Clinical trial NCT05834309: Exercise Effects on Health Status in Patients With Severe Mental Illness
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.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Exercise
Metabolic Syndrome
Mental Disorders, Severe
Severe Mental Disorder
Mental Deterioration
Physical Inactivity
Physical Disability
Health-Related Behavior
Lead sponsor: Universidad Pública de Navarra
Sponsor class: OTHER
Collaborators: name: Fundacion Miguel Servet
name: Complejo Hospitalario de Navarra
First posted: 2023-04-28
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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. 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Prevalence of metabolic syndrome
timeFrame: 14 weeks
Secondary outcomes:
measure: International Physical Activity Questionnaire (IPAQ)
timeFrame: 14 weeks
measure: Muscle strength
timeFrame: 14 weeks
measure: European Quality of Life-5 Dimensions (EuroQol-5D)
timeFrame: 14 weeks
measure: Physical condition
timeFrame: 14 weeks
measure: Beck questionnaire
timeFrame: 14 weeks
measure: State Strait Anxiety Inventory (STAI)
timeFrame: 14 weeks
measure: Positive And Negative Syndrome Scale (PANSS)
timeFrame: 14 weeks
measure: Screen for Cognitive Impairment in Psychiatry (SCIP)
timeFrame: 14 weeks
measure: Adverse events related to medication
timeFrame: 14 weeks
measure: Muscle mass
timeFrame: 14 weeks
measure: Densitometry
timeFrame: 14 weeks
measure: Medication
timeFrame: 14 weeks
measure: Blood pressure
timeFrame: 14 weeks
measure: Oviedo questionnaire
timeFrame: 14 weeks
measure: Schizophrenia Quality of Life Scale Revision 4 (SQLS-R4)
timeFrame: 14 weeks
measure: The Matrics Consensus Cognitive Battery
timeFrame: At baseline
measure: Medical history of substance abuse
timeFrame: 14 weeks
measure: Vascular stiffness
timeFrame: 14 weeks
measure: Vascular stiffness
timeFrame: 14 weeks
Other outcomes:
Locations:
city: Pamplona
country: Spain
facility: Complejo Hospitalario de Navarra
state: Navarra
city: Pamplona
country: Spain
facility: Fundacion Miguel Servet
state: Navarra
Study officials:
affiliation: Complejo Hospitalario de Navarra
name: Ana Urteaga
role: PRINCIPAL_INVESTIGATOR
References: