Acute Effects of Physical Exercise in Patients with Borderline Personality Disorder

NCT ID: NCT05246527

Last Updated: 2024-12-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-02-08

Study Completion Date

2025-12-31

Brief Summary

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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

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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).

Conditions

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Borderline Personality Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Exercise condition: cycle on an ergometer with moderate or high intensity Control condition: watching a movie
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Exercise

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.

Group Type EXPERIMENTAL

Physical Exercise

Intervention Type BEHAVIORAL

30 min of cycling on an ergometer, moderate or high intensity

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.

Group Type ACTIVE_COMPARATOR

Control Intervention

Intervention Type BEHAVIORAL

30 min of watching a movie

Interventions

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Physical Exercise

30 min of cycling on an ergometer, moderate or high intensity

Intervention Type BEHAVIORAL

Control Intervention

30 min of watching a movie

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University Hospital, Bonn

OTHER

Sponsor Role lead

Responsible Party

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Aylin Mehren

Dr., Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University Hospital Bonn

Bonn, North Rhine-Westphalia, Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Aylin Mehren, Dr.

Role: CONTACT

Phone: +4922828731370

Email: [email protected]

Facility Contacts

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Aylin Mehren, Dr.

Role: primary

Other Identifiers

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ExBPD

Identifier Type: -

Identifier Source: org_study_id