Affective DisorderVegaNCT05461885
Value of Gym-based Exercise Training for Young Adults Receiving Antipsychotic Medication: The Vega Trial
A study testing Supervised exercise in people with Affective Disorder and Psychosis, run by Copenhagen University Hospital, Rigshospitalet at 4 sites in Denmark.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 35 years
- Conditions the study is for
- Affective Disorder, Psychosis
- What is being tested?
- Supervised exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 226 participants
- Where
- 4 sitesDenmark
- Study dates
- 25 Oct 2022to 4 Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- advised from participating in exercise training by their treating doctor
Trial locations and contacts
4 sites in 1 country.
Denmark4 sites
Aalborg University Hospital
Aalborg, 9220
Aarhus University Hospital
Aarhus, 8200
Mental Health Centre Copenhagen
Copenhagen, 2100
Mental Health Centre Glostrup
Glostrup Municipality, 2600
About this study
Official title: Value of Gym-based Exercise Training for Young Adults Receiving Antipsychotic Medication: A Pragmatic, Single-blinded, Multicenter Randomized Controlled Trial
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.
Read the detailed description
Background:
Antipsychotic medications are associated with development of metabolic side-effects. Patients with schizophrenia have a four-fold higher prevalence of metabolic syndrome, and a two-to-three-fold higher risk of cardiovascular diseases compared to the general population. These factors may contribute to the premature mortality of 15-20 years observed in people with schizophrenia. The increased morbidity and mortality in people with mental illness can be explained by several risk factors, including physical inactivity.
Evidence suggests that exercise can have beneficial effects on multiple cardiometabolic outcomes, and improve clinical symptoms, quality of life, global functioning, and reduce negative and depressive symptoms in people with schizophrenia. In general, greater effects are seen for higher doses of aerobic exercise and motivational theory-based interventions supervised by exercise professionals. However, because of strict inclusion criteria, the external validity of existing studies is limited, and effectiveness studies are urgently needed
Objectives:
The primary objective is to determine the effectiveness of participation in a four-month supervised, gym-based exercise program among people treated with antipsychotic medication compared to usual care on patient-rated recovery (primary outcome).
Secondary objectives are to examine if the gym-based exercise program compared to usual care improves the following:
- Mental health
- Health-related quality of life
- Behavioral and functional symptoms
- Metabolic health
As tertiary objectives, we will investigate if:
- Prolongation of subsidized gym membership in addition to motivational text messages (extended support) will be superior to subsidized gym membership alone (minimal support), and to treatment as usual in relation to post-intervention adoption of physical activity.
- The exercise program impacts the quality of life and physical and mental health of the participants' primary relative.
- Participation in the gym-based program is associated with a reduction in the participants' use of mental health care services.
- The exercise program is cost-effective.
Design:
This is a multi-center, pragmatic, randomized (1:2) superiority trial to compare a 4-month, supervised, gym-based exercise training program to usual care. The pragmatic nature of the trial entails that it is designed to evaluate the effectiveness of interventions in real-life routine practice conditions.
In order to explore different ways to support sustainment (i.e., post-intervention adherence/adoption of physical activity), and to guide strategies to facilitate adherence, we will do "a study within a trial" (SWAT). Hence participants randomized to the intervention at baseline, will be randomized (allocation ratio 1:1) after four months to minimal vs. extended support with regards to sustainment of physical activity.
- Conditions
- Affective Disorder, Psychosis
- Being tested
- Supervised exercise
- Medical subject headings
- Mood Disorders, Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supervised exerciseBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Personal recovery
15-item Questionnaire about the Process of Recovery
Measured: Baseline to four months
Secondary outcomes (22)
Personal recovery
15-item Questionnaire about the Process of Recovery
Measured: Baseline to six months and 12 months
Mental health
Mental Component Summary from the Short-Form 12 (SF-12) Health survey
Measured: Baseline to four months
Health-related quality of life
Short-Form 12 (SF-12) Health survey
Measured: Baseline to four, six and 12 months
Affective symptoms
Patient-Reported Outcomes Measurement Information System (PROMIS) Emotional distress
Measured: Baseline to four, six and 12 months
Physical Activity
International Physical Activity Questionnaire short form (IPAQ-SF)
Measured: Baseline to four, six and 12 months
Internalized Stigma
Internalized Stigma of Mental Illness Inventory (ISMI-9) short form
Measured: Baseline to four, six and 12 months
Use of substance (alcohol, cannabis, drugs)
Measured by self-developed items with responses for each substance: "never used", "use less than once a month", "regular use", "harmful use"
Measured: Baseline to four, six and 12 months
Sleep
Brief Pittsburgh Sleep Quality Index (B-PSQI)
Measured: Baseline to four, six and 12 months
Positive and negative symptoms
Colorado Symptom Index (MCSI)
Measured: Baseline to four, six and 12 months
Loneliness
Measured by a single item on a Likert scale of 4 levels: "During the past 12 months, have you felt lonely?"
Measured: Baseline to four, six and 12 months
Abdominal circumference
Measured with tape measure
Measured: Baseline to four, six and 12 months
Body weight
Measured on a scale
Measured: Baseline to four, six and 12 months
Skeletal muscle mass
Measured by bioimpedance
Measured: Baseline to four, six and 12 months
Total body fat
Measured by bioimpedance
Measured: Baseline to four, six and 12 months
Cardiorespiratory fitness
measured with the modified Ekblom-Bak submaximal cycle ergometer test
Measured: Baseline to four, six and 12 months
Blood pressure
measured by a digital blood pressure monitor
Measured: Baseline to four, six and 12 months
Resting heart rate
measured by a heart rate monitor
Measured: Baseline to four, six and 12 months
High density lipoproteins (HDL)
Taken from routine blood tests (mmol/l)
Measured: Baseline to four, six and 12 months
Low density lipoproteins (LDL)
Taken from routine blood tests (mmol/l)
Measured: Baseline to four, six and 12 months
Triglycerides
Taken from routine blood tests (mmol/l)
Measured: Baseline to four, six and 12 months
Glycosylated haemoglobin (HbA1c)
Taken from routine blood tests (mmol/l)
Measured: Baseline to four, six and 12 months
C-reactive protein (CRP)
Taken from routine blood tests (mg/L)
Measured: Baseline to four, six and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2022
- Study start25 Oct 2022
- Primary completion4 Jan 2026
- Study completion4 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Affective DisorderStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 226 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Collaborators
- Aarhus University Hospital, Aalborg University Hospital
- Responsible party
- Principal investigator, Bolette Rafn, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05461885
- Sponsor's protocol ID
- Vega Trial
- Acronym
- Vega
- Status last verified
- May 2026
- First submitted
- 29 Jun 2022
- Last updated
- 20 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 37648977
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Value of Gym-based Exercise Training for Young Adults Receiving Antipsychotic Medication: A Pragmatic, Single-blinded, Multicenter Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05461885
- Acronym / sponsor ID
- Vega / Vega Trial
- Conditions
- Affective Disorder, Psychosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 226 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Collaborators
- Aarhus University Hospital, Aalborg University Hospital
- Study start
- 25 Oct 2022 (actual)
- Primary completion
- 4 Jan 2026 (actual)
- Study completion
- 4 Jan 2026 (actual)
- First posted
- 18 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Background:
Antipsychotic medications are associated with development of metabolic side-effects. Patients with schizophrenia have a four-fold higher prevalence of metabolic syndrome, and a two-to-three-fold higher risk of cardiovascular diseases compared to the general population. These factors may contribute to the premature mortality of 15-20 years observed in people with schizophrenia. The increased morbidity and mortality in people with mental illness can be explained by several risk factors, including physical inactivity.
Evidence suggests that exercise can have beneficial effects on multiple cardiometabolic outcomes, and improve clinical symptoms, quality of life, global functioning, and reduce negative and depressive symptoms in people with schizophrenia. In general, greater effects are seen for higher doses of aerobic exercise and motivational theory-based interventions supervised by exercise professionals. However, because of strict inclusion criteria, the external validity of existing studies is limited, and effectiveness studies are urgently needed
Objectives:
The primary objective is to determine the effectiveness of participation in a four-month supervised, gym-based exercise program among people treated with antipsychotic medication compared to usual care on patient-rated recovery (primary outcome).
Secondary objectives are to examine if the gym-based exercise program compared to usual care improves the following:
- Mental health
- Health-related quality of life
- Behavioral and functional symptoms
- Metabolic health
As tertiary objectives, we will investigate if:
- Prolongation of subsidized gym membership in addition to motivational text messages (extended support) will be superior to subsidized gym membership alone (minimal support), and to treatment as usual in relation to post-intervention adoption of physical activity.
- The exercise program impacts the quality of life and physical and mental health of the participants' primary relative.
- Participation in the gym-based program is associated with a reduction in the participants' use of mental health care services.
- The exercise program is cost-effective.
Design:
This is a multi-center, pragmatic, randomized (1:2) superiority trial to compare a 4-month, supervised, gym-based exercise training program to usual care. The pragmatic nature of the trial entails that it is designed to evaluate the effectiveness of interventions in real-life routine practice conditions.
In order to explore different ways to support sustainment (i.e., post-intervention adherence/adoption of physical activity), and to guide strategies to facilitate adherence, we will do "a study within a trial" (SWAT). Hence participants randomized to the intervention at baseline, will be randomized (allocation ratio 1:1) after four months to minimal vs. extended support with regards to sustainment of physical activity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vega Exercise Community | Experimental | Behavioral: Supervised exerciseParticipants 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. |
| 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. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- advised from participating in exercise training by their treating doctor
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Supervised exerciseThe 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. | Behavioural | Vega Exercise Community |
Primary outcome
Personal recovery
Time frame: Baseline to four months
15-item Questionnaire about the Process of Recovery
22 secondary outcomes
Personal recovery
Time frame: Baseline to six months and 12 months
Mental health
Time frame: Baseline to four months
Health-related quality of life
Time frame: Baseline to four, six and 12 months
Affective symptoms
Time frame: Baseline to four, six and 12 months
Physical Activity
Time frame: Baseline to four, six and 12 months
Internalized Stigma
Time frame: Baseline to four, six and 12 months
Use of substance (alcohol, cannabis, drugs)
Time frame: Baseline to four, six and 12 months
Sleep
Time frame: Baseline to four, six and 12 months
Positive and negative symptoms
Time frame: Baseline to four, six and 12 months
Loneliness
Time frame: Baseline to four, six and 12 months
Abdominal circumference
Time frame: Baseline to four, six and 12 months
Body weight
Time frame: Baseline to four, six and 12 months
Skeletal muscle mass
Time frame: Baseline to four, six and 12 months
Total body fat
Time frame: Baseline to four, six and 12 months
Cardiorespiratory fitness
Time frame: Baseline to four, six and 12 months
Blood pressure
Time frame: Baseline to four, six and 12 months
Resting heart rate
Time frame: Baseline to four, six and 12 months
High density lipoproteins (HDL)
Time frame: Baseline to four, six and 12 months
Low density lipoproteins (LDL)
Time frame: Baseline to four, six and 12 months
Triglycerides
Time frame: Baseline to four, six and 12 months
Glycosylated haemoglobin (HbA1c)
Time frame: Baseline to four, six and 12 months
C-reactive protein (CRP)
Time frame: Baseline to four, six and 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2026.
- Derived from this study: PubMed 37648977Rafn 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Supervised exercise in people with Affective Disorder and Psychosis, run by Copenhagen University Hospital, Rigshospitalet at 4 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Personal recovery (time frame: Baseline to four months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05461885, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2026.