HIIT in Patients With a First-episode Psychosis

NCT04792476 | Unknown

• 1 other identifier: ITPCan
• Study Type: interventional
• Target: 48
• Locations: 0 countries
• Sites: N/A

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.

Conditions

First-episode Psychosis

Outcome Measures

Primary Outcomes (2)

• Change in weight gain induced by antipsychotic treatment in patients with a first episode of psychosis with a 12-week High Intensity Interval Training.

  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.

  9 months post-intervention

Secondary Outcomes (4)

• Change in the lipid metabolism: triglycerides levels, total cholesterol levels, HDL cholesterol levels and LDL cholesterol levels.

  12 weeks and 9 months post-intervention

• Change in abdominal obesity measured by waist circumference.

  12 weeks and 9 months post-intervention

• Change in glycemic measured by fasting plasma glucose, glycosylated hemoglobin HbA1c and insulin.

  12 weeks and 9 months post-intervention

• Change in hypertension measured by blood pressure.

  12 weeks and 9 months post-intervention

Study Arms (2)

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.

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.

Interventions

High Intensity Interval Training OTHER

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.

Active Comparator: Experimental group

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Age ≥18 years and ≤40 years.
• Treatment with antipsychotic medication ≤6 weeks.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Intervención Temprana en Psicosis de Cantabria (ITPCan): lead

MeSH Terms

Interventions

High-Intensity Interval Training

Intervention Hierarchy (Ancestors)

Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Jose Antonio Cortés Fernández

CONTACT

685961535; josecortesfdez@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 28, 2021
• First Posted: March 11, 2021
• Study Start: March 1, 2021
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: March 11, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share