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Search / Trial NCT06172790

The Effects of the Otago Exercise Program

Launched by ISTANBUL UNIVERSITY - CERRAHPASA · Dec 7, 2023

Trial Information

Current as of June 26, 2025

Not yet recruiting

Keywords

Otago Exercise Program Functional Exercise Capacity Blood Lactate Levels Quality Of Life

ClinConnect Summary

This clinical trial is studying the effects of a special exercise program called the Otago Exercise Program (OEP) on adults who have pulmonary arterial hypertension (PAH) related to congenital heart disease (CHD). The main goal is to see if this exercise program can improve various aspects of health, such as how well participants can exercise, their strength, balance, and overall quality of life. Participants will be randomly divided into two groups: one group will do the OEP with a trained physiotherapist three times a week for eight weeks, while the other group will receive general information about their condition and the benefits of physical activity.

To be eligible for this study, participants need to be at least 18 years old, stable in their health, and under appropriate treatment for their PAH for at least two months. Specific health conditions, such as certain heart issues or recent surgeries, would prevent someone from joining the trial. Throughout the study, participants will have assessments before and after the 8-week exercise program to measure any changes in their health and well-being. This research aims to find out if the Otago Exercise Program can make a positive difference for those living with PAH and CHD.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Being clinically and hemodynamically stable.
  • Resting mean pulmonary artery pressure measured with left heart catheterization to be 20 mmHg or higher.
  • Being 18 years of age or older.
  • Being classified as World Health Organization-functional class II and III.
  • Being under optimized advanced medical treatment for PAH for at least 2 months before entering the study.
  • No changes in pulmonary arterial hypertension medical treatment for at least 6 months before entering the study.
  • Exclusion Criteria:
  • The coexistence of Down syndrome.
  • Group 1 PAH patients with another etiology.
  • Changes in PAH medical treatment during follow-up.
  • Acute decompensated heart failure.
  • Unstable angina pectoris.
  • Recent thoracic or abdominal surgeries.
  • Using immunosuppressive drugs due to organ or tissue transplantation.
  • Heavy neurological disorders causing autonomic dysfunction.
  • The presence of cognitive impairment preventing communication.
  • Recent syncope, fractures, osteoporosis, presence of tumors, pregnancy.

About Istanbul University Cerrahpasa

Istanbul University - Cerrahpasa is a prestigious academic institution renowned for its commitment to advancing medical research and education. With a focus on innovative clinical trials, the university harnesses cutting-edge methodologies to address pressing health challenges. Its collaborative environment fosters interdisciplinary research, enabling the development of effective therapeutic strategies and enhancing patient care. The institution's dedication to ethical standards and patient safety underscores its reputation as a leader in clinical research within the region and beyond.

Locations

Istanbul, Fatih, Turkey

Patients applied

0 patients applied

Trial Officials

Rengin Demir, Prof

Study Director

Istanbul University - Cerrahpasa (IUC) Cardiology Institute

Mehmet Serdar Kucukoglu, Prof

Study Chair

Istanbul University - Cerrahpasa (IUC) Cardiology Institute

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported