Physical Inactivity Among Patients With Cardiovascular Risk

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age35-65
SponsorUniversity of Colombo

About this trial

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

Eligibility criteria

Qualifiers

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

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • INSPIRE-PA intervention study arm

Treatment groups

192 Participants
are divided into 2 treatment groups

Sponsors and collaborators