PsychosisTREPPNCT05719116
A Combined Aerobic and Resistance Training Program for Adults With Psychotic Disorders
A study testing Physical exercise in people with Psychosis, run by Solli Distriktspsykiatriske Senter at 1 site in Norway.
Trial summary
The study is a feasibility study of a combined high intensity aerobic and strenght exercise program for persons with psychotic disorders. The feasibility of the protocol will be investigated, in addition to the participants subjective experience with the participation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psychosis
- What is being tested?
- Physical exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteNorway
- Study dates
- 23 Nov 2022to 31 Dec 2028
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed informed consent
- Diagnosed with psychotic disorder
- Physically able to participate in physical exercise
- Is a patient at Solli DPS
- Motivated for participating in physical exercise
- Signed informed consent
Show all 10Show fewer
- Diagnosed with psychiatric disorder, but not a psychotic disorder
- Physically able to participate in physical exercise
- Is a patient at Solli DPS
- Motivated for participating in physical exercise
Who cannot join
- Physical conditions precluding the participant from the physical testing/training
- Mental state that hinders participation, such as ongoing suicidality, substance abuse or brain organic disorder
- Participants with psychiatric disorder, but no psychotic disorder:
- Physical conditions precluding the participant from the physical testing/training
- Mental state that hinders participation, such as ongoing suicidality, substance abuse or brain organic disorder
Trial locations and contacts
1 site in 1 country.
About this study
The study is a feasibility study of a combined high intensity aerobic and strenght exercise program for persons with psychotic disorders. The feasibility of the protocol will be investigated, in addition to the participants subjective experience with the participation.
Read the detailed description
The aim of this study is to investigate the feasibility of a 16 week physical exercise intervention combining strenght and aerobic training in group for patients with psychotic disorders. In addition, the feasibility of the test protocol and participants subjective experience with the intervention will be investigated.
Research shows positive effects of physical exercise for patients with psychotic disorders regarding maximal aerob training, maximal muscle strength, physical, cognitive and social functioning, and symptom levels. Effects and the degree of feasibility of physical exercise for patients with psychotic disorders are amplified by regarding their preferences and needs, and if they experience support and guidance during the intervention. Earlier studies have focused mostly on either strength og endurance training, or combined interventions of moderate intensity. We now want to investigate the feasibility of an invidually adjusted combined program of high intensity.
After the intervention, participants will be interviewed about their experience with participating.
- Conditions
- Psychosis
- Being tested
- Physical exercise
- Medical subject headings
- Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical exerciseBehavioural
The physical exercise will be aerobic and strength training. The sessions will last app. 1 hour.
| Study group | Role | What they receive |
|---|---|---|
| Physical exercise for participants with psychotic disorder | Experimental | Participants with a psychotic disorder will exercise in a group supervised by a physiotherapist for 16 weeks, three times a week. Receives: Behavioral: Physical exercise |
| Physical exercise for participants with psychiatric disorder, but not psychotic disorder | Active comparator | Participants with a psychiatric disorder will exercise in a group supervised by a physiotherapist for 16 weeks, three times a week. Receives: Behavioral: Physical exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of the intervention program
How many participants completed the physical training intervention.
Measured: After 16 weeks of intervention
Secondary outcomes (8)
Aerobic capasity: Ekblom Bak submaximal ergometer cycle test
Estimating Vo2max
Measured: At week 0 and 16
Aerobic capasity: 4 x 4 interval for estimating VO2max
Standarised 4x4 interval training for estimating VO2max with the smartphone app My Workout GO
Measured: At week 0 and 16
Strength: 1 RM test of bench press
Maximal test of strenght of upper body
Measured: At week 0 and 16
Strenght: 1 RM test of squat
Maximal test of lower body musculature
Measured: At week 0 and 16
Psychotic symptoms: The Positive and Negative Syndrome Scale
For the participants with psychotic disorders only. A measure of positive and negative psychotic symptoms. Each item is scored on a scale from 1-7 with a higher score indicating higher symptom level.
Measured: At week 0 and 16
Depression symptoms: The Calgary Depression Scale for Schizophrenia
A measure of depressive symptoms. Each item is scored on a scale from 0-3 with a higher score indicating higher symptom level.
Measured: At week 0 and 16
Anxiety symptoms: GAD-7
A measure of anxiety symptoms. This is a 7-item self-report questionnaire where participants rate on a scale from 0 (not at all sure) to 3 (nearly every day). A higher score indicates greater symptom severity.
Measured: At week 0 and 16
Quality of life: SF-12
A measure of health related quality of life. The items is scored after variying categories such as "yes" and "no", and "How much time during the past 4 weeks...".
Measured: At week 0 and 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2023
- Study start23 Nov 2022
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PsychosisStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- As the main aim of the study is to investigate feasibility, no randomisation is done at this stage. The participants with psychotic disorder will be compared with participants with a psychiatric disorder (but no psychotic disorder).
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Solli Distriktspsykiatriske Senter
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kristine Sirevåg, Principal investigator, Solli DPS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05719116
- Sponsor's protocol ID
- 2018-17695
- Other IDs
- 2018
- Acronym
- TREPP
- Status last verified
- Sep 2025
- First submitted
- 23 Nov 2022
- Last updated
- 24 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We plan to publish our results in peer-reviewed journals.
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Combined Aerobic and Resistance Training Program for Adults With Psychotic Disorders
- ClinicalTrials.gov ID
- NCT05719116
- Acronym / sponsor ID
- TREPP / 2018-17695
- Conditions
- Psychosis
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Solli Distriktspsykiatriske SenterUniversity, hospital or other
- Study start
- 23 Nov 2022 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 8 Feb 2023 (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 is a feasibility study of a combined high intensity aerobic and strenght exercise program for persons with psychotic disorders. The feasibility of the protocol will be investigated, in addition to the participants subjective experience with the participation.
Detailed description
The aim of this study is to investigate the feasibility of a 16 week physical exercise intervention combining strenght and aerobic training in group for patients with psychotic disorders. In addition, the feasibility of the test protocol and participants subjective experience with the intervention will be investigated.
Research shows positive effects of physical exercise for patients with psychotic disorders regarding maximal aerob training, maximal muscle strength, physical, cognitive and social functioning, and symptom levels. Effects and the degree of feasibility of physical exercise for patients with psychotic disorders are amplified by regarding their preferences and needs, and if they experience support and guidance during the intervention. Earlier studies have focused mostly on either strength og endurance training, or combined interventions of moderate intensity. We now want to investigate the feasibility of an invidually adjusted combined program of high intensity.
After the intervention, participants will be interviewed about their experience with participating.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- As the main aim of the study is to investigate feasibility, no randomisation is done at this stage. The participants with psychotic disorder will be compared with participants with a psychiatric disorder (but no psychotic disorder).
| Arm | Type | Receives |
|---|---|---|
| Physical exercise for participants with psychotic disorder | Experimental | Behavioral: Physical exerciseParticipants with a psychotic disorder will exercise in a group supervised by a physiotherapist for 16 weeks, three times a week. |
| Physical exercise for participants with psychiatric disorder, but not psychotic disorder | Active comparator | Behavioral: Physical exerciseParticipants with a psychiatric disorder will exercise in a group supervised by a physiotherapist for 16 weeks, three times a week. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Signed informed consent
- Diagnosed with psychotic disorder
- Physically able to participate in physical exercise
- Is a patient at Solli DPS
- Motivated for participating in physical exercise
Key exclusion criteria (5 listed)
- Physical conditions precluding the participant from the physical testing/training
- Mental state that hinders participation, such as ongoing suicidality, substance abuse or brain organic disorder
- Physical conditions precluding the participant from the physical testing/training
- Mental state that hinders participation, such as ongoing suicidality, substance abuse or brain organic disorder
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 |
|---|---|---|
| Physical exerciseThe physical exercise will be aerobic and strength training. The sessions will last app. 1 hour. | Behavioural | Physical exercise for participants with psychiatric disorder, but not psychotic disorder, Physical exercise for participants with psychotic disorder |
Primary outcome
Feasibility of the intervention program
Time frame: After 16 weeks of intervention
How many participants completed the physical training intervention.
8 secondary outcomes
Aerobic capasity: Ekblom Bak submaximal ergometer cycle test
Time frame: At week 0 and 16
Aerobic capasity: 4 x 4 interval for estimating VO2max
Time frame: At week 0 and 16
Strength: 1 RM test of bench press
Time frame: At week 0 and 16
Strenght: 1 RM test of squat
Time frame: At week 0 and 16
Psychotic symptoms: The Positive and Negative Syndrome Scale
Time frame: At week 0 and 16
Depression symptoms: The Calgary Depression Scale for Schizophrenia
Time frame: At week 0 and 16
Anxiety symptoms: GAD-7
Time frame: At week 0 and 16
Quality of life: SF-12
Time frame: At week 0 and 16
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 24 Sep 2025.
- Individual participant dataSharing planned: Yes. We plan to publish our results in peer-reviewed journals.
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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.
Kristine Sirevåg principal investigator
Solli DPS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical exercise in people with Psychosis, run by Solli Distriktspsykiatriske Senter 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 10 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: under way, not looking for participants, as of the sponsor's last update on 24 Sep 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?
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?
Feasibility of the intervention program (time frame: After 16 weeks of intervention). 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 24 Sep 2025.