Effects of Inspiratory Muscle Training in Patients With Parkinson's Disease

Parkinson Disease Clinical Trial

Official title:

Investigation of the Effects of Inspiratory Muscle Training on Oxygen Consumption, Muscle Oxygen and Physical Activity Level in Patients With Parkinson's Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06017336
• Other study ID #: Gazi University 78
• Status: Recruiting
• Phase: N/A
• Start date: August 15, 2023
• Est. completion date: February 15, 2025

Study information

• Verified date: December 2023
• Source: Gazi University
• Contact: Meral BOSNAK GÜÇLÜ, Prof. Dr.
• Phone: +903122162647
• Email: meralbosnak[@]gazi.edu.tr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Parkinson's patients usually have a significant decrease in respiratory muscle strength and respiratory function, which may increase in proportion to the severity of the disease. In addition, peripheral muscles may become dysfunctional by the rigidity caused by the disease. This reduces exercise capacity and may lead to a decrease in oxygen consumption. Respiratory muscle training has increased respiratory muscle strength in people with Parkinson's Disease (PD). However, its effectiveness on other functional outcomes has not been determined and studied.

Description:

Parkinson's disease is the second most common neurodegenerative disease. The main motor symptoms seen in Parkinson's disease are tremors, rigidity, bradykinesia, and decreased postural reflexes. In addition, respiratory problems that lead to death may often be seen. This is caused by dysfunction in the respiratory muscles and postural abnormalities, as well as changes in upper airway muscle activation and coordination. The coughing or exhaling reflex requires coordinated motor activity, and inadequate airway defence puts patients at risk for pneumonia. Aspiration into the lower airways results in a distinct series of events, including coughing and swallowing as the first attempt to clear the airway. Aspiration pneumonia is seen in Parkinson's patients because the coordination of these processes is unsuccessful, and the cough force is insufficient. Upper airway obstruction may occur due to stiffness and fatigue in the thyroarytenoid muscles. In addition, pathological processes such as bradykinesia, coordination disorder, and inspiratory muscle weakness can cause kyphoscoliosis and a decrease in lung volumes, resulting in restrictive respiratory function abnormality due to decreased chest wall compliance due to rigidity. In Parkinson's disease, respiratory muscles, like other skeletal muscles, are affected by stiffness, and weakness of the respiratory muscles makes it difficult to overcome this stiffness, resulting in reduced lung volumes. It is thought that this condition may develop due to the decrease in elastic retraction of the chest wall. In addition, mitochondrial dysfunction due to the pathogenesis of the disease also leads to deterioration in muscle oxygen metabolism. In individuals with reduced muscle oxygen, exercise tolerance and muscle strength decrease. Autonomic dysfunction of varying severity is observed in almost all patients, depending on the degeneration of spinal autonomic neurons or the side effects of dopaminergic that are part of pharmacological treatment. Patients may experience increased fatigue as well as autonomic dysfunction. Inadequate oxygen delivery and utilization to the muscles may limit skeletal muscle oxygenation and lead to increased use of anaerobic systems, resulting in fatigue. This causes a decrease in the level of physical activity and reduces the quality of life.

However, studies investigating the effects of inspiratory muscle training in Parkinson's patients are insufficient. The aim of this study is to investigate the effects of inspiratory muscle training on maximum and functional exercise capacity, muscle oxygen, peripheral and respiratory muscle strength, respiratory muscle endurance, respiratory function, dyspnea, fatigue, cough strength, autonomic dysfunction, physical activity level and quality of life in patients with Parkinson's disease.For this purpose, our study was planned as a randomized, controlled, three-blind (investigators, patient, and analyzer) prospective study. According to the block randomization result, at least 20 patients with a diagnosis of Parkinson's Disease will be included in the training and control groups.

Patients in the inspiratory muscle training group will be given inspiratory muscle strength training with the Powerbreathe device at 50% of the maximal inspiratory pressure for a total of 8 weeks, for a total of 30 minutes a day. Thoracic expansion exercises will be given to the control group as a home program for 8 weeks. All assessments will be completed in two days, before and after eight weeks of training.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: February 15, 2025
• Est. primary completion date: January 15, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years to 80 Years

Eligibility

Inclusion Criteria:

1. Between the ages of 45-80,

2. Follow-up with a diagnosis of Parkinson's disease for more than six months

3. Stages I-III according to the modified Hoehn and Yahr scale

4. Parkinson's patients with independent walking capacity will be included.

Exclusion Criteria:

1. Having a neurological disease other than Parkinson's disease

2. Patients with a diagnosed lung disease that may affect respiratory functions

3. At least 10 pack years or more of smoking history

4. According to the American Association of Sports Medicine (ACSM) with absolute and relative contraindications to exercise tests

5. Those with a Mini-Mental State Rating Scale score of less than 18

6. Patients with additional cardiac orthopaedic and psychological problems that limit the evaluation will be excluded from the study.

Related Conditions & MeSH terms

• Parkinson Disease
• Respiratory Aspiration

Intervention

Other:
• Inspiratory Muscle Training Group
Patients in the inspiratory muscle training group will be given inspiratory muscle strength training with the Powerbreathe® (inspiratory muscle training device) device at 50% of the maximal inspiratory pressure, 2 sets of 15 minutes a day for a total of 30 min/day or a single set of 30 min/day, 7 days/week for 8 weeks. Patients in the inspiratory muscle training group will continue their respiratory muscle strength training with a home program 6 days a week under the supervision of a physiotherapist 1 day a week. The MIPs of the patients will be re-measured every week and the training workload will be determined at 50% of the new maximal inspiratory pressure.
• Control Group (breathing exercises)
Thoracic expansion exercises will be given to the control group as a home program. The control group will be asked to do thoracic expansion exercises seven days/week and 120 times/day for eight weeks. The patients in the control group will be called once a week to check their home schedules, and they will be asked to keep a diary.

Locations

Country	Name	City	State
Turkey	Gazi University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Cardiopulmonary Rehabilitation Clinic	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Gazi University

Country where clinical trial is conducted

Turkey, 

References & Publications (5)

Huang CC, Lai YR, Wu FA, Kuo NY, Cheng BC, Tsai NW, Kung CT, Chiang YF, Lu CH. Detraining Effect on Pulmonary and Cardiovascular Autonomic Function and Functional Outcomes in Patients With Parkinson's Disease After Respiratory Muscle Training: An 18-Month Follow-Up Study. Front Neurol. 2021 Oct 21;12:735847. doi: 10.3389/fneur.2021.735847. eCollection 2021. — View Citation

McMahon L, Blake C, Lennon O. Nonpharmacological interventions for respiratory health in Parkinson's disease: A systematic review and meta-analysis. Eur J Neurol. 2021 Mar;28(3):1022-1040. doi: 10.1111/ene.14605. Epub 2020 Dec 1. — View Citation

Mohammed Yusuf SF, Bhise A, Nuhmani S, Alghadir AH, Khan M. Effects of an incentive spirometer versus a threshold inspiratory muscle trainer on lung functions in Parkinson's disease patients: a randomized trial. Sci Rep. 2023 Feb 13;13(1):2516. doi: 10.1038/s41598-023-29534-8. — View Citation

Reyes A, Castillo A, Castillo J, Cornejo I, Cruickshank T. The Effects of Respiratory Muscle Training on Phonatory Measures in Individuals with Parkinson's Disease. J Voice. 2020 Nov;34(6):894-902. doi: 10.1016/j.jvoice.2019.05.001. Epub 2019 May 31. — View Citation

Reyes A, Castillo A, Castillo J, Cornejo I. The effects of respiratory muscle training on peak cough flow in patients with Parkinson's disease: a randomized controlled study. Clin Rehabil. 2018 Oct;32(10):1317-1327. doi: 10.1177/0269215518774832. Epub 2018 May 13. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Oxygen Consumption	Cardiopulmonary Exercises Test	Trough study completion, an average of 2 year
Secondary	Respiratory Muscle Strength	Maximal inspiratory (MIP) and maximal expiratory (MEP) pressures expressing respiratory muscle strength were	Trough study completion, an average of 2 year
Secondary	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.	Trough study completion, an average of 2 year
Secondary	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.	Trough study completion, an average of 2 year
Secondary	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.	Trough study completion, an average of 2 year
Secondary	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.	Trough study completion, an average of 2 year
Secondary	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.	Trough study completion, an average of 2 year
Secondary	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.	Trough study completion, an average of 2 year
Secondary	Peripheral Muscle Strength	Peripheral muscle strength will be evaluated with a dynamometer.	Trough study completion, an average of 2 year
Secondary	Lower extremity exercise capacity	Lower extremity exercise capacity will be evaluated with six- minute walking test.	Trough study completion, an average of 2 year
Secondary	Upper extremity exercise capacity	Upper extremity exercise capacity will be evaluated with the six-minute pegboard and ring test (6-PBRT).	Trough study completion, an average of 2 year
Secondary	Cough Strength	Cough strength will be assessed using a peak cough flow meter (PEFmeter) (ExpiRite Peak Flow Meter, China).	Trough study completion, an average of 2 year
Secondary	Autonomic dysfunction	It will be measured by postural change during ECG recording	Trough study completion, an average of 2 year
Secondary	Fatigue Severity	Fatigue will be evaluated using the Parkinson Fatigue Scale. Total score varies between 16-80. As the score increases, the severity of fatigue increases.	Trough study completion, an average of 2 year
Secondary	Life quality	Patients' health-related quality of life will be evaluated using the Parkinson's disease questionnaire-39. The total score varies between 0-156, and the quality of life worsens as the score increases.	Trough study completion, an average of 2 year
Secondary	Muscle oxygenation	Muscle oxygenation assessment will be performed using the Moxy monitor (Moxy, Fortiori Design LLC, Minnesota, USA).	Trough study completion, an average of 2 year
Secondary	Physical Activity Level	A multi-sensor activity monitor will be used to assess the level of physical activity.	Trough study completion, an average of 2 year