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

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

Interventions

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.

OTHER

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.

Sponsors & Collaborators

• Fundação de Amparo à Pesquisa do estado de Minas Gerais

  collaborator OTHER

• Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.

  collaborator OTHER_GOV

• Conselho Nacional de Desenvolvimento Científico e Tecnológico

  collaborator OTHER_GOV

• Pró-reitoria de Pesquisa da Universidade Federal de Minas Gerais

  collaborator UNKNOWN

• Federal University of Minas Gerais

  lead OTHER

Principal Investigators

• Christina CM Faria, Doctor · Federal University of Minas Gerais

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

50 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-12-01

Primary Completion

2024-04-30

Completion

2024-04-30

Countries

• Brazil

Study Locations