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

NCT05816889 | Completed

• 1 other identifier: Gazi University 35
• Study Type: observational
• Target: 56
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson Disease

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (16)

• Respiratory muscle strength

  First day

• Respiratory muscle endurance

  Second Day

• Pulmonary function (Forced vital capacity (FVC)

  First Day

• Pulmonary function (Forced expiratory volume in the first second (FEV1)

  First Day

• Pulmonary function (FEV1 / FVC)

  First Day

Study Arms (2)

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.

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.

Eligibility Criteria

• Age: 45 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Between the ages of 45-80
• Diagnosed with Parkinson's disease
• Volunteer to participate in the study
• Healthy adults aged 45-80 years
• Volunteer to participate in the study

You may not qualify if:

• 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
• Those with a Mini Mental State Rating Scale score less than 18
• Have a smoking history of at least 10 pack years or more.

Sponsors & Collaborators

• Gazi University: lead

Study Sites (1)

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

Ankara, Çankaya, 06490, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Ayşenur GÜVENİR, Pt.

  Gazi University

  STUDY CHAIR

• Meral BOŞNAK GÜÇLÜ, Prof. Dr.

  Gazi University

  STUDY DIRECTOR

• Ece BAYTOK, MSc

  Gazi University

  PRINCIPAL INVESTIGATOR

• Betül YOLERİ, MSc

  Gazi University

  PRINCIPAL INVESTIGATOR

• Ayşe BORA TOKÇAER, Prof. Dr.

  Gazi University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr.

Study Record Dates

• First Submitted: April 4, 2023
• First Posted: April 18, 2023
• Study Start: March 1, 2023
• Primary Completion: May 20, 2024
• Study Completion: July 30, 2024
• Last Updated: April 18, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)