ONLINE AEROBIC THERAPEUTIC EXERCISE PROGRAM FOR PATIENTS WITH LIMITATION OF PERSONALITY

NCT ID: NCT05001295

Last Updated: 2022-07-18

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-01
• Study Completion Date: 2024-12-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Physical Activity

Group Type: EXPERIMENTAL

Physical Activity

Intervention Type: 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

Group Type: PLACEBO_COMPARATOR

Physical Activity

Intervention Type: 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.

Interventions

Physical Activity

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.

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Valencia

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Aurora Romero

Valencia, , Spain

Countries

Spain

Other Identifiers

1518010

Identifier Type: -

Identifier Source: org_study_id