Cardiovascular Diseases (CVD)NCT07025590
Effect of Exercise on Tapering Antipsychotics in Patients With Psycho-cardiological Disease(EXTRA-study)
A study testing Moderate-intensity continuous movement and Antipsychotics intervention and Antipsychotics intervention(sertraline, escitalopram, fluoxetine, duloxetine, paroxetine, venlafaxine, and fluvoxamine) in people with Cardiovascular Diseases (CVD) and Depression Anxiety Disorder, run by Guangdong Provincial People's Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Cardiovascular Diseases (CVD), Depression Anxiety Disorder
- What is being tested?
- Moderate-intensity continuous movement and Antipsychotics intervention and Antipsychotics intervention(sertraline, escitalopram, fluoxetine, duloxetine, paroxetine, venlafaxine, and fluvoxamine)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 106 participants
- Where
- 1 siteChina
- Study dates
- 22 Apr 2025to 31 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed with depression/anxiety;
- Continued use of SSris and SNris for six months prior to study start;
- Aged between 18 and 70;
- 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.);
- The patients voluntarily participated in the study, signed a written informed consent, and were willing to cooperate with the follow-up.
Who cannot join
- currently has mania or hypomania, or a history of bipolar disorder and any mental disorders (current and previous);
- organic brain injury, etc., or serious non-cardiovascular system diseases (such as advanced cancer);
- Unable to participate in sports training or have drug contraindications;
- Current alcohol, drug abuse, drug use or suicidal intent;
- Patients who were receiving other doses of eligible drugs and other antidepressants were excluded from the trial;
- Myocardial infarction <2 weeks or unstable angina attack period;
Show all 15Show fewer
- Severe and uncontrolled arrhythmia;
- Acute heart failure stage;
- Severe and symptomatic obstruction of the outflow tract;
- Acute deep vein thrombosis with or without pulmonary embolism;
- Acute myocarditis, pericarditis or endocarditis;
- Acute aortic dissection;
- Intracardiac thrombus with high risk of embolism;
- Massive pericardial effusion;
- Those who fail to exercise adequately or refuse to sign informed consent.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, 510080
About this study
Official title: Effect of Exercise on Tapering Antipsychotics in Patients With Psycho-cardiological Disease: a Multicenter, Randomized Controlled, Non-inferior Clinical Study
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.
- Being tested
- Moderate-intensity continuous movement and Antipsychotics intervention, Antipsychotics intervention(sertraline, escitalopram, fluoxetine, duloxetine, paroxetine, venlafaxine, and fluvoxamine)
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Moderate-intensity continuous movement and Antipsychotics interventionBehavioural
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.
Antipsychotics intervention(sertraline, escitalopram, fluoxetine, duloxetine, paroxetine, venlafaxine, and fluvoxamine)Drug
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.
| Study group | Role | What they receive |
|---|---|---|
| Exercise and medicine | Active comparator | Exercise:Moderate-intensity continuous movement(MICT) The drugs include: sertraline, escitalopram, fluoxetine, duloxetine, paroxetine, venlafaxine, and fluvoxamine Receives: Behavioral: Moderate-intensity continuous movement and Antipsychotics intervention |
| medicine | Active comparator | The drugs include: sertraline, escitalopram, fluoxetine, duloxetine, paroxetine, venlafaxine, and fluvoxamine Receives: Drug: Antipsychotics intervention(sertraline, escitalopram, fluoxetine, duloxetine, paroxetine, venlafaxine, and fluvoxamine) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dosage of anti-anxiety/depression drugs
The proportion of patients with cardiovascular diseases complicated with anxiety and depression who received a 50% reduction in the dosage of anti-anxiety/depression drugs
Measured: Baseline and after 12 weeks of intervention
Secondary outcomes (9)
Hamilton Depression and Anxiety Scale (HAMD, HAMA)
HAMD：0-76 points; HAMA: 0-56 points The higher the score is, the worse the result will be
Measured: 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
Perceived Stress Scale (PSS)
PSS: 0-40 points The higher the score is, the worse the result will be
Measured: 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
Pittsburgh Sleep Quality Index (PSQI)
PSQI: 0-21 points the higher the score, the worse the result.
Measured: 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
12-Item Short Form Health Survey（SF-12）
SF-12:0-100 points. The higher the score, the better the health condition
Measured: 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
Discontinuation Emergent Symptoms and Signs Scale（DESS）
The more new symptoms emerge, the more severe the adverse reactions of drug withdrawal will be.
Measured: 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
Cardiopulmonary exercise test（CPET）
Measured: Baseline and at the end of the intervention (Week 12), one month after the end of the intervention
The recurrence rate of anxiety/depression
Measured: Baseline and one month, six months, one year and two years after the intervention ended
Electrocardiogram
Evaluate QTc
Measured: Baseline and at the end of the intervention (Week 12), one month after the end of the intervention
Blood test
Liver function, seven items of blood lipid, two items of myocardial function, blood routine, biochemical indicators
Measured: Baseline and at the end of the intervention (Week 12)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2025
- Study start22 Apr 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular Diseases (CVD)Studies of the same condition, open and under way.
- More trials run by Guangdong Provincial People's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 106 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangdong Provincial People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Huan Ma, Guangdong Provincial People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07025590
- Sponsor's protocol ID
- KY2025-198-01
- Status last verified
- Apr 2025
- First submitted
- 15 Apr 2025
- Last updated
- 17 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Exercise on Tapering Antipsychotics in Patients With Psycho-cardiological Disease: a Multicenter, Randomized Controlled, Non-inferior Clinical Study
- ClinicalTrials.gov ID
- NCT07025590
- Acronym / sponsor ID
- KY2025-198-01
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 106 participants (estimated)
- Lead sponsor
- Guangdong Provincial People's HospitalUniversity, hospital or other
- Study start
- 22 Apr 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 17 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise and medicine | Active comparator | Behavioral: Moderate-intensity continuous movement and Antipsychotics interventionExercise:Moderate-intensity continuous movement(MICT) The drugs include: sertraline, escitalopram, fluoxetine, duloxetine, paroxetine, venlafaxine, and fluvoxamine |
| medicine | Active comparator | Drug: Antipsychotics intervention(sertraline, escitalopram, fluoxetine, duloxetine, paroxetine, venlafaxine, and fluvoxamine)The drugs include: sertraline, escitalopram, fluoxetine, duloxetine, paroxetine, venlafaxine, and fluvoxamine |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Diagnosed with depression/anxiety;
- Continued use of SSris and SNris for six months prior to study start;
- Aged between 18 and 70;
- 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.);
- The patients voluntarily participated in the study, signed a written informed consent, and were willing to cooperate with the follow-up.
Key exclusion criteria (15 listed)
- currently has mania or hypomania, or a history of bipolar disorder and any mental disorders (current and previous);
- organic brain injury, etc., or serious non-cardiovascular system diseases (such as advanced cancer);
- Unable to participate in sports training or have drug contraindications;
- Current alcohol, drug abuse, drug use or suicidal intent;
- Patients who were receiving other doses of eligible drugs and other antidepressants were excluded from the trial;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Moderate-intensity continuous movement and Antipsychotics interventionOn 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. | Behavioural | Exercise and medicine |
| Antipsychotics 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. | Drug | medicine |
Primary outcome
Dosage of anti-anxiety/depression drugs
Time frame: Baseline and after 12 weeks of intervention
The proportion of patients with cardiovascular diseases complicated with anxiety and depression who received a 50% reduction in the dosage of anti-anxiety/depression drugs
9 secondary outcomes
Hamilton Depression and Anxiety Scale (HAMD, HAMA)
Time frame: 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
Perceived Stress Scale (PSS)
Time frame: 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
Pittsburgh Sleep Quality Index (PSQI)
Time frame: 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
12-Item Short Form Health Survey（SF-12）
Time frame: 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
Discontinuation Emergent Symptoms and Signs Scale（DESS）
Time frame: 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
Cardiopulmonary exercise test（CPET）
Time frame: Baseline and at the end of the intervention (Week 12), one month after the end of the intervention
The recurrence rate of anxiety/depression
Time frame: Baseline and one month, six months, one year and two years after the intervention ended
Electrocardiogram
Time frame: Baseline and at the end of the intervention (Week 12), one month after the end of the intervention
Blood test
Time frame: Baseline and at the end of the intervention (Week 12)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Moderate-intensity continuous movement and Antipsychotics intervention and Antipsychotics intervention(sertraline, escitalopram, fluoxetine, duloxetine, paroxetine, venlafaxine, and fluvoxamine) in people with Cardiovascular Diseases (CVD) and Depression Anxiety Disorder, run by Guangdong Provincial People's Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Huan Ha, PhD (+86 15078755932, mahuandoctor@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dosage of anti-anxiety/depression drugs (time frame: Baseline and after 12 weeks of intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2025; AzTrials last refreshed its copy on 6 Nov 2026.