NCT07799675

Brief Summary

Context: Pulmonary arterial hypertension (PAH) causes severe exercise intolerance and reduced quality of life, while access to supervised rehabilitation remains limited. Objective: Evaluate the safety, feasibility, and clinical effects of an 8-week structured home-based telerehabilitation program in stable PAH patients. Methods: A multicenter, prospective, single-arm study including 34 adults with Group 1 PAH (WHO functional class II-III) performing three weekly exercise sessions via a digital platform. Outcomes: The primary endpoint is peak oxygen consumption (VO₂peak) via cardiopulmonary exercise testing, alongside 6-minute walk distance, quality of life questionnaires, inflammatory biomarkers, and safety tracking.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at P25-P50 for not_applicable

Timeline
34mo left

Started Aug 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress3%
Aug 2026Jul 2029

First Submitted

Initial submission to the registry

August 13, 2026

Completed
17 days until next milestone

Study Start

First participant enrolled

August 30, 2026

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 2, 2026

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2029

Last Updated

September 2, 2026

Status Verified

August 1, 2026

Enrollment Period

2.8 years

First QC Date

August 13, 2026

Last Update Submit

August 28, 2026

Conditions

Pulmonary Arterial Hypertension (PAH)

Keywords

TelerehabilitationPulmonary rehabilitationPulmonary arterial hypertensionCardiopulmonary exercise testingVentilatory efficiency

Outcome Measures

Primary Outcomes (1)

  • Functional capacity determined by peak O2 consumption (VO2peak)

    Evaluation of the intervention's efficacy through the increase in peak oxygen consumption during cardiopulmonary exercise testing (CPET/PECP).

    Comparison between baseline and the value obtained after 8 weeks of intervention.

Secondary Outcomes (11)

  • 6-Minute Walk Distance (6MWD)

    Baseline and 8 weeks post-intervention.

  • Inflammatory Analytes (Chemokines and Interleukins)

    Baseline and 8 weeks post-intervention.

  • Safety and Adverse Events During Exercise

    Throughout the 8-week intervention period.

  • Maximal Minute Ventilation During Cardiopulmonary Exercise Testing (CPET)

    Baseline and 8 weeks post-intervention.

  • Oxygen Desaturation During Cardiopulmonary Exercise Testing (CPET)

    Baseline and 8 weeks post-intervention.

  • +6 more secondary outcomes

Study Arms (1)

Telerehabilitation Group

EXPERIMENTAL

Participants receiving an 8-week home-based telerehabilitation program combining three weekly sessions (one live-supervised via videoconference and two independent sessions using pre-recorded modules) focusing on respiratory physiotherapy, inspiratory muscle training, strength, coordination, and aerobic walking.

Other: Home-based telerehabilitation program

Interventions

Home-based telerehabilitation programOTHER

An 8-week home-based telerehabilitation program delivered via a mobile application, consisting of three weekly 60-minute sessions combining respiratory physiotherapy, inspiratory muscle training, strength exercises, coordination, aerobic walking, and stretching. One session is live-supervised via videoconference and two are completed independently using pre-recorded modules.

Telerehabilitation Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Confirmed diagnosis of stable pulmonary arterial hypertension (PAH).
  • Age 18 years or older.
  • Ability to use a smartphone or mobile application for the telerehabilitation program.
  • Signed informed consent.

You may not qualify if:

  • Acute cardiorespiratory instability or medical contraindication to physical exercise.
  • Cognitive impairment or psychiatric disorders preventing comprehension or use of the telerehabilitation program.
  • Simultaneous participation in another interventional clinical trial.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

FIMABIS

Málaga, Málaga, 29007, Spain

Location

MeSH Terms

Conditions

Pulmonary Arterial Hypertension

Condition Hierarchy (Ancestors)

Hypertension, PulmonaryLung DiseasesRespiratory Tract Diseases

Central Study Contacts

FIMABIS

CONTACT

+34 951030435investigacion.independiente@ibima.eu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: A multicenter, prospective, single-arm interventional study with a pre-post design, evaluating an 8-week home-based telerehabilitation program in patients with stable pulmonary arterial hypertension (PAH).
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 13, 2026

First Posted

September 2, 2026

Study Start

August 30, 2026

Primary Completion (Estimated)

July 1, 2029

Study Completion (Estimated)

July 1, 2029

Last Updated

September 2, 2026

Record last verified: 2026-08

Locations

ES(1)