Urban-training Intervention in Pulmonary Hypertension (UTHAP)

NCT05523557 | Recruiting

• 1 other identifier: UrbanTrainHAP
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

Pulmonary rehabilitation is effective in the treatment of pulmonary hypertension (PH). However, the beneficial effects of such intervention have been seen to disappear over time in other chronic diseases. The objective of the project is to evaluate the efficacy of an urban exercise program after a rehabilitation program and to identify possible determinants of sustainability of the effect, both in patients and in a murine experimental model. Methodology: 1) Study in humans: randomized study (urban training) in 80 patients with PH. The main variable is the improvement in physical activity measured by accelerometry at 12 months. Improvements in bioimpedance and aerobic capacity will be analysed as secondary variables, as well as possible determinants of vascular function that guarantee the sustainability of the effect (pulse wave velocity, endothelial function, metabolic profile and other plasma biomarkers), and all of them will be correlated with the evolution of the disease (admission due to clinical deterioration). 2) Studies in a murine experimental model: Mice with pulmonary hypertension induced by the administration of SU5416 (sugen) and exposure to hypoxia for 3 weeks will be studied after a three-week rehabilitation program. Half of them will exercise 1-2 days a week for 4 more weeks. At the end of the program, the right ventricular pressure will be measured and subsequently the animals will be sacrificed. Morphometric studies will be performed on lung, cardiac and muscular tissue. Vascular endothelial function and autophagy will be also measured. The differences in these variables between the different experimental groups will be analysed.

Conditions

Pulmonary Hypertension

Outcome Measures

Primary Outcomes (2)

• Change in Moderate to Vigorous Physical Activity (MVPA)

  Total time in minutes spent in moderate- to-vigorous physical activity (MVPA) as measured by accelerometer

  Baseline and after one-year of follow-up

• Change in Peak oxygen consumption (VO2peak)

  VO2peak measured through of cardiopulmonary exercise test (CPET). Adjusted by anthropometrics measures and compared with reference values.

  Baseline and after one-year of follow-up

Secondary Outcomes (1)

• Change in steps/day

  Baseline and after one-year of follow-up

Study Arms (2)

Urban Training Group

EXPERIMENTAL

The PA will consist of the following components: motivational interview, exercise following a dossier containing various maps of Urban Training walking trails (at least 30 minutes per day/5 days per week) and use of a Fitbit Inspire (FitBit, San Francisco) and motivational follow-up visit, in group, once per month during the follow-up period.

Behavioral: Urban Training

Control Group

NO INTERVENTION

The intervention will consist of a general recommendation to perform regular physical activity .

Interventions

Urban Training BEHAVIORAL

1\) one-to-one motivational interview for a maximum of 1h; 2) exercise following a dossier containing various maps of Urban Training walking trails, previously used in patients with COPD with a recommendation of doing a minimum of 1 circuit/day; or in case of living faraway from Urban Training walking trails, the instructions will be to walk at least 30 minutes per day ⩾5 days per week, at a pace reaching a dyspnoea Borg scale score of 4 -6; 3) a FitBit Inspire (FitBit, San Francisco, United States) to obtain direct feedback on the step count and intensity of PA; and 4) a motivational follow-up visit, in group, once per month during the follow-up period.

Urban Training Group

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18 years;
• New York Health Association (NYHA) II-III functional class;
• PAH or CTEPH diagnosed by right heart catheterization, evidencing: mean pulmonary arterial pressure (PAPm) ≥25 mmHg; pulmonary wedge pressure (PCWP) ≤15 mmHg; and pulmonary vascular resistance (PVR) ≥240 din/s/cm5 or 3 woods unit (WU);
• Patients with optimized PH targeted treatment, including intensified diuretic treatment and who have remained stable for at least 2 months before entering the study (no changes in medical treatment are expected throughout the 12-week study period);
• Patients who already finished a 3-months rehabilitation program;
• Be able to understand and be willing to sign the informed consent form.

You may not qualify if:

• Patients with other forms of PH (groups 2, 3 or 5);
• Pregnancy;
• Patients with signs of right heart decompensation;
• Inability to exercise on a cycle ergometer or walking;
• Acute infection or fever;
• Any change in the treatment of the disease in the last 2 months;
• Acute ischemic heart disease, unstable angina pectoris, exercise-induced ventricular arrhythmias, decompensated heart failure;
• History or suspicion of inability to cooperate properly in the study.

Sponsors & Collaborators

• Hospital Clinic of Barcelona: lead

Study Sites (1)

Hospital Clínic

Barcelona, 08036, Spain

RECRUITING

MeSH Terms

Conditions

Hypertension, Pulmonary

Condition Hierarchy (Ancestors)

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

Study Officials

• Isabel Blanco, MD, PhD

  Hospital Clinic of Barcelona

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Isabel Blanco, MD, PhD

CONTACT

+932275540; iblanco2@clinic.cat

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 16, 2022
• First Posted: August 31, 2022
• Study Start: February 1, 2023
• Primary Completion: July 31, 2025
• Study Completion: December 31, 2025
• Last Updated: April 23, 2024

Record last verified: 2024-04

Locations

ES (1)