NCT04792476

HIIT in Patients With a First-episode Psychosis

High Intensity Interval Training to Prevent Weight Gain in Patients With a First-episode Psychosis: a Randomized Clinical Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 48 (estimated)
• Sponsor: Intervención Temprana en Psicosis de Cantabria (ITPCan) · Academic / Other
• Sex: All
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

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.

Conditions

• First-episode Psychosis

Interventions

Type	Name	Description
OTHER	High Intensity Interval Training	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.

Timeline

• Start date: 2021-03-01
• Primary completion: 2022-12-31
• Completion: 2022-12-31
• First posted: 2021-03-11
• Last updated: 2021-03-11