Pedometers and Walking Tests for Pulmonary Hypertension Patients

NCT03810482 | Unknown

• 1 other identifier: RECHMPL18_0186
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

Concordance between walking tests and pedometer data may seem like a logical outcome for pulmonary hypertension (PH) patients. However, many individuals have discordant results: results much worse or better during an in-hospital walking test as compared to real life activity. The primary objective of this study is: to determine variables associated with discordance between the distance walked during an in-hospital 6-minute walking test (6MWT) and the average distance travelled per day (observed over a period of 28 days (2 × 14 days) using a pedometer) among PH patients.

Conditions

Hypertension, Pulmonary

Keywords

health related quality of life; anxiety; depression; coping; fatigue

Outcome Measures

Primary Outcomes (1)

• The patient's discordance category as precisely defined here:

  Linear regression is performed for the distance walked during an initial 6 minute walking test (6MWT) and the average distance walked per day according to the pedometer intervention. The residuals from this regression will determine categories: Category 1 (pedometer high): the 25% of subjects not in category 2 and with higher values for pedometer data Category 2 (concordance): the 50% of included subjects with the smallest residuals in terms of absolute value. Category 3 (6MWT high): the 25% of subjects not in category 2 and with higher values for 6MWT data

  74 days

Secondary Outcomes (10)

• Health related quality of life questionnaire (the Medical Outcome Study - Short Form (SF36))

  Day 0

• Health related quality of life questionnaire (the Medical Outcome Study - Short Form (SF36))

  Month 3

• Hospital Anxiety and Depression (HAD) scale

  Day 0

• Hospital Anxiety and Depression (HAD) scale

  Month 3

• State-Trait Anxiety Inventory (STAI) questionnaire

  Day 0

Study Arms (1)

The study population

EXPERIMENTAL

The study population as described by eligibility criteria. Intervention: 6 minute walking test Intervention: pedometer

Device: Pedometer; Other: 6 minute walking test

Interventions

Pedometer DEVICE

A pedometer will be worn by the patient at home for days 1 to 14 and 60 to 74.

The study population

6 minute walking test OTHER

Performed according to current recommendations during routine visits (baseline and \~90 days for the purposes of this study).

The study population

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient with idiopathic pulmonary hypertension (PH), familial PH, or PH associated with various pathologies (groups I to IV of the international classification)
• New York Heart Association (NYHA) severity classes II to IV
• Incident cases, or prevalent cases with stable disease over the last 3 months
• Collection of informed written consent
• Affiliation with or beneficiary of a social security program (health insurance)

You may not qualify if:

• Patients protected or unable to give consent according to Article L1121-8 of the French Public Health Code (CSP)
• Pregnant or lactating women according to article L1121-5 of the CSP
• Vulnerable persons according to article L1121-6 of the CSP
• Simultaneous participation in any other research protocol
• It is impossible to correctly inform the patient (language barrier, etc.)
• The patient has already been included in the study

Sponsors & Collaborators

• University Hospital, Montpellier: lead

Study Sites (1)

Arnaud de Villeneuve Hospital

Montpellier, 34295, France

RECRUITING

MeSH Terms

Conditions

Hypertension, Pulmonary; Anxiety Disorders; Depression; Fatigue

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases; Mental Disorders; Behavioral Symptoms; Behavior; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Arnaud Bourdin, MD, PhD

  University Hospitals of Monpellier

  STUDY DIRECTOR

Central Study Contacts

Laurence Halimi, PhD, psychologist

CONTACT

+33.(0)4.67.33.07.45; l-halimi@chu-montpellier.fr

Study Design

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

Model Details: In this first study, the links between variables and discordance between walking test and pedometer results will be searched.

Study Record Dates

• First Submitted: January 17, 2019
• First Posted: January 18, 2019
• Study Start: March 21, 2019
• Primary Completion: June 21, 2024
• Study Completion: June 21, 2024
• Last Updated: September 8, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)