- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03043976
Using Step Count to Enhance Daily Physical Activity in Pulmonary Hypertension (STEPinPH)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Pulmonary hypertension (PH) is a rare and progressive disorder and shortness of breath and fatigue, especially during exercise, are very common symptoms, resulting in a reduced capacity to perform daily activities and in an impaired quality of life. Furthermore, reduced exercise capacity in PH is associated with depression and anxiety disorders. Recent literature reveals a strong association of sedentary time with adverse cardiovascular outcomes, so that the development of therapeutic strategies to avoid this event is pivotal in the management of PH, in addition to the beneficial results of modern medical treatment. Recently the role of exercise and rehabilitation in different respiratory and cardiac conditions has been evaluated in the literature, overtaking the concerns raised in the past that exercise could worsen the condition and thus the progression of these kind of diseases, but just a few studies have been done in patients affected by PH.
International guidelines on pulmonary hypertension recommend avoiding strenuous exercise that leads to distressing symptoms, while encourage low level graded aerobic exercise, such as walking, as tolerated. Nonetheless, little is still known about the effects of lifestyle changes, such as the amount of physical activity that patients can or should practice. Pedometers have been used to enhance the daily physical activity and to improve, when assessed, some prognosis related outcomes, both in healthy subjects and those affected by different pathological conditions, in particular cardiac and respiratory diseases. However, a training model based on step count targets has never been evaluated in PH, to our knowledge. Step counting devices have recently experienced a surge in popularity as a tool for motivating and monitoring physical activity in the general population, especially combined with applications for smartphones, that provide feedback, such as an overview of the data recorded. Thus, it seems reasonable to explore the opportunity to develop a step count based training model to enhance daily exercise in PH patients, through these non-invasive, patient friendly and relatively inexpensive devices.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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London, United Kingdom, W12 0HS
- Hammersmith Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: feedback and goal-setting group
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.
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Assessment of the level of physical activity of PH patients using the Actigraph GT9X Link device that includes a triaxial accelerometer and can be enabled to show on its display the number of steps taken for the day, so that it can also be used by the patients as a common pedometer. Evaluation of the effects of an 8 week step count-based light touch training programme to see if activity can be increased |
Active Comparator: Control group
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)
|
Assessment of the level of physical activity of PH patients using the Actigraph GT9X Link device that includes a triaxial accelerometer and can be enabled to show on its display the number of steps taken for the day, so that it can also be used by the patients as a common pedometer. Evaluation of the effects of an 8 week step count-based light touch training programme to see if activity can be increased |
Placebo Comparator: newly diagnosed patients
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 |
Assessment of the level of physical activity of PH patients using the Actigraph GT9X Link device that includes a triaxial accelerometer and can be enabled to show on its display the number of steps taken for the day, so that it can also be used by the patients as a common pedometer. Evaluation of the effects of an 8 week step count-based light touch training programme to see if activity can be increased |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in daily physical activity
Time Frame: From baseline to 16 - 25 weeks
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The principal objective is to demonstrate a difference in the intensity of daily physical activity, measured in activity counts per minute, from the basal period to the last week of the 8-week training programme compared with control
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From baseline to 16 - 25 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in 6MWT
Time Frame: From baseline to 16 - 25 weeks
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Evaluation of the difference in the 6MWT from the basal period to the end of the 8-week training programme compared with control
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From baseline to 16 - 25 weeks
|
Change in BNP
Time Frame: From baseline to 16 - 25 weeks
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Evaluation of the difference in BNP values from the basal period to the end of the 8-week training programme compared with control
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From baseline to 16 - 25 weeks
|
Change in Quality of life
Time Frame: From baseline to 16 - 25 weeks
|
Evaluation of the difference in quality of life (assessed by SF36 questionnaire) from the basal period to the end of the 8-week training programme compared with control
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From baseline to 16 - 25 weeks
|
Long-term effects of training protocol
Time Frame: End of the 8 week period
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Evaluate if the eventual benefit gained after the 8 week training period (measured in activity counts per minute) is maintained, reduced or increased for a further 8 week period (group1+ group 2).
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End of the 8 week period
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Comparison between training protocol and initiation of PH treatment in terms of increased physical activity
Time Frame: 5-6 weeks
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Comparing the efficacy of our training protocol to the effects of the initiation of the PH drug treatment in newly diagnosed patients, in terms of increased physical activity assessed in terms of activity counts.
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5-6 weeks
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Collaborators and Investigators
Investigators
- Principal Investigator: Luke SGE Howard, Imperial College Healthcare NHS Trust
Publications and helpful links
General Publications
- Mainguy V, Provencher S, Maltais F, Malenfant S, Saey D. Assessment of daily life physical activities in pulmonary arterial hypertension. PLoS One. 2011;6(11):e27993. doi: 10.1371/journal.pone.0027993. Epub 2011 Nov 16.
- Mereles D, Ehlken N, Kreuscher S, Ghofrani S, Hoeper MM, Halank M, Meyer FJ, Karger G, Buss J, Juenger J, Holzapfel N, Opitz C, Winkler J, Herth FF, Wilkens H, Katus HA, Olschewski H, Grunig E. Exercise and respiratory training improve exercise capacity and quality of life in patients with severe chronic pulmonary hypertension. Circulation. 2006 Oct 3;114(14):1482-9. doi: 10.1161/CIRCULATIONAHA.106.618397. Epub 2006 Sep 18.
- Mendoza L, Horta P, Espinoza J, Aguilera M, Balmaceda N, Castro A, Ruiz M, Diaz O, Hopkinson NS. Pedometers to enhance physical activity in COPD: a randomised controlled trial. Eur Respir J. 2015 Feb;45(2):347-54. doi: 10.1183/09031936.00084514. Epub 2014 Sep 26.
- McLaughlin VV, Archer SL, Badesch DB, Barst RJ, Farber HW, Lindner JR, Mathier MA, McGoon MD, Park MH, Rosenson RS, Rubin LJ, Tapson VF, Varga J, Harrington RA, Anderson JL, Bates ER, Bridges CR, Eisenberg MJ, Ferrari VA, Grines CL, Hlatky MA, Jacobs AK, Kaul S, Lichtenberg RC, Lindner JR, Moliterno DJ, Mukherjee D, Pohost GM, Rosenson RS, Schofield RS, Shubrooks SJ, Stein JH, Tracy CM, Weitz HH, Wesley DJ; ACCF/AHA. ACCF/AHA 2009 expert consensus document on pulmonary hypertension: a report of the American College of Cardiology Foundation Task Force on Expert Consensus Documents and the American Heart Association: developed in collaboration with the American College of Chest Physicians, American Thoracic Society, Inc., and the Pulmonary Hypertension Association. Circulation. 2009 Apr 28;119(16):2250-94. doi: 10.1161/CIRCULATIONAHA.109.192230. Epub 2009 Mar 30. No abstract available. Erratum In: Circulation. 2009 Jul 14;120(2):e13.
- Galie N, Hoeper MM, Humbert M, Torbicki A, Vachiery JL, Barbera JA, Beghetti M, Corris P, Gaine S, Gibbs JS, Gomez-Sanchez MA, Jondeau G, Klepetko W, Opitz C, Peacock A, Rubin L, Zellweger M, Simonneau G; ESC Committee for Practice Guidelines (CPG). Guidelines for the diagnosis and treatment of pulmonary hypertension: the Task Force for the Diagnosis and Treatment of Pulmonary Hypertension of the European Society of Cardiology (ESC) and the European Respiratory Society (ERS), endorsed by the International Society of Heart and Lung Transplantation (ISHLT). Eur Heart J. 2009 Oct;30(20):2493-537. doi: 10.1093/eurheartj/ehp297. Epub 2009 Aug 27. No abstract available. Erratum In: Eur Heart J. 2011 Apr;32(8):926.
- Ulrich S, Fischler M, Speich R, Bloch KE. Wrist actigraphy predicts outcome in patients with pulmonary hypertension. Respiration. 2013;86(1):45-51. doi: 10.1159/000342351. Epub 2012 Dec 11.
- Pugh ME, Buchowski MS, Robbins IM, Newman JH, Hemnes AR. Physical activity limitation as measured by accelerometry in pulmonary arterial hypertension. Chest. 2012 Dec;142(6):1391-1398. doi: 10.1378/chest.12-0150.
- Grunig E, Lichtblau M, Ehlken N, Ghofrani HA, Reichenberger F, Staehler G, Halank M, Fischer C, Seyfarth HJ, Klose H, Meyer A, Sorichter S, Wilkens H, Rosenkranz S, Opitz C, Leuchte H, Karger G, Speich R, Nagel C. Safety and efficacy of exercise training in various forms of pulmonary hypertension. Eur Respir J. 2012 Jul;40(1):84-92. doi: 10.1183/09031936.00123711. Epub 2012 Feb 9.
- de Man FS, Handoko ML, Groepenhoff H, van 't Hul AJ, Abbink J, Koppers RJ, Grotjohan HP, Twisk JW, Bogaard HJ, Boonstra A, Postmus PE, Westerhof N, van der Laarse WJ, Vonk-Noordegraaf A. Effects of exercise training in patients with idiopathic pulmonary arterial hypertension. Eur Respir J. 2009 Sep;34(3):669-75. doi: 10.1183/09031936.00027909.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 15/LO/1185
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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