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ACTIVE NOT RECRUITING
NCT05461885
NA

Value of Gym-based Exercise Training for Young Adults Receiving Antipsychotic Medication: The Vega Trial

Sponsor: Rigshospitalet, Denmark

View on ClinicalTrials.gov

Summary

This is a multicentre, pragmatic, randomised controlled trial to estimate the effect of a 4-month gym-based exercise training program on 1) patient-rated personal recovery (primary outcome), 2) Health-related quality of life, behavioral and functional symptoms, and cardiometabolic risk factors (secondary outcomes) in young adults with psychotic disorders. Four-hundred antipsychotic-treated young adults (between the age of 18 and 35), who are capable to undertake an exercise program (potentially with a friend or family member where possible) will be recruited from outpatient treatment units and mental health services. Participants will be randomised to treatment as usual or exercise at a 2:1 ratio in favor of exercise. Outcomes will be measured at baseline and at 4, 6 and 12 months after randomisation, by researchers masked to participant allocation.

Official title: Value of Gym-based Exercise Training for Young Adults Receiving Antipsychotic Medication: A Pragmatic, Single-blinded, Multicenter Randomized Controlled Trial

Key Details

Gender

All

Age Range

18 Years - 35 Years

Study Type

INTERVENTIONAL

Enrollment

400

Start Date

2022-10-25

Completion Date

2026-01

Last Updated

2025-04-30

Healthy Volunteers

No

Interventions

BEHAVIORAL

Supervised exercise

The exercise sessions start with warm-up exercises, followed by 10-20 minutes resistance training (Part A), 10-20 minutes High Intensity Functional Training (HIFT) (Part B) and cool down. Instructors are allowed to make local adjustments as the delivery of the intervention is considered pragmatic. The participants can either perform the exercise together as one group, in pairs or one-by-one depending on individual needs and requests.

Locations (4)

Aalborg University Hospital

Aalborg, Denmark

Aarhus University Hospital

Aarhus, Denmark

Mental Health Centre Copenhagen

Copenhagen, Denmark

Mental Health Centre Glostrup

Glostrup Municipality, Denmark