Exercise Effects on Health Status in Patients With Severe Mental Illness

NCT05834309 | Active Not Recruiting

• 1 other identifier: UPNavarra
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 2

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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.

  14 weeks

Secondary Outcomes (19)

• International Physical Activity Questionnaire (IPAQ)

  14 weeks

• Muscle strength

  14 weeks

• European Quality of Life-5 Dimensions (EuroQol-5D)

  14 weeks

• Physical condition

  14 weeks

• Beck questionnaire

  14 weeks

Study Arms (2)

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.

Other: Physical exercise

Interventions

Physical exercise OTHER

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.

Exercise training group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad Pública de Navarra: lead
• Fundacion Miguel Servet: collaborator
• Complejo Hospitalario de Navarra: collaborator

Study Sites (2)

Complejo Hospitalario de Navarra

Pamplona, Navarre, 31008, Spain

Location

Fundacion Miguel Servet

Pamplona, Navarre, 31008, Spain

Location

MeSH Terms

Conditions

Motor Activity; Metabolic Syndrome; Mental Disorders; Cognitive Dysfunction; Sedentary Behavior; Health Behavior

Interventions

Exercise

Condition Hierarchy (Ancestors)

Behavior; Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Cognition Disorders; Neurocognitive Disorders

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Ana Urteaga

  Complejo Hospitalario de Navarra

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 7, 2023
• First Posted: April 28, 2023
• Study Start: December 5, 2022
• Primary Completion: April 25, 2026
• Study Completion: April 26, 2026
• Last Updated: April 29, 2026

Record last verified: 2026-04

Locations

ES (2)