The Effects of the Otago Exercise Program

NCT06172790 | Unknown

• 1 other identifier: IUC-FTR-CV-01
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pulmonary Arterial Hypertension; Heart Defects, Congenital

Keywords

Otago Exercise Program; Functional Exercise Capacity; Blood Lactate Levels; Quality of Life

Outcome Measures

Primary Outcomes (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.

  Change from Baseline at 8 weeks

Secondary Outcomes (9)

• Duke Activity Status Index

  Change from Baseline at 8 weeks

• Blood Lactate Levels

  Change from Baseline at 8 weeks

• Modified Borg Scale

  Change from Baseline at 8 weeks

• Peripheral Muscle Strength Assessment

  Change from Baseline at 8 weeks

• 30-Second Sit-to-Stand Test

  Change from Baseline at 8 weeks

Study Arms (2)

Training Group

EXPERIMENTAL

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.

Other: Training

Control Group

NO INTERVENTION

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.

Interventions

Training OTHER

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.

Training Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Istanbul University - Cerrahpasa: lead

Study Sites (1)

Istanbul University - Cerrahpasa (IUC) Cardiology Institute

Istanbul, Fatih, Turkey (Türkiye)

Location

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MeSH Terms

Conditions

Pulmonary Arterial Hypertension; Heart Defects, Congenital

Condition Hierarchy (Ancestors)

Hypertension, Pulmonary; Lung Diseases; Respiratory Tract Diseases; Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Rengin Demir, Prof

  Istanbul University - Cerrahpasa (IUC) Cardiology Institute

  STUDY DIRECTOR

• Mehmet Serdar Kucukoglu, Prof

  Istanbul University - Cerrahpasa (IUC) Cardiology Institute

  STUDY CHAIR

Central Study Contacts

Cansu Varol, MSc

CONTACT

+905066958993; cansuvarol@hotmail.com.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Our study was conducted as single (assessor) blind.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Physiotherapist MSc

Model Details: Two groups: training group and control group.

Study Record Dates

• First Submitted: December 7, 2023
• First Posted: December 15, 2023
• Study Start: February 1, 2024
• Primary Completion: September 1, 2025
• Study Completion: February 1, 2026
• Last Updated: December 22, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)