Clinical trial NCT04792476: HIIT in Patients With a First-episode Psychosis
Official title: High Intensity Interval Training to Prevent Weight Gain in Patients With a First-episode Psychosis: a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: First-episode Psychosis
Lead sponsor: Intervención Temprana en Psicosis de Cantabria (ITPCan)
Sponsor class: OTHER
First posted: 2021-03-11
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* Age ≥18 years and ≤40 years.
* Treatment with antipsychotic medication ≤6 weeks.
* Diagnosis of First Episode Psychosis, for inclusion in the ITPCan Clinical Program.

Exclusion Criteria:

* 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.

Primary outcomes:
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.
timeFrame: 12 weeks
measure: Change in weight gain induced by antipsychotic treatment in patients with a first episode of psychosis at 9 months after finishing the intervention.
timeFrame: 9 months post-intervention
Secondary outcomes:
measure: Change in the lipid metabolism: triglycerides levels, total cholesterol levels, HDL cholesterol levels and LDL cholesterol levels.
timeFrame: 12 weeks and 9 months post-intervention
measure: Change in abdominal obesity measured by waist circumference.
timeFrame: 12 weeks and 9 months post-intervention
measure: Change in glycemic measured by fasting plasma glucose, glycosylated hemoglobin HbA1c and insulin.
timeFrame: 12 weeks and 9 months post-intervention
measure: Change in hypertension measured by blood pressure.
timeFrame: 12 weeks and 9 months post-intervention
Other outcomes:
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