Physical Inactivity Among Patients With Cardiovascular Risk (NCT07440056) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Physical Inactivity Among Patients With Cardiovascular Risk
Sri Lanka192 participantsStarted 2026-04-01
Plain-language summary
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
Who can participate
Age range
35 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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
Exclusion criteria
. 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. 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