Investigation of Exercise Capacity, Muscle Oxygenation and Physical Activity Level in Parkinson's Patients
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Gazi University
- Enrollment
- 56
- Locations
- 2
- Primary Endpoint
- Lower extremity exercise capacity
Study Overview
Brief 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.
Detailed 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.
Study Design
- Study Type
- Observational
- Observational Model
- Case Control
- Time Perspective
- Cross Sectional
Eligibility Criteria
- Ages
- 45 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Inclusion Criteria for Patients:
- •Between the ages of 45-80
- •Diagnosed with Parkinson's disease
- •Volunteer to participate in the study
- •Inclusion Criteria for Healthy Controls:
- •Healthy adults aged 45-80 years
- •Volunteer to participate in the study
Exclusion Criteria
- •Exclusion Criteria for Patients:
- •Having a neurological disease other than Parkinson's disease
- •Having a diagnosed lung disease that may affect respiratory functions
- •Having had Coronavirus disease (COVID-19)
- •Have a smoking history of at least 10 pack×years or more.
- •Those with absolute and relative contraindications to exercise tests according to the American College of Sports Medicine (ACSM)
- •Those with a Mini Mental State Rating Scale score less than 18
- •Having orthopedic, neurological or psychological problems that would limit evaluations
- •Exclusion Criteria for Healthy Controls:
- •Those with a Mini Mental State Rating Scale score less than 18
- •Have a smoking history of at least 10 pack years or more.
Outcomes
Primary Outcomes
Lower extremity exercise capacity
Time Frame: First Day
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.
Upper extremity exercise capacity
Time Frame: Second Day
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.
Muscle Oxygenation
Time Frame: First and Second Day
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.
Secondary Outcomes
- Respiratory muscle strength(First day)
- Physical activity (Total energy expenditure)(Second Day)
- Pulmonary function (Flow rate 25-75% of forced expiratory volume (FEF 25-75%))(First Day)
- Physical activity (Number of steps (steps / day)(Second Day)
- Physical activity (Time spent lying down (min / day) days)(Second Day)
- Physical activity (Sleep time (min / day)(Second Day)
- Pulmonary function (Forced vital capacity (FVC)(First Day)
- Pulmonary function (FEV1 / FVC)(First Day)
- Pulmonary function (Peak flow rate (PEF))(First Day)
- Physical activity (Physical activity time (min / day)(Second Day)
- Fatigue(Second Day)
- Respiratory muscle endurance(Second Day)
- Pulmonary function (Forced expiratory volume in the first second (FEV1)(First Day)
- Muscle Strength(First Day)
- Physical activity (Active energy expenditure (joule / day)(Second Day)
- Physical activity (Average metabolic equivalent (MET / day)(Second Day)
Investigators
Meral Boşnak Güçlü
Prof. Dr.
Gazi University