Clinical trial NCT04834258: 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
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson Disease
Keywords: walking training
respiratory muscle training
pulmonary function
functional capacity
Lead sponsor: Marmara University
Sponsor class: OTHER
First posted: 2021-04-08
Enrollment: 30
Sex: ALL
Minimum age (years): 40
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Randomized controlled
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Maximal Inspiratory mouth pressure (PImax) and Maximal Expiratory mouth pressure (PEmax)
timeFrame: Change from baseline maximal inspiratory mouth pressure and maximal expiratory pressure at 8 weeks
measure: Functional Exercise Capacity
timeFrame: Change from baseline functional exercise capacity at week 8
Secondary outcomes:
measure: Spirometric measurements
timeFrame: Baseline and week 8
measure: Unified Parkinson's Disease Rating Scale - motor examination
timeFrame: Baseline and week 8
Other outcomes:
measure: Sniff nasal inspiratory pressure (SNIP)
timeFrame: Baseline and week 8
Locations:
Study officials:
affiliation: Marmara University
name: Semra OGUZ, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Bezmialem Vakif University
name: Nilgun Gurses, Prof.
role: STUDY_DIRECTOR
affiliation: Istanbul University - Cerrahpasa
name: Hulya Apaydin, Prof
role: STUDY_CHAIR
References:
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.
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.
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.
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.
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.
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.
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.