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

Primary Purpose

Parkinson Disease

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Walking and respiratory training
Respiratory muscle training
Sponsored by
Marmara University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson Disease focused on measuring walking training, respiratory muscle training, pulmonary function, functional capacity

Eligibility Criteria

40 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Walking and respiratory muscle training group

    Respiratory muscle training group

    Arm Description

    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.

    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

    Outcomes

    Primary Outcome Measures

    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.
    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.

    Secondary Outcome Measures

    Spirometric measurements
    Forced expiratory volume in one second (FEV1),Forced Vital Capacity (FVC),FEV1/FVC ratio were measured.
    Unified Parkinson's Disease Rating Scale - motor examination
    Unified Parkinson's Disease Rating Scale - motor examination (UPDRS- III) of the scale assesses the motor signs of Parkinson's disease.All items must have an integer rating (no half points, no missing ratings). Specific instructions are provided for the testing of each item. The motor UPDRS consists of five-category ordinal items scored 0-4.The total motor UPDRS exam score ranges from 0 to 108. A higher scores indicating greater disability.

    Full Information

    First Posted
    March 28, 2021
    Last Updated
    April 3, 2021
    Sponsor
    Marmara University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04834258
    Brief Title
    Effects of Walking and Respiratory Muscle Training on Pulmonary Function and Functional Exercise Capacity in PD
    Official Title
    What Happens to Pulmonary Function and Functional Exercise Capacity When Walking Training is Combined With Respiratory Muscle Training in Patients With Parkinson's Disease: A Randomized Double-blind Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2021
    Overall Recruitment Status
    Completed
    Study Start Date
    January 5, 2010 (Actual)
    Primary Completion Date
    August 10, 2011 (Actual)
    Study Completion Date
    September 15, 2011 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Marmara University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.
    Detailed Description
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Parkinson Disease
    Keywords
    walking training, respiratory muscle training, pulmonary function, functional capacity

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Model Description
    Randomized controlled
    Masking
    ParticipantInvestigatorOutcomes Assessor
    Masking Description
    Outcomes Assessor (PFT, PImax, PEmax, SNIP, 6MWT, UPDRS III): Blind to group allocation Investigator: Blind to initial and final assessments Participant: Blind to training
    Allocation
    Randomized
    Enrollment
    30 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Walking and respiratory muscle training group
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Respiratory muscle training group
    Arm Type
    Active Comparator
    Arm Description
    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
    Intervention Type
    Other
    Intervention Name(s)
    Walking and respiratory training
    Other Intervention Name(s)
    Respiratory muscle training device and exercise program
    Intervention Description
    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
    Intervention Name(s)
    Respiratory muscle training
    Other Intervention Name(s)
    Respiratory muscle training device
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Maximal Inspiratory mouth pressure (PImax) and Maximal Expiratory mouth pressure (PEmax)
    Description
    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.
    Time Frame
    Change from baseline maximal inspiratory mouth pressure and maximal expiratory pressure at 8 weeks
    Title
    Functional Exercise Capacity
    Description
    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.
    Time Frame
    Change from baseline functional exercise capacity at week 8
    Secondary Outcome Measure Information:
    Title
    Spirometric measurements
    Description
    Forced expiratory volume in one second (FEV1),Forced Vital Capacity (FVC),FEV1/FVC ratio were measured.
    Time Frame
    Baseline and week 8
    Title
    Unified Parkinson's Disease Rating Scale - motor examination
    Description
    Unified Parkinson's Disease Rating Scale - motor examination (UPDRS- III) of the scale assesses the motor signs of Parkinson's disease.All items must have an integer rating (no half points, no missing ratings). Specific instructions are provided for the testing of each item. The motor UPDRS consists of five-category ordinal items scored 0-4.The total motor UPDRS exam score ranges from 0 to 108. A higher scores indicating greater disability.
    Time Frame
    Baseline and week 8
    Other Pre-specified Outcome Measures:
    Title
    Sniff nasal inspiratory pressure (SNIP)
    Description
    Sniff nasal inspiratory pressure (SNIP) measurement is a volitional noninvasive assessment of inspiratory muscle strength. A maximum of 10 sniffs is generally used. It is a simple procedure consisting of measuring peak nasal pressure (cmH2O) as a result of maximal sniff performance through from the end of expiration with the open nostril while the the other one is closed.
    Time Frame
    Baseline and week 8

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    40 Years
    Maximum Age & Unit of Time
    85 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Semra OGUZ, PhD
    Organizational Affiliation
    Marmara University
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Nilgun Gurses, Prof.
    Organizational Affiliation
    Bezmialem Vakif University
    Official's Role
    Study Director
    First Name & Middle Initial & Last Name & Degree
    Hulya Apaydin, Prof
    Organizational Affiliation
    Istanbul University - Cerrahpasa (IUC)
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    27314755
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    8554470
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    9041903
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    16403998
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    31875689
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    31113177
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    9503194
    Citation
    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.
    Results Reference
    background

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

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