Using Step Count to Enhance Daily Physical Activity in Pulmonary Hypertension (STEPinPH)
Hypertension, Pulmonary
About this trial
This is an interventional treatment trial for Hypertension, Pulmonary focused on measuring Physical activity, Steps count
Eligibility Criteria
Inclusion Criteria:
- Able to give informed consent
- Nice Classification Groups 1 and 4 Pulmonary Hypertension (pulmonary arterial hypertension and chronic thromboembolic pulmonary hypertension)
- WHO functional class I-IV
- Stable on current medication for 8/52 for group 1 (feedback and goal-setting group) and group 2 (control group)
- For group 3 (newly diagnosed patients), treatment-naïve patients undergoing investigation who are likely to start therapy (based on clinical judgment of the clinician)
- Patients with handheld devices (such as smartphones or tablets) which can run the Study Admin Mobile application.
Exclusion Criteria:
- Pregnancy: we will screen for this on the basis of the history from the patient, and if she is not sure if she might be pregnant, a pregnancy test will be offered
- Malignant arrhythmias
- Syncope within the last 6 months
- Skeletal or muscle abnormalities prohibiting walking
Sites / Locations
- Hammersmith Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Active Comparator
Active Comparator
Placebo Comparator
feedback and goal-setting group
Control group
newly diagnosed patients
At the baseline, patients will fill a questionnaire about their quality of life (SF36), will perform a 6'walk test (6MWT), will undertake a blood sample (BNP). In the run-in period (1 week) patients will wear an Actigraph GT9X Link device which only displays the time and the battery level; all activity data will be recorded. Then participants will wear an Actigraph GT9X Link device which shows real time data about the number of steps and will upload their data via the Study Admin Mobile application for smartphones/tablets. Patients will be asked to aim for an average specified number of steps/day week by week and will receive a weekly report with results from the previous week and targets to achieve. After 8 weeks, patients will attend visit 2 (6MWT, SF36 and BNP assessment) and will carry on wearing the activated device for 8 weeks receiving weekly feedbacks and targets. After 8 weeks patients will attend visit 3 (6MWD, SF36 and BNP will be assessed) which is the end of the study.
At the baseline, patients will fill a questionnaire about their quality of life (SF36), will perform a 6'WT and will undertake a blood sample (BNP). After a run-in period (1 week) with an Actigraph GT9X Link device disabled from showing the number of steps, patients will wear an Actigraph GT9X Link device which still only displays time and battery level and will upload data via the Study Admin Mobile application for smartphones/tablets without receiving any feedback. After 8 weeks, patients will be assessed (SF36, 6'WT, BNP) and will start to wear a new device enabled to display the daily step count. Patients will be asked to aim for an average specified number of steps/day, receiving a weekly summary of the previous week with targets to achieve week by week. After 8 weeks, patients will be assessed (6'WT, SF36, BNP) and will carry on wearing the device and receiving feedbacks and targets for a further 8 week period, after that patients will be finally assessed (SF36, 6'WT, BNP)
In the week leading up to their inpatient admission for diagnostic investigations, patients who are treatment-naïve will be given the Actigraph GT9X Link device which will only display the time and the charge level of the battery. Patients will be asked, as well, to fill a questionnaire about their quality of life, to perform a 6MWT and a blood sample (BNP). As soon as patients start the drug therapy, patients will wear a second Actigraph GT9X Link device still disabled from showing real time data about the number of daily steps. Participants will not receive any feedback during the whole period and will be asked, as well, to upload the data collected through the remote mobile system. At their first clinical assessment (after about 4 or 5 weeks), 6'WT, BNP and questionnaire about quality of life will be reassessed. If patients are not being started on drug therapy then they will be withdrawn from the study