Physical Activity in People With Borderline Personality Disorder (PABORD)
NCT06461104 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60
Last updated 2024-06-14
Summary
The aim of this Randomised Controlled Trial (RCT) is to test the effects of a structured physical activity (PA) program on symptoms in female outpatients aged 18 to 40 years with a diagnosis of Borderline Personality Disorder (BPD). The main questions it aims to answer are:
1. Does a structured PA program reduce clinical symptoms in patients with BPD?
2. How does the effectiveness of a structured PA program compare to a psychoeducational intervention in reducing clinical symptoms and improving physical activity parameters?
Participants will participate in a 12-week structured PA program preceded by three weekly psychoeducation sessions focused on nutrition (intervention group) or will receive a 12-week psychoeducational program on nutrition and PA (control group).
Researchers will compare the intervention group (structured PA program) and the control group (psychoeducational program) to see if the structured PA program leads to greater improvements in clinical symptoms and physical activity parameters. Moreover, the study includes a multidimensional assessment (physical, psychological, and biological) at four time points: at the start of the treatment (T0), at 6 weeks (mid-treatment, when changes from PA become visible and measurable), at the end of the 3-month treatment period (T3), and at a 3-month follow-up after the treatment (T6).
Conditions
- Borderline Personality Disorder
Interventions
- BEHAVIORAL
-
Structured Physical Activity Programme
A somatic examination will also be conducted by a sports physician, which will include the assessment of muscle strength, cardiorespiratory fitness, walking gait, blood pressure, and body mass index (BMI). Based on this evaluation, the sports physician will design a personalised physical activity programme for the participants in the intervention group.
- BEHAVIORAL
-
Psychoeducational Programme
The control group undergoes a 12-week psychoeducational programme on nutrition and PA, consisting of 8 sessions. Led by a dietitian and psychologist, topics include PA benefits, healthy eating, and sedentary lifestyle risks. The experimental group receives 3 sessions on dietary habits before starting PA intervention, ensuring differentiation. It's expected the experimental group directly benefits from exercise, while the control group benefits from PA education. At the trial's end, control group members can join the PA programme for free.
Sponsors & Collaborators
-
IRCCS Centro San Giovanni di Dio Fatebenefratelli
lead OTHER
Principal Investigators
-
Giovanni de Girolamo, MD · IRCCS Istituto Centro San Giovanni di Dio Fatebenefratelli, Brescia, Italy
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 40 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-09-01
- Primary Completion
- 2024-12-31
- Completion
- 2025-04-01
Countries
- Italy
Study Locations
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