Exercise Effects on Health Status in Patients With Severe Mental Illness (SMI01)

Universidad Pública de Navarra

Status: Enrolling

Conditions: Physical Inactivity; Physical Disability; Severe Mental Disorder; Mental Deterioration; Metabolic Syndrome; Exercise; Health-Related Behavior; Mental Disorders, Severe

Treatments: Other: Physical exercise

Study type: Interventional

Funder types: Other

Identifiers

NCT05834309

UPNavarra

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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 design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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100 participants in 2 patient groups

Control group

No Intervention group

Description:

Patients in this group will receive clinical usual care.

Exercise training group

Experimental group

Description:

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.

Treatment:

Other: Physical exercise