Investigation of Exercise Capacity, Muscle Oxygenation and Physical Activity Level in Parkinson's Patients

Parkinson Disease Clinical Trial

Official title:

Investigation of Exercise Capacity, Muscle Oxygenation and Physical Activity Level in Parkinson's Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05816889
• Other study ID #: Gazi University 35
• Status: Recruiting
• Start date: March 1, 2023
• Est. completion date: June 30, 2024

Study information

• Verified date: May 2024
• Source: Gazi University
• Contact: Meral BOSNAK GÜÇLÜ, Prof. Dr.
• Phone: 03122162647
• Email: meralbosnak[@]gazi.edu.tr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The primary aim of this study is to compare maximum and functional exercise capacity and muscle oxygenation during exercise test in patients with Parkinson's disease. The secondary aim is to evaluate respiratory functions, respiratory muscle strength and endurance, peripheral muscle strength, physical activity level, shortness of breath and fatigue in Parkinson's patients and compare with healthy individuals.

Description:

Parkinson's disease is the second most common neurodegenerative disease. The main motor symptoms in Parkinson's disease are tremor, rigidity, bradykinesia, and decreased postural reflexes, and respiratory problems are seen that cause mortality. Disturbances in the control of the epiglottis, laryngeal and pharyngeal muscles may cause aspiration pneumonia. The coughing or exhalation reflex requires coordinated motor activity and inadequate airway defense poses a risk for pneumonia. Upper airway obstruction may occur due to rigidity and fatigue in the thyroarytenoid muscles. It can cause a decrease in lung volumes and thus the development of restrictive respiratory function abnormality.

Pulmonary functions, exercise capacity, respiratory muscle strength and endurance, peripheral muscle strength, physical activity level and fatigue were affected in patients. The number of studies on these subjects is limited.

Mitochondrial dysfunction in Parkinson's patients has been proven in several studies. There is no study in the literature evaluating muscle oxygenation at rest and during exercise in Parkinson's patients.

The primary aim of this study is to compare maximum and functional exercise capacity and muscle oxygenation during exercise test in patients with Parkinson's disease. The secondary aim is to evaluate respiratory functions, respiratory muscle strength and endurance, peripheral muscle strength, physical activity level, shortness of breath and fatigue in Parkinson's patients and compare with healthy individuals.

The study was planned cross-sectional. Patients with Parkinson Disease referred to the Cardiopulmonary Rehabilitation Unit of Gazi University Physiotherapy and Rehabilitation Department by the physicians of the Neurology Department of Gazi University Faculty of Medicine will be included in the study. At least 26 patients with Parkinson Disease and at least 26 healthy controls of similar age and sex will be evaluated in the study. The assessments will be completed in two days.

Upper extremity exercise capacity (6 minutes Pegboard and Ring Test), muscle oxygenation ("Moxy" monitor), functional exercise capacity(6 minutes walk test), respiratory functions (spirometer), respiratory muscle strength (mouth pressure measurement), respiratory muscle endurance (incremental threshold loading test), peripheral muscle strength (dynamometer), physical activity level (multi-sensor activity monitor) and fatigue (Parkinson's Fatigue Scale) will be evaluated.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 52
• Est. completion date: June 30, 2024
• Est. primary completion date: May 20, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 45 Years to 80 Years

Eligibility

Inclusion Criteria

Inclusion Criteria for Patients:

1. Between the ages of 45-80

2. Diagnosed with Parkinson's disease

3. Volunteer to participate in the study

Inclusion Criteria for Healthy Controls:

1. Healthy adults aged 45-80 years

2. Volunteer to participate in the study

Exclusion Criteria:

Exclusion Criteria for Patients:

1. Having a neurological disease other than Parkinson's disease

2. Having a diagnosed lung disease that may affect respiratory functions

3. Having had Coronavirus disease (COVID-19)

4. Have a smoking history of at least 10 pack×years or more.

5. Those with absolute and relative contraindications to exercise tests according to the American College of Sports Medicine (ACSM)

6. Those with a Mini Mental State Rating Scale score less than 18

7. Having orthopedic, neurological or psychological problems that would limit evaluations

Exclusion Criteria for Healthy Controls:

1. Those with a Mini Mental State Rating Scale score less than 18

2. Have a smoking history of at least 10 pack years or more.

Related Conditions & MeSH terms

• Parkinson Disease

Locations

Country	Name	City	State
Turkey	Gazi University Faculty of Health Sciences Department of Physiotherapy and Rehabilitation, Cardiopulmonary Rehabilitation Unit	Ankara	Çankaya

Sponsors (1)

Lead Sponsor	Collaborator
Gazi University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Lower extremity exercise capacity	Lower extremity exercise capacity will be evaluated with six- minute walking test. The test will be performed according to the criteria of the American Thoracic Society and the European Respiratory Society.	First Day
Primary	Upper extremity exercise capacity	Upper extremity exercise capacity will be evaluated with the six-minute pegboard and ring test (6-PBRT). A pegboard with two upper and lower bars set at participants shoulder level and above the shoulder level will used. Ten rings will placed on both the lower bars. Patients will be asked to move a single ring at a time with both hands from the lower bars to the upper. The score is the total number of rings moved the six-minute period.	Second Day
Primary	Muscle Oxygenation	Muscle oxygenation assessment will be performed using the Moxy monitor (Moxy, Fortiori Design LLC, Minnesota, USA). The device will be placed on the 1/3 lower motor point of the quadriceps muscle group of the dominant leg and on the dominant arm deltoid muscle. A minimum of 3 minutes will be waited until the resting measurements and skeletal muscle oxygenation (StO2) signal stabilize. The measurements will be repeated during six minute walking test and six minute pegboard and ring test.	First and Second Day
Secondary	Respiratory muscle strength	Maximal inspiratory (MIP) and maximal expiratory (MEP) pressures expressing respiratory muscle strength will be measured with a portable mouth pressure measuring device according to American Thoracic Society and European Respiratory Society criteria.	First day
Secondary	Respiratory muscle endurance	Respiratory muscle endurance will be assessed by the POWERbreathe Wellness (POWERbreathe, Inspiratory Muscle Training (IMT) Technologies Ltd., Birmingham, UK) device and the respiratory muscle endurance test at increased threshold load. The test will be started with 20% of the maximal inspiratory pressure and the pressure will be increased to 40%, 60%, 80% and 100% every two minutes. Patients will be asked to continue breathing through the device during the test. If the individual cannot breathe 3 consecutive times, the test will be terminated by the physiotherapist. During the test, the number of breaths delivered and the maximal time reached during each 2-minute period will be recorded.The total duration of the test and the maximum pressure value at which it continues to breathe for at least 1 minute will be multiplied. The value found will be recorded as the respiratory muscle endurance value.	Second Day
Secondary	Pulmonary function (Forced vital capacity (FVC)	Pulmonary function will be evaluated using the spirometry, according to American Thoracic Society and European Respiratory Society criteria. Forced vital capacity (FVC) will be measured.	First Day
Secondary	Pulmonary function (Forced expiratory volume in the first second (FEV1)	Pulmonary function will be evaluated using the spirometry, according to American Thoracic Society and European Respiratory Society criteria. Forced expiratory volume in the first second (FEV1) will be measured.	First Day
Secondary	Pulmonary function (FEV1 / FVC)	Pulmonary function will be evaluated using the spirometry, according to American Thoracic Society and European Respiratory Society criteria. FEV1 / FVC will be measured.	First Day
Secondary	Pulmonary function (Flow rate 25-75% of forced expiratory volume (FEF 25-75%))	Pulmonary function will be evaluated using the spirometry, according to American Thoracic Society and European Respiratory Society criteria. Flow rate 25-75% of forced expiratory volume (FEF 25-75%) will be measured.	First Day
Secondary	Pulmonary function (Peak flow rate (PEF))	Pulmonary function will be evaluated using the spirometry, according to American Thoracic Society and European Respiratory Society criteria. Peak flow rate (PEF) will be measured.	First Day
Secondary	Muscle Strength	Peripheral muscle strength will be evaluated with a dynamometer.	First Day
Secondary	Physical activity (Total energy expenditure)	Physical activity will be evaluated with the Multi sensor activity monitor (SenseWear®, Inc Pittsburgh, ABD). The patient will wear the multisensor physical activity monitor over the triceps muscle of the non-dominant arm for 3 continuous days. The parameters measured over two days will be averaged and analyzed with the "SenseWear® 7.0 Software" program.	Second Day
Secondary	Physical activity (Active energy expenditure (joule / day)	Physical activity will be evaluated with the Multi sensor activity monitor (SenseWear®, Inc Pittsburgh, ABD). The patient will wear the multisensor physical activity monitor over the triceps muscle of the non-dominant arm for 3 continuous days. The parameters measured over two days will be averaged and analyzed with the "SenseWear® 7.0 Software" program.	Second Day
Secondary	Physical activity (Physical activity time (min / day)	Physical activity will be evaluated with the Multi sensor activity monitor (SenseWear®, Inc Pittsburgh, ABD). The patient will wear the multisensor physical activity monitor over the triceps muscle of the non-dominant arm for 3 continuous days. The parameters measured over two days will be averaged and analyzed with the "SenseWear® 7.0 Software" program.	Second Day
Secondary	Physical activity (Average metabolic equivalent (MET / day)	Physical activity will be evaluated with the Multi sensor activity monitor (SenseWear®, Inc Pittsburgh, ABD). The patient will wear the multisensor physical activity monitor over the triceps muscle of the non-dominant arm for 3 continuous days. The parameters measured over two days will be averaged and analyzed with the "SenseWear® 7.0 Software" program.	Second Day
Secondary	Physical activity (Number of steps (steps / day)	Physical activity will be evaluated with the Multi sensor activity monitor (SenseWear®, Inc Pittsburgh, ABD). The patient will wear the multisensor physical activity monitor over the triceps muscle of the non-dominant arm for 3 continuous days. The parameters measured over two days will be averaged and analyzed with the "SenseWear® 7.0 Software" program.	Second Day
Secondary	Physical activity (Time spent lying down (min / day) days)	Physical activity will be evaluated with the Multi sensor activity monitor (SenseWear®, Inc Pittsburgh, ABD). The patient will wear the multisensor physical activity monitor over the triceps muscle of the non-dominant arm for 3 continuous days. The parameters measured over two days will be averaged and analyzed with the "SenseWear® 7.0 Software" program.	Second Day
Secondary	Physical activity (Sleep time (min / day)	Physical activity will be evaluated with the Multi sensor activity monitor (SenseWear®, Inc Pittsburgh, ABD). The patient will wear the multisensor physical activity monitor over the triceps muscle of the non-dominant arm for 3 continuous days. The parameters measured over two days will be averaged and analyzed with the "SenseWear® 7.0 Software" program.	Second Day
Secondary	Fatigue	Fatigue will be evaluated using the Parkinson Fatigue Scale. Total score varies between 16-80. As the score increases, the severity of fatigue increases.	Second Day