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NCT Number: NCT04834258

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Other names: Respiratory muscle training device and exercise program

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.

Other names: Respiratory muscle training device

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. Spirometric measurements

    Time frame: Baseline and week 8

    Forced expiratory volume in one second (FEV1),Forced Vital Capacity (FVC),FEV1/FVC ratio were measured.

  2. 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.

Other outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Marmara University

Other

Registry information

Official study 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

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Apr 8, 2021
Registry last updated
Apr 8, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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