The Effects of the Otago Exercise Program

Pulmonary Arterial Hypertension Clinical Trial

Official title:

Investigation of the Effects of the Otago Exercise Program in Adults With Pulmonary Arterial Hypertension Associated With Congenital Heart Disease

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06172790
• Other study ID #: IUC-FTR-CV-01
• Status: Not yet recruiting
• Phase: N/A
• Start date: February 1, 2024
• Est. completion date: February 1, 2026

Study information

• Verified date: December 2023
• Source: Istanbul University - Cerrahpasa (IUC)
• Contact: Cansu Varol, MSc
• Phone: +905066958993
• Email: cansuvarol[@]hotmail.com.tr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The objective of this experimental study is to conduct a comparative evaluation of the effects of a supervised Otago Exercise Program (OEP) functional exercise capacity, blood lactate levels, dyspnea, fatigue, peripheral muscle strength, functional mobility, balance performance, quality of life, sleep status, and comorbidities in adults with pulmonary arterial hypertension (PAH) associated with congenital heart disease (CHD), as compared to a control group.

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.

Description:

Pulmonary hypertension (PH) is characterized by a mean pulmonary artery pressure exceeding 20 mmHg, as measured during heart catheterization. In patients with PH, a pulmonary artery wedge pressure of <15 mmHg and a pulmonary vascular resistance of >2 Wood Units indicate the presence of pre-capillary pulmonary hypertension (PubMed ID: 36017548). The current clinical classification for pulmonary arterial hypertension (PAH) associated with congenital heart disease (CHD) comprises four subgroups: Eisenmenger syndrome, left-to-right shunts, coincidental or small defects, and postoperative/closed defects (PubMed ID: 30545968). Prognosis varies based on the type and size of the congenital heart defect, the timing of PAH development, and the response to treatment (PubMed ID:33541620). Adults with PAH associated with CHD exhibit symptoms of dyspnea, cyanosis, chest pain, syncope-presyncope, hemoptysis, decreased exercise capacity, and muscle fatigue (PubMed ID: 34211699). A reduction in exercise capacity is the primary clinical feature of PAH (PubMed ID: 25880178). Compared to other CHD patients, in adults with CHD associated with PAH experience lower exercise tolerance, more severe symptoms, and lower survival rates (PubMed ID: 25896865, 17164490, 21777753). ). The decrease in exercise capacity is linked to the risk of hospitalization or mortality, and exercise intolerance is frequent even in asymptomatic cases (PubMed ID: 16061735). While the benefits of physical activity and exercise in managing chronic diseases are well-established, the therapeutic role of exercise for the CHD-associated PAH population has not been sufficiently investigated (PubMed ID: 32201288). The impact of advanced medical treatment on exercise capacity and quality of life seems to be very limited for this population. Therefore, it is emphasized that additional treatment approaches aimed at improving exercise capacity and quality of life may be necessary for this patient group (PubMed ID: 23041100).

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: February 1, 2026
• Est. primary completion date: September 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Congenital Abnormalities
• Familial Primary Pulmonary Hypertension
• Heart Defects, Congenital
• Hypertension
• Pulmonary Arterial Hypertension

Intervention

Other:
• 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.

Locations

Country	Name	City	State
Turkey	Istanbul University - Cerrahpasa (IUC) Cardiology Institute	Istanbul	Fatih

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul University - Cerrahpasa (IUC)

Country where clinical trial is conducted

Turkey, 

References & Publications (33)

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* Note: There are 33 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Six-Minute Walk Test	Distance walked in six minutes will be recorded. Test will be conducted according to the guideline of American Thoracic Society. Functional exercise capacity will be evaluated with the six-minute walk test. Patients will be walked in a 30-meter-long corridor for 6 minutes and the maximum walking distance will be measured. Before and after the test, heart rate, blood pressure and O2 saturation will be measured with pulse oximetry, and dyspnea and fatigue levels will be determined according to the Modified Borg scale.	Change from Baseline at 8 weeks
Secondary	Duke Activity Status Index	The Duke Activity Status Index includes self care, ambulation, household tasks, sexual function and recreational activities. Maximal oxygen consumption values for the cases will be obtained using the formula based on the Duke Activity Status Index result. As a result of scoring, a total score ranging from 0 to 58.2 is obtained. Higher scores indicate higher functional capacity.	Change from Baseline at 8 weeks
Secondary	Blood Lactate Levels	Before, immediately after, and 5 minutes after the six-minute walk test, three measurements will be taken using a portable lactate measurement device.	Change from Baseline at 8 weeks
Secondary	Modified Borg Scale	The Modified Borg Scale is used to determine the level of breathlessness and fatigue at rest and during exertion. Before and after the six-minute walk test, the levels of dyspnea and fatigue will be evaluated using 'Modified Borg Dyspnea' and 'Modified Borg Fatigue.' It consists of 10 items that define the intensity of breathlessness and fatigue on a scale ranging from 0 (none) to 10 (very severe). A rating of "0" means you feel no breathlessness and fatigue. From 0 to 10, symptoms worsen.	Change from Baseline at 8 weeks
Secondary	Peripheral Muscle Strength Assessment	Hand grip strength will be assessed with a hydraulic hand dynamometer while the patient is in a seated position, following the guidelines of the American Society of Hand Therapists. The highest scores within the measurements will be recorded as hand grip strength in kilograms.	Change from Baseline at 8 weeks
Secondary	30-Second Sit-to-Stand Test	Functional mobility and balance performances are assessed. The patient will be instructed to sit in the middle of a standard chair with feet touching the ground and arms crossed on the chest. The test begins with the 'start' command, and the patient is asked to perform as many full stands as possible within a 30-second period. The number of full stands completed by the patient during the 30-second interval is recorded.	Change from Baseline at 8 weeks
Secondary	Timed Up and Go Test	A standard chair is used for the test. Initially, the patient is asked to sit on the chair with support. Subsequently, the patient is instructed to stand up, walk with regular steps over a predetermined distance of 3 meters, turn around at the end of the 3 meters, and return to sit back on the chair. The time taken by the patient to complete the test is recorded. A shorter duration indicates better performance. Functional mobility and balance performances are assessed.	Change from Baseline at 8 weeks
Secondary	Four-Stage Balance Test	The balance is assessed for 10 seconds in four different positions and the total time is summed. Stages are passed if the patient can hold the stance for 10 seconds. An inability to maintain tandem stance for 10 seconds with eyes open is associated with higher risk of falling. For scoring purposes, a score of 1 (success) is recorded for each test position if the participant was able to complete the task for 10 seconds; If the task is not completed within 10 seconds, a score of 0 (failure) is recorded. Scores (range: 0-4) are sum across the four test conditions, with higher values indicating better balance.	Change from Baseline at 8 weeks
Secondary	The emPHasis-10 Questionnaire	The emPHasis-10 questionnaire will be used to measure quality of life. The emPHasis-10, as a single-dimensional, easily applicable, short questionnaire, consists of 10 simple questions addressing concerns related to fatigue, dyspnea, lack of energy, social limitations, and the impact on family members. Each question is scored on a Likert scale of 0-5. The total score ranges from 0 to 50, with a higher score indicating a deterioration in quality of life due to pulmonary hypertension symptoms.	Change from Baseline at 8 weeks
Secondary	Pittsburgh Sleep Quality Index	The Pittsburgh Sleep Quality Index is a 10-item self-report questionnaire that is designed to measure sleep quality in clinical populations, and assess usual sleep habits during the past one-month. This scale generates seven "component" scores: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. Items 1-4 inquire about the amount of sleep and responses are recorded in free-text boxes. Items 5-10 inquire about specific sleep behaviors and quality, which are rated on 4-point scale. Finally, the scores for each component are summed to get a total score, also termed the global score (range: 0 to 21). A global sum of "5"or greater indicates a "poor" sleeper.	Change from Baseline at 8 weeks