Physical ActivitiesINSPIRE-PANCT07440056
Physical Inactivity Among Patients With Cardiovascular Risk
A study testing INSPIRE-PA intervention study arm in people with Physical Activities and Cardiovascular (CV) Risk, run by University of Colombo at 1 site in Sri Lanka.
Trial 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. Read more about this study
- Who is it for?
- Ages 35 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Physical Activities, Cardiovascular (CV) Risk, Empowerment
- What is being tested?
- INSPIRE-PA intervention study arm
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 192 participants
- Where
- 1 siteSri Lanka
- Study dates
- 1 Apr 2026to 30 Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Dulshani Pujitha Gunawardhana, MBBS, MSc (Community Medicine) contact
Sri Lanka1 site
Primary Medical Care Institutes in Gampaha district
Gampaha, Western Province, 11000
Regional Director of Health Services, Gampaha District, MBBS, MSc, MD, 0332222874, rdhsgampaha@gmail.com
Provincial Director of Health Services, MBBS, MD, 0112434660, info@healthdept.wp.gov.lk
About this study
Official title: Physical Inactivity Among Patients With Cardiovascular Risk: Proportion, Associated Factors, Perceived Barriers, and Effectiveness of an Intervention for Improvement at Government Primary Medical Care Institutions in Gampaha District
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?
Read more
- 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
Read the detailed description
Development of intervention package
Based on the identified literature evidence and identified behavioural change theory, an intervention model will be developed by the principal investigator and consensus will be obtained from the expert panel [consisted of Consultant Community Physicians, Consultant in Sports Medicine, Consultant Family physician, Two Medical officer In charge (one from DH and one from PMCU) and Public Health Nursing Officer] using the modified delphi technique and seeking opinions from a few, purposively selected patients with intermediate risk factors for chronic NCDs from Kalutara district. The framework of the intervention will be finalized along with the content of the intervention.
The recommended evidence-based behavioral change techniques can be adopted to design an effective program to achieve physical activity promotion, which consists of different key components. These components can be basically described as replicable, observable and irreducible components of the intervention designed to modify physical activity behavior. These active elements will be used to promote physical activity behavior change of an individual . Following behavioral change techniques will be considered in developing the intervention package.
- Set goals and plans Realistic goals will be set to achieve the expected and recommended physical activity behavior in individuals. The goals will be aligned with the concept of SMART (Specific, Measurable, Attainable, Realistic and Time bound). The goals will be tailor made to everyone. Promoting small activities and graded goal setting will be considered. This will promote individual's small achievements without experiencing failures with unrealistic goals.
- Enhance knowledge Practical knowledge and skills on physical activity will be increased by enhancing awareness on physical activity and self-efficacy levels, that will be delivered in sessions. These sessions will consist of both educational and practical components.
- Social support Advice and practical help from their family members, caregivers, peers and healthcare staff to individuals to support achieving their expected behavior change goals.
- Monitoring and evaluation of behavioral outcomes Monitoring and evaluating behavioral outcomes are essential for assessing participants' adoption and maintenance of regular physical activity following an intervention. This process includes systematic tracking of both short-term and long-term changes in activity levels with validated instruments such as the international physical activity questionnaire (IPAQ). Additionally, it examines modifications in associated factors such as motivation, self-efficacy, and perceived barriers. By analyzing pre- and post-intervention data, the evaluation determines whether there have been improvements in both physical activity and health-related beliefs. Continuous monitoring and feedback facilitate iterative adjustments to optimize participant adherence and maintain the intervention's effectiveness and relevance. Overall, the evaluation of behavioral outcomes provides critical insights into the intervention's capacity to support sustained, healthy lifestyle change. Future intervention development will be informed by constructs from the health belief model. The topics for each interactive session, delivery mode, and targeted construct are detailed as follows.
Topics, Mode of delivery and intended constructs in new intervention package Session /Topic /Mode of delivery
Topic 1 :
1.1NCDs, Behavioral risk factors and intermediate risk factors of Chronic NCDs 1.2 Consequences following physical inactivity
Mode of delivery:
Interactive sessions PowerPoint presentation Educational pamphlets
Topic 2:
2.1Benefits of physical activity, Barriers \& Solutions
Mode of delivery:
Interactive learning/discussion sessions PowerPoint presentation Educational pamphlets and leaflets
Topic 3:
3.1Physical activity pyramid, level and types (based on F.I.T.T.E principle; Frequency, Intensity, Time, Type, Enjoyment) 3.2Regular \& correct physical activity 3.3 Role of friends, family in the continuation of physical activity \& doing walking
Mode of delivery:
Posters Practical training Videos PowerPoint presentation
Topic 4:
4.1Improvement of self-efficacy in physical activities
Mode of delivery:
Group discussion -Practical training
The newly developed intervention package will be delivered to a randomly selected intervention group and will be compared with a control group receiving usual care. A quasi-experimental study design will be employed to evaluate the effectiveness of the newly developed intervention package.
- Conditions
- Physical Activities, Cardiovascular (CV) Risk, Empowerment
- Being tested
- INSPIRE-PA intervention study arm
- Keywords
- Physical activity, primary care, behavioural intervention, level of physical activity improvement
- Medical subject headings
- Motor Activity, Empowerment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
INSPIRE-PA intervention study armBehavioural
newly developed package will be derived to them
| Study group | Role | What they receive |
|---|---|---|
| Intervention arm | Experimental | INSPIRE-PA intervention study arm Receives: Behavioral: INSPIRE-PA intervention study arm |
| Control arm | No intervention | Usual care control arm |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: baseline, three and six months
Secondary outcomes (3)
Blood pressure
Systolic and Diastolic blood pressure, sphygmomanometer will be used to assess the blood pressure in "mmHg".
Measured: Baseline, three and six months
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.
Measured: Baseline,3 months and 6 months
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.
Measured: Baseline and three, six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2026
- Study start1 Apr 2026 (estimated)
- Primary completion30 Sep 2026 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Physical ActivitiesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Quasi experimental study design
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 192 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Colombo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dulshani Pujitha Gunawardhana, University of Colombo
- Investigators
- Dulshani Gunawardhana, Principal investigator, PGIM, University of Colombo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07440056
- Sponsor's protocol ID
- ERC/PGIM/2025/268
- Acronym
- INSPIRE-PA
- Status last verified
- Feb 2026
- First submitted
- 18 Feb 2026
- Last updated
- 27 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physical Inactivity Among Patients With Cardiovascular Risk: Proportion, Associated Factors, Perceived Barriers, and Effectiveness of an Intervention for Improvement at Government Primary Medical Care Institutions in Gampaha District
- ClinicalTrials.gov ID
- NCT07440056
- Acronym / sponsor ID
- INSPIRE-PA / ERC/PGIM/2025/268
- Conditions
- Physical Activities, Cardiovascular (CV) Risk, Empowerment
- Keywords
- Physical activity, primary care, behavioural intervention, level of physical activity improvement
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 192 participants (estimated)
- Lead sponsor
- University of ColomboUniversity, hospital or other
- Study start
- 1 Apr 2026 (estimated)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 27 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
Development of intervention package
Based on the identified literature evidence and identified behavioural change theory, an intervention model will be developed by the principal investigator and consensus will be obtained from the expert panel [consisted of Consultant Community Physicians, Consultant in Sports Medicine, Consultant Family physician, Two Medical officer In charge (one from DH and one from PMCU) and Public Health Nursing Officer] using the modified delphi technique and seeking opinions from a few, purposively selected patients with intermediate risk factors for chronic NCDs from Kalutara district. The framework of the intervention will be finalized along with the content of the intervention.
The recommended evidence-based behavioral change techniques can be adopted to design an effective program to achieve physical activity promotion, which consists of different key components. These components can be basically described as replicable, observable and irreducible components of the intervention designed to modify physical activity behavior. These active elements will be used to promote physical activity behavior change of an individual . Following behavioral change techniques will be considered in developing the intervention package.
- Set goals and plans Realistic goals will be set to achieve the expected and recommended physical activity behavior in individuals. The goals will be aligned with the concept of SMART (Specific, Measurable, Attainable, Realistic and Time bound). The goals will be tailor made to everyone. Promoting small activities and graded goal setting will be considered. This will promote individual's small achievements without experiencing failures with unrealistic goals.
- Enhance knowledge Practical knowledge and skills on physical activity will be increased by enhancing awareness on physical activity and self-efficacy levels, that will be delivered in sessions. These sessions will consist of both educational and practical components.
- Social support Advice and practical help from their family members, caregivers, peers and healthcare staff to individuals to support achieving their expected behavior change goals.
- Monitoring and evaluation of behavioral outcomes Monitoring and evaluating behavioral outcomes are essential for assessing participants' adoption and maintenance of regular physical activity following an intervention. This process includes systematic tracking of both short-term and long-term changes in activity levels with validated instruments such as the international physical activity questionnaire (IPAQ). Additionally, it examines modifications in associated factors such as motivation, self-efficacy, and perceived barriers. By analyzing pre- and post-intervention data, the evaluation determines whether there have been improvements in both physical activity and health-related beliefs. Continuous monitoring and feedback facilitate iterative adjustments to optimize participant adherence and maintain the intervention's effectiveness and relevance. Overall, the evaluation of behavioral outcomes provides critical insights into the intervention's capacity to support sustained, healthy lifestyle change. Future intervention development will be informed by constructs from the health belief model. The topics for each interactive session, delivery mode, and targeted construct are detailed as follows.
Topics, Mode of delivery and intended constructs in new intervention package Session /Topic /Mode of delivery
Topic 1 :
1.1NCDs, Behavioral risk factors and intermediate risk factors of Chronic NCDs 1.2 Consequences following physical inactivity
Mode of delivery:
Interactive sessions PowerPoint presentation Educational pamphlets
Topic 2:
2.1Benefits of physical activity, Barriers \& Solutions
Mode of delivery:
Interactive learning/discussion sessions PowerPoint presentation Educational pamphlets and leaflets
Topic 3:
3.1Physical activity pyramid, level and types (based on F.I.T.T.E principle; Frequency, Intensity, Time, Type, Enjoyment) 3.2Regular \& correct physical activity 3.3 Role of friends, family in the continuation of physical activity \& doing walking
Mode of delivery:
Posters Practical training Videos PowerPoint presentation
Topic 4:
4.1Improvement of self-efficacy in physical activities
Mode of delivery:
Group discussion -Practical training
The newly developed intervention package will be delivered to a randomly selected intervention group and will be compared with a control group receiving usual care. A quasi-experimental study design will be employed to evaluate the effectiveness of the newly developed intervention package.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Quasi experimental study design
| Arm | Type | Receives |
|---|---|---|
| Intervention arm | Experimental | Behavioral: INSPIRE-PA intervention study armINSPIRE-PA intervention study arm |
| Control arm | No intervention | –Usual care control arm |
Who may qualify
- Ages
- 35 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| INSPIRE-PA intervention study armnewly developed package will be derived to them | Behavioural | Intervention arm |
Primary outcome
Level of physical activity
Time frame: Baseline, three and six months
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.
Exercise self-efficacy
Time frame: baseline, three and six months
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.
3 secondary outcomes
Blood pressure
Time frame: Baseline, three and six months
Knowledge
Time frame: Baseline,3 months and 6 months
Attitude
Time frame: Baseline and three, six months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2026.
- Individual participant dataSharing planned: No
Related trials for Physical Activities
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruiting
Feasibility of a Robot-Guided Active Play Intervention for Children With Cerebral Palsy
Cerebral Palsy
Enrolling by invitation
Online Exercise Program for Transplant Patients: A Pilot Study
Kidney Transplantation, Physical Function
Recruiting
Effect of a Brief Daily Digital Meditation on Well-Being in US Young Adults (BEGIN II)
Mental Health and General Well-being
RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life(COREVIVE-HFrEF)
Heart Failure With Reduced Ejection Fraction, Iron Deficiency
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Dulshani Pujitha Gunawardhana, MBBS, MSc (Community Medicine) contact
Dulshani Gunawardhana principal investigator
PGIM, University of Colombo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing INSPIRE-PA intervention study arm in people with Physical Activities and Cardiovascular (CV) Risk, run by University of Colombo at 1 site in Sri Lanka.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sri Lanka. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dulshani Pujitha Gunawardhana, MBBS, MSc (Community Medicine) (+94707490191, gunawardhana.dulshani1@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Level of physical activity (time frame: Baseline, three and six months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2026.