Value of Gym-based Exercise Training for Young Adults Receiving Antipsychotic Medication: The Vega Trial
NCT05461885 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 226
Last updated 2026-05-20
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.
Conditions
- Affective Disorder
- Psychosis
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.
Sponsors & Collaborators
-
Aarhus University Hospital
collaborator OTHER -
Aalborg University Hospital
collaborator OTHER -
Rigshospitalet, Denmark
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 35 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-10-25
- Primary Completion
- 2026-01-04
- Completion
- 2026-01-04
Countries
- Denmark
Study Locations
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