Borderline Personality DisorderNCT05001295
ONLINE AEROBIC THERAPEUTIC EXERCISE PROGRAM FOR PATIENTS WITH LIMITATION OF PERSONALITY
A study testing Physical Activity in people with Borderline Personality Disorder, run by University of Valencia at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Borderline Personality Disorder
- What is being tested?
- Physical Activity
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteSpain
- Study dates
- 1 Sep 2022to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: STUDY ON THE EFFECTIVENESS OF AN ONLINE AEROBIC THERAPEUTIC EXERCISE PROGRAM FOR PATIENTS WITH LIMITATION OF PERSONALITY: RANDOMIZED CLINICAL TRIAL
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
- Being tested
- Physical Activity
- Keywords
- Border personality disorder, Physiotherapy, Aerobic Exercise, Emotional Regulation, Teleassitence
- Medical subject headings
- Borderline Personality Disorder, Emotional Regulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical ActivityProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Physical Activity | Experimental | Not described Receives: Procedure: Physical Activity |
| Daily Live | Placebo comparator | Not described Receives: Procedure: Physical Activity |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
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)
Measured: 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)
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
Measured: 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)
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
Measured: 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)
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.
Measured: 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 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
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2021
- Study start1 Sep 2022 (estimated)
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Borderline Personality DisorderStudies of the same condition, open and under way.
- More trials run by University of ValenciaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Valencia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05001295
- Sponsor's protocol ID
- 1518010
- Status last verified
- Aug 2021
- First submitted
- 5 Aug 2021
- Last updated
- 18 Jul 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- STUDY ON THE EFFECTIVENESS OF AN ONLINE AEROBIC THERAPEUTIC EXERCISE PROGRAM FOR PATIENTS WITH LIMITATION OF PERSONALITY: RANDOMIZED CLINICAL TRIAL
- ClinicalTrials.gov ID
- NCT05001295
- Acronym / sponsor ID
- 1518010
- Conditions
- Borderline Personality Disorder
- Keywords
- Border personality disorder, Physiotherapy, Aerobic Exercise, Emotional Regulation, Teleassitence
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of ValenciaUniversity, hospital or other
- Study start
- 1 Sep 2022 (estimated)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 11 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Physical Activity | Experimental | Procedure: Physical Activity |
| Daily Live | Placebo comparator | Procedure: Physical Activity |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physical ActivityFollowing 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. | Procedure or surgery | Daily Live, Physical Activity |
Primary outcome
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
5 secondary outcomes
Quality of life SF-8
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.
Beck Anxiety Inventory (BAI)
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.
Difficulty in emotional regulation (DERS)
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.
The Beck Depression Inventory (BDI-II)
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.
Physical Function 30-Seconds Chair Stand 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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical Activity in people with Borderline Personality Disorder, run by University of Valencia at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2022.