Physical Inactivity Among Patients With Cardiovascular Risk

NCT07440056 | Not Yet Recruiting

• 1 other identifier: ERC/PGIM/2025/268
• Study Type: interventional
• Target: 192
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Physical Activities; Cardiovascular (CV) Risk; Empowerment

Keywords

Physical activity; primary care; behavioural intervention; level of physical activity improvement

Outcome Measures

Primary Outcomes (2)

• 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.

  Baseline, three and six months

• 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.

  baseline, three and six months

Secondary Outcomes (3)

• Blood pressure

  Baseline, three and six months

• Knowledge

  Baseline,3 months and 6 months

• Attitude

  Baseline and three, six months

Study Arms (2)

Intervention arm

EXPERIMENTAL

INSPIRE-PA intervention study arm

Behavioral: INSPIRE-PA intervention study arm

Control arm

NO INTERVENTION

Usual care control arm

Interventions

INSPIRE-PA intervention study arm BEHAVIORAL

newly developed package will be derived to them

Intervention arm

Eligibility Criteria

• Age: 35 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• University of Colombo: lead

Study Sites (1)

Primary Medical Care Institutes in Gampaha district

Gampaha, Western Province, 11000, Sri Lanka

Location

MeSH Terms

Conditions

Motor Activity; Empowerment

Condition Hierarchy (Ancestors)

Behavior; Social Behavior

Study Officials

• Dulshani Gunawardhana

  PGIM, University of Colombo

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dulshani Pujitha Gunawardhana, MBBS, MSc (Community Medicine)

CONTACT

+94707490191; gunawardhana.dulshani1@gmail.com

Dulshani P. Gunawardhana, MBBS,MSc

CONTACT

+94707490191; gunawardhana.dulshani1@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Since the newly developed intervention will be a behavioral intervention it is impossible to mask the participants, care provider and the investigator
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Registrar in Community Medicine

Model Details: Quasi experimental study design

Study Record Dates

• First Submitted: February 18, 2026
• First Posted: February 27, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: February 27, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

SR (1)