An interventional study of Physical exercise in Exercise, Metabolic Syndrome and Mental Disorders, Severe, sponsored by Universidad Pública de Navarra. Active, not recruiting at 2 sites in Spain. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-04-29.
Sponsored by Universidad Pública de Navarra · Not applicable, Interventional, and Treatment
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.
2,426 studies on the registry are indexed under Motor Activity; 1,161 are open to participants now.
This study's planned enrollment of 100 is above the median of 60 across 2,118 interventional studies indexed under Motor Activity.
Browse Motor Activity studies →Universidad Pública de Navarra is the lead sponsor of 13 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients in this group will receive clinical usual care.
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.
Other: Physical exercise
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.
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.
Time frame: 14 weeks
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 14 weeks
Beck questionnaire
Depression. The minimum value is 0 points and the maximum value is 63 points. Higher scores mean a worse outcome.
Time frame: 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.
Time frame: 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.
Time frame: 14 weeks
Screen for Cognitive Impairment in Psychiatry (SCIP)
Cognitive function. Memory, attention, executive function and processing speed.
Time frame: 14 weeks
Adverse events related to medication
Neurological side effects related to the medication assessed by the Side Effect Rating Scale.
Time frame: 14 weeks
Muscle mass
Muscle thickness by ultrasound examination
Time frame: 14 weeks
Densitometry
Body composition
Time frame: 14 weeks
Medication
Pharmacologic/antipsichotic treatment (i.e., pills consumption) associated with the disorder obtained by the medical history.
Time frame: 14 weeks
Blood pressure
Blood pressure will be assessed using a Vasera 2000 device (Fukuda Denshi, Japan).
Time frame: 14 weeks
Oviedo questionnaire
Sleep quality.The insomnia subscale ranges from 9 to 45, where a higher scores means increased severity of insomnia.
Time frame: 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.
Time frame: 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).
Time frame: At baseline
Medical history of substance abuse
Alcohol consumption, use of drugs and other substances.
Time frame: 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.
Time frame: 14 weeks
Vascular stiffness
Pulse wave velocity (PWV) will be estimated by brachial-ankle oscillometry using a Vasera 2000 device (Fukuda Denshi, Japan).
Time frame: 14 weeks
Plan to share: Undecided
No publications or documents are linked to this record.
This study is active, not recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Universidad Pública de Navarra