Evaluation of a New 6 Minute Walk Test Smartphone App in Patients With Pulmonary Hypertension

NCT04633538 | Completed Results

• 1 other identifier: PID13040
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Comparison of standard 6 minute walk test with 6 minute walk test smartphone app.

Conditions

Pulmonary Hypertension

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants Who Perform App-based Home 6MWT

  Percentage of participants who perform app-based home 6MWT.

  6 months

Secondary Outcomes (4)

• Difference in Walked Distance Between 6MWT Test at the Clinic as Measured by Physiologists and the App in Indoor Mode

  At start, at month 3 and at month 6.

• Difference in Walked Distance Between 6MWT Test as Measured by Physiologists at the Clinic and App in Outdoor Mode at the Community

  Clinic tests at start, at month 3, at month 6. Community tests undertaken within 7 days of clinic test.

• Test-Retest Reliability of Community-Based 6MWT

  6MWT in the community, at the patient's discretion (recommended once/month), over 6 months

• Compliance to Monitoring Regime in the Community

  At month 6

Study Arms (1)

6MWT app group

Patients who received the 6MWT app and performed tests at the clinic and in the community using the app

Device: 6MWT smartphone app

Interventions

6MWT smartphone app DEVICE

Use of smartphone app to measure 6 minute walk test (6MWT)

6MWT app group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing follow up in the PAH clinic will be eligible for participation. They will be approached by a member of the clinical team for consideration and recruited. We will recruit 30 compliant patients to enrol in the study.

You may qualify if:

• Participant is willing and able to give informed consent for participation in the study
• Male or Female, aged 18 years or above
• Diagnosed with PAH who are able to undertake 6MWT off-oxygen
• Being of PAH group 1 or 4
• Participant owns a compatible smartphone (Android or iPhone) and is able to use it.

You may not qualify if:

• Long term oxygen therapy
• Cognitive impairments
• Rheumatological diseases that limit the measurement of finger Oxygen saturations
• PAH groups 2, 3 or 5
• Cannot use a smartphone
• Pregnancy.

Sponsors & Collaborators

• Oxford University Hospitals NHS Trust: lead
• University of Oxford: collaborator

Study Sites (1)

Oxford University Hospitals NHS Foundation Trust

Oxford, United Kingdom

Location

Related Publications (8)

• Agarwal R, Gomberg-Maitland M. Current therapeutics and practical management strategies for pulmonary arterial hypertension. Am Heart J. 2011 Aug;162(2):201-13. doi: 10.1016/j.ahj.2011.05.012. Epub 2011 Jul 13.

  PMID: 21835279 BACKGROUND

• Galie N, Brundage BH, Ghofrani HA, Oudiz RJ, Simonneau G, Safdar Z, Shapiro S, White RJ, Chan M, Beardsworth A, Frumkin L, Barst RJ; Pulmonary Arterial Hypertension and Response to Tadalafil (PHIRST) Study Group. Tadalafil therapy for pulmonary arterial hypertension. Circulation. 2009 Jun 9;119(22):2894-903. doi: 10.1161/CIRCULATIONAHA.108.839274. Epub 2009 May 26.

  PMID: 19470885 BACKGROUND

• Tan MP, Bansal SK, Wynn NN, Umerov M, Gillham A, Henderson A, Hildreth A, Junejo S. Long term survival of patients with raised pulmonary arterial systolic pressure utilizing echocardiography-a five-year prospective study. J Geriatr Cardiol. 2012 Dec;9(4):328-35. doi: 10.3724/SP.J.1263.2012.06191.

  PMID: 23341836 BACKGROUND

• Gabler NB, French B, Strom BL, Palevsky HI, Taichman DB, Kawut SM, Halpern SD. Validation of 6-minute walk distance as a surrogate end point in pulmonary arterial hypertension trials. Circulation. 2012 Jul 17;126(3):349-56. doi: 10.1161/CIRCULATIONAHA.112.105890. Epub 2012 Jun 13.

  PMID: 22696079 BACKGROUND

• Mathai SC, Puhan MA, Lam D, Wise RA. The minimal important difference in the 6-minute walk test for patients with pulmonary arterial hypertension. Am J Respir Crit Care Med. 2012 Sep 1;186(5):428-33. doi: 10.1164/rccm.201203-0480OC. Epub 2012 Jun 21.

  PMID: 22723290 BACKGROUND

• Miyamoto S, Nagaya N, Satoh T, Kyotani S, Sakamaki F, Fujita M, Nakanishi N, Miyatake K. Clinical correlates and prognostic significance of six-minute walk test in patients with primary pulmonary hypertension. Comparison with cardiopulmonary exercise testing. Am J Respir Crit Care Med. 2000 Feb;161(2 Pt 1):487-92. doi: 10.1164/ajrccm.161.2.9906015.

  PMID: 10673190 BACKGROUND

• Barst RJ, Rubin LJ, Long WA, McGoon MD, Rich S, Badesch DB, Groves BM, Tapson VF, Bourge RC, Brundage BH, Koerner SK, Langleben D, Keller CA, Murali S, Uretsky BF, Clayton LM, Jobsis MM, Blackburn SD, Shortino D, Crow JW; Primary Pulmonary Hypertension Study Group. A comparison of continuous intravenous epoprostenol (prostacyclin) with conventional therapy for primary pulmonary hypertension. N Engl J Med. 1996 Feb 1;334(5):296-301. doi: 10.1056/NEJM199602013340504.

  PMID: 8532025 BACKGROUND

• Salvi D, Poffley E, Tarassenko L, Orchard E. App-Based Versus Standard Six-Minute Walk Test in Pulmonary Hypertension: Mixed Methods Study. JMIR Mhealth Uhealth. 2021 Jun 7;9(6):e22748. doi: 10.2196/22748.

  PMID: 34096876 DERIVED

MeSH Terms

Conditions

Hypertension, Pulmonary

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Dr Elizabeth Orchard
• Organization: Oxford University Hospital

elizabeth.orchard@ouh.nhs.uk

01865223084

Study Officials

• Elizabeth Orchard

  Oxford University Hospitals NHS Trust

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Primary Investigator

Study Record Dates

• First Submitted: August 26, 2020
• First Posted: November 18, 2020
• Study Start: January 15, 2018
• Primary Completion: August 28, 2019
• Study Completion: April 1, 2020
• Last Updated: March 7, 2025
• Results First Posted: March 7, 2025

Record last verified: 2025-02

Locations

GB (1)