SchizophreniaNCT01310998
Acute Psychological Effects of High Intensity Exercise With Schizophrenia
A study testing High intensity exercise in people with Schizophrenia, run by Norwegian University of Science and Technology at 1 site in Norway.
Trial summary
The purpose of this study is to study the acute psychological effects in patients with schizophrenia after one session of high intensity exercise. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Schizophrenia
- What is being tested?
- High intensity exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteNorway
- Study dates
- Dec 2010to Jun 2011
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- They will be allocated into groups by their diagnoses
Who cannot join
- Not being able to complete the exercise
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Acute Psychological Effects of High Intensity Exercise in Patients With Schizophrenia
The purpose of this study is to study the acute psychological effects in patients with schizophrenia after one session of high intensity exercise.
Read the detailed description
We will examine if there is an acute effect of one high intensity session of physical exercise (4x4 intervals) on psychological variables state mood, state anxiety, well-being and psychological distress. This possible effect will be examined in three groups, one group being the main group that the other two groups will be compared up against. Group 1: Patients with schizophrenia and other psychotic illnesses. Group 2: people with non-psychotic diagnosis. Group 3: people without any psychological diagnosis.
- Conditions
- Schizophrenia
- Being tested
- High intensity exercise
- Keywords
- Schizophrenia, high intensity exercise, interval training exercise
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High intensity exerciseBehavioural
4x4 intervals
| Study group | Role | What they receive |
|---|---|---|
| schizophrenic disorder | Experimental | Not described Receives: Behavioral: High intensity exercise |
| other psychotic disorder | Experimental | Not described Receives: Behavioral: High intensity exercise |
| no mental disorder | Experimental | Not described Receives: Behavioral: High intensity exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Positive and negative affects
Positive and Negative Affect Schedule - Expanded Form (PANSS)
Measured: baseline and 2 days postintervention
Secondary outcomes (1)
state anxiety
Questionnaire, self-report. State anxiety inventory (SAI)
Measured: baseline and 2 days postintervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2011 (estimated)
- Study startDec 2010
- Primary completionJun 2011
- Study completionJun 2011
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 SchizophreniaStudies of the same condition, open and under way.
- More trials run by Norwegian University of Science and TechnologyThe 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
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norwegian University of Science and Technology
- Sponsor type
- University, hospital or other
- Collaborators
- St. Olavs Hospital
- Responsible party
- Sponsor
- Investigators
- Einar Vedul-Kjelsås, dr.philos, Principal investigator, Employee at AFFU at St Olavs Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01310998
- Sponsor's protocol ID
- 2010/2898-3
- Status last verified
- Jul 2016
- First submitted
- 11 Jan 2011
- Last updated
- 28 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Heggelund J, Kleppe KD, Morken G, Vedul-Kjelsas E. High aerobic intensity training and psychological States in patients with depression or schizophrenia. Front Psychiatry. 2014 Oct 30;5:148. doi: 10.3389/fpsyt.2014.00148. eCollection 2014.
PubMed 25400592
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Psychological Effects of High Intensity Exercise in Patients With Schizophrenia
- ClinicalTrials.gov ID
- NCT01310998
- Acronym / sponsor ID
- 2010/2898-3
- Conditions
- Schizophrenia
- Keywords
- Schizophrenia, high intensity exercise, interval training exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Norwegian University of Science and TechnologyUniversity, hospital or other
- Collaborators
- St. Olavs Hospital
- Study start
- Dec 2010
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 9 Mar 2011 (estimated)
- 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 purpose of this study is to study the acute psychological effects in patients with schizophrenia after one session of high intensity exercise.
Detailed description
We will examine if there is an acute effect of one high intensity session of physical exercise (4x4 intervals) on psychological variables state mood, state anxiety, well-being and psychological distress. This possible effect will be examined in three groups, one group being the main group that the other two groups will be compared up against. Group 1: Patients with schizophrenia and other psychotic illnesses. Group 2: people with non-psychotic diagnosis. Group 3: people without any psychological diagnosis.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| schizophrenic disorder | Experimental | Behavioral: High intensity exercise |
| other psychotic disorder | Experimental | Behavioral: High intensity exercise |
| no mental disorder | Experimental | Behavioral: High intensity exercise |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- They will be allocated into groups by their diagnoses
Key exclusion criteria (1 listed)
- Not being able to complete the exercise
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 exercise4x4 intervals | Behavioural | no mental disorder, other psychotic disorder, schizophrenic disorder |
Primary outcome
Positive and negative affects
Time frame: baseline and 2 days postintervention
Positive and Negative Affect Schedule - Expanded Form (PANSS)
1 secondary outcome
state anxiety
Time frame: baseline and 2 days postintervention
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 28 Jul 2016.
- Results publication: PubMed 25400592Heggelund J, Kleppe KD, Morken G, Vedul-Kjelsas E. High aerobic intensity training and psychological States in patients with depression or schizophrenia. Front Psychiatry. 2014 Oct 30;5:148. doi: 10.3389/fpsyt.2014.00148. eCollection 2014.
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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.
Einar Vedul-Kjelsås, dr.philos principal investigator
Employee at AFFU at St Olavs Hospital
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 exercise in people with Schizophrenia, run by Norwegian University of Science and Technology 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 1 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 28 Jul 2016. 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?
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?
Positive and negative affects (time frame: baseline and 2 days postintervention). 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 NCT01310998, 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 28 Jul 2016.