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Pulmonary Arterial HypertensionNCT06172790

The Effects of the Otago Exercise Program

A study testing Training in people with Pulmonary Arterial Hypertension and Heart Defects, Congenital, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Training
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Feb 2024to 1 Feb 2026
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 10Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

Cansu Varol, MSc contact

+905066958993

cansuvarol@hotmail.com.tr

Turkey (Türkiye)1 site

  • Istanbul University - Cerrahpasa (IUC) Cardiology Institute

    Istanbul, Fatih

    Cansu Varol, MSc, +905066958993, cansuvarol@hotmail.com.tr

    Cansu Varol, MSc

Other trials in Turkey (Türkiye)

About this study

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

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:

Read more
  • 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.

Read the detailed 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.

Being tested
Training
Keywords
Otago Exercise Program, Functional Exercise Capacity, Blood Lactate Levels, Quality of Life
Medical subject headings
Pulmonary Arterial Hypertension, Heart Defects, Congenital

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TrainingOther

    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.

Study groups in NCT06172790
Study groupRoleWhat they receive
Training GroupExperimentalThe 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.
Receives: Other: Training
Control GroupNo interventionAny 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Change from Baseline at 8 weeks

Secondary outcomes (9)

  1. 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.

    Measured: Change from Baseline at 8 weeks

  2. 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.

    Measured: Change from Baseline at 8 weeks

  3. 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.

    Measured: Change from Baseline at 8 weeks

  4. 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.

    Measured: Change from Baseline at 8 weeks

  5. 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.

    Measured: Change from Baseline at 8 weeks

  6. 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.

    Measured: Change from Baseline at 8 weeks

  7. 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.

    Measured: Change from Baseline at 8 weeks

  8. 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.

    Measured: Change from Baseline at 8 weeks

  9. 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.

    Measured: Change from Baseline at 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Dec 2023
  2. Study start1 Feb 2024 (estimated)
  3. Primary completion1 Sep 2025 (estimated)
  4. Study completion1 Feb 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Two groups: training group and control group.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06172790
Sponsor's protocol ID
IUC-FTR-CV-01
Status last verified
Dec 2023
First submitted
7 Dec 2023
Last updated
22 Dec 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Humbert M, Kovacs G, Hoeper MM, Badagliacca R, Berger RMF, Brida M, Carlsen J, Coats AJS, Escribano-Subias P, Ferrari P, Ferreira DS, Ghofrani HA, Giannakoulas G, Kiely DG, Mayer E, Meszaros G, Nagavci B, Olsson KM, Pepke-Zaba J, Quint JK, Radegran G, Simonneau G, Sitbon O, Tonia T, Toshner M, Vachiery JL, Vonk Noordegraaf A, Delcroix M, Rosenkranz S; ESC/ERS Scientific Document Group. 2022 ESC/ERS Guidelines for the diagnosis and treatment of pulmonary hypertension. Eur Heart J. 2022 Oct 11;43(38):3618-3731. doi: 10.1093/eurheartj/ehac237. No abstract available.

    PubMed 36017548

  • Simonneau G, Montani D, Celermajer DS, Denton CP, Gatzoulis MA, Krowka M, Williams PG, Souza R. Haemodynamic definitions and updated clinical classification of pulmonary hypertension. Eur Respir J. 2019 Jan 24;53(1):1801913. doi: 10.1183/13993003.01913-2018. Print 2019 Jan.

    PubMed 30545968

  • Rosenzweig EB, Krishnan U. Congenital Heart Disease-Associated Pulmonary Hypertension. Clin Chest Med. 2021 Mar;42(1):9-18. doi: 10.1016/j.ccm.2020.11.005. Epub 2021 Jan 12.

    PubMed 33541620

  • Kucukoglu SM, Kaymaz C, Alehan D, Kula S, Akcevin A, Celiker A, Cicek SM, Tokgozoglu LS, Kentli S; THALES Registry Investigators. Pulmonary arterial hypertension associated with congenital heart disease: lessons learnt from the large Turkish Nationwide Registry (THALES). Pulm Circ. 2021 Jun 18;11(3):20458940211024206. doi: 10.1177/20458940211024206. eCollection 2021 Jul-Sep.

    PubMed 34211699

  • Demir R, Kucukoglu MS. Six-minute walk test in pulmonary arterial hypertension. Anatol J Cardiol. 2015 Mar;15(3):249-54. doi: 10.5152/akd.2015.5834.

    PubMed 25880178

  • Bhatt AB, Foster E, Kuehl K, Alpert J, Brabeck S, Crumb S, Davidson WR Jr, Earing MG, Ghoshhajra BB, Karamlou T, Mital S, Ting J, Tseng ZH; American Heart Association Council on Clinical Cardiology. Congenital heart disease in the older adult: a scientific statement from the American Heart Association. Circulation. 2015 May 26;131(21):1884-931. doi: 10.1161/CIR.0000000000000204. Epub 2015 Apr 20. No abstract available.

    PubMed 25896865

  • Engelfriet PM, Duffels MG, Moller T, Boersma E, Tijssen JG, Thaulow E, Gatzoulis MA, Mulder BJ. Pulmonary arterial hypertension in adults born with a heart septal defect: the Euro Heart Survey on adult congenital heart disease. Heart. 2007 Jun;93(6):682-7. doi: 10.1136/hrt.2006.098848. Epub 2006 Dec 12.

    PubMed 17164490

  • Lowe BS, Therrien J, Ionescu-Ittu R, Pilote L, Martucci G, Marelli AJ. Diagnosis of pulmonary hypertension in the congenital heart disease adult population impact on outcomes. J Am Coll Cardiol. 2011 Jul 26;58(5):538-46. doi: 10.1016/j.jacc.2011.03.033.

    PubMed 21777753

  • Diller GP, Dimopoulos K, Okonko D, Li W, Babu-Narayan SV, Broberg CS, Johansson B, Bouzas B, Mullen MJ, Poole-Wilson PA, Francis DP, Gatzoulis MA. Exercise intolerance in adult congenital heart disease: comparative severity, correlates, and prognostic implication. Circulation. 2005 Aug 9;112(6):828-35. doi: 10.1161/CIRCULATIONAHA.104.529800. Epub 2005 Aug 1.

    PubMed 16061735

  • Tran D, Maiorana A, Ayer J, Lubans DR, Davis GM, Celermajer DS, d'Udekem Y, Cordina R. Recommendations for exercise in adolescents and adults with congenital heart disease. Prog Cardiovasc Dis. 2020 May-Jun;63(3):350-366. doi: 10.1016/j.pcad.2020.03.002. Epub 2020 Mar 19.

    PubMed 32201288

  • Becker-Grunig T, Klose H, Ehlken N, Lichtblau M, Nagel C, Fischer C, Gorenflo M, Tiede H, Schranz D, Hager A, Kaemmerer H, Miera O, Ulrich S, Speich R, Uiker S, Grunig E. Efficacy of exercise training in pulmonary arterial hypertension associated with congenital heart disease. Int J Cardiol. 2013 Sep 20;168(1):375-81. doi: 10.1016/j.ijcard.2012.09.036. Epub 2012 Oct 5.

    PubMed 23041100

  • Nootens M, Wolfkiel CJ, Chomka EV, Rich S. Understanding right and left ventricular systolic function and interactions at rest and with exercise in primary pulmonary hypertension. Am J Cardiol. 1995 Feb 15;75(5):374-7. doi: 10.1016/s0002-9149(99)80557-8.

    PubMed 7856531

  • Sun XG, Hansen JE, Oudiz RJ, Wasserman K. Exercise pathophysiology in patients with primary pulmonary hypertension. Circulation. 2001 Jul 24;104(4):429-35. doi: 10.1161/hc2901.093198.

    PubMed 11468205

  • Babu AS, Arena R, Myers J, Padmakumar R, Maiya AG, Cahalin LP, Waxman AB, Lavie CJ. Exercise intolerance in pulmonary hypertension: mechanism, evaluation and clinical implications. Expert Rev Respir Med. 2016 Sep;10(9):979-90. doi: 10.1080/17476348.2016.1191353. Epub 2016 Jun 10.

    PubMed 27192047

  • Skjorten I, Hilde JM, Melsom MN, Hisdal J, Hansteen V, Steine K, Humerfelt S. Exercise capacity in COPD patients with exercise-induced pulmonary hypertension. Int J Chron Obstruct Pulmon Dis. 2018 Oct 31;13:3599-3610. doi: 10.2147/COPD.S161175. eCollection 2018.

    PubMed 30464443

Questions about this trial

What is this clinical trial studying?

A study testing Training in people with Pulmonary Arterial Hypertension and Heart Defects, Congenital, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 22 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Cansu Varol, MSc (+905066958993, cansuvarol@hotmail.com.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The Six-Minute Walk Test (time frame: Change from Baseline at 8 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06172790, which also lists 33 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2023; AzTrials last refreshed its copy on 30 Oct 2026.

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