Physical Inactivity Among Patients With Cardiovascular Risk

Starting soon · Not applicable

Conditions studied: Physical Activities, Cardiovascular (CV) Risk, Empowerment

In brief

The goal of this clinical trial is to learn if newly developed intervention package works to improve physical activity level among patients with intermediate cardiovascular risk factors. The main questions it aims to answer are: Does the INSPIRE-PA intervention increase the level of physical activity among participants with intermediate cardiovascular risk factors? * What changes occur in physical activity level, BMI and blood pressure following participation in the intervention? * Are there any challenges, barriers, or unintended effects experienced by participants during the intervention period? * Researchers will compare the INSPIRE-PA intervention to usual care to determine whether the empowerment-based strategy is effective in improving physical activity levels and reducing cardiovascular risk among patients attending government primary medical care Iinstitutions. Participants will: * Participate in the INSPIRE-PA program for 6 months * Attend scheduled follow-up visits at the primary medical care institution (e.g., every 2-4 weeks)for counselling, evaluation of physical activity level, and assessment of cardiovascular risk indicators * Engage in structured physical activity as recommended in the intervention package * Record their daily physical activity and any challenges or barriers in a physical activity logbook or diary * Undergo periodic measurements such as blood pressure, weight, waist circumference, and other relevant clinical assessments

Key facts

Study ID

NCT07440056

Run by

University of Colombo

People needed

192

Starts

2026-04-01

Expected to finish

2026-09-30

Last updated by the study team

2026-02-27

Who can join

Age: 35 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Patients permanently residing in Gampaha district for six months or more
• Patients registered and followed up at medical clinics in the same state sector PMCIs in Gampaha district, for a duration of three months or more

You may not qualify if…

• Pregnant mothers with any intermediate risk factor of chronic NCDs, followed up at state PMCIs in Gampaha district
• Patients diagnosed with atherosclerotic cardiovascular disease (ASCVD) (e.g. Coronary heart disease, Cerebrovascular disease, Peripheral artery disease, Aortic atherosclerotic disease) followed up at state sector primary medical care institutions in Gampaha district.
• Patients already diagnosed and on treatment for diabetes mellitus, any type of cancer and any chronic respiratory disease (e.g. Asthma, chronic obstructive pulmonary disease) followed up at state sector primary medical care institutions in Gampaha district, as their physical activity level and their knowledge on it may have changed following the diagnosis
• Patients with impaired cognitive functions (confirmed with medical records), as they are unable to report accurate responses independently.
• Patients who have undergone any surgical procedure within the last three months (confirmed by clinical documentation)
• Patients who have had any debilitating illness during the preceding week limiting their physical activity during the period of illness
• Patients who plan to change/change their place of residence or shift their treatment follow-up from a state-sector PMCI to the private sector or any other treatment modality (e.g: Ayurveda) within the next six months

Where it is running

• Primary Medical Care Institutes in Gampaha district — Gampaha, Western Province, Sri Lanka

Full record on ClinicalTrials.gov

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