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Physical activity interventions to reduce risk of cardiovasular risks in persons with mental illness

Effectiveness of integrated clinical and behavioral interventions for cardiovascular risk management among patients with serious mental disorders in psychiatric outpatient settings: A multi-centric randomized controlled trial

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2019/12/022586
Enrollment
332
Registered
2019-12-31
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: F317- Bipolar disorder, currently in remission Health Condition 2: F201- Disorganized schizophrenia Health Condition 3: F200- Paranoid schizophrenia

Interventions

Intervention1: HEARTS: The intervention group will receive a comprehensive package of care for management of CVD risks called HEARTS. HEARTS is the technical package for cardiovascular disease managem

Sponsors

Indian Council of Medical Research
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Diagnosis of Schizophrenia and related disorders (ICD F20-F29) and Mood Disorders (ICD F30-F 39); diagnosis of hypertension (defined as systolic blood pressure >=140 mmHg or diastolic blood pressure >=90 mmHg).and/ or diabetes (WHO diagnostic criteria for diabetes â?? fasting plasma glucose >= 126mg/dl or 2â??h plasma glucose 200mg/dl; both genders, age over 18 years, on regular psychiatric medication and CGI <5

Exclusion criteria

Exclusion criteria: CGI > 5, medical condition requiring active specialist treatment, h/o recent MI within 1 year, COPD, major stroke with significant neurological deficit, malignancy within 2 years and women who are pregnant.

Design outcomes

Primary

MeasureTime frame
Improved CVD risks among the SMD subjects in the intervention arm compared to control arm.Timepoint: 24 months

Secondary

MeasureTime frame
Prevalence of CVD risks in persons with SMDTimepoint: 18 months

Countries

India

Contacts

Public ContactPadmavati Ramachandran

Schizophrenia Research Foundation

padmavati@scarfindia.org9444008424

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026