Clinical trial NCT07025590: Effect of Exercise on Tapering Antipsychotics in Patients With Psycho-cardiological Disease(EXTRA-study)
Official title: Effect of Exercise on Tapering Antipsychotics in Patients With Psycho-cardiological Disease: a Multicenter, Randomized Controlled, Non-inferior Clinical Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cardiovascular Diseases (CVD)
Depression Anxiety Disorder
Lead sponsor: Guangdong Provincial People's Hospital
Sponsor class: OTHER
First posted: 2025-06-17
Enrollment: 106
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Psycho-Cardiological Disease studies the complex links between the cardiovascular system and emotions. The two diseases are now the focus of public health organizations, forming a vicious circle of mutual influence. Anxiety and depressive symptoms are three to four times more common in patients with cardiovascular disease than in the general population, and about 15 to 18 percent of patients with coronary heart disease also have major depression, while 25 to 30 percent show significant depressive symptoms. At least 20% of patients with chronic heart failure have some degree of depression. In addition, the probability of cardiovascular events is 2.5 times higher in patients with two hearts, the risk of recurrence of cardiovascular events is heightened, and is strongly associated with higher mortality. At present, the common treatment methods show different advantages and disadvantages, for example, Antipsychotics treatment is a common means of depression/anxiety symptoms, with rapid onset, significant efficacy, wide application and other advantages. However, medications often struggle to fully relieve symptoms, have a high recurrence rate, and can have side effects. Psychotherapy as a traditional intervention method for mental disorders. Its advantages are long-lasting efficacy and no Antipsychotics dependence, but the effect is slower, and patients need to invest more time, energy and financial resources, and the psychological burden is also heavier. In recent years, exercise therapy, as a safe intervention without significant side effects, has been gradually included in a number of international clinical guidelines, and is regarded as the first-line recommended treatment for mild to moderate depression. Research has shown that exercise can effectively relieve anxiety and depression symptoms through a variety of mechanisms, such as lowering cortisol levels, regulating autonomic nervous system function, and reducing stress responses. A study of aerobic exercise in patients with Psycho-Cardiological Disease showed that a 16-week exercise intervention significantly reduced patients' depression scores and significantly improved mood and cognitive function. In addition, it has been validated in multiple studies that exercise can significantly reduce anxiety and depression symptoms by enhancing neuroplasticity, promoting neurogenesis and synaptic remodeling, improving cognitive and emotional regulation. These findings provide a strong theoretical and practical basis for the application of exercise therapy in the comprehensive management of Psycho-Cardiological Disease. The above studies provide important theoretical support for the treatment of biheart disease with exercise, but most studies focus on scale scores, biomarkers, and changes in social behavior. It is well known that antidepressant or anti-anxiety drugs can have many side effects due to their dosage, duration and long-term use, which in turn poses a potential risk to the overall health and quality of life of patients. Therefore, it is of significant clinical significance and research value to explore whether exercise as an adjunct therapy can effectively reduce the use of Antipsychotics and shorten the withdrawal period. This will not only help optimize personalized treatment plans, provide scientific basis for clinical decision-making, but also promote the development of Psycho-Cardiological Disease treatment to the direction of precision and integration.


Eligibility criteria: Inclusion Criteria:

1. Diagnosed with depression/anxiety;
2. Continued use of SSris and SNris for six months prior to study start;
3. Aged between 18 and 70;
4. Confirmed cardiovascular disease (such as chronic stable coronary heart disease, heart failure, cardiomyopathy, arrhythmia, valvular heart disease, cardiac surgery, cardiac intervention, ischemia with non-obstructive coronary artery disease, etc.);
5. The patients voluntarily participated in the study, signed a written informed consent, and were willing to cooperate with the follow-up.

Exclusion Criteria:

1. currently has mania or hypomania, or a history of bipolar disorder and any mental disorders (current and previous);
2. organic brain injury, etc., or serious non-cardiovascular system diseases (such as advanced cancer);
3. Unable to participate in sports training or have drug contraindications;
4. Current alcohol, drug abuse, drug use or suicidal intent;
5. Patients who were receiving other doses of eligible drugs and other antidepressants were excluded from the trial;
6. Myocardial infarction \<2 weeks or unstable angina attack period;
7. Severe and uncontrolled arrhythmia;
8. Acute heart failure stage;
9. Severe and symptomatic obstruction of the outflow tract;
10. Acute deep vein thrombosis with or without pulmonary embolism;
11. Acute myocarditis, pericarditis or endocarditis;
12. Acute aortic dissection;
13. Intracardiac thrombus with high risk of embolism;
14. Massive pericardial effusion;
15. Those who fail to exercise adequately or refuse to sign informed consent.

Primary outcomes:
measure: Dosage of anti-anxiety/depression drugs
timeFrame: Baseline and after 12 weeks of intervention
Secondary outcomes:
measure: Hamilton Depression and Anxiety Scale (HAMD, HAMA)
timeFrame: Baseline and at the end of the intervention (Week 12), 1 month, 6 months, 1 year and 2 years after the end of the intervention
measure: Perceived Stress Scale (PSS)
timeFrame: Baseline and at the end of the intervention (Week 12), 1 month, 6 months, 1 year and 2 years after the end of the intervention
measure: Pittsburgh Sleep Quality Index (PSQI)
timeFrame: Baseline and at the end of the intervention (Week 12), 1 month, 6 months, 1 year and 2 years after the end of the intervention
measure: 12-Item Short Form Health Survey（SF-12）
timeFrame: Baseline and at the end of the intervention (Week 12), 1 month, 6 months, 1 year and 2 years after the end of the intervention
measure: Discontinuation Emergent Symptoms and Signs Scale（DESS）
timeFrame: Baseline and at the end of the intervention (Week 12), 1 month, 6 months, 1 year and 2 years after the end of the intervention
measure: Cardiopulmonary exercise test（CPET）
timeFrame: Baseline and at the end of the intervention (Week 12), one month after the end of the intervention
measure: The recurrence rate of anxiety/depression
timeFrame: Baseline and one month, six months, one year and two years after the intervention ended
measure: Electrocardiogram
timeFrame: Baseline and at the end of the intervention (Week 12), one month after the end of the intervention
measure: Blood test
timeFrame: Baseline and at the end of the intervention (Week 12)
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Guangdong Provincial People's Hospital
state: Guangdong
Study officials:
References: