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

NCT ID: NCT04834258

Last Updated: 2021-04-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-05

Study Completion Date

2011-09-15

Brief Summary

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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.

Detailed Description

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Although respiratory dysfunction has been recognized as a cause of morbidity and mortality in patients with Parkinson's disease (PD), most of the patients were not aware of their respiratory problems due to restriction in their activities.

Respiratory dysfunction in patients with PD has not been well characterized. However, there are many studies showing restrictive or obstructive type respiratory disorders and decreased respiratory muscle strength in the literature. Ineffective cough due to decreased respiratory muscle strength may cause to secretion retention and secondary infections in PD patients who have severe symptoms. Therefore, the assessment and rehabilitation of these respiratory problems is important in PD patients treatment. There are studies in the literature showing that respiratory muscle training is effective in PD.

Walking difficulty is seen as a common problem in PD. Typically, walking is slow despite adequate Levodopa therapy. It is known that exercise capacity may be affected by respiratory impairment, walking difficulties and personal exercise habits in patients with PD. Respiratory and walking problems lead to limitation of physical activity in PD, which leads to a decrease in exercise capacity. In a recently published article reported that walking is a good example of exercise.

Although walking training is important for PD patients, there is no studies what happens to pulmonary function and functional exercise capacity when walking training is combined with respiratory muscle training in patients with Parkinson's disease. Therefore, this study planned to investigate the effects of walking and respiratory muscle training on pulmonary function and functional exercise capacity in PD.

Conditions

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Parkinson Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Randomized controlled
Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors
Outcomes Assessor (PFT, PImax, PEmax, SNIP, 6MWT, UPDRS III): Blind to group allocation Investigator: Blind to initial and final assessments Participant: Blind to training

Study Groups

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Walking and respiratory muscle training group

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.

Group Type EXPERIMENTAL

Walking and respiratory training

Intervention Type 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

Respiratory muscle training group

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

Group Type ACTIVE_COMPARATOR

Respiratory muscle training

Intervention Type 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.

Interventions

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Walking and respiratory training

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

Intervention Type OTHER

Respiratory muscle training

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.

Intervention Type OTHER

Other Intervention Names

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Respiratory muscle training device and exercise program Respiratory muscle training device

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* • 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.
Minimum Eligible Age

40 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Marmara University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Semra OGUZ, PhD

Role: PRINCIPAL_INVESTIGATOR

Marmara University

Nilgun Gurses, Prof.

Role: STUDY_DIRECTOR

Bezmialem Vakif University

Hulya Apaydin, Prof

Role: STUDY_CHAIR

Istanbul University - Cerrahpasa

References

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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.

Reference Type BACKGROUND
PMID: 27314755 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 8554470 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 9041903 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16403998 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31875689 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31113177 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 9503194 (View on PubMed)

Other Identifiers

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5562

Identifier Type: -

Identifier Source: org_study_id

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