Activity Monitoring in Pulmonary Hypertension

Pulmonary Hypertension Clinical Trial

Official title:

Activity Monitoring in Pulmonary Hypertension

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04101630
• Other study ID #: Physical Activity in PH
• Status: Recruiting
• Start date: October 24, 2019
• Est. completion date: June 2026

Study information

• Verified date: September 2023
• Source: Vanderbilt University Medical Center
• Contact: Alisha Lindsey
• Phone: 937-638-2416
• Email: alisha.lindsey[@]vumc.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This is a prospective, longitudinal, observational study of free-living activity trackers and patient reported outcomes to test the hypothesis that daily activity will have stronger prognostic value than 6MWD in patients with pulmonary hypertension after 12 weeks.

Description:

A prospective, longitudinal, observational study of free-living activity tracking and patient-reported outcomes in patients with pulmonary hypertension. Participants will undergo activity monitoring for 12 weeks once a year for 4 years. Patient-reported outcomes will be collected including quality of life (emphasis-10, Minnesota Living with Heart Failure (MLHF), and SF-36 surveys), medication changes, hospitalization, and death. This study aims to enroll 500 participants. The objectives of this study are to establish the clinical utility of daily activity tracking in patients with pulmonary hypertension and to identify clinical factors associated with reduced daily activity.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: June 2026
• Est. primary completion date: June 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Enrolled in L-PVDOMICS or

• Any patient in the United States with pulmonary hypertension confirmed by hemodynamics and expert clinical diagnosis

Exclusion Criteria:

• Pregnancy

• Hospitalization within the prior 3 months

• Orthopedic limitations that preclude 6MWD testing

Related Conditions & MeSH terms

• Hypertension
• Hypertension, Pulmonary
• Pulmonary Hypertension

Intervention

Behavioral:
• Activity Monitoring
Monitoring with FitBit

Locations

Country	Name	City	State
United States	Vanderbilt University Medical Center	Nashville	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Vanderbilt University Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Activity Monitoring	Participants will wear an accelerometer to record activity level	Baseline
Primary	Activity Monitoring	Participants will wear an accelerometer to record activity level	1 year
Primary	Activity Monitoring	Participants will wear an accelerometer to record activity level	2 year
Primary	Activity Monitoring	Participants will wear an accelerometer to record activity level	3 year
Secondary	Six Minute Walk Distance (6MWD) Test	Six Minute Walk Distance Test	Baseline, 1 year, 2 year, 3 year
Secondary	Intensity of Activity	Intensity of activity is categorized as rest, light, moderate, and vigorous based on calculated metabolic equivalents.	Baseline, 1 year, 2 year, 3 year
Secondary	Quality of Life 36-Item Short Form Survey (SF-36)	Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.	Baseline, 1 year, 2 year, 3 year
Secondary	emPHasis-10	The emPHasis-10 is a pulmonary hypertension-specific questionnaire to assess health related quality of life. It covers breathlessness, fatigue and lack of energy, social restrictions, and concerns regarding effects on patient's significant others, such as family and friends. Each item is scored on a semantic differential six-point scale (0-5), with contrasting adjectives at each end. A total emPHasis-10 score is derived using simple aggregation of the 10 items. emPHasis-10 scores range from 0 to 50, higher scores indicating worse quality of life.	Baseline, 1 year, 2 year, 3 year
Secondary	Minnesota Living with Heart Failure (MLHF)	The MLHFQ is one of the most widely used health-related quality of life questionnaires for patients with heart failure. It provides scores for two dimensions, physical and emotional, and a total score. It is a reliable and valid patient-oriented measure of the adverse effects of heart failure on a patient's life. The score can range from 0-126 with 0 being minimal impact and 126 being high impact.	Baseline, 1 year, 2 year, 3 year