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

April 3, 2021 updated by: Marmara University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Other: 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

Other Names:
  • Respiratory muscle training device and exercise program
Active Comparator: 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
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.
Other Names:
  • Respiratory muscle training device

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maximal Inspiratory mouth pressure (PImax) and Maximal Expiratory mouth pressure (PEmax)
Time Frame: Change from baseline maximal inspiratory mouth pressure and maximal expiratory pressure at 8 weeks

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
Time Frame: Change from baseline functional exercise capacity at week 8
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Spirometric measurements
Time Frame: Baseline and week 8
Forced expiratory volume in one second (FEV1),Forced Vital Capacity (FVC),FEV1/FVC ratio were measured.
Baseline and week 8
Unified Parkinson's Disease Rating Scale - motor examination
Time Frame: Baseline and week 8
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.
Baseline and week 8

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sniff nasal inspiratory pressure (SNIP)
Time Frame: Baseline and week 8
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.
Baseline and week 8

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Marmara University

Investigators

  • Principal Investigator: Semra OGUZ, PhD, Marmara University
  • Study Director: Nilgun Gurses, Prof., Bezmialem Vakif University
  • Study Chair: Hulya Apaydin, Prof, Istanbul University - Cerrahpasa (IUC)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 5, 2010

Primary Completion (Actual)

August 10, 2011

Study Completion (Actual)

September 15, 2011

Study Registration Dates

First Submitted

March 28, 2021

First Submitted That Met QC Criteria

April 3, 2021

First Posted (Actual)

April 8, 2021

Study Record Updates

Last Update Posted (Actual)

April 8, 2021

Last Update Submitted That Met QC Criteria

April 3, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 5562

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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