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Health Education Programme Through Physical Exercise for People With Severe Mental Disorders (HEPPE-PSMI)

Primary Purpose

Severe Mental Disorder, Obesity

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Guided physical activity
Standard physical activity
Sponsored by
Fundación para la Investigación del Hospital Clínico de Valencia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Severe Mental Disorder focused on measuring Exercise, Neurocognition, Inflammation, Oxidative stress, Vascular damage, Metabolic activity, Mental illnesses, Obesity

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Guided physical activity group

    Standard physical activity group

    Arm Description

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

    Standard physical activity without guided and incentives.

    Outcomes

    Primary Outcome Measures

    Verbal learning and memory
    Complutense Verbal Learning Test total immediate recall, short-term free recall and long-term free recall The higher scores mean a better outcome.
    Cognitive flexibility
    Wisconsin Card Sorting Test The higher scores mean a better outcome.
    Verbal fluency
    Animal naming test for phonemic and semantic fluency. The higher scores mean a better outcome.
    Working memory
    Trail Making Test The higher scores mean a better outcome.
    Short-term memory
    Complutense Verbal Learning Test total immediate recall, short-term free recall and long-term free recall The higher scores mean a better outcome.
    Visual memory
    Rey-Osterrieth Complex Figure Test figure two minutes after the copy and 20 minutes after the copy. The higher scores mean a better outcome.
    Processing speed
    Stroop Color and Word test color/word subtest The higher scores mean a better outcome.
    Functional Assessment Short Test
    Functional performance. The higher scores mean a better outcome.
    Short Form-36 Health Survey questionnaire
    Quality of life. The higher scores mean a better outcome.
    World Health Organization Quality of Life brief scale
    Quality of life. The higher scores mean a better outcome.
    Inflammatory markers
    Serum cytokine concentrations were determined using Luminex® X-MAP technology (Luminex Corp., Austin, TX, USA) based on flow cytometry. Sample processing and data analysis were performed according to the manufacturer's instructions. (Behring Nephelometer II, Dade Behring, Inc., Newark, DE, USA)..
    Oxidative stress markers
    Oxidative stress in leukocytes was evaluated using fluorimetry techniques with a fluoroscan (Synergy MX). In total, 100 000 cells were plated in each well of 96-well plates and incubated for 30 min at 37 °C with the corresponding fluorochromes, as follows: dichlorofluorescein diacetate to measure reactive oxygen species (ROS) production (485 nm excitation, 535 nm emission), MitoSOX to measure mitochondrial ROS (mROS) (510 nm excitation, 580 nm emission), tetramethylrodamin methyl ester to assess mitochondrial membrane potential (552 nm excitation, 574 nm emission), nonylacridin orange mitochondrial mass (495 nm excitation, 519 nm emission), and 5-chloromethylfluorescein diacetate to measure intracellular glutathione (492 nm excitation, 517 nm emission). The monocyte cell line U-937 was used as an internal control to avoid potential fluctuations in fluorescence over time.
    Adhesion molecules markers
    Serum lipid peroxidation levels were measured using a commercial thiobarbituric acid reactive substances (TBARS) kit according to the manufacturer's instructions (Olympus, Hamburg, Germany). A Luminex 200 flow analyzer system (Austin, TX, USA) was employed to analyze adhesion molecules in serum. To measure immunological markers, citrated blood samples were incubated with dextran (3%) for 45 min to isolate human polymorphonuclear leukocytes (PMNs). The supernatant was layered over Ficoll-Hypaque (GE Healthcare, Barcelona, Spain) and centrifuged for 25 min at room temperature at 650g. Lysis buffer was added to the remaining erythrocytes in the pellet, which were incubated at room temperature for 5 min and then spun at 240g for 5 min. PMNs were rinsed twice and resuspended at 37 ℃ in Hanks' balanced salt solution (Sigma Aldrich, MO). Scepter 2.0 cell counters (Millipore, MA, USA) was employed to count cells
    Metabolic markers
    Under aseptic conditions, fasting venous blood samples were collected between 8 and 9 am to measure.
    Maximum heart rate
    Measured with a watch-shaped device that was worn on the wrist and captured the beats per minute.
    Systolic pressure/diastolic pressure
    Measured on the right arm using an automatic sphygmomanometer with participants in the sitting position after resting for 5 minutes.
    Waist circumference
    Measured in the standing position at the end of normal expiration and at the midway between the inferior costal margin and the superior border of the iliac crest.

    Secondary Outcome Measures

    Full Information

    First Posted
    September 5, 2023
    Last Updated
    October 3, 2023
    Sponsor
    Fundación para la Investigación del Hospital Clínico de Valencia
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06069739
    Brief Title
    Health Education Programme Through Physical Exercise for People With Severe Mental Disorders
    Acronym
    HEPPE-PSMI
    Official Title
    Development and Evaluation of a Health Education Programme Through Physical Exercise for the Development of Autonomous Physical Activity Habits in People With Severe Mental Disorders
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2023
    Overall Recruitment Status
    Completed
    Study Start Date
    March 1, 2016 (Actual)
    Primary Completion Date
    June 30, 2016 (Actual)
    Study Completion Date
    June 30, 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Fundación para la Investigación del Hospital Clínico de Valencia

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Severe Mental Disorder, Obesity
    Keywords
    Exercise, Neurocognition, Inflammation, Oxidative stress, Vascular damage, Metabolic activity, Mental illnesses, Obesity

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Eligible participants were randomly assigned in a 1:1 ratio to a 12-week program of either; (a) 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). Both groups followed the same randomized recruitment procedure, data collection and follow-up. All treatment sessions were conducted from March to June 2016. To maintain the rigor of the research, possible risks that could question the internal and external validity of the study results were identified and strategies were proposed to eliminate them.
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    29 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Guided physical activity group
    Arm Type
    Experimental
    Arm Description
    Guided-exercise of moderate intensity and frecuency, and incentive of autonomous physical activity proposals by the specialist.
    Arm Title
    Standard physical activity group
    Arm Type
    Active Comparator
    Arm Description
    Standard physical activity without guided and incentives.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Guided physical activity
    Intervention Description
    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
    Intervention Name(s)
    Standard physical activity
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Verbal learning and memory
    Description
    Complutense Verbal Learning Test total immediate recall, short-term free recall and long-term free recall The higher scores mean a better outcome.
    Time Frame
    4 months
    Title
    Cognitive flexibility
    Description
    Wisconsin Card Sorting Test The higher scores mean a better outcome.
    Time Frame
    4 months
    Title
    Verbal fluency
    Description
    Animal naming test for phonemic and semantic fluency. The higher scores mean a better outcome.
    Time Frame
    4 months
    Title
    Working memory
    Description
    Trail Making Test The higher scores mean a better outcome.
    Time Frame
    4 months
    Title
    Short-term memory
    Description
    Complutense Verbal Learning Test total immediate recall, short-term free recall and long-term free recall The higher scores mean a better outcome.
    Time Frame
    4 months
    Title
    Visual memory
    Description
    Rey-Osterrieth Complex Figure Test figure two minutes after the copy and 20 minutes after the copy. The higher scores mean a better outcome.
    Time Frame
    4 months
    Title
    Processing speed
    Description
    Stroop Color and Word test color/word subtest The higher scores mean a better outcome.
    Time Frame
    4 months
    Title
    Functional Assessment Short Test
    Description
    Functional performance. The higher scores mean a better outcome.
    Time Frame
    4 months
    Title
    Short Form-36 Health Survey questionnaire
    Description
    Quality of life. The higher scores mean a better outcome.
    Time Frame
    4 months
    Title
    World Health Organization Quality of Life brief scale
    Description
    Quality of life. The higher scores mean a better outcome.
    Time Frame
    4 months
    Title
    Inflammatory markers
    Description
    Serum cytokine concentrations were determined using Luminex® X-MAP technology (Luminex Corp., Austin, TX, USA) based on flow cytometry. Sample processing and data analysis were performed according to the manufacturer's instructions. (Behring Nephelometer II, Dade Behring, Inc., Newark, DE, USA)..
    Time Frame
    4 months
    Title
    Oxidative stress markers
    Description
    Oxidative stress in leukocytes was evaluated using fluorimetry techniques with a fluoroscan (Synergy MX). In total, 100 000 cells were plated in each well of 96-well plates and incubated for 30 min at 37 °C with the corresponding fluorochromes, as follows: dichlorofluorescein diacetate to measure reactive oxygen species (ROS) production (485 nm excitation, 535 nm emission), MitoSOX to measure mitochondrial ROS (mROS) (510 nm excitation, 580 nm emission), tetramethylrodamin methyl ester to assess mitochondrial membrane potential (552 nm excitation, 574 nm emission), nonylacridin orange mitochondrial mass (495 nm excitation, 519 nm emission), and 5-chloromethylfluorescein diacetate to measure intracellular glutathione (492 nm excitation, 517 nm emission). The monocyte cell line U-937 was used as an internal control to avoid potential fluctuations in fluorescence over time.
    Time Frame
    4 months
    Title
    Adhesion molecules markers
    Description
    Serum lipid peroxidation levels were measured using a commercial thiobarbituric acid reactive substances (TBARS) kit according to the manufacturer's instructions (Olympus, Hamburg, Germany). A Luminex 200 flow analyzer system (Austin, TX, USA) was employed to analyze adhesion molecules in serum. To measure immunological markers, citrated blood samples were incubated with dextran (3%) for 45 min to isolate human polymorphonuclear leukocytes (PMNs). The supernatant was layered over Ficoll-Hypaque (GE Healthcare, Barcelona, Spain) and centrifuged for 25 min at room temperature at 650g. Lysis buffer was added to the remaining erythrocytes in the pellet, which were incubated at room temperature for 5 min and then spun at 240g for 5 min. PMNs were rinsed twice and resuspended at 37 ℃ in Hanks' balanced salt solution (Sigma Aldrich, MO). Scepter 2.0 cell counters (Millipore, MA, USA) was employed to count cells
    Time Frame
    4 months
    Title
    Metabolic markers
    Description
    Under aseptic conditions, fasting venous blood samples were collected between 8 and 9 am to measure.
    Time Frame
    4 months
    Title
    Maximum heart rate
    Description
    Measured with a watch-shaped device that was worn on the wrist and captured the beats per minute.
    Time Frame
    4 months
    Title
    Systolic pressure/diastolic pressure
    Description
    Measured on the right arm using an automatic sphygmomanometer with participants in the sitting position after resting for 5 minutes.
    Time Frame
    4 months
    Title
    Waist circumference
    Description
    Measured in the standing position at the end of normal expiration and at the midway between the inferior costal margin and the superior border of the iliac crest.
    Time Frame
    4 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Rafael Tabarés-Seisdedos
    Organizational Affiliation
    Consorcio Centro de Investigación Biomédica en Red (CIBER)
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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