NCT07648524

Brief Summary

This study aims to investigate the effect of cardiopulmonary rehabilitation on cardiorespiratory parameters and functional capacity in patients with pulmonary hypertension.

Trial Health

63
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Trial Health Score

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

Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
3mo left

Started Jun 2026

Shorter than P25 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%
Jun 2026Sep 2026

First Submitted

Initial submission to the registry

June 10, 2026

Completed
3 days until next milestone

Study Start

First participant enrolled

June 13, 2026

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 15, 2026

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 13, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 13, 2026

Last Updated

June 15, 2026

Status Verified

June 1, 2026

Enrollment Period

3 months

First QC Date

June 10, 2026

Last Update Submit

June 10, 2026

Conditions

Keywords

Pulmonary Hypertension Cardiopulmonary Rehabilitation Inspiratory Muscle Training Exercise Training Functional Capacity Pulmonary Function

Outcome Measures

Primary Outcomes (3)

  • 6-minute walk distance

    total distance walked in 6 minutes

    12 weeks

  • Maximal Oxygen Consumption

    Estimated VO2max

    12weeks

  • spirometry

    FEV1, FVC, FEV1/FVC, MVV

    12weeks

Secondary Outcomes (3)

  • Dyspnea Severity

    12weeks

  • change Pulmonary Artery Pressure

    12weeks

  • change of total score of SF-12 Questionnaire) Quality of Life

    12weeks

Study Arms (4)

group III PH with obstructive lung disease

EXPERIMENTAL

Group (A), (n =16) patients with group III PH with obstructive lung disease will receive cardiopulmonary Rehabilitation in the form of moderate-intensity interval aerobic training and inspiratory muscle training in addition to the routine medical treatment.

Behavioral: cardiopulmonary rehabilitation in the form of moderate-intensity interval aerobic trainingDevice: Inspiratory Muscle Training

group III PHT with restrictive lung disease

EXPERIMENTAL

group (B), (n =16) patients with group III PHT with restrictive lung disease will receive cardiopulmonary rehabilitation in the form of moderate-intensity interval aerobic training and inspiratory muscle training in addition to the routine medical treatment.

Behavioral: cardiopulmonary rehabilitation in the form of moderate-intensity interval aerobic trainingDevice: Inspiratory Muscle Training

control group III PH with obstructive lung disease

EXPERIMENTAL

Group (c), (n =5) patients with group III PH with obstructive lung disease will receive medical treatment only

Other: Medical treatment

control group III PHT with restrictive lung disease

EXPERIMENTAL

Group (D), (n =5) patients with group III PH with restrictive lung disease will receive medical treatment only

Other: Medical treatment

Interventions

Training will be conducted on a treadmill three times weekly for 12 weeks. Exercise intensity will progress from 30-40% to 60-70% of target heart rate. Each session will last 30 minutes and include warm-up and cool-down periods.

group III PH with obstructive lung diseasegroup III PHT with restrictive lung disease

inspiratory muscle training will be performed using a Threshold Inspiratory Muscle Trainer (Philips Respironics). Training intensity will correspond to moderate-to-severe effort (3-5 on the Modified Borg Scale).

group III PH with obstructive lung diseasegroup III PHT with restrictive lung disease

medication

control group III PH with obstructive lung diseasecontrol group III PHT with restrictive lung disease

Eligibility Criteria

Age45 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \- a)Medically stable pulmonary hypertension patients who were under optimized medical therapy. b)Pulmonary artery pressure ≥ 25 mmHg confirmed by RT side heart catheterization.
  • c)Forty two male patients with group 3 pulmonary hypertension (Chest cause) include Obstructive lung disease ( COPD and sleep apnea ) and restrictive lung disease (ILD). d)The patients' ages will range from 45 to 65 years old. e)BMI (25 - 34.9) kg/m2. f)World Health Organization (WHO) classification of functional classes II to III ( class II are patients with pulmonary hypertension who have a mild limitation of physical activity )(class III are patients with pulmonary hypertension who have a marked limitation of physical activity

You may not qualify if:

  • g)Uncontrolled systemic HTN. h)Other types of pulmonary hypertension.. i)Smoker j)Any condition of kidney failure. k)Neurological or musculoskeletal conditions that interfere with gait
  • l)Impaired vision and/or hearing.
  • m)Patients who are unable to follow verbal instructions. n)acute exacerbation condition. o)unstable angina, serious cardiac dysrhythmias on resting ECG.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Physical Therapy ,Cairo University

Giza, Egypt

Location

Study Officials

  • NESREEN GHAREEB MOHAMED EL-NAHAS, Prof PT

    faculty of P.T. Cairo University

    STUDY CHAIR
  • HEBA AHMED ALI ABDEEN, Prof

    faculty of P.T. Cairo University

    STUDY CHAIR
  • HEND ABD EL-MONAEM ABD EL-MONAEM, Lecturer of physical therapy

    faculty of P.T. Cairo University

    STUDY CHAIR
  • REEM IBRAHIM EL KORASHY, prof of pulmonology

    Cairo University

    STUDY CHAIR

Central Study Contacts

Rana Essam El Din Abd Elbar, Assistant lecturer

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 10, 2026

First Posted

June 15, 2026

Study Start

June 13, 2026

Primary Completion (Estimated)

September 13, 2026

Study Completion (Estimated)

September 13, 2026

Last Updated

June 15, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

to protect participant confidentiality

Locations