- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05246527
Acute Effects of Physical Exercise in Patients with Borderline Personality Disorder
Study Overview
Status
Conditions
Intervention / Treatment
Detailed 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).
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Aylin Mehren, Dr.
- Phone Number: +4922828731370
- Email: aylin.mehren@ukbonn.de
Study Locations
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-
Nordrhein-Westfalen
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Bonn, Nordrhein-Westfalen, Germany, 53127
- Recruiting
- University Hospital Bonn
-
Contact:
- Aylin Mehren, Dr.
- Phone Number: +22828731370
- Email: aylin.mehren@ukbonn.de
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Exercise
30 min of cycling on a stationary ergometer, guided by a video of a professional cycling instructor.
Heart rate will be continuously recorded using a chest strap heart rate monitor and monitored by the patients themselves and the experimenter. |
30 min of cycling on an ergometer, moderate or high intensity
|
|
Active Comparator: Control condition
30 min of watching a documentary about the benefits of physical activity on health.
Heart rate will be recorded also during the control condition.
|
30 min of watching a movie
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
change in cognitive interference
Time Frame: directly before and 10 minutes after exercise and control condition
|
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
|
|
change in subjective stress perception
Time Frame: 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
|
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
|
|
change in cortisol levels
Time Frame: 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
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
change in emotional interference
Time Frame: directly before and 15 minutes after exercise and control condition
|
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
|
|
change in affect
Time Frame: directly before and 5 minutes after exercise and control condition, and before stress test and 0, 10, 20, and 30 minutes after stress test
|
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
|
|
change in alpha-amylase
Time Frame: saliva samples are collected before stress test and 0, 10, 20, and 30 minutes after stress test
|
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
|
|
change in biomarkers
Time Frame: directly before and 5 minutes after exercise and control condition
|
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
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ExBPD
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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