ONLINE AEROBIC THERAPEUTIC EXERCISE PROGRAM FOR PATIENTS WITH LIMITATION OF PERSONALITY

NCT05001295 | Unknown

• 1 other identifier: 1518010
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Borderline Personality Disorder

Keywords

Border personality disorder; Physiotherapy; Aerobic Exercise; Emotional Regulation; Teleassitence

Outcome Measures

Primary Outcomes (1)

• 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

  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 Outcomes (5)

• Quality of life SF-8

  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.

• Beck Anxiety Inventory (BAI)

  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.

• Difficulty in emotional regulation (DERS)

  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.

• The Beck Depression Inventory (BDI-II)

  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.

• Physical Function 30-Seconds Chair Stand Test

  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.

Study Arms (2)

Physical Activity

EXPERIMENTAL

Procedure: Physical Activity

Daily Live

PLACEBO COMPARATOR

Procedure: Physical Activity

Interventions

Physical Activity PROCEDURE

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.

Daily Live; Physical Activity

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Valencia: lead

Study Sites (1)

Aurora Romero

Valencia, 46010, Spain

Location

MeSH Terms

Conditions

Borderline Personality Disorder; Emotional Regulation

Interventions

Exercise

Condition Hierarchy (Ancestors)

Personality Disorders; Mental Disorders; Self-Control; Social Behavior; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 5, 2021
• First Posted: August 11, 2021
• Study Start: September 1, 2022
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2024
• Last Updated: July 18, 2022

Record last verified: 2021-08

Locations

ES (1)