experimental | Other: Experimental-Exercise trainingEach session lass 60 minutes, during which time 20 minutes are allocated for warming up and cooling down (stretching), 15 minutes are allocated to brisk walking and 25 minutes are allocated to strength training involving the major muscle groups. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Diagnosis of Schizophrenia
- Age between 18-65 years
Key exclusion criteria (3 listed)
- Patients with other mental diseases
- Patients with mental disabilities
- Patients who present motor or behavioral pathologies that prevent the realization of the exercise training.
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 |
|---|---|---|
| Experimental-Exercise trainingEach session lass 60 minutes, during which time 20 minutes are allocated for warming up and cooling down (stretching) and 40 minutes are allocated to strength or/and aerobic training exercises. | Other | Experimental-Aerobic training, Experimental-Strength training, Experimental-Strength/Aerobic training |
Primary outcome
Positive and Negative Syndrome Scale (PANSS)
Time frame: 16 weeks
Symptoms of schizophrenia are measured according to the subscale scores and total score on the PANSS which consists of 30 items scored from 1 (Absent) to 7 (Extreme). Scores range from 30 to 210, with higher scores indicating more symptoms.
2 secondary outcomes
World Health Organization Quality of Life-Short version (WHOQOL-BREF)
Time frame: 16 weeks
Body Mass Index (BMI)
Time frame: 16 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 29 Jun 2021.
- Individual participant dataSharing planned: Yes. Individual deidentified participant data will be available to other researchers.
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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.
JF Lisón, PhD study director
Cardenal Herrera University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental-Exercise training in people with Schizophrenia, run by Cardenal Herrera University 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: finished, as of the sponsor's last update on 29 Jun 2021. 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?
Positive and Negative Syndrome Scale (PANSS) (time frame: 16 weeks). 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 29 Jun 2021.