First-episode PsychosisNCT04792476
HIIT in Patients With a First-episode Psychosis
A study testing High Intensity Interval Training in people with First-episode Psychosis, run by Intervención Temprana en Psicosis de Cantabria (ITPCan).
Trial summary
This study aims to estimate the effect of a 3-month High Intensity Interval Training on antipsychotic-induced weight gain in patients with a first episode of psychosis, as well as to determine whether these effects are maintained 9 months after the intervention has ended. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- First-episode Psychosis
- What is being tested?
- High Intensity Interval Training
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2021to 31 Dec 2022
- 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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age ≥18 years and ≤40 years.
- Treatment with antipsychotic medication ≤6 weeks.
- Diagnosis of First Episode Psychosis, for inclusion in the ITPCan Clinical Program.
Who cannot join
- Pregnancy or breastfeeding
- Poorly controlled diabetes.
- Moderate or severe intellectual disability.
- Current High Intensity Interval Training program.
- Any systematic disease that contraindicates High Intensity Interval Training.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: High Intensity Interval Training to Prevent Weight Gain in Patients With a First-episode Psychosis: a Randomized Clinical Trial
This study aims to estimate the effect of a 3-month High Intensity Interval Training on antipsychotic-induced weight gain in patients with a first episode of psychosis, as well as to determine whether these effects are maintained 9 months after the intervention has ended.
Read the detailed description
Weight gain associated with antipsychotic medication has been recognized for years as a very common side effect, occurring mainly during the first months after the start of antipsychotic treatment. Patients with schizophrenia have a risk of obesity 1.5-2 times higher than the general population and the chances of developing physical problems such as hypertension, diabetes, metabolic syndrome, and coronary heart disease are also higher. Patients diagnosed with schizophrenia have a life expectancy of up to 25 years lower than the general population, with cardiovascular disease being the main cause of premature death. The first months of treatment constitute a critical period for the implementation of strategies that could prevent or mitigate this side effect of the medication, as well as the adverse consequences derived from weight gain.
This project is the response to the need to implement physical exercise interventions to prevent weight gain in patients with a first psychotic episode.To date, there is little evidence from randomized clinical trials that have used physical exercise as the only intervention to prevent weight gain in the first weeks from the start of antipsychotic treatment.
Numerous systematic reviews and meta-analyses have evaluated non-pharmacological interventions to reduce weight in people with severe mental illness, including chronic psychotic disorders. However, there is little research on this type of intervention in patients with a first episode of psychosis. Studies are needed that implement physical exercise programs from the initial phases of antipsychotic treatment, and that are capable of defining the parameters used in the design of an effective physical exercise intervention for the prevention of weight gain in first psychotic episodes.
- Conditions
- First-episode Psychosis
- Being tested
- High Intensity Interval Training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High Intensity Interval TrainingOther
Experimental group will receive, in addition to the conventional treatment, a physical exercise intervention along 12 weeks, which will consist of complying with the general recommendations for physical activity: 75 minutes weekly of high intensity physical exercise. The therapeutic exercise intervention will be supervised by a physiotherapist and designed in a progressive, structured and personalized way.
| Study group | Role | What they receive |
|---|---|---|
| Active Comparator: Experimental group | Active comparator | The experimental group will receive, in addition to the conventional treatment, a physical exercise intervention along 12 weeks, which will consist of complying with the general recommendations for physical activity: 75 minutes weekly of high intensity physical exercise. The therapeutic exercise intervention will be supervised by a physiotherapist and designed in a progressive, structured and personalized way. Receives: Other: High Intensity Interval Training |
| No Intervention: Control group | No intervention | The control group will only receive the conventional treatment offered in the clinical program. For 12 weeks, parients will attend 8 visits with mental health specialist nurse, where they will receive information, oral and written, to comply with the recommendations for physical exercise: 150-300 min/week of moderate physical activity or 75-150 min/week of vigorous physical activity. In both groups (experimental and control), patients will be informed of the risk of weight gain, and they will be advised, regardless of the group assigned, to watch their diet and increase physical exercise until they meet the weekly recommendations. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in weight gain induced by antipsychotic treatment in patients with a first episode of psychosis with a 12-week High Intensity Interval Training.
Measured: 12 weeks
Change in weight gain induced by antipsychotic treatment in patients with a first episode of psychosis at 9 months after finishing the intervention.
Measured: 9 months post-intervention
Secondary outcomes (4)
Change in the lipid metabolism: triglycerides levels, total cholesterol levels, HDL cholesterol levels and LDL cholesterol levels.
Dyslipidemia is an abnormal amount of lipids (e.g.,triglycerides, cholesterol and/or fat phospholipids) in the blood.
The normal triglyceride level is between 30 and 150 mg/dL. The normal HDL cholesterol level is between 40 and 60 mg/dL.
Measured: 12 weeks and 9 months post-intervention
Change in abdominal obesity measured by waist circumference.
Abdominal obesity, also known as central obesity, is when excessive abdominal fat around the stomach and abdomen has built up to the extent that it is likely to have a negative impact on health.
Men are considered to be at high risk from abdominal obesity if their waist measurements are 102 cm or higher, while women are considered to be at high risk if their waist measurements are 88 cm or higher.
Measured: 12 weeks and 9 months post-intervention
Change in glycemic measured by fasting plasma glucose, glycosylated hemoglobin HbA1c and insulin.
Hyperglycemia, or high blood sugar (also spelled hyperglycaemia) is a condition in which an excessive amount of glucose circulates in the blood plasma.
A subject with a consistent range between 100-126 mg/dl is considered hyperglycemic, while above 126 mg/dl is generally held to have diabetes.
Measured: 12 weeks and 9 months post-intervention
Change in hypertension measured by blood pressure.
Hypertension (HTN or HT), also known as high blood pressure (HBP), is a long term medical condition in which the blood pressure in the arteries is persistently elevated.
Blood pressure is expressed by two measurements, the systolic and diastolic pressures, which are the maximum and minimum pressures, respectively. Normal blood pressure at rest is within the range of 100-130 millimeters mercury (mmHg) systolic and 60-85 mmHg diastolic.
Measured: 12 weeks and 9 months post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2021
- Study start1 Mar 2021 (estimated)
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for First-episode PsychosisStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Intervención Temprana en Psicosis de Cantabria (ITPCan)
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jose Antonio Cortés Fernández, Intervención Temprana en Psicosis de Cantabria (ITPCan)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04792476
- Sponsor's protocol ID
- ITPCan
- Status last verified
- Mar 2021
- First submitted
- 28 Feb 2021
- Last updated
- 11 Mar 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High Intensity Interval Training to Prevent Weight Gain in Patients With a First-episode Psychosis: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04792476
- Acronym / sponsor ID
- ITPCan
- Conditions
- First-episode Psychosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Intervención Temprana en Psicosis de Cantabria (ITPCan)University, hospital or other
- Study start
- 1 Mar 2021 (estimated)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 11 Mar 2021 (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.
This study aims to estimate the effect of a 3-month High Intensity Interval Training on antipsychotic-induced weight gain in patients with a first episode of psychosis, as well as to determine whether these effects are maintained 9 months after the intervention has ended.
Detailed description
Weight gain associated with antipsychotic medication has been recognized for years as a very common side effect, occurring mainly during the first months after the start of antipsychotic treatment. Patients with schizophrenia have a risk of obesity 1.5-2 times higher than the general population and the chances of developing physical problems such as hypertension, diabetes, metabolic syndrome, and coronary heart disease are also higher. Patients diagnosed with schizophrenia have a life expectancy of up to 25 years lower than the general population, with cardiovascular disease being the main cause of premature death. The first months of treatment constitute a critical period for the implementation of strategies that could prevent or mitigate this side effect of the medication, as well as the adverse consequences derived from weight gain.
This project is the response to the need to implement physical exercise interventions to prevent weight gain in patients with a first psychotic episode.To date, there is little evidence from randomized clinical trials that have used physical exercise as the only intervention to prevent weight gain in the first weeks from the start of antipsychotic treatment.
Numerous systematic reviews and meta-analyses have evaluated non-pharmacological interventions to reduce weight in people with severe mental illness, including chronic psychotic disorders. However, there is little research on this type of intervention in patients with a first episode of psychosis. Studies are needed that implement physical exercise programs from the initial phases of antipsychotic treatment, and that are capable of defining the parameters used in the design of an effective physical exercise intervention for the prevention of weight gain in first psychotic episodes.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active Comparator: Experimental group | Active comparator | Other: High Intensity Interval TrainingThe experimental group will receive, in addition to the conventional treatment, a physical exercise intervention along 12 weeks, which will consist of complying with the general recommendations for physical activity: 75 minutes weekly of high intensity physical exercise. The therapeutic exercise intervention will be supervised by a physiotherapist and designed in a progressive, structured and personalized way. |
| No Intervention: Control group | No intervention | –The control group will only receive the conventional treatment offered in the clinical program. For 12 weeks, parients will attend 8 visits with mental health specialist nurse, where they will receive information, oral and written, to comply with the recommendations for physical exercise: 150-300 min/week of moderate physical activity or 75-150 min/week of vigorous physical activity. In both groups (experimental and control), patients will be informed of the risk of weight gain, and they will be advised, regardless of the group assigned, to watch their diet and increase physical exercise until they meet the weekly recommendations. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Age ≥18 years and ≤40 years.
- Treatment with antipsychotic medication ≤6 weeks.
- Diagnosis of First Episode Psychosis, for inclusion in the ITPCan Clinical Program.
Key exclusion criteria (5 listed)
- Pregnancy or breastfeeding
- Poorly controlled diabetes.
- Moderate or severe intellectual disability.
- Current High Intensity Interval Training program.
- Any systematic disease that contraindicates High Intensity Interval 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 |
|---|---|---|
| High Intensity Interval TrainingExperimental group will receive, in addition to the conventional treatment, a physical exercise intervention along 12 weeks, which will consist of complying with the general recommendations for physical activity: 75 minutes weekly of high intensity physical exercise. The therapeutic exercise intervention will be supervised by a physiotherapist and designed in a progressive, structured and personalized way. | Other | Active Comparator: Experimental group |
Primary outcome
Change in weight gain induced by antipsychotic treatment in patients with a first episode of psychosis with a 12-week High Intensity Interval Training.
Time frame: 12 weeks
Change in weight gain induced by antipsychotic treatment in patients with a first episode of psychosis at 9 months after finishing the intervention.
Time frame: 9 months post-intervention
4 secondary outcomes
Change in the lipid metabolism: triglycerides levels, total cholesterol levels, HDL cholesterol levels and LDL cholesterol levels.
Time frame: 12 weeks and 9 months post-intervention
Change in abdominal obesity measured by waist circumference.
Time frame: 12 weeks and 9 months post-intervention
Change in glycemic measured by fasting plasma glucose, glycosylated hemoglobin HbA1c and insulin.
Time frame: 12 weeks and 9 months post-intervention
Change in hypertension measured by blood pressure.
Time frame: 12 weeks and 9 months post-intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2021.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A study testing High Intensity Interval Training in people with First-episode Psychosis, run by Intervención Temprana en Psicosis de Cantabria (ITPCan).
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 3 inclusion and 5 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 11 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
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 Jose Antonio Cortés Fernández (685961535 ext. +34, josecortesfdez@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in weight gain induced by antipsychotic treatment in patients with a first episode of psychosis with a 12-week High Intensity Interval Training. (time frame: 12 weeks). The study lists 2 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 11 Mar 2021.