NCT05834309: SMI01

Exercise Effects on Health Status in Patients With Severe Mental Illness

Recruiting now NA Last updated 8 May 2024

What this trial tests

NA trial testing Physical exercise in Exercise in 100 participants. Currently enrolling.

Timeline

5 December 2022

Primary endpoint
5 May 2025

31 December 2025

Quick facts

Lead sponsor	Universidad Pública de Navarra
Phase	NA
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	100
Start date	5 December 2022
Primary completion	5 May 2025
Estimated completion	31 December 2025
Sites	2 locations across Spain

Drugs / interventions tested

• Physical exercise

Conditions studied

• Exercise — all drugs for Exercise →
• Metabolic Syndrome — all drugs for Metabolic Syndrome →
• Mental Disorders, Severe — all drugs for Mental Disorders, Severe →
• Severe Mental Disorder — all drugs for Severe Mental Disorder →

Sponsor

Universidad Pública de Navarra

Who can join

Adults 18 to 65, any sex, with Exercise or Metabolic Syndrome. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.