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HIIT in Patients With a First-episode Psychosis

Primary Purpose

First-episode Psychosis

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
High Intensity Interval Training
Sponsored by
Intervención Temprana en Psicosis de Cantabria (ITPCan)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for First-episode Psychosis

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    No Intervention

    Arm Label

    Active Comparator: Experimental group

    No Intervention: Control group

    Arm Description

    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.

    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.

    Outcomes

    Primary Outcome Measures

    Change in weight gain induced by antipsychotic treatment in patients with a first episode of psychosis with a 12-week High Intensity Interval Training.
    Change in weight gain induced by antipsychotic treatment in patients with a first episode of psychosis at 9 months after finishing the intervention.

    Secondary Outcome Measures

    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.
    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.
    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.
    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.

    Full Information

    First Posted
    February 28, 2021
    Last Updated
    March 7, 2021
    Sponsor
    Intervención Temprana en Psicosis de Cantabria (ITPCan)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04792476
    Brief Title
    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

    2. Study Status

    Record Verification Date
    March 2021
    Overall Recruitment Status
    Unknown status
    Study Start Date
    March 1, 2021 (Anticipated)
    Primary Completion Date
    December 31, 2022 (Anticipated)
    Study Completion Date
    December 31, 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Intervención Temprana en Psicosis de Cantabria (ITPCan)

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    First-episode Psychosis

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    48 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Active Comparator: Experimental group
    Arm Type
    Active Comparator
    Arm Description
    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.
    Arm Title
    No Intervention: Control group
    Arm Type
    No Intervention
    Arm Description
    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.
    Intervention Type
    Other
    Intervention Name(s)
    High Intensity Interval Training
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    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
    Title
    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
    Secondary Outcome Measure Information:
    Title
    Change in the lipid metabolism: triglycerides levels, total cholesterol levels, HDL cholesterol levels and LDL cholesterol levels.
    Description
    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.
    Time Frame
    12 weeks and 9 months post-intervention
    Title
    Change in abdominal obesity measured by waist circumference.
    Description
    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.
    Time Frame
    12 weeks and 9 months post-intervention
    Title
    Change in glycemic measured by fasting plasma glucose, glycosylated hemoglobin HbA1c and insulin.
    Description
    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.
    Time Frame
    12 weeks and 9 months post-intervention
    Title
    Change in hypertension measured by blood pressure.
    Description
    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.
    Time Frame
    12 weeks and 9 months post-intervention

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    40 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Jose Antonio Cortés Fernández
    Phone
    685961535
    Ext
    +34
    Email
    josecortesfdez@gmail.com

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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