Pulmonary Hypertension and Measurement of Exercise Capacity Remotely

NCT04903704 | Completed

• 1 other identifier: STH21477
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

Background Hospital-based walking exercise tests are routinely used in patients with pulmonary hypertension to assess functional ability and disease progression over time. We are seeing a greater emphasis on non-face-to-face clinical assessments, where such tests cannot be conducted. It is important to identify alternative tests which can be which can be conducted by patients at home and used to support clinical decision making. Aim To test the safety of the 1-minute sit-to-stand test in patients with pulmonary hypertension and its comparability with hospital-based walking exercise tests. Methods A sample of 75 patients attending hospital appointments will carry out an Incremental Shuttle Walk Test, followed by a 1-minute sit-to-stand test after a 30 minute rest. Data will be analysed for safety and comparability between the 2 tests. In the event of favourable findings (safety and comparability) from the hospital-based testing, a further sample of patients will be asked to perform the 1-minute sit-to-stand test in the home setting

Conditions

Pulmonary Hypertension

Outcome Measures

Primary Outcomes (1)

• Sit to stand repititions

  The number of completed sit to stand repetitions in 1 minute

  Counted during testing

Study Arms (1)

Sit to Stand testing

OTHER

Participants will undergo an ISWT in the hospital setting. This test is a standard of clinical care and it is essential to the patient assessment on their clinical visit. This test will therefore be conducted first in all cases. They will be allowed a 30 minute rest before undertaking the 1MSTS test. Clinical observations (heart rate, blood pressure, oxygen saturations) will be taken before and after both tests. Heart rate and oxygen saturations will be monitored during both tests. Patient reported measures of dyspnoea and perceived exertion will be recorded on completion of both tests. Adverse events e.g. dizziness, syncope or the participant becoming unwell be recorded. Descriptive and inferential statistical analysis will be used to determine the safety of 1MSTS in the hospital setting and comparability between 1MSTS and ISWT for participants. We will also examine comparability between 1MSTS outcomes and other available routinely collected clinical data.

Diagnostic Test: 1 Minute Sit to Stand Test

Interventions

1 Minute Sit to Stand Test DIAGNOSTIC_TEST

Participants are asked to stand repeatedly from a chair for one minute without the use of their arms for support. The number of completed repetitions is counted.

Sit to Stand testing

Eligibility Criteria

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

You may qualify if:

• diagnosis of pulmonary arterial hypertension (PAH) or chronic thromboembolic pulmonary hypertension (CTEPH)

You may not qualify if:

• mobility significantly impaired by musculoskeletal or neurological co-morbidities; learning difficulties or cognitive impairment that would prohibit informed consent

Sponsors & Collaborators

• Sheffield Teaching Hospitals NHS Foundation Trust: lead
• Manchester Metropolitan University: collaborator

Study Sites (1)

Sheffield Teaching Hospitals NHS Foundation Trust

Sheffield, S10 2JF, United Kingdom

Location

MeSH Terms

Conditions

Hypertension, Pulmonary

Condition Hierarchy (Ancestors)

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

Study Officials

• Carol Keen

  Physiotherapist

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: May 21, 2021
• First Posted: May 26, 2021
• Study Start: June 8, 2021
• Primary Completion: December 15, 2021
• Study Completion: December 15, 2021
• Last Updated: March 17, 2022

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)