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Acute Effects of Physical Exercise in Patients With Borderline Personality Disorder

Primary Purpose

Borderline Personality Disorder

Status
Recruiting
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Physical Exercise
Control Intervention
Sponsored by
University Hospital, Bonn
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Borderline Personality Disorder

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University Hospital BonnRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Exercise

Control condition

Arm Description

30 min of cycling on a stationary ergometer, guided by a video of a professional cycling instructor. Half of the patients (n=30) and their respective matched healthy controls (n=30) will perform moderate-intensity exercise: continuous cycling at 64-76% of the individual HRmax). The other half will perform a high-intensity interval training (HIIT) protocol: 5 min warm-up phase, followed by bursts of high-intensity cycling interspersed with varied recovery times (21 min in total), 4 min cool-down. Excluding warm-up and cool-down, intensities will remain >77% of individual HRmax during the whole routine. 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 watching a documentary about the benefits of physical activity on health. Heart rate will be recorded also during the control condition.

Outcomes

Primary Outcome Measures

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
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
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

Secondary Outcome Measures

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
change in affect
Positive and Negative Affect Scale (PANAS)
change in alpha-amylase
measured in saliva; changes between pre-stress and post-stress are compared between exercise and control condition
change in biomarkers
blood samples to measure: serotonin metabolism (e.g., tryptophan metabolism: tryptophan, kynurenine, and kynurenine acid), BDNF, Lactate, Noradrenaline

Full Information

First Posted
January 27, 2022
Last Updated
May 8, 2023
Sponsor
University Hospital, Bonn
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1. Study Identification

Unique Protocol Identification Number
NCT05246527
Brief Title
Acute Effects of Physical Exercise in Patients With Borderline Personality Disorder
Official Title
Acute Effects of Physical Exercise in Patients With Borderline Personality Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 8, 2022 (Actual)
Primary Completion Date
June 30, 2023 (Anticipated)
Study Completion Date
January 5, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital, Bonn

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Borderline Personality Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Exercise condition: cycle on an ergometer with moderate or high intensity Control condition: watching a movie
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Exercise
Arm Type
Experimental
Arm Description
30 min of cycling on a stationary ergometer, guided by a video of a professional cycling instructor. Half of the patients (n=30) and their respective matched healthy controls (n=30) will perform moderate-intensity exercise: continuous cycling at 64-76% of the individual HRmax). The other half will perform a high-intensity interval training (HIIT) protocol: 5 min warm-up phase, followed by bursts of high-intensity cycling interspersed with varied recovery times (21 min in total), 4 min cool-down. Excluding warm-up and cool-down, intensities will remain >77% of individual HRmax during the whole routine. Heart rate will be continuously recorded using a chest strap heart rate monitor and monitored by the patients themselves and the experimenter.
Arm Title
Control condition
Arm Type
Active Comparator
Arm Description
30 min of watching a documentary about the benefits of physical activity on health. Heart rate will be recorded also during the control condition.
Intervention Type
Behavioral
Intervention Name(s)
Physical Exercise
Intervention Description
30 min of cycling on an ergometer, moderate or high intensity
Intervention Type
Behavioral
Intervention Name(s)
Control Intervention
Intervention Description
30 min of watching a movie
Primary Outcome Measure Information:
Title
change in cognitive interference
Description
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
Time Frame
directly before and 10 minutes after exercise and control condition
Title
change in subjective stress perception
Description
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
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
Title
change in cortisol levels
Description
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
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
Secondary Outcome Measure Information:
Title
change in emotional interference
Description
emotional Stroop task: reaction time difference between neutral and emotional words, difference between pre- and post-intervention is compared between exercise and control condition
Time Frame
directly before and 15 minutes after exercise and control condition
Title
change in affect
Description
Positive and Negative Affect Scale (PANAS)
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
Title
change in alpha-amylase
Description
measured in saliva; changes between pre-stress and post-stress are compared between exercise and control condition
Time Frame
saliva samples are collected before stress test and 0, 10, 20, and 30 minutes after stress test
Title
change in biomarkers
Description
blood samples to measure: serotonin metabolism (e.g., tryptophan metabolism: tryptophan, kynurenine, and kynurenine acid), BDNF, Lactate, Noradrenaline
Time Frame
directly before and 5 minutes after exercise and control condition

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Aylin Mehren, Dr.
Phone
+4922828731370
Email
aylin.mehren@ukbonn.de
Facility Information:
Facility Name
University Hospital Bonn
City
Bonn
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
53127
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aylin Mehren, Dr.
Phone
+22828731370
Email
aylin.mehren@ukbonn.de

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Acute Effects of Physical Exercise in Patients With Borderline Personality Disorder

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