Clinical trial NCT05001295: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Borderline Personality Disorder
Keywords: Border personality disorder
Physiotherapy
Aerobic Exercise
Emotional Regulation
Teleassitence
Lead sponsor: University of Valencia
Sponsor class: OTHER
First posted: 2021-08-11
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Border Line Symptom list BSL 23
timeFrame: 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:
measure: Quality of life SF-8
timeFrame: 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.
measure: Beck Anxiety Inventory (BAI)
timeFrame: 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.
measure: Difficulty in emotional regulation (DERS)
timeFrame: 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.
measure: The Beck Depression Inventory (BDI-II)
timeFrame: 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.
measure: Physical Function 30-Seconds Chair Stand Test
timeFrame: 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.
Other outcomes:
Locations:
city: Valencia
country: Spain
facility: Aurora Romero
Study officials:
References: