Examination of safety and efficacy of pulmonary rehabilitation for patients with pulmonary hypertension: Appropriate exercise prescription on pulmonary hypertension during exercise

JRCT ID: jRCT1030210240

Registered date:13/08/2021

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: pulmonary hypertension
• Date of first enrollment: 13/08/2021
• Target sample size: 21
• Study type: Interventional
• Intervention(s): For patients with PH, we start pulmonary rehabilitation, including muscle strengthening exercises, endurance traning, respiratory muscle training (POWER Breathe MEDIC, Entry Japan Inc.), respiratory gymnastics, and ADL training. Pulmonary rehabilitation program is taught to patients during their hospitalization for catheterization and continued at home as voluntary training after discharge. The frequency of outpatient respiratory rehearsal should be 1 to 4 times per month for the first 3 months, and then once per month thereafter.

Outcome(s)

• Primary Outcome: - Six-minute walking distance

Secondary Outcome

- Health-related quality of life (emPHasis-10)
- Physical activity (steps/day, activity time over 2.4 METs)
- Quadriceps muscle strength
- Respiratory muscle strength (PImax)
- Pulmonary hemodynamics during exercise (PVR, mPAP / CO slope)
- Cardiopulmonary exercise stress test (Peak VO2, VE vs. VCO2 slope, VD/VT)*.
- Number of pulmonary rehabilitation (hospital visit, home)
- Adverse events of pulmonary rehabilitaion
- Resting pulmonary hemodynamics (RHC [mPAP, PVR, CO], echocardiography [TRPG, esPAP])

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1) Patients diagnosed with pulmonary hypertension (resting mPAP of 20 mmHg or more by right heart catheterization)
2) Patients who have already been treated with vasodilators for pulmonary hypertension and have not changed their treatment for more than 3 months
3) Patients with resting mPAP < 35 mmHg and PVR not increased by more than 15% compared with the previous right heart catheterization.
4) Patients who underwent a cardiopulmonary exercise stress test during the previous right heart catheterization
5) Patients aged 20 years or older at the time of consent.
6) Patients who have received sufficient explanation for participation in the study and have given written consent of their own free will with sufficient understanding.

Exclude criteria

1) Patients with poorly controlled heart failure, heart disease, or arrhythmia
2) Patients with osteoarticular diseases or neuromuscular diseases that affect ADL
3) Patients with mental illness or cognitive decline that makes it difficult to perform the test safely and accurately

Related Information

• Primary Sponsor: Sugiura Toshihiko