STUDY ON THE EFFECTIVENESS OF AN ONLINE AEROBIC THERAPEUTIC EXERCISE PROGRAM FOR PATIENTS WITH LIMITATION OF PERSONALITY: RANDOMIZED CLINICAL TRIAL
Trial Snapshot
- Phase
- Not Applicable
- Status
- Enrolling By Invitation
- Sponsor
- University of Valencia
- Enrollment
- 50
- Locations
- 2
- Primary Endpoint
- Border Line Symptom list BSL 23
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 50 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
Border Line Symptom list BSL 23
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.
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 Outcomes
- 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.)
- 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.)
- 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.)
- 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.)
- 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.)