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

NCT05461885 | Active Not Recruiting

• 1 other identifier: Vega Trial
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 4

Brief 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

Outcome Measures

Primary Outcomes (1)

• Personal recovery

  15-item Questionnaire about the Process of Recovery

  Baseline to four months

Secondary Outcomes (22)

• Personal recovery

  Baseline to six months and 12 months

• Mental health

  Baseline to four months

• Health-related quality of life

  Baseline to four, six and 12 months

• Affective symptoms

  Baseline to four, six and 12 months

• Physical Activity

  Baseline to four, six and 12 months

Other Outcomes (9)

• Use of the subsidized membership

  four to six months

• Extended vs. minimal support for physical activity

  four to six months

• Quality of life of primary relatives to participants

  Baseline to four, six and 12 months

Study Arms (2)

Vega Exercise Community

EXPERIMENTAL

Participants will be offered one hour of tailored supervised, gym-based exercise training three times per week for a period of four months. In addition, participants are offered free-of-charge membership to the gym for six months and are invited to take part in training classes and use fitness equipment provided by the gym to regular members. The supervised program is tailored to meet the needs and requirements of this particular group of young adults and will include three weekly sessions of moderate-to-high intensity and mobility exercises.

Behavioral: Supervised exercise

Usual care

NO INTERVENTION

Participants will receive treatment as usual and be informed of the official physical activity guidelines as part of the information on group allocation. Moreover, they will be advised to continue their daily living, as they normally would do, not guiding them to other interventions neither preventing them to do so. In addition, participants in the usual care group will be given a subsidized membership including access to the exercise classes for four months after the 12 months follow up.

Interventions

Supervised exercise BEHAVIORAL

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.

Vega Exercise Community

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• diagnosed with a psychotic disorder (F20-F29 Schizophrenia, schizotypal and delusional disorders) or an affective disorder (F30-F39 Mood \[affective\] disorders)
• able to read and speak Danish or English

You may not qualify if:

• advised from participating in exercise training by their treating doctor

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead
• Aarhus University Hospital: collaborator
• Aalborg University Hospital: collaborator

Study Sites (4)

Aalborg University Hospital

Aalborg, 9220, Denmark

Location

Aarhus University Hospital

Aarhus, 8200, Denmark

Location

Mental Health Centre Copenhagen

Copenhagen, 2100, Denmark

Location

Mental Health Centre Glostrup

Glostrup Municipality, 2600, Denmark

Location

Related Publications (1)

• Rafn BS, Andersen MF, Sorensen V, Bjerre ED, Baandrup L, Vernal DL, Mors O, Knop FK, Wolf RT, Tolver A, Firth J, Nohr N, Skou ST, Ebdrup BH, Midtgaard J. Value of gym-based group exercise versus usual care for young adults receiving antipsychotic medication: study protocol for the multicenter randomized controlled Vega trial. BMC Psychiatry. 2023 Aug 30;23(1):634. doi: 10.1186/s12888-023-05086-z.

  PMID: 37648977 DERIVED

MeSH Terms

Conditions

Mood Disorders; Psychotic Disorders

Condition Hierarchy (Ancestors)

Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Postdoc

Study Record Dates

• First Submitted: June 29, 2022
• First Posted: July 18, 2022
• Study Start: October 25, 2022
• Primary Completion: May 1, 2025
• Study Completion: January 1, 2026
• Last Updated: April 30, 2025

Record last verified: 2025-04

Locations

DK (4)