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ONLINE AEROBIC THERAPEUTIC EXERCISE PROGRAM FOR PATIENTS WITH LIMITATION OF PERSONALITY

Primary Purpose

Borderline Personality Disorder

Status
Enrolling by invitation
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Physical Activity
Sponsored by
University of Valencia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Borderline Personality Disorder focused on measuring Border personality disorder, Physiotherapy, Aerobic Exercise, Emotional Regulation, Teleassitence

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Men or women, diagnosed with Borderline Personality Disorder according to DSM-V with moderate-high severity who are admitted to a care center 24 hours a day.
  • People over 18 years of age.
  • People who do not perform scheduled physical exercise.
  • Have electronic means (computer / tablet / mobile) with an internet connection, as well as the cognitive and motor skills necessary to carry out the proposed exercises.

Exclusion Criteria:

  • People with intellectual or physical disabilities that prevent them from carrying out the intervention.
  • People with heart or respiratory problems that prevent them from doing physical exercise.
  • People who are legally incapacitated.
  • Not meeting the inclusion criteria.

Sites / Locations

  • Aurora Romero

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Physical Activity

Daily Live

Arm Description

Outcomes

Primary Outcome Measures

Border Line Symptom list BSL 23
It is composed of 23 items that refer to the symptoms that the participant had the previous week, and must be answered using a 5-point Likert-type scale where 0 is never and 4 is a lot. The patient is considered to be in a mild state up to a score of 48, in a serious state between 49 and 62 and in a very serious state with a score greater than 63

Secondary Outcome Measures

Quality of life SF-8
he 8 items of the instrument cover the following scales: Physical function, Physical role, Body pain, General health, Vitality, Social function, Emotional role and Mental health. The items on the SF-8 are ordered in such a way that the higher the score, the better the health status. To calculate the score of the questionnaire, the items will have to be recoded so that they follow the gradient of "the higher the score, the better the health" and then calculate the sum of the items that make up the scale (raw score of the scale)
Beck Anxiety Inventory (BAI)
It consists of 21 items related to common anxiety symptoms. This inventory emphasizes the consequential physical aspects of anxiety during the past week and now. For correction, each item III. it is valued from 0 to 3 points according to the selected option (0 'not at all'-1' slightly'-2 'moderately'-3' severely '); To obtain the overall score, the total value of all the items will be added (in the event that any item has more than one option selected, the one with the highest score will be considered). The score range varies from 0 to 63. Minimal anxiety is considered to have a score between 0 and 7, mild anxiety between 8 and 15, moderate anxiety between 16 and 25 and severe anxiety a score equal to or greater than 26
Difficulty in emotional regulation (DERS)
consists of 28 items that are grouped into five subscales: emotional inattention (lack of emotional awareness), emotional rejection (non-acceptance of emotional experiences), everyday interference (difficulty in focusing on goal-centered behaviors when is emotionally activated) and emotional lack of control (difficulty controlling strong emotions). The minimum score for this scale is 23 and the maximum 135
The Beck Depression Inventory (BDI-II)
consists of 21 items with four alternative responses ordered from least to greatest severity. The instrument must be answered according to the state in which each participant has been in the last two weeks, including today. For its correction, each item is valued from 0 to 3 points according to the selected option (0-1-2-3); To obtain the global score, the total value of all the items will be added, obtaining a total score that can vary from 0 to 63.
Physical Function 30-Seconds Chair Stand Test
the strength, endurance, speed and mobility of the lower limbs, as well as the ability to response to change after a therapeutic exercise intervention. The transition from sitting to standing as a form of exercise can be used to determine the aerobic threshold in young, physically healthy individuals. The therapist in charge of the evaluation will count the number of times that the participant has stood up completely during the 30 seconds of the test

Full Information

First Posted
August 5, 2021
Last Updated
July 15, 2022
Sponsor
University of Valencia
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1. Study Identification

Unique Protocol Identification Number
NCT05001295
Brief Title
ONLINE AEROBIC THERAPEUTIC EXERCISE PROGRAM FOR PATIENTS WITH LIMITATION OF PERSONALITY
Official Title
STUDY ON THE EFFECTIVENESS OF AN ONLINE AEROBIC THERAPEUTIC EXERCISE PROGRAM FOR PATIENTS WITH LIMITATION OF PERSONALITY: RANDOMIZED CLINICAL TRIAL
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Enrolling by invitation
Study Start Date
September 1, 2022 (Anticipated)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Valencia

4. Oversight

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

5. Study Description

Brief Summary
Introduction: Borderline personality disorder is a serious mental illness with high prevalence and difficult to diagnose. BPD is characterized by unstable relationships, distorted sense of self, emotional instability and a strong impulsiveness with weak impulse control. Physiotherapy in mental health, currently being developed, is considered potentially effective in order to improve physical and mental health and the quality of life related to health. Objective: The main objective of this study is to analyze the effect of an aerobic therapeutic exercise plan in the quality of life of patients with BDP. Methodological design: A random controlled critical trial is going to be carried out. A sample of 50 participants diagnosed with BPD, aged 18 years and older, will be taken. They will be divided randomly in two groups: control group and treatment group. The treatment group will carry out a program of aerobic exercise twice a week for five weeks divided in four defined levels of variable length. The variables that will be compared before and after the intervention are: seriousness according to symptomatology, depression and anxiety level, emotion regulation difficulty, life quality level, physical condition level and ability of effort. After the intervention, the results will be analyzed by means of statistical processing based on the data obtained.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Borderline Personality Disorder
Keywords
Border personality disorder, Physiotherapy, Aerobic Exercise, Emotional Regulation, Teleassitence

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Physical Activity
Arm Type
Experimental
Arm Title
Daily Live
Arm Type
Placebo Comparator
Intervention Type
Procedure
Intervention Name(s)
Physical Activity
Intervention Description
Following the guidelines of NICE, the program to be followed by the IG is designed so that the intervention lasts 5 weeks, divided into 4 levels of progressive intensity, in which sessions of 30 to 45 minutes of aerobic exercise will be carried out 2 days a week. week.
Primary Outcome Measure Information:
Title
Border Line Symptom list BSL 23
Description
It is composed of 23 items that refer to the symptoms that the participant had the previous week, and must be answered using a 5-point Likert-type scale where 0 is never and 4 is a lot. The patient is considered to be in a mild state up to a score of 48, in a serious state between 49 and 62 and in a very serious state with a score greater than 63
Time Frame
The evaluations will be carried out before and after the intervention to be able to compare the results after the completion of the marked exercise program.
Secondary Outcome Measure Information:
Title
Quality of life SF-8
Description
he 8 items of the instrument cover the following scales: Physical function, Physical role, Body pain, General health, Vitality, Social function, Emotional role and Mental health. The items on the SF-8 are ordered in such a way that the higher the score, the better the health status. To calculate the score of the questionnaire, the items will have to be recoded so that they follow the gradient of "the higher the score, the better the health" and then calculate the sum of the items that make up the scale (raw score of the scale)
Time Frame
The evaluations will be carried out before and after the intervention to be able to compare the results after the completion of the marked exercise program.
Title
Beck Anxiety Inventory (BAI)
Description
It consists of 21 items related to common anxiety symptoms. This inventory emphasizes the consequential physical aspects of anxiety during the past week and now. For correction, each item III. it is valued from 0 to 3 points according to the selected option (0 'not at all'-1' slightly'-2 'moderately'-3' severely '); To obtain the overall score, the total value of all the items will be added (in the event that any item has more than one option selected, the one with the highest score will be considered). The score range varies from 0 to 63. Minimal anxiety is considered to have a score between 0 and 7, mild anxiety between 8 and 15, moderate anxiety between 16 and 25 and severe anxiety a score equal to or greater than 26
Time Frame
The evaluations will be carried out before and after the intervention to be able to compare the results after the completion of the marked exercise program.
Title
Difficulty in emotional regulation (DERS)
Description
consists of 28 items that are grouped into five subscales: emotional inattention (lack of emotional awareness), emotional rejection (non-acceptance of emotional experiences), everyday interference (difficulty in focusing on goal-centered behaviors when is emotionally activated) and emotional lack of control (difficulty controlling strong emotions). The minimum score for this scale is 23 and the maximum 135
Time Frame
The evaluations will be carried out before and after the intervention to be able to compare the results after the completion of the marked exercise program.
Title
The Beck Depression Inventory (BDI-II)
Description
consists of 21 items with four alternative responses ordered from least to greatest severity. The instrument must be answered according to the state in which each participant has been in the last two weeks, including today. For its correction, each item is valued from 0 to 3 points according to the selected option (0-1-2-3); To obtain the global score, the total value of all the items will be added, obtaining a total score that can vary from 0 to 63.
Time Frame
The evaluations will be carried out before and after the intervention to be able to compare the results after the completion of the marked exercise program.
Title
Physical Function 30-Seconds Chair Stand Test
Description
the strength, endurance, speed and mobility of the lower limbs, as well as the ability to response to change after a therapeutic exercise intervention. The transition from sitting to standing as a form of exercise can be used to determine the aerobic threshold in young, physically healthy individuals. The therapist in charge of the evaluation will count the number of times that the participant has stood up completely during the 30 seconds of the test
Time Frame
The evaluations will be carried out before and after the intervention to be able to compare the results after the completion of the marked exercise program.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Men or women, diagnosed with Borderline Personality Disorder according to DSM-V with moderate-high severity who are admitted to a care center 24 hours a day. People over 18 years of age. People who do not perform scheduled physical exercise. Have electronic means (computer / tablet / mobile) with an internet connection, as well as the cognitive and motor skills necessary to carry out the proposed exercises. Exclusion Criteria: People with intellectual or physical disabilities that prevent them from carrying out the intervention. People with heart or respiratory problems that prevent them from doing physical exercise. People who are legally incapacitated. Not meeting the inclusion criteria.
Facility Information:
Facility Name
Aurora Romero
City
Valencia
ZIP/Postal Code
46010
Country
Spain

12. IPD Sharing Statement

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ONLINE AEROBIC THERAPEUTIC EXERCISE PROGRAM FOR PATIENTS WITH LIMITATION OF PERSONALITY

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