Clinical trial NCT05867511: A Study to Promote Physical Activity Motivation in Cardiovascular Disease Patients
Official title: A Pilot Feasibility Study to Promote Physical Activity Motivation in Cardiovascular Disease Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Diseases
Keywords: Cardiovascular Diseases
Health behavior change
Physical activity
Sedentary behavior
App based intervention
Transtheoretical model
Habit formation
Lead sponsor: University of Bern
Sponsor class: OTHER
Collaborators: name: University of Bern
First posted: 2023-05-22
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: The study is a one-armed pilot 8-week tailored intervention with a pre-post-design, as well as an intensive-longitudinal design with weekly measurements.
Primary purpose: PREVENTION

Brief summary: This study investigates the feasibility of an app based intervention, which uses questionnaires and personalized motivational messages to achieve change in physical activity and sedentary behaviour of cardiovascular patients. The questionnaires and messages are based on behaviour change theories, such as the transtheoretical model. The intervention will take place over eight weeks. One week before and during the last week, physical activity will be measured via accelerometers. A comprehensive questionnaire will be given before and at the end of the intervention and Feasibility measures will be evaluated at the end as well, including an optional qualitative interview with the participants.

Detailed description: Cardiovascular diseases are the leading cause of death and disability worldwide. They are mainly caused by lifestyle risk factors, such as physical inactivity, which is also the fourth leading risk factor for mortality. Regular physical activity is crucial for the prevention and treatment of cardiovascular diseases. Nevertheless, success in achieving long-term adherence to physical activity recommendations after an acute cardiac event or even after exercise-based cardiac rehabilitation is rather low. Furthermore, even though most research has focused on physical activity, engaging in reduced amounts of sedentary behavior is also crucial, as it represents an important cardiovascular risk even after adjusting for physical activity. Health behavior change theories, such as the transtheoretical model, and empirical evidence highlight the importance of motivation and motivational factors in the behavior maintenance or change process. Thus, the main goal of the present study is to assess preliminary effectiveness of an intervention mostly based on the transtheoretical model to promote cardiovascular patients' motivation to be physically active and to engage in reduced amounts of sedentary behavior. Most intervention components will be delivered digitally to the participants' smartphones via a study specific app. Furthermore, weekly questionnaires allow the investigators' to individualize the intervention components and investigate associations not only between-subjects, but also within-subjects over time, which is essential and has been neglected in the literature. The primary objective is to assess study feasibility.

Eligibility criteria: Inclusion criteria:

* Cardiovascular disease patients
* Participating in cardiovascular rehabilitation OR having received the recommendation from a cardiologist to participate in cardiovascular rehabilitation and having refused
* Signing the informed consent form
* Owning a smartphone with internet access

Exclusion criteria:

* Age under 18 years
* Having a contraindication for physical activity
* Existing or suspected non-fulfilment of the participation requirements
* Inability to follow the procedures of the study (e.g., by not speaking German, being unable to read or write, or severe cognitive impairment)
* Being in palliative care
* Being pregnant
* Having an assisted living situation
* Stroke patients

Primary outcomes:
measure: Percentage of approached patients included
timeFrame: Approx. 5 Months
measure: Dropout rate
timeFrame: Participants can dropout at any time during the study (during 9 weeks for each participant)
measure: Completion of study assessments
timeFrame: Participants may fill out study questionnaires weekly during the 8-week intervention or not.
Secondary outcomes:
measure: Overall satisfaction
timeFrame: Last questionnaire of the study for each participant (post questionnaire right after the 8 intervention weeks; 9 weeks after study start)
measure: Usability
timeFrame: Last questionnaire of the study for each participant (post questionnaire right after the 8 intervention weeks; 9 weeks after study start)
measure: Engagement
timeFrame: Last questionnaire of the study for each participant (post questionnaire right after the 8 intervention weeks; 9 weeks after study start)
measure: Satisfaction with the specific intervention components
timeFrame: Last questionnaire of the study for each participant (post questionnaire right after the 8 intervention weeks; 9 weeks after study start)
measure: Needs assessment
timeFrame: Last questionnaire of the study for each participant (post questionnaire right after the 8 intervention weeks; 9 weeks after study start)
measure: Motivation
timeFrame: Weekly right before, during and right after the 8-week intervention for each participant.
measure: Stage of change
timeFrame: Weekly right before, during and right after the 8-week intervention for each participant.
measure: Processes of change
timeFrame: Weekly right before, during and right after the 8-week intervention for each participant.
measure: Decisional balance
timeFrame: Weekly right before, during and right after the 8-week intervention for each participant.
measure: Self-efficacy
timeFrame: Weekly right before, during and right after the 8-week intervention for each participant.
measure: Temptation
timeFrame: Weekly right before, during and right after the 8-week intervention for each participant.
measure: Social support
timeFrame: Weekly right before, during and right after the 8-week intervention for each participant.
measure: Habit
timeFrame: Weekly right before, during and right after the 8-week intervention for each participant.
measure: Affect
timeFrame: Weekly right before, during and right after the 8-week intervention for each participant.
measure: Self reported health-related quality of life
timeFrame: Weekly right before, during and right after the 8-week intervention for each participant.
measure: Physical activity
timeFrame: Self-report: Weekly right before, during and right after the 8-week intervention. Device-based: during the 8 days before and the last 7 days of the intervention.
measure: Sedentary behaviour
timeFrame: Self-report: Weekly right before, during and right after the 8-week intervention. Device-based: during the 8 days before and the last 7 days of the intervention.
Other outcomes:
Locations:
city: Bern
country: Switzerland
facility: Institute of Sport Science, University of Bern
Study officials:
affiliation: University of Bern
name: Claudio Nigg, PhD
role: PRINCIPAL_INVESTIGATOR
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