Using Step Count to Enhance Daily Physical Activity in Pulmonary Hypertension

NCT03043976 | Terminated

• 1 other identifier: 15/LO/1185
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hypertension, Pulmonary

Keywords

Physical activity; Steps count

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Change in 6MWT

  From baseline to 16 - 25 weeks

• Change in BNP

  From baseline to 16 - 25 weeks

• Change in Quality of life

  From baseline to 16 - 25 weeks

• Long-term effects of training protocol

  End of the 8 week period

• Comparison between training protocol and initiation of PH treatment in terms of increased physical activity

  5-6 weeks

Study Arms (3)

feedback and goal-setting group

ACTIVE COMPARATOR

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.

Device: Actigraph GT9X Link device

Control group

ACTIVE COMPARATOR

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)

Device: Actigraph GT9X Link device

newly diagnosed patients

PLACEBO COMPARATOR

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

Device: Actigraph GT9X Link device

Interventions

Actigraph GT9X Link device 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

Control group; feedback and goal-setting group; newly diagnosed patients

Eligibility Criteria

• Age: 19 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Imperial College Healthcare NHS Trust: lead

Study Sites (1)

Hammersmith Hospital

London, W12 0HS, United Kingdom

Location

Related Publications (9)

• 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.

  PMID: 22323570 BACKGROUND

• 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.

  PMID: 22110770 BACKGROUND

• 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.

  PMID: 19720810 BACKGROUND

• 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.

  PMID: 25261324 BACKGROUND

• 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.

  PMID: 19332472 BACKGROUND

• 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.

  PMID: 16982941 BACKGROUND

• 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.

  PMID: 22576635 BACKGROUND

• 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.

  PMID: 19713419 BACKGROUND

• 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.

  PMID: 23234873 BACKGROUND

MeSH Terms

Conditions

Hypertension, Pulmonary; Motor Activity

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases; Behavior

Study Officials

• Luke SGE Howard

  Imperial College Healthcare NHS Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Partial crossover. A group of 10 underwent the intervention, a group of 10 was observed for 8 weeks without receiveng any feedback, then underwent the intervention. The main outcome was evaluated as the difference between the end of intervention and baseline (paired data). We did not recuit any patient in arm 3.

Study Record Dates

• First Submitted: September 9, 2016
• First Posted: February 6, 2017
• Study Start: October 1, 2015
• Primary Completion: February 1, 2017
• Study Completion: January 1, 2019
• Last Updated: October 16, 2023

Record last verified: 2023-10

Locations

GB (1)