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

NCT ID: NCT05816889

Last Updated: 2025-04-18

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 56 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-03-01
• Study Completion Date: 2024-07-30

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.

Conditions

Parkinson Disease

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Patients

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.

No interventions assigned to this group

Healthy Controls

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.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

1. Between the ages of 45-80

2. Diagnosed with Parkinson's disease

3. Volunteer to participate in the study

1. Healthy adults aged 45-80 years

2. Volunteer to participate in the study

Exclusion Criteria

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

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.

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Gazi University

OTHER

Sponsor Role: lead

Responsible Party

Meral Boşnak Güçlü

Prof. Dr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ayşenur GÜVENİR, Pt.

Role: STUDY_CHAIR

Gazi University

Meral BOŞNAK GÜÇLÜ, Prof. Dr.

Role: STUDY_DIRECTOR

Gazi University

Ece BAYTOK, MSc

Role: PRINCIPAL_INVESTIGATOR

Gazi University

Betül YOLERİ, MSc

Role: PRINCIPAL_INVESTIGATOR

Gazi University

Ayşe BORA TOKÇAER, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

Gazi University

Locations

Gazi University Faculty of Health Sciences Department of Physiotherapy and Rehabilitation, Cardiopulmonary Rehabilitation Unit

Ankara, Çankaya, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

Gazi University 35

Identifier Type: -

Identifier Source: org_study_id