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

Sponsor

Fundación para la Investigación del Hospital Clínico de Valencia (Other)

Overall Status

Completed

CT.gov ID

NCT06069739

Collaborator

(none)

Enrollment

Arms

Actual Duration (Months)

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Severe Mental Disorder Obesity	Behavioral: Guided physical activity Behavioral: Standard physical activity	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

29 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention 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.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:

Single (Participant)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Mar 1, 2016

Actual Primary Completion Date :

Jun 30, 2016

Actual Study Completion Date :

Jun 30, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Guided physical activity group Guided-exercise of moderate intensity and frecuency, and incentive of autonomous physical activity proposals by the specialist.	Behavioral: 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.
Active Comparator: Standard physical activity group Standard physical activity without guided and incentives.	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.

Arm

Intervention/Treatment

Experimental: Guided physical activity group

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

Behavioral: 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.

Active Comparator: Standard physical activity group

Standard physical activity without guided and incentives.

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.

Outcome Measures

Primary Outcome Measures

Verbal learning and memory [4 months]
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 [4 months]
Wisconsin Card Sorting Test The higher scores mean a better outcome.
Verbal fluency [4 months]
Animal naming test for phonemic and semantic fluency. The higher scores mean a better outcome.
Working memory [4 months]
Trail Making Test The higher scores mean a better outcome.
Short-term memory [4 months]
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 [4 months]
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 [4 months]
Stroop Color and Word test color/word subtest The higher scores mean a better outcome.
Functional Assessment Short Test [4 months]
Functional performance. The higher scores mean a better outcome.
Short Form-36 Health Survey questionnaire [4 months]
Quality of life. The higher scores mean a better outcome.
World Health Organization Quality of Life brief scale [4 months]
Quality of life. The higher scores mean a better outcome.
Inflammatory markers [4 months]
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 [4 months]
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 [4 months]
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 [4 months]
Under aseptic conditions, fasting venous blood samples were collected between 8 and 9 am to measure.
Maximum heart rate [4 months]
Measured with a watch-shaped device that was worn on the wrist and captured the beats per minute.
Systolic pressure/diastolic pressure [4 months]
Measured on the right arm using an automatic sphygmomanometer with participants in the sitting position after resting for 5 minutes.
Waist circumference [4 months]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.