Parkinson DiseaseNCT05816889
Investigation of Exercise Capacity, Muscle Oxygenation and Physical Activity Level in Parkinson's Patients
An observational study of Parkinson Disease, run by Gazi University at 1 site in Turkey (Türkiye).
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… Read more about this study
- Who is it for?
- Ages 45 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Parkinson Disease
- How many people
- 56 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2023to 30 Jul 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Gazi University Faculty of Health Sciences Department of Physiotherapy and Rehabilitation, Cardiopulmonary Rehabilitation Unit
Ankara, Çankaya, 06490
About this study
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.
Read the 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
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: First and Second Day
Secondary outcomes (16)
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.
Measured: First day
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.
Measured: Second Day
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.
Measured: First Day
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.
Measured: First Day
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.
Measured: First Day
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.
Measured: First Day
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.
Measured: First Day
Muscle Strength
Peripheral muscle strength will be evaluated with a dynamometer.
Measured: First Day
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.
Measured: Second Day
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.
Measured: Second Day
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.
Measured: Second Day
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.
Measured: Second Day
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.
Measured: Second Day
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.
Measured: Second Day
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.
Measured: Second Day
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.
Measured: Second Day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2023
- Study start1 Apr 2023
- Primary completion20 May 2024
- Study completion30 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by Gazi UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Meral Boşnak Güçlü, Gazi University
- Investigators
- Ayşenur GÜVENİR, Pt., Study chair, Gazi UniversityMeral BOŞNAK GÜÇLÜ, Prof. Dr., Study director, Gazi UniversityEce BAYTOK, MSc, Principal investigator, Gazi UniversityBetül YOLERİ, MSc, Principal investigator, Gazi UniversityAyşe BORA TOKÇAER, Prof. Dr., Principal investigator, Gazi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05816889
- Sponsor's protocol ID
- Gazi University 35
- Status last verified
- Aug 2026
- First submitted
- 4 Apr 2023
- Last updated
- 4 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Exercise Capacity, Muscle Oxygenation and Physical Activity Level in Parkinson's Patients
- ClinicalTrials.gov ID
- NCT05816889
- Acronym / sponsor ID
- Gazi University 35
- Conditions
- Parkinson Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Gazi UniversityUniversity, hospital or other
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- 20 May 2024 (actual)
- Study completion
- 30 Jul 2024 (actual)
- First posted
- 18 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 45 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
16 secondary outcomes
Respiratory muscle strength
Time frame: First day
Respiratory muscle endurance
Time frame: Second Day
Pulmonary function (Forced vital capacity (FVC)
Time frame: First Day
Pulmonary function (Forced expiratory volume in the first second (FEV1)
Time frame: First Day
Pulmonary function (FEV1 / FVC)
Time frame: First Day
Pulmonary function (Flow rate 25-75% of forced expiratory volume (FEF 25-75%))
Time frame: First Day
Pulmonary function (Peak flow rate (PEF))
Time frame: First Day
Muscle Strength
Time frame: First Day
Physical activity (Total energy expenditure)
Time frame: Second Day
Physical activity (Active energy expenditure (joule / day)
Time frame: Second Day
Physical activity (Physical activity time (min / day)
Time frame: Second Day
Physical activity (Average metabolic equivalent (MET / day)
Time frame: Second Day
Physical activity (Number of steps (steps / day)
Time frame: Second Day
Physical activity (Time spent lying down (min / day) days)
Time frame: Second Day
Physical activity (Sleep time (min / day)
Time frame: Second Day
Fatigue
Time frame: Second Day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2026.
- Individual participant dataSharing planned: No
Related trials for Parkinson Disease
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
Enrolling by invitationObservational study
Early Molecular Biomarkers for Differentiating Parkinsonian Syndromes
PARKINSON DISEASE (Disorder), Atypical Parkinsonism
RecruitingPhase 3
A Clinical Study of Sacituzumab Tirumotecan (MK-2870) in Combination With Pembrolizumab (MK-3475) as First-line Maintenance Treatment of Cervical Cancer (MK-2870-036/TroFuse-036/GOG-3123/ENGOT-cx22)
Cervical Cancer
Active, not recruitingPhase 1/2
Clinical Safety and Efficacy of Umbilical Cord Mesenchymal Stromal Cells-derived Exosomes in Patients With Parkinson's Disease
Parkinson Disease (PD)
Active, not recruitingObservational study
Adaptive DBS to Offset STN Dysregulation During Exercise in PD
Parkinson Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ayşenur GÜVENİR, Pt. study chair
Gazi University
Meral BOŞNAK GÜÇLÜ, Prof. Dr. study director
Gazi University
Ece BAYTOK, MSc principal investigator
Gazi University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinson Disease, run by Gazi University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lower extremity exercise capacity (time frame: First Day). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2026.