High-Intensity Respiratory Muscle Training in Individuals With Parkinson's Disease

Parkinson Disease Clinical Trial

Official title:

Effects of High-Intensity Respiratory Muscle Training on Respiratory Muscle Strength, Functional Outcomes and Quality of Life in Individuals With Parkinson's Disease: A Randomized Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05608941
• Other study ID #: CAAE: 53970421.0.0000.5149
• Status: Completed
• Phase: N/A
• Start date: December 1, 2022
• Est. completion date: April 30, 2024

Study information

• Verified date: May 2024
• Source: Federal University of Minas Gerais
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Background: Individuals with PD commonly have a significant reduction in respiratory muscle strength and inspiratory muscle endurance, and it can intensify with the disease progression. Respiratory muscle training has shown to increase respiratory muscle strength in individuals with Parkinson's Disease (PD). However, the effect size on other functional outcomes has not been determined and/or investigated. In addition, no studies have investigated the effects of high-intensity respiratory muscle training (inspiratory and expiratory) in this population.

Objectives: The primary aim of this study will be to investigate the effects of high-intensity respiratory muscle training on inspiratory and expiratory muscle strength in individuals with PD. The secondary aim of this study will be to investigate the efficacy of high-intensity respiratory muscle training in improving inspiratory muscle endurance, peak cough flow, dyspnea, fatigue, exercise capacity, and quality of life in this population.

Design: A randomized controlled trial with blinded assessment will assign eligible participants to either: high-intensity respiratory muscle training (experimental group) or sham training (control group). Individuals will perform a home-based intervention, not directly supervised, consisted of two daily 20-min sessions (morning and afternoon), seven times a week, during eight weeks.

Study Outcomes: Primary outcomes are inspiratory and expiratory muscle strength (MIP and MEP). Secondary outcomes are respiratory muscle endurance, peak cough flow, dyspnea, fatigue, exercise capacity, and quality of life.The outcomes will be measured at baseline, post-intervention (after the 8-week intervention), and one month after the cessation of the intervention (12-week follow-up).

Conclusion: The results of this trial will provide valuable new information on the efficacy of high-intensity respiratory muscle training in improving muscle strength and other functional outcomes in individuals with PD.

Description:

Sample size calculation: The sample size calculation was performed considering the primary outcome measures (inspiratory and expiratory muscle strength). The effect size for inspiratory muscle training was derived from a RCT with a similar population and intervention. Considering a significance level (α) of 5% and a power of 0.80, thirteen participants per group are required (a total of 26 participants). The effect size for expiratory muscle training was also derived from a RCT with a similar population and intervention. Considering a significance level (α) of 5% and a power of 0.80, fourteen participants per group are required (a total of 28 participants). Therefore, a sample size of 28 individuals (14 in each group) was defined (largest sample size calculated). Assuming an expected dropout rate of 20%, a total sample size of 34 individuals was set (17 in each group).

Statistical analyzes: All statistical analyzes will be performed by an independent examiner, blinded to the group allocation. Each participant will assigned a unique code. All analyzes will be performed using SPSS (SPSS Inc., Chicago, IL, USA). The normality of data distribution will be for all continuous numeric variables. Descriptive statistics will be calculated for all outcomes.The effects of the interventions will be analyzed from the collected data using intention-to-treat. Data from the last available assessment will be used for missed sessions. Two-way ANOVA with repeated measures (2*3) will be used to evaluate the differences between groups, considering the time factor (considering baseline, post-intervention, and 4-week follow-up), for the variables: inspiratory and expiratory muscle strength, respiratory muscle endurance, peak cough flow and exercise capacity. The level of significance will be set at 5% and adjusted for multiple comparisons. Data distribution and equality of variance will also be analyzed, to ensure the parametric analysis has been applied correctly. The effect sizes will be calculated to determine the magnitude of the differences between the groups. The differences between the two mean values will be expressed in units of their SD, expressed as Cohen's d, or mean results for the experimental group minus the mean results for the control group, divided by the SD of the control group. Effect sizes between 0.2 and 0.5 will be considered small; between 0.5 and 0.8, medium; and above 0.8, large.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: April 30, 2024
• Est. primary completion date: April 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

Inclusion Criteria:

• Parkinson's disease diagnosed by a neurologist

• Ability to walk independently, with or without assistive devices

• Taking anti parkinsonian medication, and who have been medically stable for at least six months

• Classified between stages 1-3 of the modified Hoehn & Yahr Scale (Schenkman et al., 2001)

• Maximum inspiratory pressure less or equal to -80 cmH2O or maximum expiratory pressure less or equal to 90 cmH2O

Exclusion Criteria:

• Possible cognitive impairment as determined by cutoff scores (in points) of the Mini-Mental Status Examination

• Use deep brain stimulation (DBS)

• Smokers or who stopped smoking less than six months ago; have been affected by respiratory or cardiac infections in the last month

• Had any other neurological, musculoskeletal, cardiovascular or respiratory disorders that could affect their ability to perform the tests

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

Other:
• Respiratory muscle training
The training program will be carried-out with the Orygen Dual Valve. Individuals will perform a home-based intervention, split into two daily 20-min sessions (morning and afternoon), totaling 40 min per day, seven times a week, during eight weeks. Each daily session will be composed into four blocks of three minutes, with a two-minute rest between blocks. The initial training load for each participant will be set at 60% of his/her maximal baseline MIP and MEP for both inspiratory and expiratory strength training, respectively. Borg score of dyspnea and effort was also considered for adjusting training intensity, and scores from 4 to 6 were targeted. Once a week, a trained researcher will visit their homes, the MIP and MEP will be evaluated and the training load will be progressed to ensure that 60% of the new pressure values are maintained.
• Control
The control/sham group will underwent exactly the same protocol and weekly monitoring at home, but the participants will receive the devices without resistance of the spring.

Locations

Country	Name	City	State
Brazil	Federal University of Minas Gerais	Belo Horizonte	Minas Gerais

Sponsors (4)

Lead Sponsor	Collaborator
Federal University of Minas Gerais	Conselho Nacional de Desenvolvimento Científico e Tecnológico, Coordenação de Aperfeiçoamento de Pessoal de Nível Superior., Fundação de Amparo à Pesquisa do estado de Minas Gerais

Country where clinical trial is conducted

Brazil, 

References & Publications (15)

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Reyes A, Castillo A, Castillo J, Cornejo I. The effects of respiratory muscle training on peak cough flow in patients with Parkinson's disease: a randomized controlled study. Clin Rehabil. 2018 Oct;32(10):1317-1327. doi: 10.1177/0269215518774832. Epub 2018 May 13. — View 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. — View Citation

Santos RBD, Fraga AS, Coriolano MDGWS, Tiburtino BF, Lins OG, Esteves ACF, Asano NMJ. Respiratory muscle strength and lung function in the stages of Parkinson's disease. J Bras Pneumol. 2019 Sep 30;45(6):e20180148. doi: 10.1590/1806-3713/e20180148. eCollection 2019. — View Citation

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* Note: There are 15 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in Maximal inspiratory pressure (MIP)	Maximum inspiratory pressure will be measured using a digital manovacuometer (LEB-LabCare/UFMG, Brazil) , following previously described protocols.	At baseline, post-intervention (after the 8-week intervention), and one month after the cessation of the intervention (12-week follow-up).
Primary	Change from baseline in Maximal expiratory pressure (MEP)	Maximum expiratory pressure will be measured using a digital manovacuometer (LEB-LabCare/UFMG, Brazil) , following previously described protocols.	At baseline, post-intervention (after the 8-week intervention), and one month after the cessation of the intervention (12-week follow-up).
Secondary	Change from baseline in Inspiratory muscle endurance	Inspiratory endurance will be assessed by the powerbreathe device. The measurement will be carried out following the recommended guideline for the flow-resistive loading tests.	At baseline, post-intervention (after the 8-week intervention), and one month after the cessation of the intervention (12-week follow-up).
Secondary	Change from baseline in Peak cough flow	Peak cough flow measurement will be performed with the with peak expiratory flow meter (Mini-Wright Peak Expiratory Flow Meter), following previously described protocols.	At baseline, post-intervention (after the 8-week intervention), and one month after the cessation of the intervention (12-week follow-up).
Secondary	Change from baseline in perception of Dyspnea	Dyspnea will be measured using the instrument of the Medical Research Council (MRC). This is a 5-point scale, in which 0 indicates 'breathless only with strenuous exercise' and 4 indicates 'too breathless to leave the house'.	At baseline, post-intervention (after the 8-week intervention), and one month after the cessation of the intervention (12-week follow-up).
Secondary	Change from baseline in Fatigue	Fatigue will be measured using the Fatigue Severity Scale. The scale consists of 9 items, for each item the scores range from 1 (strongly disagree) to 7 (strongly agree). A higher score indicates a higher level of fatigue.	At baseline, post-intervention (after the 8-week intervention), and one month after the cessation of the intervention (12-week follow-up).
Secondary	Change from baseline in Exercise capacity	Exercise capacity will be measured using the Six-minute Walk Test (6MWT), following previously described protocols.	At baseline, post-intervention (after the 8-week intervention), and one month after the cessation of the intervention (12-week follow-up).
Secondary	Change from baseline in Quality of life	Quality of life will be measured using the Parkinson's Disease Questionnaire-39. This instrument is composed of 39 items divided into eight dimensions. The score for each domain ranges from 0 (zero) to 100 (one hundred), where zero means better and one hundred means worse quality of life.	At baseline, post-intervention (after the 8-week intervention), and one month after the cessation of the intervention (12-week follow-up).