Parkinson DiseaseNCT04228887
Effects of Inspiratory Muscle Training in Patients With Parkinson's Disease
A study testing Respiratory Muscle Strength, Balance Training and Inspiratory Muscle Training in people with Parkinson Disease, run by Bezmialem Vakif University at 1 site in Turkey (Türkiye).
Trial summary
In this study investigators will examine the effects of inspiratory muscle training and balance training in patients with Parkinson's Disease Read more about this study
- Who is it for?
- Ages 60 to 85 years
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Respiratory Muscle Strength, Balance Training and Inspiratory Muscle Training
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 4 May 2018to 15 Jan 2020
- Phase
- Interventional
- 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 60 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed with Parkinson'S Disease
- Ages between 60 and 85 years
- Grades 1 to 3 according to Modified Hoehn-Yahr Scale
Who cannot join
- Lung surgery or diagnosed lung disease history
- Dementia
- Having a orthopedic disorder which may affect balance and/or mobility
- Severe dyskinesia and cognition problems
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Inspiratory Muscle Training on Postural Stability, Mobility, Activities of Daily Living, Quality of Life and Respiratory Function in Patients With Parkinson's Disease
In this study investigators will examine the effects of inspiratory muscle training and balance training in patients with Parkinson's Disease
Read the detailed description
Parkinson's Disease (PD) is the most common type of Parkinsonism and mainly due to degeneration of basal ganglions and substantia nigra occurs. Balance disorders are one of the common problems in patients with Parkinson's disease. These balance disorders; loss of postural reflexes, insufficiency in postural adjustments, rigidity in the trunk and extremities, and many disorders such as akinesia. Because of balance disorders in patients with PD, increase in addiction to daily life activities, causes physical disability. In the case of PD pulmonary problems may be the leading cause of mortality and mortality. Respiratory symptoms in these patients cause problems in weakness, swallowing, coughing, voice and speech functions. When the investigators look at the current literature, the effect of balance and respiration on Parkinson's patients is found to be seperately but their effect on each other is not sufficiently emphasized. For this reason, the researchers' aim to investigate balance and postural control in patients with Parkinson's disease and to increase the strength of respiratory muscles and to improve balance and postural control.
- Conditions
- Parkinson Disease
- Being tested
- Respiratory Muscle Strength, Balance Training, Inspiratory Muscle Training
- Keywords
- Parkinson's Disease, Inspiratory Muscle Training, Balance Training
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Respiratory Muscle StrengthDiagnostic test
Respiratory muscle strengths will evalueted with inspiratory and expiratory mouth pressure devices.
Balance TrainingDevice
Balance training will provide with Biodex® Balance Training System
Inspiratory Muscle TrainingDevice
15 minutes twice a day, 5 times a week for 8 week with Threshold IMT device
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Active comparator | The control group will be receive 45 minutes training sessions 3 times a week for 8 weeks; 2 days a week for home based balance training and 1 day for supervisory training with Bio-Dex Balance-System ®. Receives: Diagnostic Test: Respiratory Muscle Strength; Device: Balance Training |
| Training Group | Active comparator | The training group will receive inspiratory muscle training; 15 minutes sessions 5 times a week for 8 weeks in addion to balance training same as control. Receives: Diagnostic Test: Respiratory Muscle Strength; Device: Balance Training; Device: Inspiratory Muscle Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Inspiratory Muscle Strength
Maximal inspiratory pressure (MIP) is the most widely used measure of respiratory muscle strength in patients with suspected respiratory muscle weakness. It is determined by measuring upper airway pressure (mouth for outpatients and trachea for intubated or tracheostomized patients) during a maximal voluntary inspiratory effort. The measured pressure is a composite of the pressure generated by the inspiratory muscles and the elastic recoil pressure of the lungs and chest wall.
Measured: Change from baselines to final evaluation at 8th weeks
Respiratory Function- Forced Vital Capasity (FVC)
Forced vital capacity (FVC) is the total amount of air exhaled during the FEV test. FVC can also help doctors assess the progression of lung disease and evaluate the effectiveness of treatment.
Measured: Change from baselines to final evaluation at 8th weeks
Respiratory Function- Forced Expiratory Volume in 1 second
Forced expiratory volume (FEV) measures how much air a person can exhale during a forced breath. Forced expiratory volume and forced vital capacity are lung function tests that are measured during spirometry. Forced expiratory volume is the most important measurement of lung function. It is used to:
Diagnose obstructive lung diseases such as asthma and chronic obstructive pulmonary disease (COPD). A person who has asthma or COPD has a lower FEV1 result than a healthy person.
See how well medicines used to improve breathing are working. Check if lung disease is getting worse. Decreases in the FEV1 value may mean the lung disease is getting worse.
Measured: Change from baselines to final evaluation at 8th weeks
Respiratory Function- Peak Expiratory Flow
The peak expiratory flow (PEF), also called peak expiratory flow rate (PEFR), is a person's maximum speed of expiration, as measured with a peak flow meter, a small, hand-held device used to monitor a person's ability to breathe out air.
Measured: Change from baselines to final evaluation at 8th weeks
Postural Control and Balance
Biodex Balance System evaluations
Measured: Change from baselines to final evaluation at 8th weeks
Parkinson's Status- Unified Parkinson's Disease Rating Scale
The UPDRS scale refers to Unified Parkinson Disease Rating Scale, and it is a rating tool used to gauge the course of Parkinson's disease in patients. The UPDRS scale includes series of ratings for typical Parkinson's symptoms that cover all of the movement hindrances of Parkinson's disease. The UPDRS scale consists of the following five segments: 1) Mentation, Behavior, and Mood, 2) ADL, 3) Motor sections, 4) Modified Hoehn and Yahr Scale, and 5) Schwab and England ADL scale. Each answer to the scale is evaluated by a medical professional that specializes in Parkinson's disease during patient interviews.
Measured: Change from baselines to final evaluation at 8th weeks
Secondary outcomes (3)
Mobility Status- Rivermead mobility index
The Rivermead Mobility Index assesses functional mobility in gait, balance and transfers. The Rivermead Mobility Index is appropriate for a range of disabilities that include anything from being bedridden to being able to run 15 items:
14-self-reported items
1 direct observation item Items progress in difficulty Items are coded as either 0 or 1, depending on whether the patient can complete the task according to specific instructions Items receive a score of 0 for a "No" response and 1 for a "Yes" response Total scores are determined by summing the points for all items A maximum of 15 points is possible; higher scores indicate better mobility performance A score of "0" indicates an inability to perform any of the activities on the measure
Measured: Change from baselines to final evaluation at 8th weeks
Quality of Life Parameter-Nottingham Health Profile
The Nottingham Health Profile is intended for primary health care, to provide a brief indication of a patient's perceived emotional, social and physical health problems. Breakdown of questionaire
(1) Part I: 38 questions in 6 subareas, with each question assigned a weighted value; the sum of all weighted values in a given subarea adds up to 100
- energy level (EL): 3
- pain (P): 8
- emotional reaction (ER): 9
- sleep (S): 5
- social isolation (SI): 5
- physical abilities (PA): 8
Measured: Change from baselines to final evaluation at 8th weeks
Activities of Daily Living-Barthel
The Barthel Scale/Index (BI) is an ordinal scale used to measure performance in activities of daily living (ADL). Ten variables describing ADL and mobility are scored, a higher number being a reflection of greater ability to function independently following hospital discharge.Time taken and physical assistance required to perform each item are used in determining the assigned value of each item. The Barthel Index measures the degree of assistance required by an individual on 10 items of mobility and self care ADL.
Measured: Change from baselines to final evaluation at 8th weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2020
- Study start4 May 2018
- Primary completion1 Jan 2020
- Study completion15 Jan 2020
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 Bezmialem Vakif 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bezmialem Vakif University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hülya N Gürses, Prof, Study director, Bezmialem Vakif University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04228887
- Sponsor's protocol ID
- BezmialemVU27
- Status last verified
- Jun 2020
- First submitted
- 5 Aug 2019
- Last updated
- 18 Jun 2020
- 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 18 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Inspiratory Muscle Training on Postural Stability, Mobility, Activities of Daily Living, Quality of Life and Respiratory Function in Patients With Parkinson's Disease
- ClinicalTrials.gov ID
- NCT04228887
- Acronym / sponsor ID
- BezmialemVU27
- Conditions
- Parkinson Disease
- Keywords
- Parkinson's Disease, Inspiratory Muscle Training, Balance Training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Bezmialem Vakif UniversityUniversity, hospital or other
- Study start
- 4 May 2018 (actual)
- Primary completion
- 1 Jan 2020 (actual)
- Study completion
- 15 Jan 2020 (actual)
- First posted
- 14 Jan 2020 (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.
In this study investigators will examine the effects of inspiratory muscle training and balance training in patients with Parkinson's Disease
Detailed description
Parkinson's Disease (PD) is the most common type of Parkinsonism and mainly due to degeneration of basal ganglions and substantia nigra occurs. Balance disorders are one of the common problems in patients with Parkinson's disease. These balance disorders; loss of postural reflexes, insufficiency in postural adjustments, rigidity in the trunk and extremities, and many disorders such as akinesia. Because of balance disorders in patients with PD, increase in addiction to daily life activities, causes physical disability. In the case of PD pulmonary problems may be the leading cause of mortality and mortality. Respiratory symptoms in these patients cause problems in weakness, swallowing, coughing, voice and speech functions. When the investigators look at the current literature, the effect of balance and respiration on Parkinson's patients is found to be seperately but their effect on each other is not sufficiently emphasized. For this reason, the researchers' aim to investigate balance and postural control in patients with Parkinson's disease and to increase the strength of respiratory muscles and to improve balance and postural control.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | Active comparator | Diagnostic Test: Respiratory Muscle Strength, Device: Balance TrainingThe control group will be receive 45 minutes training sessions 3 times a week for 8 weeks; 2 days a week for home based balance training and 1 day for supervisory training with Bio-Dex Balance-System ®. |
| Training Group | Active comparator | Diagnostic Test: Respiratory Muscle Strength, Device: Balance Training, Device: Inspiratory Muscle TrainingThe training group will receive inspiratory muscle training; 15 minutes sessions 5 times a week for 8 weeks in addion to balance training same as control. |
Who may qualify
- Ages
- 60 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosed with Parkinson'S Disease
- Ages between 60 and 85 years
- Grades 1 to 3 according to Modified Hoehn-Yahr Scale
Key exclusion criteria (4 listed)
- Lung surgery or diagnosed lung disease history
- Dementia
- Having a orthopedic disorder which may affect balance and/or mobility
- Severe dyskinesia and cognition problems
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Respiratory Muscle StrengthRespiratory muscle strengths will evalueted with inspiratory and expiratory mouth pressure devices. | Diagnostic test | Control Group, Training Group |
| Balance TrainingBalance training will provide with Biodex® Balance Training System | Device | Control Group, Training Group |
| Inspiratory Muscle Training15 minutes twice a day, 5 times a week for 8 week with Threshold IMT device | Device | Training Group |
Primary outcome
Inspiratory Muscle Strength
Time frame: Change from baselines to final evaluation at 8th weeks
Maximal inspiratory pressure (MIP) is the most widely used measure of respiratory muscle strength in patients with suspected respiratory muscle weakness. It is determined by measuring upper airway pressure (mouth for outpatients and trachea for intubated or tracheostomized patients) during a maximal voluntary inspiratory effort. The measured pressure is a composite of the pressure generated by the inspiratory muscles and the elastic recoil pressure of the lungs and chest wall.
Respiratory Function- Forced Vital Capasity (FVC)
Time frame: Change from baselines to final evaluation at 8th weeks
Forced vital capacity (FVC) is the total amount of air exhaled during the FEV test. FVC can also help doctors assess the progression of lung disease and evaluate the effectiveness of treatment.
Respiratory Function- Forced Expiratory Volume in 1 second
Time frame: Change from baselines to final evaluation at 8th weeks
Forced expiratory volume (FEV) measures how much air a person can exhale during a forced breath. Forced expiratory volume and forced vital capacity are lung function tests that are measured during spirometry. Forced expiratory volume is the most important measurement of lung function. It is used to: Diagnose obstructive lung diseases such as asthma and chronic obstructive pulmonary disease (COPD). A person who has asthma or COPD has a lower FEV1 result than a healthy person. See how well medicines used to improve breathing are working. Check if lung disease is getting worse. Decreases in the FEV1 value may mean the lung disease is getting worse.
Respiratory Function- Peak Expiratory Flow
Time frame: Change from baselines to final evaluation at 8th weeks
The peak expiratory flow (PEF), also called peak expiratory flow rate (PEFR), is a person's maximum speed of expiration, as measured with a peak flow meter, a small, hand-held device used to monitor a person's ability to breathe out air.
Postural Control and Balance
Time frame: Change from baselines to final evaluation at 8th weeks
Biodex Balance System evaluations
Parkinson's Status- Unified Parkinson's Disease Rating Scale
Time frame: Change from baselines to final evaluation at 8th weeks
The UPDRS scale refers to Unified Parkinson Disease Rating Scale, and it is a rating tool used to gauge the course of Parkinson's disease in patients. The UPDRS scale includes series of ratings for typical Parkinson's symptoms that cover all of the movement hindrances of Parkinson's disease. The UPDRS scale consists of the following five segments: 1) Mentation, Behavior, and Mood, 2) ADL, 3) Motor sections, 4) Modified Hoehn and Yahr Scale, and 5) Schwab and England ADL scale. Each answer to the scale is evaluated by a medical professional that specializes in Parkinson's disease during patient interviews.
3 secondary outcomes
Mobility Status- Rivermead mobility index
Time frame: Change from baselines to final evaluation at 8th weeks
Quality of Life Parameter-Nottingham Health Profile
Time frame: Change from baselines to final evaluation at 8th weeks
Activities of Daily Living-Barthel
Time frame: Change from baselines to final evaluation at 8th weeks
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 18 Jun 2020.
- Individual participant dataSharing planned: No
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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.
Hülya N Gürses, Prof study director
Bezmialem Vakif University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Respiratory Muscle Strength, Balance Training and Inspiratory Muscle Training in people with Parkinson Disease, run by Bezmialem Vakif 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 3 inclusion and 4 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 18 Jun 2020. 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?
Inspiratory Muscle Strength (time frame: Change from baselines to final evaluation at 8th weeks). The study lists 6 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 18 Jun 2020.