Effects of Walking and Respiratory Muscle Training on Pulmonary Function and Functional Exercise Capacity in PD

NCT04834258 | Completed

• 1 other identifier: 5562
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this randomised and controlled study is to investigate the effects of walking training combined with respiratory muscle training on pulmonary function, respiratory muscle strength, and functional exercise capacity.

Conditions

Parkinson Disease

Keywords

walking training; respiratory muscle training; pulmonary function; functional capacity

Outcome Measures

Primary Outcomes (2)

• Maximal Inspiratory mouth pressure (PImax) and Maximal Expiratory mouth pressure (PEmax)

  Maximum inspiratory pressure (PImax) is the classic volitional test for inspiratory muscle strength. It is measured as the highest mouth pressure (cmH2O) sustained for 1 s during a maximum inspiratory effort against a quasi occlusion. Assessment is carried out according to the Black and Hyatt technique. Maximum expiratory pressure (PEmax) is the classic volitional test for expiratory muscle strength. It is measured as the highest mouth pressure (cmH2O) sustained for 1 s during a maximum expiratory effort against a quasi occlusion. Assessment is carried out according to the Black and Hyatt technique.

  Change from baseline maximal inspiratory mouth pressure and maximal expiratory pressure at 8 weeks

• Functional Exercise Capacity

  Functional exercise capacity was measured with the 6 Minute Walk Test (6MWT) according to the American Thoracic Society (ATS) guidelines. The 6 minutes walking distance (6MWD) was recorded in meters.

  Change from baseline functional exercise capacity at week 8

Secondary Outcomes (2)

• Spirometric measurements

  Baseline and week 8

• Unified Parkinson's Disease Rating Scale - motor examination

  Baseline and week 8

Other Outcomes (1)

• Sniff nasal inspiratory pressure (SNIP)

  Baseline and week 8

Study Arms (2)

Walking and respiratory muscle training group

EXPERIMENTAL

Walking and respiratory muscle training group (W+ RMT) received walking training in addition to respiratory muscle training for a period of 8 weeks. Walking training was performed at least 5 days a week, twice a day, for 15 min. Walking distance was calculated according to patients' 6 minute walking distance. Respiratory muscle training was performed using the threshold loading method as inspiratory and expiratory muscle training. This training was applied at least 5 days per week, twice a day, 15 minutes each session. (15 minutes inspiratory muscle training + 15 minutes expiratory muscle training). A Threshold Inspiratory Muscle Trainer (IMT) and threshold positive expiratory pressure (Threshold PEP) were used for the training. Patients were called for the hospital once a week to asses mouth pressure and 6 minute walking test (6 MWT) and their training intensity was arranged.

Other: Walking and respiratory training

Respiratory muscle training group

ACTIVE COMPARATOR

In the Respiratory muscle training group (RMT), Respiratory muscle training was performed using the threshold loading method as inspiratory and expiratory muscle training. This training was applied at least 5 days per week, twice a day, 15 minutes each session. (15 minutes inspiratory muscle training + 15 minutes expiratory muscle training). A Threshold Inspiratory Muscle Trainer (IMT) and threshold positive expiratory pressure (Threshold PEP) were used for the training. Patients were called for the hospital once a week to asses mouth pressure and their training intensity was arranged

Other: Respiratory muscle training

Interventions

Walking and respiratory training OTHER

Walking and respiratory muscle training group ( W+ RMT) received walking training in addition to respiratory muscle training for a period of 8 weeks. Walking training was performed at least 5 days a week, twice a day, for 15 min. Walking distance was calculated according to patients' 6 minute walking distance. Respiratory muscle training was performed using the threshold loading method as inspiratory and expiratory muscle training. This training was applied at least 5 days per week, twice a day, 15 minutes each session. (15 minutes inspiratory muscle training + 15 minutes expiratory muscle training). A Threshold Inspiratory Muscle Trainer (IMT) and threshold positive expiratory pressure (Threshold PEP) were used for the training. Patients were called for the hospital once a week to asses mouth pressure and 6 minute walking test (6 MWT) and their training intensity was arranged

Also known as: Respiratory muscle training device and exercise program

Walking and respiratory muscle training group

Respiratory muscle training OTHER

In the Respiratory muscle training group, Respiratory muscle training was performed using the threshold loading method as inspiratory and expiratory muscle training. This training was applied at least 5 days per week, twice a day, 15 minutes each session. (15 minutes inspiratory muscle training + 15 minutes expiratory muscle training). A Threshold Inspiratory Muscle Trainer (IMT) and threshold positive expiratory pressure (Threshold PEP) were used for the training. Patients were called for the hospital once a week to asses mouth pressure and their training intensity was arranged.

Also known as: Respiratory muscle training device

Respiratory muscle training group

Eligibility Criteria

• Age: 40 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Have been diagnosed according with PD to the clinical criteria of the United Kingdom Parkinson's Disease Society Brain Bank diagnostic criteria
• being in phase 1-3 according to the Hoehn-Yahr (H-Y) scale,
• being under anti-parkinson's treatment, and
• being in the "on"period.

You may not qualify if:

• dyskinesia, (which may be obstacles to the tests),
• chronic respiratory disease,
• dementia,
• co-operation difficulty,
• cognitive impairment (mini-mental test score \<24), and
• other neurologic, cardiovascular or musculoskeletal problems that impede walking.

Sponsors & Collaborators

• Marmara University: lead

Related Publications (7)

• Baille G, De Jesus AM, Perez T, Devos D, Dujardin K, Charley CM, Defebvre L, Moreau C. Ventilatory Dysfunction in Parkinson's Disease. J Parkinsons Dis. 2016 Jun 16;6(3):463-71. doi: 10.3233/JPD-160804.

  PMID: 27314755 BACKGROUND

• Sabate M, Rodriguez M, Mendez E, Enriquez E, Gonzalez I. Obstructive and restrictive pulmonary dysfunction increases disability in Parkinson disease. Arch Phys Med Rehabil. 1996 Jan;77(1):29-34. doi: 10.1016/s0003-9993(96)90216-6.

  PMID: 8554470 BACKGROUND

• Canning CG, Alison JA, Allen NE, Groeller H. Parkinson's disease: an investigation of exercise capacity, respiratory function, and gait. Arch Phys Med Rehabil. 1997 Feb;78(2):199-207. doi: 10.1016/s0003-9993(97)90264-1.

  PMID: 9041903 BACKGROUND

• Saleem AF, Sapienza CM, Okun MS. Respiratory muscle strength training: treatment and response duration in a patient with early idiopathic Parkinson's disease. NeuroRehabilitation. 2005;20(4):323-33.

  PMID: 16403998 BACKGROUND

• Rodriguez MA, Crespo I, Del Valle M, Olmedillas H. Should respiratory muscle training be part of the treatment of Parkinson's disease? A systematic review of randomized controlled trials. Clin Rehabil. 2020 Apr;34(4):429-437. doi: 10.1177/0269215519896054. Epub 2019 Dec 26.

  PMID: 31875689 BACKGROUND

• Alves WM, Alves TG, Ferreira RM, Lima TA, Pimentel CP, Sousa EC, Abrahin O, Alves EA. Strength training improves the respiratory muscle strength and quality of life of elderly with Parkinson disease. J Sports Med Phys Fitness. 2019 Oct;59(10):1756-1762. doi: 10.23736/S0022-4707.19.09509-4. Epub 2019 May 20.

  PMID: 31113177 BACKGROUND

• Koseoglu F, Inan L, Ozel S, Deviren SD, Karabiyikoglu G, Yorgancioglu R, Atasoy T, Ozturk A. The effects of a pulmonary rehabilitation program on pulmonary function tests and exercise tolerance in patients with Parkinson's disease. Funct Neurol. 1997 Nov-Dec;12(6):319-25.

  PMID: 9503194 BACKGROUND

MeSH Terms

Conditions

Parkinson Disease

Interventions

Walking; Breathing Exercises

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Locomotion; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Exercise; Motor Activity; Mind-Body Therapies; Complementary Therapies; Therapeutics; Exercise Movement Techniques; Physical Therapy Modalities

Study Officials

• Semra OGUZ, PhD

  Marmara University

  PRINCIPAL INVESTIGATOR

• Nilgun Gurses, Prof.

  Bezmialem Vakif University

  STUDY DIRECTOR

• Hulya Apaydin, Prof

  Istanbul University - Cerrahpasa

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Outcomes Assessor (PFT, PImax, PEmax, SNIP, 6MWT, UPDRS III): Blind to group allocation Investigator: Blind to initial and final assessments Participant: Blind to training
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized controlled

Study Record Dates

• First Submitted: March 28, 2021
• First Posted: April 8, 2021
• Study Start: January 5, 2010
• Primary Completion: August 10, 2011
• Study Completion: September 15, 2011
• Last Updated: April 8, 2021

Record last verified: 2021-03