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

NCT06017336 | Unknown

• 1 other identifier: Gazi University 78
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson Disease

Keywords

Parkinson Disease; inspiratory muscle training; oxygen consumption; physical activity

Outcome Measures

Primary Outcomes (1)

• Oxygen Consumption

  Cardiopulmonary Exercises Test

  Trough study completion, an average of 2 year

Secondary Outcomes (16)

• Respiratory Muscle Strength

  Trough study completion, an average of 2 year

• Respiratory Muscle Endurance

  Trough study completion, an average of 2 year

• Pulmonary function (Forced vital capacity (FVC)

  Trough study completion, an average of 2 year

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

  Trough study completion, an average of 2 year

• Pulmonary function (FEV1 / FVC)

  Trough study completion, an average of 2 year

Study Arms (2)

Inspiratory Muscle Training Group

EXPERIMENTAL

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.

Other: Inspiratory Muscle Training Group

Control Group

SHAM COMPARATOR

Control group will be given breathing exercises as a home program for 8 weeks.

Other: Control Group (breathing exercises)

Interventions

Inspiratory Muscle Training Group OTHER

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.

Inspiratory Muscle Training Group

Control Group (breathing exercises) OTHER

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.

Control Group

Eligibility Criteria

• Age: 45 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Between the ages of 45-80,
• Follow-up with a diagnosis of Parkinson's disease for more than six months
• Stages I-III according to the modified Hoehn and Yahr scale
• Parkinson's patients with independent walking capacity will be included.

You may not qualify if:

• Having a neurological disease other than Parkinson's disease
• Patients with a diagnosed lung disease that may affect respiratory functions
• At least 10 pack years or more of smoking history
• According to the American Association of Sports Medicine (ACSM) with absolute and relative contraindications to exercise tests
• Those with a Mini-Mental State Rating Scale score of less than 18
• Patients with additional cardiac orthopaedic and psychological problems that limit the evaluation will be excluded from the study.

Sponsors & Collaborators

• Gazi University: lead

Study Sites (1)

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

Ankara, 06560, Turkey (Türkiye)

RECRUITING

Related Publications (6)

• 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.

  PMID: 29756459 BACKGROUND

• 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.

  PMID: 31155431 BACKGROUND

• 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.

  PMID: 33098349 BACKGROUND

• 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.

  PMID: 36781936 BACKGROUND

• 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.

  PMID: 34744975 BACKGROUND

• Gunes M, Bosnak Guclu M, Guvenir A, Bora Tokcaer A. Effects of inspiratory muscle training on upper and lower extremity functional exercise capacity, muscle oxygen, and cough strength in patients with Parkinson's disease. Physiother Theory Pract. 2025 Dec 14:1-14. doi: 10.1080/09593985.2025.2602854. Online ahead of print.

  PMID: 41392483 DERIVED

MeSH Terms

Conditions

Parkinson Disease; Motor Activity

Interventions

Control Groups; Breathing Exercises

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods; Mind-Body Therapies; Complementary Therapies; Therapeutics; Exercise Movement Techniques; Physical Therapy Modalities

Study Officials

• Musa GÜNEŞ, MsC

  Gazi University

  PRINCIPAL INVESTIGATOR

• Hatice Ayşe TOKÇAER BORA, Prof. Dr.

  Gazi University

  PRINCIPAL INVESTIGATOR

• Meral BOŞNAK GÜÇLÜ, Prof. Dr.

  Gazi University

  STUDY DIRECTOR

Central Study Contacts

Meral BOŞNAK GÜÇLÜ, Prof. Dr.

CONTACT

+903122162647; meralbosnak@gazi.edu.tr

Musa GÜNEŞ, MsC

CONTACT

musagunes339@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Triple-blind study; the patients will not be informed about training group or control group and they will be evaluated and trained at different places and times.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Study director, PT, PhD, Prof.Dr. Faculty of Health Sciences, Department of Cardiopulmonary Physiotherapy and Rehabilitation

Model Details: Parallel Assignment

Study Record Dates

• First Submitted: August 15, 2023
• First Posted: August 30, 2023
• Study Start: August 15, 2023
• Primary Completion: January 15, 2025
• Study Completion: February 15, 2025
• Last Updated: December 15, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)