Schizophrenia and Related DisordersNCT06313918
Exercise Therapy in Mental Disorders-study
A study testing High intensity training (HIT) in people with Schizophrenia and Related Disorders and Bipolar Disorder, run by Haukeland University Hospital at 1 site in Norway.
Trial summary
The study will compare standard high-intensity training with brief high-intensity training in people with schizophrenia-spectrum or bipolar disorder. The overall aim is to determine which of the two is superior in a long-term perspective. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Schizophrenia and Related Disorders, Bipolar Disorder
- What is being tested?
- High intensity training (HIT)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteNorway
- Study dates
- 27 Sep 2023to 26 Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- ICD-10 schizophrenia-spectrum disorder (F2)
- ICD-10 bipolar disorder (F3)
- Capacity to provide informed consent.
Who cannot join
- Contra-indication for exercise training and testing according to the American College of Sports Medicine specifications
- Life threatening or terminal medical conditions
- Not able to carry out intervention or test procedures
- Current pregnancy
- Mothers less than 6 months post-partum.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Norway1 site, 1 recruiting
- Recruiting
Haukeland University Hospital
Bergen, 5020
Erik Johnsen, MD, PhD, +47 55958400, erik.johnsen@helse-bergen.no
Rune A Kroken, MD, PhD, +47 55958400, rune.andreas.kroken@helse-bergen.no
About this study
The study will compare standard high-intensity training with brief high-intensity training in people with schizophrenia-spectrum or bipolar disorder. The overall aim is to determine which of the two is superior in a long-term perspective.
Read the detailed description
Background: Patients with severe mental disorders (SMD), including schizophrenia spectrum and bipolar disorders, frequently experience suboptimal treatment effectiveness resulting in disabling residual symptoms and cognitive challenges, and have elevated mortality risk amounting to 15-20 years of shortened life expectancy compared to the general population.
Cardiovascular disease (CVD) is a major contributor in this regard. Exercise in general improves cognitive functioning, negative symptoms, quality of life, and reduces the risk of CVD. High intensity training (HIT) has been shown to be feasible for persons with SMD, but attrition and noncompliance are substantial and likely to limit the effectiveness of HIT. A less strenuous HIT could increase adherence to the intervention, which might compensate for a slightly lower efficacy compared to standard HIT. Our study will compare standard 4x4-min HIT to a 4-min single-bout HIT session, as well as explore exercise effects on basic processes in the body. Methods: Patients with schizophrenia spectrum and bipolar disorders are eligible for participation, and those included will be randomized to 26 weeks of either 1) Standard 4 x 4 min HIT at treadmill, or 2) Short 1 x 4 min HIT at treadmill. To reduce dropout, the intervention will usually be delivered in group format, and conducted under the supervision of a physical therapist in collaboration with a postdoctor. The research group has a stable staff with research nurses, biostatisticians and researchers that will secure the dayto- day conductance of the project, including psychometric assessments, drawing of and biobanking of blood, as well as data collection and storing. Measures: Mental and cognitive symptoms, quality of life, motivation, Peak oxygen uptake (V
- Being tested
- High intensity training (HIT)
- Keywords
- Exercise therapy, Effectiveness
- Medical subject headings
- Schizophrenia, Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High intensity training (HIT)Other
Please see information already included in the arm descriptions.
| Study group | Role | What they receive |
|---|---|---|
| Standard HIT | Active comparator | Standard 4 x 4 min HIT at treadmill. First 7 min warm-up, then 4 sessions with 4 min walking/running at 80-95% of maximal heart rate, with 3 min of active rest in between. Ending with 5 min of cooling down. Two sessions per week for 26 weeks. Receives: Other: High intensity training (HIT) |
| Short HIT | Experimental | Short 1 x 4 min HIT at treadmill. Starting with 7 min warm-up walking/running, then 1 session with 4 min walking/running at 80-95% of maximal heart rate, ending with 5 min of cooling down. Two sessions per week for 26 weeks. Receives: Other: High intensity training (HIT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence
Proportion (number and percent) of completers at 26 weeks.
Measured: 26 weeks
Secondary outcomes (20)
Change of the Simplified Negative and Positive Symptoms Interview (SNAPSI) score
Symptoms of psychosis
Measured: 4, 12, 26 and 52 weeks from baseline
Change of the Calgary Depression Scale in Schizophrenia score
Symptoms of depression
Measured: 4, 12, 26 and 52 weeks from baseline
Change of the Clinical Global Impression (CGI) score
Overall clinical state
Measured: 4, 12, 26 and 52 weeks from baseline
Change of the Global Assessment of Funtioning (GAF) score
Functioning
Measured: 4, 12, 26 and 52 weeks from baseline
Change of quality of life (QOL10) score
Quality of life
Measured: 4, 12, 26 and 52 weeks from baseline
Change of the International Physical Activity Questionaire (IPAQ) score
Physical activity
Measured: 4, 12, 26 and 52 weeks from baseline
Change of the Brief Assessment of Cognition in Schizophrenia (BACS) score
Cognition
Measured: 4, 12, 26 and 52 weeks from baseline
Change of the Behavioural Regulation in Exercise Questionaire (BREQ) score
Motivation
Measured: 4, 12, 26 and 52 weeks from baseline
Change of the Difficulties in Emotion Regulation (DERS) score
Emotion regulation
Measured: 4, 12, 26 and 52 weeks from baseline
Change in heart rate (beats per minute)
Heart rate variability
Measured: 4, 12, 26 and 52 weeks from baseline
Change of maximal oxygene extraction (VO2max)
Aerobic capacity
Measured: 4, 12, 26 and 52 weeks from baseline
Change of level of inflammatory markers in blood
Inflammation
Measured: 4, 12, 26 and 52 weeks from baseline
Change of body weight (kilograms)
Body weight change
Measured: 4, 12, 26 and 52 weeks from baseline
Change of hip- and waist circumference (centimetres)
Change of hip- and waist circumference
Measured: 4, 12, 26 and 52 weeks from baseline
Change of serum glucose (mmol/L)
Change of serum glucose
Measured: 4, 12, 26 and 52 weeks from baseline
Change of serum cholesterols (mmol/L)
Change of serum cholesterols
Measured: 4, 12, 26 and 52 weeks from baseline
Change of serum triglyceride (mmol/L)
Change of serum triglyceride (mmol/L)
Measured: 4, 12, 26 and 52 weeks from baseline
Change of gene expression
RNA
Measured: 4, 12, 26 and 52 weeks from baseline
Change of methylation of DNA
Epigenetic changes
Measured: 4, 12, 26 and 52 weeks from baseline
Change of the Young Mania Rating Scale (YMRS) score
Symptoms of mania
Measured: 4, 12, 26 and 52 weeks from baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2024
- Study start27 Sep 2023
- Primary completion26 Sep 2026 (estimated)
- Study completion26 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Schizophrenia and Related DisordersStudies of the same condition, open and under way.
- 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
- Model description
- Open label, two-arm, parallel group, randomised trial, to compare standard and short HIT during 26 weeks of supervised exercise. The group will receive comprehensive follow-up to be able to carry out the 26 weeks exercise intervention program. Outcome measures will be taken at; baseline (T0), 4 weeks (T1), 12 weeks (T2), 26 weeks (T3), and 52 weeks (T4) post randomisation.
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Haukeland University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06313918
- Sponsor's protocol ID
- REK nr. 428096
- Status last verified
- Dec 2025
- First submitted
- 20 Oct 2023
- Last updated
- 30 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exercise Therapy in Mental Disorders-study
- ClinicalTrials.gov ID
- NCT06313918
- Acronym / sponsor ID
- REK nr. 428096
- Keywords
- Exercise therapy, Effectiveness
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Haukeland University HospitalUniversity, hospital or other
- Study start
- 27 Sep 2023 (actual)
- Primary completion
- 26 Sep 2026 (estimated)
- Study completion
- 26 Sep 2026 (estimated)
- First posted
- 15 Mar 2024 (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.
The study will compare standard high-intensity training with brief high-intensity training in people with schizophrenia-spectrum or bipolar disorder. The overall aim is to determine which of the two is superior in a long-term perspective.
Detailed description
Background: Patients with severe mental disorders (SMD), including schizophrenia spectrum and bipolar disorders, frequently experience suboptimal treatment effectiveness resulting in disabling residual symptoms and cognitive challenges, and have elevated mortality risk amounting to 15-20 years of shortened life expectancy compared to the general population.
Cardiovascular disease (CVD) is a major contributor in this regard. Exercise in general improves cognitive functioning, negative symptoms, quality of life, and reduces the risk of CVD. High intensity training (HIT) has been shown to be feasible for persons with SMD, but attrition and noncompliance are substantial and likely to limit the effectiveness of HIT. A less strenuous HIT could increase adherence to the intervention, which might compensate for a slightly lower efficacy compared to standard HIT. Our study will compare standard 4x4-min HIT to a 4-min single-bout HIT session, as well as explore exercise effects on basic processes in the body. Methods: Patients with schizophrenia spectrum and bipolar disorders are eligible for participation, and those included will be randomized to 26 weeks of either 1) Standard 4 x 4 min HIT at treadmill, or 2) Short 1 x 4 min HIT at treadmill. To reduce dropout, the intervention will usually be delivered in group format, and conducted under the supervision of a physical therapist in collaboration with a postdoctor. The research group has a stable staff with research nurses, biostatisticians and researchers that will secure the dayto- day conductance of the project, including psychometric assessments, drawing of and biobanking of blood, as well as data collection and storing. Measures: Mental and cognitive symptoms, quality of life, motivation, Peak oxygen uptake (V
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Open label, two-arm, parallel group, randomised trial, to compare standard and short HIT during 26 weeks of supervised exercise. The group will receive comprehensive follow-up to be able to carry out the 26 weeks exercise intervention program. Outcome measures will be taken at; baseline (T0), 4 weeks (T1), 12 weeks (T2), 26 weeks (T3), and 52 weeks (T4) post randomisation.
| Arm | Type | Receives |
|---|---|---|
| Standard HIT | Active comparator | Other: High intensity training (HIT)Standard 4 x 4 min HIT at treadmill. First 7 min warm-up, then 4 sessions with 4 min walking/running at 80-95% of maximal heart rate, with 3 min of active rest in between. Ending with 5 min of cooling down. Two sessions per week for 26 weeks. |
| Short HIT | Experimental | Other: High intensity training (HIT)Short 1 x 4 min HIT at treadmill. Starting with 7 min warm-up walking/running, then 1 session with 4 min walking/running at 80-95% of maximal heart rate, ending with 5 min of cooling down. Two sessions per week for 26 weeks. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- ICD-10 schizophrenia-spectrum disorder (F2)
- ICD-10 bipolar disorder (F3)
- Capacity to provide informed consent.
Key exclusion criteria (5 listed)
- Contra-indication for exercise training and testing according to the American College of Sports Medicine specifications
- Life threatening or terminal medical conditions
- Not able to carry out intervention or test procedures
- Current pregnancy
- Mothers less than 6 months post-partum.
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 |
|---|---|---|
| High intensity training (HIT)Please see information already included in the arm descriptions. | Other | Short HIT, Standard HIT |
Primary outcome
Adherence
Time frame: 26 weeks
Proportion (number and percent) of completers at 26 weeks.
20 secondary outcomes
Change of the Simplified Negative and Positive Symptoms Interview (SNAPSI) score
Time frame: 4, 12, 26 and 52 weeks from baseline
Change of the Calgary Depression Scale in Schizophrenia score
Time frame: 4, 12, 26 and 52 weeks from baseline
Change of the Clinical Global Impression (CGI) score
Time frame: 4, 12, 26 and 52 weeks from baseline
Change of the Global Assessment of Funtioning (GAF) score
Time frame: 4, 12, 26 and 52 weeks from baseline
Change of quality of life (QOL10) score
Time frame: 4, 12, 26 and 52 weeks from baseline
Change of the International Physical Activity Questionaire (IPAQ) score
Time frame: 4, 12, 26 and 52 weeks from baseline
Change of the Brief Assessment of Cognition in Schizophrenia (BACS) score
Time frame: 4, 12, 26 and 52 weeks from baseline
Change of the Behavioural Regulation in Exercise Questionaire (BREQ) score
Time frame: 4, 12, 26 and 52 weeks from baseline
Change of the Difficulties in Emotion Regulation (DERS) score
Time frame: 4, 12, 26 and 52 weeks from baseline
Change in heart rate (beats per minute)
Time frame: 4, 12, 26 and 52 weeks from baseline
Change of maximal oxygene extraction (VO2max)
Time frame: 4, 12, 26 and 52 weeks from baseline
Change of level of inflammatory markers in blood
Time frame: 4, 12, 26 and 52 weeks from baseline
Change of body weight (kilograms)
Time frame: 4, 12, 26 and 52 weeks from baseline
Change of hip- and waist circumference (centimetres)
Time frame: 4, 12, 26 and 52 weeks from baseline
Change of serum glucose (mmol/L)
Time frame: 4, 12, 26 and 52 weeks from baseline
Change of serum cholesterols (mmol/L)
Time frame: 4, 12, 26 and 52 weeks from baseline
Change of serum triglyceride (mmol/L)
Time frame: 4, 12, 26 and 52 weeks from baseline
Change of gene expression
Time frame: 4, 12, 26 and 52 weeks from baseline
Change of methylation of DNA
Time frame: 4, 12, 26 and 52 weeks from baseline
Change of the Young Mania Rating Scale (YMRS) score
Time frame: 4, 12, 26 and 52 weeks from baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2025.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High intensity training (HIT) in people with Schizophrenia and Related Disorders and Bipolar Disorder, run by Haukeland University Hospital at 1 site in Norway.
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 3 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 30 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Erik Johnsen, PhD (004792456225, erik.johnsen@helse-bergen.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adherence (time frame: 26 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Dec 2025; AzTrials last refreshed its copy on 26 Oct 2026.