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

NCT05608941 | Completed

• 1 other identifier: CAAE: 53970421.0.0000.5149
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Parkinson Disease

Keywords

Breathing exercises; Clinical trial; Exercise; Muscle strength; Parkinson's disease; Rehabilitation

Outcome Measures

Primary Outcomes (2)

• 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).

• 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 Outcomes (6)

• Change from baseline in Inspiratory muscle endurance

  At baseline, post-intervention (after the 8-week intervention), and one month after the cessation of the intervention (12-week follow-up).

• Change from baseline in Peak cough flow

  At baseline, post-intervention (after the 8-week intervention), and one month after the cessation of the intervention (12-week follow-up).

• Change from baseline in perception of Dyspnea

  At baseline, post-intervention (after the 8-week intervention), and one month after the cessation of the intervention (12-week follow-up).

• Change from baseline in Fatigue

  At baseline, post-intervention (after the 8-week intervention), and one month after the cessation of the intervention (12-week follow-up).

• Change from baseline in Exercise capacity

  At baseline, post-intervention (after the 8-week intervention), and one month after the cessation of the intervention (12-week follow-up).

Study Arms (2)

Experimental Group

EXPERIMENTAL

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.

Other: Respiratory muscle training

Control Group

SHAM COMPARATOR

The control group will also perform the exercises using the Orygen Dual Valve device. A sham intervention will be implemented: the initial resistance of the device will be 0cmH2O, and will be maintained throughout the intervention period - there will be no load progression. All procedures adopted with experimental group, including the weekly home visit, will also be performed with individuals in the control group. However, there will be no real change in the training load. All devices will be wrapped with an opaque material so that the load or possible respiratory training load is not visualized.

Other: Control

Interventions

Respiratory muscle training OTHER

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.

Experimental Group

Control OTHER

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.

Control Group

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Federal University of Minas Gerais: lead
• Fundação de Amparo à Pesquisa do estado de Minas Gerais: collaborator
• Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.: collaborator
• Conselho Nacional de Desenvolvimento Científico e Tecnológico: collaborator
• Pró-reitoria de Pesquisa da Universidade Federal de Minas Gerais: collaborator

Study Sites (1)

Federal University of Minas Gerais

Belo Horizonte, Minas Gerais, 31270-901, Brazil

Location

Related Publications (1)

• Brito SAF, Scianni AA, Silveira BMF, Oliveira ERM, Mateus ME, Faria CDCM. Effects of high-intensity respiratory muscle training on respiratory muscle strength in individuals with Parkinson's disease: Protocol of a randomized clinical trial. PLoS One. 2023 Sep 8;18(9):e0291051. doi: 10.1371/journal.pone.0291051. eCollection 2023.

  PMID: 37682839 BACKGROUND

MeSH Terms

Conditions

Parkinson Disease; Motor Activity

Interventions

Breathing Exercises

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Behavior

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Exercise Movement Techniques; Physical Therapy Modalities

Study Officials

• Christina CM Faria, Doctor

  Federal University of Minas Gerais

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Data collection and analysis will be carried-out by a researcher, blinded to the group allocation. In order to maintain the participants blinded to the training load, the device will be covered with opaque material.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: October 27, 2022
• First Posted: November 8, 2022
• Study Start: December 1, 2022
• Primary Completion: April 30, 2024
• Study Completion: April 30, 2024
• Last Updated: September 26, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)