SchizophreniaLEXUSNCT02743143
Long-Term Exercise Training Therapy Versus Usual Care in Patients With Schizophrenia
A study testing Exercise therapy and Follow-up care as usual in people with Schizophrenia, run by St. Olavs Hospital at 1 site in Norway.
Trial summary
Patients with schizophrenia have disabling symptoms and cognitive deficits that limit motivation, drive, social- and occupational performance, quality of life and self-efficacy. Schizophrenia also leads to a high risk of dying from cardiovascular disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Schizophrenia
- What is being tested?
- Exercise therapy and Follow-up care as usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteNorway
- Study dates
- Dec 2015to Jun 2018
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- International Classification of Diseases (ICD-10) schizophrenia, schizotypal or delusional disorders (F20 to F29)
- able to carry out long-term exercise.
- capable of giving informed consent.
Who cannot join
- contra-indication for exercise training and testing according to the American College of Sports Medicine (ACSM) 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).
- patients under admittance to an acute psychiatric ward.
Trial locations and contacts
1 site in 1 country.
Norway1 site
St. Olavs University Hospital, Division of Psychiatry, Department of Østmarka
Trondheim
About this study
Official title: Effectiveness of 1 Year Supervised Exercise Training Versus Usual Care on Cardiovascular Health, Functional Skills and Physical Fitness in Patients With Schizophrenia
Patients with schizophrenia have disabling symptoms and cognitive deficits that limit motivation, drive, social- and occupational performance, quality of life and self-efficacy. Schizophrenia also leads to a high risk of dying from cardiovascular disease. Explanatory trials suggest that exercise improves cognitive functioning, symptoms, and quality of life, and reduces the risk of cardiovascular disease. However, due to this illness, the participation in regular exercise is challenging. In this study it will be tested if patients with schizophrenia can participate in long-term exercise therapy, and whether long-term supervised exercise therapy is more beneficial than today's usual care.
- Conditions
- Schizophrenia
- Being tested
- Exercise therapy, Follow-up care as usual
- Keywords
- Exercise therapy, Cardiovascular disease, Risk
- Medical subject headings
- Schizophrenia, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise therapyBehavioural
Follow-up care as usualOther
| Study group | Role | What they receive |
|---|---|---|
| Exercise therapy | Experimental | High aerobic intensity training and maximal strength training 2 times per week in 1 year at the Hospital's Exercise Training Clinic. Patients receive comprehensive support from Trondheim municipal administration to facilitate adherence. Receives: Behavioral: Exercise therapy |
| Follow-up care as usual | Active comparator | The usual care (UC) group will receive the usual physical activity offered by the primary health care system. UC includes the traditional physical activity advice from the Health Directorate. The UC group are invited to supervised exercise at the exercise training Clinic after 1 year. Receives: Other: Follow-up care as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in peak oxygen uptake.
Peak oxygen uptake after the training period subtracted Peak oxygen uptake at baseline.
Measured: Baseline, 12 weeks, 1 year, 2 years.
Secondary outcomes (22)
Change in physical activity.
Activity counts measured by Actigraph after the training period subtracted Actigraph measurements at baseline.
Measured: Baseline, 12 weeks, 1 year, 2 years.
Changes in walking economy.
Walking economy (oxygen uptake at a standard workload) after the training period subtracted walking economy at baseline.
Measured: Baseline, 12 weeks, 1 year, 2 years.
Real world functional behavior
Specific levels of functioning scale (SLOF).
Measured: Baseline, 1 year, 2 years.
Functional competence
University of California San Diego Performance-Based Skills Assessments (UPSA-Brief).
Measured: Baseline,1 year, 2 years.
Hospital stays and contact with health care providers.
Registrations from patient journals
Measured: Baseline, 1 year, 2 years.
Balance
Single leg stance. Measured in seconds.
Measured: Baseline, 12 weeks, 1 year, 2 years.
Sit-to-stand test
30-second sit-to-stand test. Number of full stands in 30 seconds.
Measured: Baseline, 12 weeks, 1 year, 2 years.
Walking performance
6-minute walk test. Performance measured in meters.
Measured: Baseline, 12 weeks, 1 year, 2 years.
Stair performance
Stair test. Participants are instructed to ascend and descend 18 steps 3 consecutive times. Performance measured in seconds.
Measured: Baseline, 12 weeks, 1 year, 2 years.
Clinical symptoms.
Positive and Negative Syndrome Scale (PANSS).
Measured: Baseline, 1 year, 2 years.
Global functioning
Global Assessment of Functioning Scale (GAFs and GAFf)
Measured: Baseline, 1 year, 2 years.
Quality of life.
SF-36® Health Survey (SF-36)
Measured: Baseline, 12 weeks, 1 year, 2 years.
Quality-adjusted life year
EuroQol five dimensions questionnaire (EQ-5D)
Measured: Baseline, 12 weeks, 1 year, 2 years.
Morning fasting blood levels.
Measured: Baseline, 12 weeks, 1 year, 2 years.
Tobacco
Tobacco use measured by Fagerströms.
Measured: Baseline, 12 weeks, 1 year, 2 years.
Alcohol and substance abuse
Substance abuse are measured by the Alcohol and Drug Use Disorder Identification test (AUDIT and DUDIT).
Measured: Baseline, 12 weeks, 1 year, 2 years.
Motivation
Behavioural Regulation in Exercise Questionnaire-2 (BREQ-2).
Measured: Baseline, 12 weeks, 1 year, 2 years.
Readiness/confidence to change
Rulers (0-10 scale: readiness, importance, confidence).
Measured: Baseline, 12 weeks, 1 year, 2 years.
Client Satisfaction
Client Satisfaction Questionnaire (CSQ-8).
Measured: Baseline, 12 weeks, 1 year, 2 years.
Changes in maximal strength.
Maximal strength (measures as 1 repetition maximum (1RM)) after the training period subtracted 1RM at baseline.
Measured: Baseline, 12 weeks, 1 year, 2 years.
Patient activation
Patient Activation Measure (PAM-13 GH)
Measured: Baseline, 1 week, 12 weeks, 6 months, 1 year, 2 years
Patient activation
Patient Activation Measure (PAM-13 MH)
Measured: Baseline, 1 week, 12 weeks, 6 months, 1 year, 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2016 (estimated)
- Study startDec 2015
- Primary completionJun 2018
- Study completionJun 2018
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 St. Olavs HospitalThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Olavs Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Trondheim Kommune, Norwegian University of Science and Technology
- Responsible party
- Sponsor
- Investigators
- Gunnar Morken, PhD, Study director, St. Olavs Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02743143
- Sponsor's protocol ID
- 2015/1611
- Acronym
- LEXUS
- Status last verified
- Oct 2019
- First submitted
- 19 Jan 2016
- Last updated
- 3 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Brobakken MF, Nygard M, Guzey IC, Morken G, Reitan SK, Heggelund J, Wang E, Vedul-Kjelsaas E. Aerobic interval training in standard treatment of out-patients with schizophrenia: a randomized controlled trial. Acta Psychiatr Scand. 2019 Dec;140(6):498-507. doi: 10.1111/acps.13105. Epub 2019 Oct 16.
PubMed 31565796
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of 1 Year Supervised Exercise Training Versus Usual Care on Cardiovascular Health, Functional Skills and Physical Fitness in Patients With Schizophrenia
- ClinicalTrials.gov ID
- NCT02743143
- Acronym / sponsor ID
- LEXUS / 2015/1611
- Conditions
- Schizophrenia
- Keywords
- Exercise therapy, Cardiovascular disease, Risk
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- St. Olavs HospitalUniversity, hospital or other
- Collaborators
- Trondheim Kommune, Norwegian University of Science and Technology
- Study start
- Dec 2015 (actual)
- Primary completion
- Jun 2018 (actual)
- Study completion
- Jun 2018 (actual)
- First posted
- 19 Apr 2016 (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.
Patients with schizophrenia have disabling symptoms and cognitive deficits that limit motivation, drive, social- and occupational performance, quality of life and self-efficacy. Schizophrenia also leads to a high risk of dying from cardiovascular disease. Explanatory trials suggest that exercise improves cognitive functioning, symptoms, and quality of life, and reduces the risk of cardiovascular disease. However, due to this illness, the participation in regular exercise is challenging. In this study it will be tested if patients with schizophrenia can participate in long-term exercise therapy, and whether long-term supervised exercise therapy is more beneficial than today's usual care.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise therapy | Experimental | Behavioral: Exercise therapyHigh aerobic intensity training and maximal strength training 2 times per week in 1 year at the Hospital's Exercise Training Clinic. Patients receive comprehensive support from Trondheim municipal administration to facilitate adherence. |
| Follow-up care as usual | Active comparator | Other: Follow-up care as usualThe usual care (UC) group will receive the usual physical activity offered by the primary health care system. UC includes the traditional physical activity advice from the Health Directorate. The UC group are invited to supervised exercise at the exercise training Clinic after 1 year. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- International Classification of Diseases (ICD-10) schizophrenia, schizotypal or delusional disorders (F20 to F29)
- able to carry out long-term exercise.
- capable of giving informed consent.
Key exclusion criteria (2 listed)
- contra-indication for exercise training and testing according to the American College of Sports Medicine (ACSM) 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).
- patients under admittance to an acute psychiatric ward.
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 |
|---|---|---|
| Exercise therapy | Behavioural | Exercise therapy |
| Follow-up care as usual | Other | Follow-up care as usual |
Primary outcome
Change in peak oxygen uptake.
Time frame: Baseline, 12 weeks, 1 year, 2 years.
Peak oxygen uptake after the training period subtracted Peak oxygen uptake at baseline.
22 secondary outcomes
Change in physical activity.
Time frame: Baseline, 12 weeks, 1 year, 2 years.
Changes in walking economy.
Time frame: Baseline, 12 weeks, 1 year, 2 years.
Real world functional behavior
Time frame: Baseline, 1 year, 2 years.
Functional competence
Time frame: Baseline,1 year, 2 years.
Hospital stays and contact with health care providers.
Time frame: Baseline, 1 year, 2 years.
Balance
Time frame: Baseline, 12 weeks, 1 year, 2 years.
Sit-to-stand test
Time frame: Baseline, 12 weeks, 1 year, 2 years.
Walking performance
Time frame: Baseline, 12 weeks, 1 year, 2 years.
Stair performance
Time frame: Baseline, 12 weeks, 1 year, 2 years.
Clinical symptoms.
Time frame: Baseline, 1 year, 2 years.
Global functioning
Time frame: Baseline, 1 year, 2 years.
Quality of life.
Time frame: Baseline, 12 weeks, 1 year, 2 years.
Quality-adjusted life year
Time frame: Baseline, 12 weeks, 1 year, 2 years.
Morning fasting blood levels.
Time frame: Baseline, 12 weeks, 1 year, 2 years.
Tobacco
Time frame: Baseline, 12 weeks, 1 year, 2 years.
Alcohol and substance abuse
Time frame: Baseline, 12 weeks, 1 year, 2 years.
Motivation
Time frame: Baseline, 12 weeks, 1 year, 2 years.
Readiness/confidence to change
Time frame: Baseline, 12 weeks, 1 year, 2 years.
Client Satisfaction
Time frame: Baseline, 12 weeks, 1 year, 2 years.
Changes in maximal strength.
Time frame: Baseline, 12 weeks, 1 year, 2 years.
Patient activation
Time frame: Baseline, 1 week, 12 weeks, 6 months, 1 year, 2 years
Patient activation
Time frame: Baseline, 1 week, 12 weeks, 6 months, 1 year, 2 years
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 3 Oct 2019.
- Results publication: PubMed 31565796Brobakken MF, Nygard M, Guzey IC, Morken G, Reitan SK, Heggelund J, Wang E, Vedul-Kjelsaas E. Aerobic interval training in standard treatment of out-patients with schizophrenia: a randomized controlled trial. Acta Psychiatr Scand. 2019 Dec;140(6):498-507. doi: 10.1111/acps.13105. Epub 2019 Oct 16.
- 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. This study is not recruiting at the moment.
Gunnar Morken, PhD study director
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 Exercise therapy and Follow-up care as usual in people with Schizophrenia, run by St. Olavs 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 2 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 3 Oct 2019. 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?
Change in peak oxygen uptake. (time frame: Baseline, 12 weeks, 1 year, 2 years.). 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 NCT02743143, 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 3 Oct 2019.