Intermittent Anaerobic Exercise as Interoceptive Exposure Strategy in the Treatment of Patients With Panic Disorder: Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 72
- 主要终点
- PD severity scores
研究概览
简要总结
The goal of this clinical trial is to test action exercises in the treatment of people with a diagnosis of Panic disorders with or without agoraphobia.
The main question it aims to answer is:
To investigate the feasibility and effectiveness of a Panic Disorder (PD) treatment protocol based on anaerobic exercise as an interoceptive exposure therapy.
Participants will The participants were randomly allocated to a 12-week program of either Intermittent Anaerobic Exercise.
Researchers will compare two groups, one with treatment through an intermittent aerobic exercise (IAE) protocol and the other group with treatment via a muscle relaxation protocol (RT), to see if there is feasibility and efficacy of a Panic Disorder treatment protocol based on anaerobic exercise as exposure therapy, compared to a relaxation activity.
详细描述
Study design
The present study compared the effectiveness of two interventions for the treatment of PD:
- Intermittent Anaerobic Exercise (IAE), performed as a regular and controlled systematic physical exercise of running and walking to provide Interoceptive Exposure (IE);
- Jacobson's Progressive Muscle Relaxation method (RT). The study was designed as a prospective, two-arm, blinded, randomized, controlled clinical trial. Patients and assessors were informed that participants could receive an active pharmacological treatment or a matching placebo; however, all patients received only a placebo. The study was carried out at the Anxiety Disorders Program of the Institute of Psychiatry and the Institute of Orthopedics and Traumatology of the Faculty of Medicine of the University of São Paulo, São Paulo, Brazil.
Subjects The subjects were referred for treatment to the Anxiety Disorder Program at the emergency room (PS) of the Heart Institute (InCor). After clinical interviews of 121 suitable individuals, it was discovered that 102 met the pre-established inclusion criteria.
Participants were randomly allocated a Microsoft Excel spreadsheet to a 12-week program of IAE (n = 51) or RT (n = 51). Seventy-two patients completed the study, 38 women (52.8%) and 34 men (47.2%), aged between 21 and 51 years (mean: 33.3 ± 7.7 years). Among them, 22 (30.6%) were smokers. The mean age of onset of panic attacks was 28.3 ± 4.5 years. These groups were not significantly different in terms of sociodemographic characteristics.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Diagnosis of PD with or without agoraphobia, based on the Mini International Neuropsychiatric Interview (MINI) and in accordance with the Diagnostic and Statistical Manual of mental disorders number 4 (DSM-IV) criteria;
- •No undergoing medical or other treatments for at least 12 weeks.
排除标准
- •Clinically relevant risk of cardiovascular disease (according to the Physical Activity Readiness Questionnaire - PAR-Q scale);
- •Practice of regular physical exercise for ≥ 150 minutes per week;
- •History or current substance abuse or dependence;
- •Pregnancy;
- •Breastfeeding;
- •Clinically relevant suicidal ideation or previous suicide attempts.
结局指标
主要结局
PD severity scores
时间窗: 12 weeks of intervention
The Panic Agoraphobia Scale scores
次要结局
- Intensity of panic attacks(12 weeks of intervention)
- Frequency of panic attacks(12 weeks of intervention)