Clinical trial NCT05816889: Investigation of Exercise Capacity, Muscle Oxygenation and Physical Activity Level in Parkinson's Patients
Official title: Investigation of Exercise Capacity, Muscle Oxygenation and Physical Activity Level in Parkinson's Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Parkinson Disease
Lead sponsor: Gazi University
Sponsor class: OTHER
First posted: 2023-04-18
Enrollment: 56
Sex: ALL
Minimum age (years): 45
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: At least 26 patients with Parkinson's diseasewill be included in patients group and 26 healthy individuals will be included in control group.

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Lower extremity exercise capacity
timeFrame: First Day
measure: Upper extremity exercise capacity
timeFrame: Second Day
measure: Muscle Oxygenation
timeFrame: First and Second Day
Secondary outcomes:
measure: Respiratory muscle strength
timeFrame: First day
measure: Respiratory muscle endurance
timeFrame: Second Day
measure: Pulmonary function (Forced vital capacity (FVC)
timeFrame: First Day
measure: Pulmonary function (Forced expiratory volume in the first second (FEV1)
timeFrame: First Day
measure: Pulmonary function (FEV1 / FVC)
timeFrame: First Day
measure: Pulmonary function (Flow rate 25-75% of forced expiratory volume (FEF 25-75%))
timeFrame: First Day
measure: Pulmonary function (Peak flow rate (PEF))
timeFrame: First Day
measure: Muscle Strength
timeFrame: First Day
measure: Physical activity (Total energy expenditure)
timeFrame: Second Day
measure: Physical activity (Active energy expenditure (joule / day)
timeFrame: Second Day
measure: Physical activity (Physical activity time (min / day)
timeFrame: Second Day
measure: Physical activity (Average metabolic equivalent (MET / day)
timeFrame: Second Day
measure: Physical activity (Number of steps (steps / day)
timeFrame: Second Day
measure: Physical activity (Time spent lying down (min / day) days)
timeFrame: Second Day
measure: Physical activity (Sleep time (min / day)
timeFrame: Second Day
measure: Fatigue
timeFrame: Second Day
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Gazi University Faculty of Health Sciences Department of Physiotherapy and Rehabilitation, Cardiopulmonary Rehabilitation Unit
state: Çankaya
Study officials:
affiliation: Gazi University
name: Ayşenur GÜVENİR, Pt.
role: STUDY_CHAIR
affiliation: Gazi University
name: Meral BOŞNAK GÜÇLÜ, Prof. Dr.
role: STUDY_DIRECTOR
affiliation: Gazi University
name: Ece BAYTOK, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Gazi University
name: Betül YOLERİ, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Gazi University
name: Ayşe BORA TOKÇAER, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References: