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
This trial accepts healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
INSPIRE-PA intervention study arm
Behavioralnewly developed package will be derived to them
Treatment groups
192 Participants
are divided into 2 treatment groupsGroup A: Intervention armExperimental treatment 1 intervention
Group B: Control armNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Level of physical activity
Physical activity will be categorized in 3 categories as low, moderate and high physical activity levels. Who is achieving minimum total physical activity of at least 600 MET-minutes/week -3000 MET min/ week will be categorized as moderate physical activity level. Those who achieve total physical activity level of more than 3000 MET min/week will be categorized as high physical activity, Those who do not meet those criteria will be considered as low physical activity.
Time frame
Baseline, three and six months2
Exercise self-efficacy
Culturally validated locally adopted Bandura's Exercise Self-Efficacy Scale (18 item) will be used. Lower score indicated lesser self efficacy and higher score indicates higher self-efficacy.
Time frame
baseline, three and six monthsSecondary outcomes
1
Blood pressure
Systolic and Diastolic blood pressure, sphygmomanometer will be used to assess the blood pressure in "mmHg".
Time frame
Baseline, three and six months2
Knowledge
Knowledge on Physical activity, Interviewer administered questionnaire is developed to assess knowledge, Pre defined score will be given to the responses. Pre-defined cut off value will be used (based on exert opinion) to categorize them in to "good" and "poor" knowledge categories.
Time frame
Baseline,3 months and 6 months3
Attitude
Attitude on physical activity, attitude on physical activity, Interviewer administered questionnaire is developed to assess attitude, Pre defined score will be given to the responses. Pre-defined cut off value will be used (based on exert opinion) to categorize them into "favorable" and "unfavorable" attitude categories.
Time frame
Baseline and three, six monthsSponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: