RecruitingNot ApplicableNCT07025590

Effect of Exercise on Tapering Antipsychotics in Patients With Psycho-cardiological Disease(EXTRA-study)

Effect of Exercise on Tapering Antipsychotics in Patients With Psycho-cardiological Disease: a Multicenter, Randomized Controlled, Non-inferior Clinical Study


Sponsor

Guangdong Provincial People's Hospital

Enrollment

106 participants

Start Date

Apr 22, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study (the EXTRA study) is testing whether adding structured exercise to a medication tapering program can help people with both heart disease and depression safely reduce their antidepressant medications (SSRIs or SNRIs). **You may be eligible if...** - You are between 18 and 70 years old - You have been diagnosed with depression or anxiety - You have been taking SSRI or SNRI antidepressants for at least 6 months - You have a confirmed cardiovascular condition (such as stable coronary heart disease, heart failure, or arrhythmia) - You are willing to participate in the exercise component and attend follow-up visits **You may NOT be eligible if...** - You currently have mania, hypomania, or a history of bipolar disorder or other mental health conditions - You have had a heart attack in the past 2 weeks or are experiencing unstable angina - You have severe or uncontrolled heart arrhythmia or acute heart failure - You are unable to exercise or have a contraindication to the medications used - You have active substance use or suicidal intent Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALModerate-intensity continuous movement and Antipsychotics intervention

On the basis of Antipsychotics intervention, Patients in the exercise group should start exercise intervention as soon as possible after completing baseline examination, and need to complete a training plan of at least 36 times, 3 times/week. At the beginning of each training session, patients need to warm up for 5-10 minutes, mainly jogging and stretching exercises. After the warm-up, the patient enters the training phase, the heart rate reserve is 70% to 85%, and after the training, the patient performs 10-15 minutes of recovery exercise, mainly jogging, slow walking and stretching. The specific exercise plan is formulated according to the patients' own aerobic capacity assessment, and the principle of formulation is gradual and individual. At each training session, patients were asked about their perceived fatigue level to adjust the training intensity.

DRUGAntipsychotics intervention(sertraline, escitalopram, fluoxetine, duloxetine, paroxetine, venlafaxine, and fluvoxamine)

Patients maintained regular medication during the intervention period, and returned to the doctor every two weeks, and the psychiatrist decided whether to maintain the current dose or gradually reduce the dose based on the patient's symptoms and diagnosis. Psychiatrists, unaware of patient groupings, use supportive measures to help manage adverse reactions.


Locations(1)

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, China

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NCT07025590


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