Acute Effects of Physical Exercise in Patients With Borderline Personality Disorder

Borderline Personality Disorder Clinical Trial

Official title:

Acute Effects of Physical Exercise in Patients With Borderline Personality Disorder

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05246527
• Other study ID #: ExBPD
• Status: Recruiting
• Phase: N/A
• Start date: February 8, 2022
• Est. completion date: December 31, 2024

Study information

• Verified date: December 2023
• Source: University Hospital, Bonn
• Contact: Aylin Mehren, Dr.
• Phone: +4922828731370
• Email: aylin.mehren[@]ukbonn.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of the proposed project is to investigate the effects of a single session of physical exercise on stress regulation, cognitive and emotional functioning, and associated neurophysiological processes (saliva and blood samples) in patients with borderline personality disorder. A further aim is to identify the optimal exercise intensity (moderate vs. high intensity). The investigatiors expect that acute exercise will lead to positive effects on behavioral and biomarker level.

Description:

Background: Borderline personality disorder (BPD) is one of the most common personality disorders, with a lifetime prevalence of up to 5.9% and core symptoms of emotional and behavioral dysregulation, instability in interpersonal relationships, identity disturbances, stress-related dissociation, non-suicidal self-injuries, and suicidal behavior. Treatment mainly consists of psychotherapeutic procedures, frequently supplemented by pharmacotherapy to reduce specific symptoms such as affective and cognitive dysregulation. Besides possible adverse effects from medication, both, psychotherapy and medication do not lead to a complete remission of BPD. Previous studies point towards a positive influence of physical exercise on BPD symptoms and related neurobiological processes, while to our knowledge no study has investigated the effects of exercise in patients with BPD yet.

Objectives: To investigate the effects of a single session of physical exercise on stress regulation, cognitive and emotional functioning, and associated neurophysiological processes in patients with borderline personality disorder. A further aim is to identify the optimal exercise intensity (moderate vs. high intensity).

Hypotheses: The investigatiors expect that acute exercise will enhance stress perception and cognitive and emotional functioning, which will be reflected in enhanced behavioral measures and changes on biomarker level. In addition, the investigatiors expect to gather insights regarding the optimal exercise intensity.

Methods: 60 patients with borderline personality disorder and 60 healthy controls will participate in two 30-min experimental conditions on separate days in counterbalanced order (at least 48 hours apart): in the exercise condition, half of the group will cycle on an ergometer with moderate intensity, the other half will perform a high-intensity interval training. Intensities will be calculated based on the individual maximal heart rate measured during a maximal exercise test in a pre-experimental session. In the control condition, all participants will watch a movie. Before and after each condition, they will perform a classic and an emotional version of the Stroop test, in order to assess exercise effects on impulsivity and emotion regulation. To test for exercise effects on stress-related responses, they will further participate in a Stress test 90 min following each condition. The investigatiors will collect saliva and blood samples together with state questionnaires at various study time points to test for effects on peripheral biomarkers related to stress, cognition, and BPD pathology (e.g., cortisol, alpha-amylase, serotonin metabolism, noradrenaline, BDNF).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• estimated verbal intelligence quotient >80 (MWT-B; Lehrl 2005)

• patients: diagnosis of borderline personality disorder according to DSM-5

Exclusion Criteria:

• neurological disorders

• health conditions interfering with exercise safety, e.g. coronary heart disease

• visual impairments that may interfere with performance of the cognitive tasks

• endocrine disorders, e.g. hyperthyreosis or diabetes mellitus;

• following psychiatric disorders: psychosis or affective disorders with psychotic symptoms, schizophrenia, substance abuse or dependence, autism spectrum disorders, anorexia nervosa;

• healthy controls: BPD, intake of psychotropic drugs

Related Conditions & MeSH terms

• Borderline Personality Disorder
• Personality Disorders

Intervention

Behavioral:
• Physical Exercise
30 min of cycling on an ergometer, moderate or high intensity
• Control Intervention
30 min of watching a movie

Locations

Country	Name	City	State
Germany	University Hospital Bonn	Bonn	Nordrhein-Westfalen

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Bonn

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change in cognitive interference	classical color-word Stroop task: reaction time difference between congruent and incongruent stimuli, difference between pre- and post-intervention is compared between exercise and control condition	directly before and 10 minutes after exercise and control condition
Primary	change in subjective stress perception	Trier social stress test: subjective stress level (visual analogue scale rated from 0=noperceived stress to 9=highest perceived stress), changes between pre-stress and post-stress are compared between exercise and control condition	stress test 90 minutes after exercise and control condition, subjective stress scale are collected before stress test and 0, 10, 20, and 30 minutes after stress test
Primary	change in cortisol levels	Trier social stress test: cortisol levels measured in saliva; changes between pre-stress and post-stress (cortisol peak expected at 20 minutes after stress test) are compared between exercise and control condition	stress test 90 minutes after exercise and control condition, saliva samples are collected before stress test and 0, 10, 20, and 30 minutes after stress test
Secondary	change in emotional interference	emotional Stroop task: reaction time difference between neutral and emotional words, difference between pre- and post-intervention is compared between exercise and control condition	directly before and 15 minutes after exercise and control condition
Secondary	change in affect	Positive and Negative Affect Scale (PANAS)	directly before and 5 minutes after exercise and control condition, and before stress test and 0, 10, 20, and 30 minutes after stress test
Secondary	change in alpha-amylase	measured in saliva; changes between pre-stress and post-stress are compared between exercise and control condition	saliva samples are collected before stress test and 0, 10, 20, and 30 minutes after stress test
Secondary	change in biomarkers	blood samples to measure: serotonin metabolism (e.g., tryptophan metabolism: tryptophan, kynurenine, and kynurenine acid), BDNF, Lactate, Noradrenaline	directly before and 5 minutes after exercise and control condition