ExerciseSMI01NCT05834309
Exercise Effects on Health Status in Patients With Severe Mental Illness
A study testing Physical exercise in people with Exercise and Metabolic Syndrome, run by Universidad Pública de Navarra at 2 sites in Spain.
Trial summary
People with severe mental disorders have a mortality rate 2 to 3 times higher than that of the general population, largely due to the presence of comorbidities, with a predominance of cardiovascular disease. This population has a higher risk of developing metabolic syndrome compared to the healthy population. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Exercise, Metabolic Syndrome, Mental Disorders, Severe
- What is being tested?
- Physical exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 2 sitesSpain
- Study dates
- 5 Dec 2022to 26 Apr 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- resident in Navarra
- diagnosis of severe mental disorder (DSM 5: Schizophrenia 295.90, Tr. Schizoaffective Disorder 295.70, Schizotypal Personality Disorder 301.22, Schizoid Personality Disorder 301.20, Schizophreniform Personality Disorder 295.40, Psychotic Disorder with Delusional Ideas 295.40, Psychotic Disorder with Delusional Ideas 295.40. Schizophreniform 295.40, Psychotic disorder with delusions 293.81, Psychotic disorder with hallucinations 293.82, Major depressive disorder 296.33, Bipolar disorder type I 296.44, Bipolar disorder type II 296.89, Obsessive Compulsive Disorder 300.
- primary nursing diagnosis NANDA and Virginia Henderson NOC 0099 Ineffective Health Maintenance
- at least one of the secondary nursing diagnoses 001 Nutritional Imbalance due to Excess, 003 Risk of Nutritional Imbalance due to Excess, 00096 Sleep Deprivation, 00146 Anxiety or 00168 Sedentary
- willing to voluntarily participate in the randomly assigned intervention, after signing the informed consent form.
Who cannot join
- acute illness that does not allow physical exercise sessions or assessments during the study
- medical contraindication that prevents physical exercise
- treatment with Interleukin-6 receptor antagonists (tocilizumab) during the last month due to drug interference with adaptations to cardiopulmonary exercise
- refusal to sign the informed consent form by the study subject
- impossibility of follow-up.
Trial locations and contacts
2 sites in 1 country.
Spain2 sites
Complejo Hospitalario de Navarra
Pamplona, Navarre, 31008
Fundacion Miguel Servet
Pamplona, Navarre, 31008
About this study
Official title: Effectiveness of a Multicomponent Exercise Program on Health Status and Health-related Quality of Life in Patients With Severe Mental Illness: Study Protocol for a Randomized Controlled Trial.
People with severe mental disorders have a mortality rate 2 to 3 times higher than that of the general population, largely due to the presence of comorbidities, with a predominance of cardiovascular disease. This population has a higher risk of developing metabolic syndrome compared to the healthy population. Several factors are involved. The usual pharmacological treatment in people with severe mental disorder is a risk factor for the development of metabolic syndrome and deterioration of physical condition. This is generally compounded by poor health care, high-calorie diets, a sedentary lifestyle, difficulties in coping with life situations that generate emotional states (anxiety and/or depression) that result in unhealthy lifestyle habits related to food, activity, interpersonal relationships, sleep, consumption habits (tobacco, alcohol and drugs) and other environmental factors. Physical exercise has been proposed as one of the most effective treatments to reverse the negative consequences of low levels of physical activity in this population. However, the mechanism of action of exercise on health status and the optimal "dose" and intensity of exercise to achieve the greatest number of benefits with respect to cardiometabolic health in patients with severe mental disorder are unknown.The study will be carried out at the Mental Health Rehabilitation Unit of Navarra, a center under the Mental Health Management of Osasunbidea, where people between 18 and 65 years of age with a diagnosis of severe mental illness in a situation of clinical stability receive treatment.The sample will be composed of 100 participants from consecutive admissions to the Rehabilitation Unit. The subjects will be randomized into 2 groups; a control group that will receive the usual specialized care and an intervention group, which in addition to receiving the usual rehabilitation treatment, will undergo a 6-week multicomponent physical exercise program performed 2 days per week. The effects of exercise on the inflammatory profile, metabolic parameters, physical condition, cognitive function, vascular function, muscle strength, health-related quality of life, lifestyle habits (diet, activation, sleep, substance use) and mood will be evaluated.
- Conditions
- Exercise, Metabolic Syndrome, Mental Disorders, Severe, Severe Mental Disorder, Mental Deterioration, Physical Inactivity
- Being tested
- Physical exercise
- Medical subject headings
- Motor Activity, Metabolic Syndrome, Mental Disorders, Cognitive Dysfunction, Sedentary Behavior, Health Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical exerciseOther
The intervention protocol consists of a 10-minute warm-up doing joint mobility exercises and adaptation exercises to the core exercises of the training session. The exercises will be performed at low intensity in the warm-up. During the main part of the training session, exercises will be performed on a stationary bike at a higher intensity than in the warm-up and strengthening exercises using weights and body weight exercises such as jumping jacks and squats will also be performed. All movements will be performed at 100% of the maximum speed reached in the propulsive phase (understood as executing the movement as fast as possible according to your muscular and functional capacity). The rests between sets will be between 1 and 2 minutes. At the end of the session, there will be a 5-minute return to calm by stretching.
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | Patients in this group will receive clinical usual care. |
| Exercise training group | Experimental | An individualized multicomponent exercise program including resistance, aerobic, balance and flexibility exercises.The duration of the sessions will be 45 minutes, and the duration of the whole program will be 6 weeks, equivalent to 12 sessions. Receives: Other: Physical exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of metabolic syndrome
Any 3 of the 5 features: Waist circumference (> 102 cm men/ > 88 cm women),Elevated triglycerides (> 150 mg/dl), reduced HDL cholesterol (< 40 mg/dl men/ < 50 mg/dl women), elevated blood pressure(> 130 mmHg Systolic blood pressure or > 85 mmHg Diastolic blood pressure), and elevated fasting glucose (> 100 mg/dl) glucose.
Measured: 14 weeks
Secondary outcomes (19)
International Physical Activity Questionnaire (IPAQ)
Physical activity questionnaire. LOW If not moderate or vigorous. MODERATE: 3 or more days of vigorous-intensity activity of at least 20 minutes per day OR b) 5 or more days of moderate-intensity activity and/or walking of at least 30 minutes per day OR c) 5 or more days of any combination of walking, moderate-intensity or vigorous intensity activities achieving a minimum T=total physical activity of at least 600 Metabolic equivalent of task (MET)-minutes/week. HIGH a) Vigorous-intensity activity on at least 3 days (20min minimum, achieving a minimum Total physical activity of at least 1500 MET-minutes/week or 7 or more days of any combination of walking, moderate-intensity or vigorous-intensity activities achieving a minimum Total physical activity of at least 3000 MET-minutes/week.
Measured: 14 weeks
Muscle strength
Maximal dynamic strength (one-maximum muscle strength) was measured for four exercises (knee extension, leg press, row and bench press) using a Smart Strength machine (eGym GmbH, München, Germany). Results were expressed in kilograms.
Measured: 14 weeks
European Quality of Life-5 Dimensions (EuroQol-5D)
Health related quality of life.The EQ-5D-5L essentially consists of 2 pages: the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). The worse score is 0 and the best score is 100.
Measured: 14 weeks
Physical condition
Graded exercise tests will be performed on a bicycle ergometer (Lode B.V., Groningen, The Netherlands) to determine the maximal oxygen uptake (VO2max), measured by ml/kg/min.
Measured: 14 weeks
Beck questionnaire
Depression. The minimum value is 0 points and the maximum value is 63 points. Higher scores mean a worse outcome.
Measured: 14 weeks
State Strait Anxiety Inventory (STAI)
Anxiety. The minimum score is 0 and the maximum score is 120. Higher scores means a worse outcome.
Measured: 14 weeks
Positive And Negative Syndrome Scale (PANSS)
Positive and negative symptoms. Positive scale (minimum score is 7 and maximum score is 49), negative scale (minimum scale is 7 and maximum score is 49) and general psychopathology scale (minimum score is 16 and maximum score is 112 points). Higher scores means a worse outcome.
Measured: 14 weeks
Screen for Cognitive Impairment in Psychiatry (SCIP)
Cognitive function. Memory, attention, executive function and processing speed.
Measured: 14 weeks
Adverse events related to medication
Neurological side effects related to the medication assessed by the Side Effect Rating Scale.
Measured: 14 weeks
Muscle mass
Muscle thickness by ultrasound examination
Measured: 14 weeks
Densitometry
Body composition
Measured: 14 weeks
Medication
Pharmacologic/antipsichotic treatment (i.e., pills consumption) associated with the disorder obtained by the medical history.
Measured: 14 weeks
Blood pressure
Blood pressure will be assessed using a Vasera 2000 device (Fukuda Denshi, Japan).
Measured: 14 weeks
Oviedo questionnaire
Sleep quality.The insomnia subscale ranges from 9 to 45, where a higher scores means increased severity of insomnia.
Measured: 14 weeks
Schizophrenia Quality of Life Scale Revision 4 (SQLS-R4)
Health related quality of life.The SQLS-R4 is a self-report measure comprising 33 items from which two domains of quality of life, psychosocial feelings (22 items) and cognition and vitality (11 items) are derived. The items are scored on a 5-point frequency-response Likert scale (''never'', ''rarely'', ''sometimes'', ''often'', ''always''). A total score of both domains can also be calculated and individual domain and total scores are standardized by scoring algorithm to a 0 - 100 scale. Higher SQLS-R4 scores indicate comparatively lower quality of life.
Measured: 14 weeks
The Matrics Consensus Cognitive Battery
Cognitive function.The MATRICS Consensus Cognitive Battery should be used as the standard battery for all clinical trials of potential cognition-enhancing agents for schizophrenia.
- The battery should always be administered in its entirety in clinical trials (64 minutes).
- An overall cognitive composite score consisting of equal weighting of the 7 domain scores is the primary cognitive endpoint for agents believed to enhance cognition broadly.
- Alternatively, a small subset of domains may be combined as the primary cognitive endpoint for agents believed to enhance cognition selectively (e.g., the learning and memory domains).
Measured: At baseline
Medical history of substance abuse
Alcohol consumption, use of drugs and other substances.
Measured: 14 weeks
Vascular stiffness
Cardio-ankle vascular index (CAVI) will be estimated by brachial-ankle oscillometry using a Vasera 2000 device (Fukuda Denshi, Japan) as marker of vascular stiffness.
Measured: 14 weeks
Vascular stiffness
Pulse wave velocity (PWV) will be estimated by brachial-ankle oscillometry using a Vasera 2000 device (Fukuda Denshi, Japan).
Measured: 14 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2023
- Study start5 Dec 2022
- Primary completion25 Apr 2026 (estimated)
- Study completion26 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ExerciseStudies 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
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad Pública de Navarra
- Sponsor type
- University, hospital or other
- Collaborators
- Fundacion Miguel Servet, Complejo Hospitalario de Navarra
- Responsible party
- Sponsor
- Investigators
- Ana Urteaga, Principal investigator, Complejo Hospitalario de Navarra
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05834309
- Sponsor's protocol ID
- UPNavarra
- Acronym
- SMI01
- Status last verified
- Apr 2026
- First submitted
- 7 Mar 2023
- Last updated
- 29 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Multicomponent Exercise Program on Health Status and Health-related Quality of Life in Patients With Severe Mental Illness: Study Protocol for a Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT05834309
- Acronym / sponsor ID
- SMI01 / UPNavarra
- Conditions
- Exercise, Metabolic Syndrome, Mental Disorders, Severe, Severe Mental Disorder, Mental Deterioration, Physical Inactivity
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Universidad Pública de NavarraUniversity, hospital or other
- Collaborators
- Fundacion Miguel Servet, Complejo Hospitalario de Navarra
- Study start
- 5 Dec 2022 (actual)
- Primary completion
- 25 Apr 2026 (estimated)
- Study completion
- 26 Apr 2026 (estimated)
- First posted
- 28 Apr 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.
People with severe mental disorders have a mortality rate 2 to 3 times higher than that of the general population, largely due to the presence of comorbidities, with a predominance of cardiovascular disease. This population has a higher risk of developing metabolic syndrome compared to the healthy population. Several factors are involved. The usual pharmacological treatment in people with severe mental disorder is a risk factor for the development of metabolic syndrome and deterioration of physical condition. This is generally compounded by poor health care, high-calorie diets, a sedentary lifestyle, difficulties in coping with life situations that generate emotional states (anxiety and/or depression) that result in unhealthy lifestyle habits related to food, activity, interpersonal relationships, sleep, consumption habits (tobacco, alcohol and drugs) and other environmental factors. Physical exercise has been proposed as one of the most effective treatments to reverse the negative consequences of low levels of physical activity in this population. However, the mechanism of action of exercise on health status and the optimal "dose" and intensity of exercise to achieve the greatest number of benefits with respect to cardiometabolic health in patients with severe mental disorder are unknown.The study will be carried out at the Mental Health Rehabilitation Unit of Navarra, a center under the Mental Health Management of Osasunbidea, where people between 18 and 65 years of age with a diagnosis of severe mental illness in a situation of clinical stability receive treatment.The sample will be composed of 100 participants from consecutive admissions to the Rehabilitation Unit. The subjects will be randomized into 2 groups; a control group that will receive the usual specialized care and an intervention group, which in addition to receiving the usual rehabilitation treatment, will undergo a 6-week multicomponent physical exercise program performed 2 days per week. The effects of exercise on the inflammatory profile, metabolic parameters, physical condition, cognitive function, vascular function, muscle strength, health-related quality of life, lifestyle habits (diet, activation, sleep, substance use) and mood will be evaluated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –Patients in this group will receive clinical usual care. |
| Exercise training group | Experimental | Other: Physical exerciseAn individualized multicomponent exercise program including resistance, aerobic, balance and flexibility exercises.The duration of the sessions will be 45 minutes, and the duration of the whole program will be 6 weeks, equivalent to 12 sessions. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- resident in Navarra
- diagnosis of severe mental disorder (DSM 5: Schizophrenia 295.90, Tr. Schizoaffective Disorder 295.70, Schizotypal Personality Disorder 301.22, Schizoid Personality Disorder 301.20, Schizophreniform Personality Disorder 295.40, Psychotic Disorder with Delusional Ideas 295.40, Psychotic Disorder with Delusional Ideas 295.40. Schizophreniform 295.40, Psychotic disorder with delusions 293.81, Psychotic disorder with hallucinations 293.82, Major depressive disorder 296.33, Bipolar disorder type I 296.44, Bipolar disorder type II 296.89, Obsessive Compulsive Disorder 300.
- primary nursing diagnosis NANDA and Virginia Henderson NOC 0099 Ineffective Health Maintenance
- at least one of the secondary nursing diagnoses 001 Nutritional Imbalance due to Excess, 003 Risk of Nutritional Imbalance due to Excess, 00096 Sleep Deprivation, 00146 Anxiety or 00168 Sedentary
- willing to voluntarily participate in the randomly assigned intervention, after signing the informed consent form.
Key exclusion criteria (5 listed)
- acute illness that does not allow physical exercise sessions or assessments during the study
- medical contraindication that prevents physical exercise
- treatment with Interleukin-6 receptor antagonists (tocilizumab) during the last month due to drug interference with adaptations to cardiopulmonary exercise
- refusal to sign the informed consent form by the study subject
- impossibility of follow-up.
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 intervention protocol consists of a 10-minute warm-up doing joint mobility exercises and adaptation exercises to the core exercises of the training session. The exercises will be performed at low intensity in the warm-up. During the main part of the training session, exercises will be performed on a stationary bike at a higher intensity than in the warm-up and strengthening exercises using weights and body weight exercises such as jumping jacks and squats will also be performed. All movements will be performed at 100% of the maximum speed reached in the propulsive phase (understood as executing the movement as fast as possible according to your muscular and functional capacity). The rests between sets will be between 1 and 2 minutes. At the end of the session, there will be a 5-minute return to calm by stretching. | Other | Exercise training group |
Primary outcome
Prevalence of metabolic syndrome
Time frame: 14 weeks
Any 3 of the 5 features: Waist circumference (> 102 cm men/ > 88 cm women),Elevated triglycerides (> 150 mg/dl), reduced HDL cholesterol (< 40 mg/dl men/ < 50 mg/dl women), elevated blood pressure(> 130 mmHg Systolic blood pressure or > 85 mmHg Diastolic blood pressure), and elevated fasting glucose (> 100 mg/dl) glucose.
19 secondary outcomes
International Physical Activity Questionnaire (IPAQ)
Time frame: 14 weeks
Muscle strength
Time frame: 14 weeks
European Quality of Life-5 Dimensions (EuroQol-5D)
Time frame: 14 weeks
Physical condition
Time frame: 14 weeks
Beck questionnaire
Time frame: 14 weeks
State Strait Anxiety Inventory (STAI)
Time frame: 14 weeks
Positive And Negative Syndrome Scale (PANSS)
Time frame: 14 weeks
Screen for Cognitive Impairment in Psychiatry (SCIP)
Time frame: 14 weeks
Adverse events related to medication
Time frame: 14 weeks
Muscle mass
Time frame: 14 weeks
Densitometry
Time frame: 14 weeks
Medication
Time frame: 14 weeks
Blood pressure
Time frame: 14 weeks
Oviedo questionnaire
Time frame: 14 weeks
Schizophrenia Quality of Life Scale Revision 4 (SQLS-R4)
Time frame: 14 weeks
The Matrics Consensus Cognitive Battery
Time frame: At baseline
Medical history of substance abuse
Time frame: 14 weeks
Vascular stiffness
Time frame: 14 weeks
Vascular stiffness
Time frame: 14 weeks
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 29 Apr 2026.
- 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.
Ana Urteaga principal investigator
Complejo Hospitalario de Navarra
2 sites 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 Exercise and Metabolic Syndrome, run by Universidad Pública de Navarra at 2 sites in Spain.
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 5 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 29 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Spain. 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?
Prevalence of metabolic syndrome (time frame: 14 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 29 Apr 2026.