Condition category
Nervous System Diseases
Date applied
03/01/2018
Date assigned
16/01/2018
Last edited
16/01/2018
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Parkinson's disease is a condition in which parts of the brain become progressively damaged over many years. In patients with Parkinson’s disease, the main cause of death is a lung inflammation produced by the entrance of bronchial secretions or other foreign materials into the lungs. The high incidence of this complication has been attributed to deglutition (swallowing) and pulmonary (breathing) problems such as reduced respiratory muscle strength and respiratory muscle slowness. Cough is an important defence mechanism that removes foreign material from the bronchus (the main passageway into the lungs). To produce an effective cough, it is necessary to breathe in an adequate volume of air before coughing, to then expel an adequate volume of air while coughing to push the foreign material out of the bronchus. Strengthening inspiratory (breathing in) and expiratory (breathing out) muscles may lead the muscles to produce a greater expiratory airflow and velocity and therefore a cough able to clean the bronchus efficiently. The aims of this study are to compare the effects of an inspiratory versus an expiratory muscle-training program on the amount of airflow produced during cough, and to determine which training (inspiratory or expiratory), produces greater improvements in the amount of cough airflow in patients with Parkinson’s disease.

Who can participate?
Patients with Parkinson's disease

What does the study involve?
Participants are randomly allocated into three groups. The first group receives home-based inspiratory muscle training, the second group receives home-based expiratory muscle training, and the third group receives home-based expiratory muscle training at a minimum and fixed load. Respiratory muscle training involves performing 25 inspiratory or expiratory efforts, from Monday to Saturday, using a specific, personal and transportable device provided by the researchers of the study. The training period lasts 2 months, and each training session takes about 15-20 minutes. Participants undergo lung assessments before and after the training. They also were also contacted every two weeks to check the progress of the training. Participants also receive phone calls and/or text messages as reminders to perform the breathing exercises and arrange appointments.

What are the possible benefits and risks of participating?
Possible benefits include improved cough effectiveness by increasing the volume of air during coughing, improved safety during deglutition and decreased risk of bronchial secretions or food getting into the airway, improved voice volume, and receiving comprehensive assessments of breathing, voice and deglutition functions. Possible risks include respiratory muscle soreness and fatigue. The risks associated with the respiratory muscle training are low, but to minimize them the training is tailored to each participant and the necessary resting time is provided to avoid fatigue.

Where is the study run from?
Chilean League Against Parkinson's Disease (Chile)

When is the study starting and how long is it expected to run for?
December 2016 to November 2017

Who is funding the study?
Fondo Nacional de Desarrollo Científico y Tecnológico (Chile)

Who is the main contact?
Alvaro Reyes
alvaro.reyes@unab.cl

Trial website

Contact information

Type

Scientific

Primary contact

Mr Alvaro Reyes

ORCID ID

Contact details

Fernandez Concha #700
Las Condes
Santiago
7591538
Chile
+56 (0)226615665
alvaro.reyes@unab.cl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

11160419

Study information

Scientific title

The effects of respiratory muscle training on peak cough flow in patients with Parkinson's disease

Acronym

Study hypothesis

An expiratory muscle-training program is more effective than an inspiratory muscle-training program to improve voluntary and reflex peak cough flow in patients with Parkinson's disease.

Ethics approval

Pontificia Universidad Católica de Chile (Pontifical Catholic University of Chile) ethics committee, 18/05/2017, ID number: 16-292

Study design

Single-centre randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Community

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details to request a patient information sheet

Condition

Parkinson's disease

Intervention

The study employed a 3 (groups) x 2 (measure times: baseline and 2 months) repeated measures design. Forty participants completed all baseline measurements and then were randomly divided into three groups using the randomisation block method. Thirteen participants were assigned to receive home-based inspiratory muscle training, 13 participants were assigned to receive home-based expiratory muscle training, and 14 participants were assigned to receive home-based expiratory muscle training at minimum and fixed load (control group). Thirty-one participants completed the study protocol. The intervention lasted 2 months for all study groups. Allocation concealment was implemented using sequential sealed envelopes prepared by an independent research assistant. The assessors were not blinded to patients allocation group.

Participants in the inspiratory training group performed a home-based inspiratory (5 sets of 5 repetitions) muscle-training program using a Threshold® Inspiratory Muscle Trainer (HS730-010. Phillips Respironics, USA).

Participants in the expiratory training group performed a home-based expiratory (5 sets of 5 repetitions) muscle-training program using an Expiratory Muscle Trainer (EMST150. Aspire Products, LLC). Both groups trained 6 times a week for 2 months. These training parameters were chosen because previous studies have shown significant improvements in pulmonary function in patients with Parkinson’s disease using a similar protocol.

Participants in both groups started training at a resistance equal to 50% of their maximum inspiratory pressure and maximum expiratory pressure, which was calculated based during baseline measurements described below. The resistance was adjusted every two weeks to reach a training intensity of 75% during the last 2 weeks of training.

Participants in the control group used a Threshold® PEP (HS-735-010. Phillips Respironics, USA) for expiratory muscle training because this device provides lower resistance for expiratory flows than those devices used by the training groups. They trained using the same protocol of the participants in the training groups for the same number of repetitions, frequency and duration, but the intensity was fixed at the minimum load of the device (9 cmH20) throughout the training period.

All participants were asked to mark on the provided training diary when a training session was completed. All participants were contacted every two weeks, to ensure that they were training and to adjust the resistance of the training devices. Phone calls or messages throughout the study period were sent to remind participants to perform the training as instructed.

Intervention type

Device

Phase

Drug names

Primary outcome measures

Voluntary and reflex peak cough flow, measured using a pneumotachograph (MLT 1000; ADInstruments, Inc) coupled to a data acquisitions system (PowerLab 8/35, ADInstruments, Inc.), before and after 2 months of inspiratory or expiratory muscle training

Secondary outcome measures

1. Maximum inspiratory and expiratory pressure, measured using a pressure manometer (Micro RPM, Micro Medical-Care Fusion, Kent, UK) before and after 2 months of inspiratory or expiratory muscle training
2. Slow vital capacity, forced vital capacity and forced expiratory volume in 1s, measured using a digital spirometer (FE141, ADInstruments, Inc.) coupled to a data acquisitions system (PowerLab 8/35, ADInstruments, Inc.) before and after 2 months of inspiratory or expiratory muscle training

Overall trial start date

20/12/2016

Overall trial end date

27/11/2017

Reason abandoned

Eligibility

Participant inclusion criteria

Participants of both genders with diagnosis of idiopathic Parkinson's disease (stage I-III Hoehn and Yahr scale) in the “on dopaminergic” state were initially recruited in the study. Inclusion criteria were:
1. Diagnosis of idiopathic Parkinson's disease confirmed by a neurologist
2. Participants with the ability to understand and respond to the instructions given in the study
3. Unaltered dose and type of antiparkinsonian medication
4. Stable disease at the moment of inclusion in this study

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

48

Participant exclusion criteria

1. Other concomitant neurological disease
2. Current smokers
3. Participants with a history of cardiovascular pathology, lung disease or the presence of respiratory symptoms such as cough, phlegm, wheezing or dyspnoea at the time of assessment
4. Participants with difficulties in maintaining a proper mouth seal or unable to avoid air leakage during pulmonary function testing

Recruitment start date

03/04/2017

Recruitment end date

01/09/2017

Locations

Countries of recruitment

Chile

Trial participating centre

Chilean League Against Parkinson's Disease
8360376

Sponsor information

Organisation

Universidad Andres Bello

Sponsor details

Fernandez Concha #700
Las Condes
Santiago
7591538
Chile
+56 (0)226615665
amartineau@unab.cl

Sponsor type

University/education

Website

www.unab.cl

Funders

Funder type

Government

Funder name

Fondo Nacional de Desarrollo Científico y Tecnológico

Alternative name(s)

National Fund for Scientific and Technological Development, FONDECYT

Funding Body Type

government organisation

Funding Body Subtype

federal

Location

Chile

Results and Publications

Publication and dissemination plan

Planned publication in a high impact peer reviewed journal in early 2018.

IPD sharing statement
The dataset will not be made available because the informed consent document that all participants signed for this study states that “the information obtained from this investigation will be kept strictly confidential. The results of this investigation will be presented in scientific journals and/or conferences; however, your name will not be revealed”. All printed documents used to collect data are kept and secured in a locked drawer placed in the principal investigator office. Digital information is kept in a desktop computer located in the principal investigator office of the sponsoring institution (Andres Bello University). The desktop computer is password locked.

Intention to publish date

01/03/2018

Participant level data

Not expected to be available

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes