Using Step Count to Enhance Daily Physical Activity in Pulmonary Hypertension

Hypertension, Pulmonary Clinical Trial

— STEPinPH  

Official title:

Using Step Count to Enhance Daily Physical Activity in Pulmonary Hypertension

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03043976
• Other study ID #: 15/LO/1185
• Status: Terminated
• Phase: N/A
• Start date: October 2015
• Est. completion date: January 2019

Study information

• Verified date: October 2023
• Source: Imperial College Healthcare NHS Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will collect information about physical activity in patients affected by pulmonary hypertension, through a specific device that can be worn on the wrist, and which measures daily step count. The purpose of the study is to demonstrate whether providing patients with their daily step count can increase their levels of daily activity if they have some basic targets to achieve. Investigators also wish to compare the effects of this approach in increasing daily physical activity, with the benefit gained when a drug therapy for pulmonary hypertension is initiated, in patients that have just been diagnosed.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 20
• Est. completion date: January 2019
• Est. primary completion date: February 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Hypertension
• Hypertension, Pulmonary

Intervention

Device:
• Actigraph GT9X Link device
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

Locations

Country	Name	City	State
United Kingdom	Hammersmith Hospital	London

Sponsors (1)

Lead Sponsor	Collaborator
Imperial College Healthcare NHS Trust

Country where clinical trial is conducted

United Kingdom, 

References & Publications (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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in daily physical activity	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	From baseline to 16 - 25 weeks
Secondary	Change in 6MWT	Evaluation of the difference in the 6MWT from the basal period to the end of the 8-week training programme compared with control	From baseline to 16 - 25 weeks
Secondary	Change in BNP	Evaluation of the difference in BNP values from the basal period to the end of the 8-week training programme compared with control	From baseline to 16 - 25 weeks
Secondary	Change in Quality of life	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	From baseline to 16 - 25 weeks
Secondary	Long-term effects of training protocol	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).	End of the 8 week period
Secondary	Comparison between training protocol and initiation of PH treatment in terms of increased physical activity	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.	5-6 weeks