Health Education Programme Through Physical Exercise for People With Severe Mental Disorders

NCT ID: NCT06069739

Last Updated: 2023-10-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 29 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-03-01
• Study Completion Date: 2016-06-30

Brief Summary

The goal of this clinical trial is to [learn about, test, compare etc.] in individuals with severe mental disorders and obesity comorbid.

The main question[s] it aims to answer are:

• Are inflammatory activity, oxidative and vascular damage and metabolic mechanisms, as well as neurocognitive and functional performance, related to different physical exercise interventions?
• Do inflammatory, oxidative stress and cardiometabolic biomarkers predict neurocognitive improvement after physical activity training?

Participants will guided-exercise of moderate intensity and frecuency, and incentive of autonomous physical activity proposals by the specialist; guided physical activity group (GPAG), or (b) 12 weeks of an exercise program standard physical activity without guided and incentives; standard physical activity group (SPAG).

If there is a comparison group: Researchers will compare GPAG and SPAG to see if inflammatory, oxidative stress, and cardio-metabolic biomarkers improve neurocognitive performance after physical activity training

Detailed Description

The psychiatric disorders and obesity comorbidity is related to neurocognitive impairment and inflammation. Exercise is crucial to improve and maintain healthy lifestyles. This randomized controlled trial tested the efficacy of aerobic exercise as promoter of neurocognitive improvement across psychiatric disorders and OB comorbid. Participants (n=29) received brief healthy lifestyle counseling and were randomized to 12 weeks of guided-exercise of moderate intensity and frequency, and incentive of autonomous physical activity proposals by the specialist; guided physical activity group (GPAG) (n=10) or 12 weeks of exercise standard physical activity without guided and incentives; standard physical activity group (SPAG) (n=19). Peripheral blood biomarkers of inflammation, oxidative stress, vascular mechanisms and metabolic activity, as well as neurocognitive and functional performance were assessed twice over after and before treatment. Mixed one-way analysis of variance and linear regression analyses were performed.

Conditions

Severe Mental Disorder; Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Guided physical activity group

Guided-exercise of moderate intensity and frecuency, and incentive of autonomous physical activity proposals by the specialist.

Group Type: EXPERIMENTAL

Guided physical activity

Intervention Type: BEHAVIORAL

To achieve the European guidelines of 150 minutes by week of moderate intensity physical activity, participants randomized to the GPAG condition were prescribed three 60 minutes exercise sessions (five minutes of warm-up and five minutes of cool-down for a total of sixty minutes per session) per week for 12 weeks. Exercise consisted of brisk walking in urban and rural open spaces during which heart rate monitors were worn and participants were instructed to stay within their moderate intensity range. The incentives were different proposals for specific exercises to train the different musculoskeletal areas more comprehensively. Autonomous exercise was monitored offside the sessions through a series of weekly checkpoints.

Standard physical activity group

Standard physical activity without guided and incentives.

Group Type: ACTIVE_COMPARATOR

Standard physical activity

Intervention Type: BEHAVIORAL

Participants randomised to the SPAG performed their usual daily activities and continued with their daily routine.

Both conditions were matched for duration of physical activity. Participants in both conditions were required to attend three on-site sessions by week over 12 weeks that served as checkpoints. Moreover, both conditions were provided with brief healthy lifestyle counseling at baseline.

Interventions

Guided physical activity

To achieve the European guidelines of 150 minutes by week of moderate intensity physical activity, participants randomized to the GPAG condition were prescribed three 60 minutes exercise sessions (five minutes of warm-up and five minutes of cool-down for a total of sixty minutes per session) per week for 12 weeks. Exercise consisted of brisk walking in urban and rural open spaces during which heart rate monitors were worn and participants were instructed to stay within their moderate intensity range. The incentives were different proposals for specific exercises to train the different musculoskeletal areas more comprehensively. Autonomous exercise was monitored offside the sessions through a series of weekly checkpoints.

Intervention Type: BEHAVIORAL

Standard physical activity

Participants randomised to the SPAG performed their usual daily activities and continued with their daily routine.

Both conditions were matched for duration of physical activity. Participants in both conditions were required to attend three on-site sessions by week over 12 weeks that served as checkpoints. Moreover, both conditions were provided with brief healthy lifestyle counseling at baseline.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• MDD, BD and SZ were diagnosed according to the criteria of the Diagnostic and Statistical Manual of Mental Disorders - DSM-5 (APA, 2014).
• Participants with MDD and BD should meet the remission criteria (Tohen et al., 2009) of an acute affective episode, defined as Young Mania Rating Scale (YMRS) score ≤ 6 and Hamilton Rating Scale for Depression (HRSD) score ≤ 8, and individuals with SZ had to be clinically stable, defined as Positive and Negative Syndrome Scale (PANSS) score ≤ 36.
• The comorbid OB diagnosis was based on World Health Organization (WHO) criteria.
• Ability to understand study procedures and willingness to give written consent was required for participation.

For recruitment as HC

• Absence of physical illness
• Absence of pharmacological treatments
• Absence of family history of psychiatric disorders in first-degree relatives were required.
• Ability to understand study procedures and willingness to give written consent was required for participation.

Exclusion Criteria

• current hospitalization
• documented cognitive impairment not secondary to psychiatric disorder (intellectual disability or major neurocognitive disorder, i.e. dementia)
• disability or inability that prevented understanding of the protocol
• current substance use disorders (except for nicotine)
• pregnancy
• intake of steroids
• corticosteroids, antioxidants, antibiotics, and immunologic therapies
• fever over 38°C
• history of vaccination within 4 weeks of the evaluation
• medical contraindications for exercise
• body mass index ≥ 40
• diastolic/systolic blood pressure ≥ 140/90
• resting heart rate ≥ 100.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Fundación para la Investigación del Hospital Clínico de Valencia

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Rafael Tabarés-Seisdedos

Role: PRINCIPAL_INVESTIGATOR

Consorcio Centro de Investigación Biomédica en Red (CIBER)

Other Identifiers

Physical exercise programme

Identifier Type: -

Identifier Source: org_study_id