Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
50 participants
INTERVENTIONAL
2024-02-01
2026-02-01
Brief Summary
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The primary questions driving our study are:
* Does the Otago Exercise Program contribute to an increase in functional capacity?
* Does the Otago Exercise Program have positive effects on blood lactate levels, dyspnea, fatigue, peripheral muscle strength, functional mobility, balance performance, quality of life, sleep status, and comorbidities?
The study participants will be randomly allocated into two groups (n = 50) using a randomized controlled design. The training group (n = 25) will undergo the Otago exercise program, supervised by a physiotherapist, conducted three days a week within a hospital setting for an 8-week intervention period. Following the initial assessment, a patient education session will be administered for the control group (n = 25) and all participants, providing information on disease pathophysiology and the benefits of physical activity. Evaluations will be conducted at baseline and post the 8-week intervention period.
Our research project is designed to investigate the effectiveness of the supervised OEP in adults with CHD associated with PAH. Researchers will compare the training and control groups to determine the effects on functional capacity, blood lactate levels, dyspnea, fatigue, peripheral muscle strength, functional mobility, balance performance, quality of life, sleep status, and comorbidities.
Detailed Description
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One of the significant symptoms observed in patients with PH is muscle fatigue. In these individuals, adenosine triphosphate is anaerobically produced at lower workloads, leading to early lactic acidosis (PubMed ID: 7856531, 11468205). These changes occur in peripheral muscles may cause to exercise limitation (PubMed ID: 27192047). Elevated lactate levels are associated with anaerobic exercise, this may potentially induced by high pulmonary artery pressure during exercise or deconditioning (PubMed ID: 30464443). Blood lactate concentration stands out as one of the frequently assessed parameters in both clinical exercise testing and performance evaluations of athletes (PubMed ID:19885119). The decrease in physical function has been demonstrated to correlate with a decline in emotional well-being and overall quality of life (PubMed ID: 33660435). Furthermore, a study revealed that maximal isometric forearm muscle strength, assessed with a handgrip in PAH patients, was significantly lower than in their healthy counterparts (PubMed ID: 17689235). Another study comparing PAH patients with healthy individuals reported preserved static balance performance but noted a decrease in dynamic balance performance and balance confidence (PubMed ID: 29251653). In a study conducted by Blok et al., utilizing the Short-form 36 Questionnaire to assess quality of life, it was underscored that the decrease in quality of life serves as a determinant of late-term mortality in patients with CHD-related PAH (PubMed ID: 25911012).
In the guidelines published by the European Society of Cardiology, emphasis is placed on the importance of regular exercise for adults with CHD and CHD associated with PAH. The guidelines encourage patients to engage in regular exercise, receive personalized exercise prescriptions, and maintain an active lifestyle. Structured regular exercise is deemed a safe and effective treatment for most patients with CHD (PubMed ID: 32860412, 32860028). ). In the literature, exercise training programs have been implemented for adults with CHD associated with PAH, both in home- and hospital-based settings, with or without supervision (PubMed ID: 23041100, 20136857). There are studies in the literature have explored the effects of aerobic and resistance training, as well as respiratory muscle training (PubMed ID: 23041100, 19604588, 20136857).
The Otago Exercise Program (OEP) is an evidence-based multimodal exercise regimen developed by Campbell and the Otago Medical School of New Zealand in 1997 (PubMed ID: 9366737). Widely utilized during rehabilitation and the postoperative recovery period, the OEP has been studied in various conditions such as osteoarthritis, rheumatoid arthritis, knee prosthesis postoperative rehabilitation, Parkinson's and Alzheimer's disease, stroke, visual impairment, depression, dementia, and cognitive impairment. Recognized as a safe protocol, it is predominantly applied in the literature as a home exercise program for the geriatric population residing in the community. Moreover, recent studies have adapted it to Kinect technologies, presenting virtual exercises, and implemented it as a telehealth service with a home-based exercise program during the Covid-19 pandemic period (PubMed ID: 31118594, 34289524, 19607686, 20458104, 33225343, 28827207, 29958232, 36339194).
Physical activity recommendations for adults with CHD associated with PAH often advise against vigorous intensity exercise in numerous guidelines. The Otago Exercise Program, chosen as an evidence-based multimodal exercise regimen to establish a safe exercise prescription, aligns with literature recommendations. This upcoming study, focusing in adults with CHD associated with PAH a population known for low exercise capacity with recommendations for further research aims to formulate exercise training strategies beneficial for patients.
Our study will be the first investigation examining the effects of the Otago Exercise Program implemented under physiotherapist supervision. With this study to be conducted in adults with congenital heart disease associated pulmonary arterial hypertension, who are reported to have low exercise capacity and further research is recommended, the aim is to develop exercise training strategies that will benefit patients.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Training Group
The training group will undergo the Otago Exercise Program (OEP) in a hospital setting, supervised by a physiotherapist, with sessions lasting 60 minutes each, three days a week for a duration of 8 weeks.
Following the initial assessment, a patient education session will be conducted to provide information about the pathophysiology of the disease and the benefits of physical activity.
Training
A protocol has been established for the progression of the strengthening and balance training components of the Otago Exercise Program, increasing every two weeks in a four-stage manner. The exercise intensity will be gradually increased based on patient tolerance, ensuring that the perceived difficulty level remains in the range of 4-6 on the Borg dyspnea scale throughout the 8-week period. Supervised walking training is planned to be conducted on a treadmill to ensure standardization. The initial treadmill walking speed for patients will be determined based on the submaximal walking speed in the 6-minute walking test. The progression of the walking program will be carried out every two weeks, similar to the other exercise components of the program, with a 10% increase in walking speed each time.
Control Group
Any intervention will not be performed. After the initial assessment, a patient education session will be conducted to provide information on the pathophysiology of the disease and the benefits of physical activity.
No interventions assigned to this group
Interventions
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Training
A protocol has been established for the progression of the strengthening and balance training components of the Otago Exercise Program, increasing every two weeks in a four-stage manner. The exercise intensity will be gradually increased based on patient tolerance, ensuring that the perceived difficulty level remains in the range of 4-6 on the Borg dyspnea scale throughout the 8-week period. Supervised walking training is planned to be conducted on a treadmill to ensure standardization. The initial treadmill walking speed for patients will be determined based on the submaximal walking speed in the 6-minute walking test. The progression of the walking program will be carried out every two weeks, similar to the other exercise components of the program, with a 10% increase in walking speed each time.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Istanbul University - Cerrahpasa
OTHER
Responsible Party
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Cansu Varol
Principal Investigator, Physiotherapist MSc
Principal Investigators
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Rengin Demir, Prof
Role: STUDY_DIRECTOR
Istanbul University - Cerrahpasa (IUC) Cardiology Institute
Mehmet Serdar Kucukoglu, Prof
Role: STUDY_CHAIR
Istanbul University - Cerrahpasa (IUC) Cardiology Institute
Locations
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Istanbul University - Cerrahpasa (IUC) Cardiology Institute
Istanbul, Fatih, Turkey (Türkiye)
Countries
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Central Contacts
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Facility Contacts
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Cansu Varol, MSc
Role: primary
References
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Other Identifiers
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IUC-FTR-CV-01
Identifier Type: -
Identifier Source: org_study_id