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

Not Applicable

Recruiting

• Conditions: Parkinson Disease
• Interventions: Other: Control Group (breathing exercises); Other: Inspiratory Muscle Training Group

• Registration Number: NCT06017336
• Lead Sponsor: Gazi University

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2023-08-15
• Study First Submitted: 2023-08-15
• Study First Submitted QC: 2023-08-29
• Study First Posted: 2023-08-30
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-09
• Last Update Posted: 2023-12-15
• Primary Completion: 2025-01-15
• Study Completion: 2025-02-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control Group	Control Group (breathing exercises)	Control group will be given breathing exercises as a home program for 8 weeks.
Inspiratory Muscle Training Group	Inspiratory Muscle Training Group	Patients in the training group will be performed inspiratory muscle training with the PowerBreathe® (inspiratory muscle training device) device at 50% of the maximal inspiratory pressure.

Primary Outcome Measures

Name	Time	Method
Oxygen Consumption	Trough study completion, an average of 2 year	Cardiopulmonary Exercises Test

Secondary Outcome Measures

Name	Time	Method
Autonomic dysfunction	Trough study completion, an average of 2 year	It will be measured by postural change during ECG recording
Pulmonary function (FEV1 / FVC)	Trough study completion, an average of 2 year	Pulmonary function will be evaluated using the spirometry, according to American Thoracic Society and European Respiratory Society criteria. FEV1 / FVC will be measured.
Pulmonary function (Flow rate 25-75% of forced expiratory volume (FEF 25-75%))	Trough study completion, an average of 2 year	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.
Upper extremity exercise capacity	Trough study completion, an average of 2 year	Upper extremity exercise capacity will be evaluated with the six-minute pegboard and ring test (6-PBRT).
Respiratory Muscle Strength	Trough study completion, an average of 2 year	Maximal inspiratory (MIP) and maximal expiratory (MEP) pressures expressing respiratory muscle strength were
Respiratory Muscle Endurance	Trough study completion, an average of 2 year	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.
Pulmonary function (Peak flow rate (PEF))	Trough study completion, an average of 2 year	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.
Cough Strength	Trough study completion, an average of 2 year	Cough strength will be assessed using a peak cough flow meter (PEFmeter) (ExpiRite Peak Flow Meter, China).
Physical Activity Level	Trough study completion, an average of 2 year	A multi-sensor activity monitor will be used to assess the level of physical activity.
Muscle oxygenation	Trough study completion, an average of 2 year	Muscle oxygenation assessment will be performed using the Moxy monitor (Moxy, Fortiori Design LLC, Minnesota, USA).
Pulmonary function (Forced vital capacity (FVC)	Trough study completion, an average of 2 year	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.
Peripheral Muscle Strength	Trough study completion, an average of 2 year	Peripheral muscle strength will be evaluated with a dynamometer.
Lower extremity exercise capacity	Trough study completion, an average of 2 year	Lower extremity exercise capacity will be evaluated with six- minute walking test.
Pulmonary function (Forced expiratory volume in the first second (FEV1)	Trough study completion, an average of 2 year	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.
Fatigue Severity	Trough study completion, an average of 2 year	Fatigue will be evaluated using the Parkinson Fatigue Scale. Total score varies between 16-80. As the score increases, the severity of fatigue increases.
Life quality	Trough study completion, an average of 2 year	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.

Trial Locations

Locations (1)

Gazi University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Cardiopulmonary Rehabilitation Clinic; 🇹🇷 Ankara, Turkey