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Not yet recruitingNCT07440056INSPIRE-PAUpdated Feb 27, 2026

Physical Inactivity Among Patients With Cardiovascular Risk

An interventional study of INSPIRE-PA intervention study arm in Physical Activities, Cardiovascular (CV) Risk and Empowerment, sponsored by University of Colombo. Not yet recruiting at 1 site in Sri Lanka. Open to participants aged 35 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-02-27.

Primary conditionEmpowermentRegistry: Motor ActivityReclassifiedWhy we changed it
Registry
Motor Activity — the first condition term the registry derived for this study.
ClinicalTrials.gg
Empowerment
Why
  1. Motor Activity is a broad heading, used only when no more specific condition is named.
  2. The study's listed conditions name Empowerment.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by University of Colombo · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
192
Allocation
Non-randomized
Ages
35 Years to 65 Years
Sex
All
01

Study 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
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.

02

Conditions studied

  • Physical Activities
  • Cardiovascular (CV) Risk
  • Empowerment

Browse trials for

Keywords

  • Physical activity
  • primary care
  • behavioural intervention
  • level of physical activity improvement
03

In context

Empowerment Reclassified

154 studies on the registry are indexed under Empowerment; 31 are open to participants now.

This study's planned enrollment of 192 is above the median of 141 across 132 interventional studies indexed under Empowerment.

Browse Empowerment studies →

Lead sponsor

University of Colombo is the lead sponsor of 6 studies on the registry; 1 is open to participants now.

Compared within Empowerment, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Motor Activity. The counts are of registry records indexed under each term, refreshed daily. How we classify →

04

Who can participate

Ages eligible
35 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Patients permanently residing in Gampaha district for six months or more
  2. 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

Exclusion Criteria:

  1. Pregnant mothers with any intermediate risk factor of chronic NCDs, followed up at state PMCIs in Gampaha district
  2. 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.
  3. Patients already diagnosed and on treatment for diabetes mellitus, any type of cancer and any chronic respiratory disease (e.g. Asthma, ) 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
  4. Patients with impaired cognitive functions (confirmed with medical records), as they are unable to report accurate responses independently.
  5. Patients who have undergone any surgical procedure within the last three months (confirmed by clinical documentation)
  6. Patients who have had any debilitating illness during the preceding week limiting their physical activity during the period of illness
  7. 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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

COPD

Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.

05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
192 participants (estimated)

Study arms

  • Experimental
    Intervention arm

    INSPIRE-PA intervention study arm

    Behavioral: INSPIRE-PA intervention study arm

  • No intervention
    Control arm

    Usual care control arm

Interventions

  • BehavioralINSPIRE-PA intervention study arm

    newly developed package will be derived to them

06

What researchers measure

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 months

  2. 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 months

Secondary 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 months

  2. 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 months

  3. 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 months

07

Study locations

1 site
  • Primary Medical Care Institutes in Gampaha district
    Gampaha, Western Province 11000, Sri Lanka
    • Regional Director of Health Services, Gampaha District, MBBS, MSc, MD · Contactrdhsgampaha@gmail.com · 0332222874
    • Provincial Director of Health Services, MBBS, MD · Contactinfo@healthdept.wp.gov.lk · 0112434660
    • Dulshani Gunawardhana, MBBS, MSc · Principal investigator
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Apr 2026; primary completion for Sep 2026, 5 months later.

Of 82 non-industry interventional studies with no phase under Empowerment, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 45. This study's planned 5 months is below that.

Counting every sponsor, half of 82 studies reached it within 22 months; a quarter within 11 and three quarters within 45.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 18, 2026
First posted
Feb 27, 2026
StartEst.
Apr 1, 2026
Primary completionEst.
Sep 30, 2026
CompletionEst.
Sep 30, 2026
Last update
Feb 27, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 27, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07440056
Lead sponsor
University of Colombo
Responsible party
Dulshani Pujitha Gunawardhana (Registrar in Community Medicine, University of Colombo) — Principal investigator
First posted
Feb 27, 2026
Start date
Apr 1, 2026 (estimated)
Primary completion
Sep 30, 2026 (estimated)
Completion
Sep 30, 2026 (estimated)
Last update
Feb 27, 2026

Study contacts

Dulshani Pujitha Gunawardhana, MBBS, MSc (Community Medicine)
Contact
gunawardhana.dulshani1@gmail.com
+94707490191
Dulshani P. Gunawardhana, MBBS,MSc
Contact
gunawardhana.dulshani1@gmail.com
+94707490191
Dulshani Gunawardhana
principal investigator · PGIM, University of Colombo

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.

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