NCT05246527

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.

Trial Health

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Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 27, 2022

Completed
12 days until next milestone

Study Start

First participant enrolled

February 8, 2022

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 18, 2022

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

December 11, 2024

Status Verified

December 1, 2024

Enrollment Period

3.9 years

First QC Date

January 27, 2022

Last Update Submit

December 6, 2024

Conditions

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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

  • 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 Outcomes (4)

  • change in emotional interference

    directly before and 15 minutes after exercise and control condition

  • change in affect

    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

    saliva samples are collected before stress test and 0, 10, 20, and 30 minutes after stress test

  • change in biomarkers

    directly before and 5 minutes after exercise and control condition

Study Arms (2)

Exercise

EXPERIMENTAL

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.

Behavioral: Physical Exercise

Control condition

ACTIVE COMPARATOR

30 min of watching a documentary about the benefits of physical activity on health. Heart rate will be recorded also during the control condition.

Behavioral: Control Intervention

Interventions

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

Exercise

30 min of watching a movie

Control condition

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • estimated verbal intelligence quotient \>80 (MWT-B; Lehrl 2005)
  • patients: diagnosis of borderline personality disorder according to DSM-5

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Bonn

Bonn, North Rhine-Westphalia, 53127, Germany

RECRUITING

MeSH Terms

Conditions

Borderline Personality Disorder

Interventions

Exercise

Condition Hierarchy (Ancestors)

Personality DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Aylin Mehren, Dr.

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Model Details: Exercise condition: cycle on an ergometer with moderate or high intensity Control condition: watching a movie
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr., Principal Investigator

Study Record Dates

First Submitted

January 27, 2022

First Posted

February 18, 2022

Study Start

February 8, 2022

Primary Completion

December 31, 2025

Study Completion

December 31, 2025

Last Updated

December 11, 2024

Record last verified: 2024-12

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