Respiratory muscle training in patients with Parkinson's disease

• Register: ISRCTN
• Last refreshed on: 17 October 2022
• Main ID: ISRCTN10301406
• Date of registration: 16/01/2018
• Prospective Registration: No
• Primary sponsor: Universidad Andres Bello
• Public title: Respiratory muscle training in patients with Parkinson's disease
• Scientific title: The effects of respiratory muscle training on peak cough flow in patients with Parkinson's disease
• Date of first enrolment: 03/04/2017
• Target sample size: 48
• Recruitment status: Completed
• URL: https://www.isrctn.com/ISRCTN10301406
• Study type: Interventional
• Study design: Single-centre randomised controlled trial (Treatment)
• Phase: Not Specified

Countries of recruitment

Chile

Contacts

• Name: Alvaro Reyes

Key inclusion & exclusion criteria

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

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


Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Parkinson's disease
Nervous System Diseases
Parkinson disease

Intervention(s)

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 w

Primary Outcome(s)

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(s)

Current secondary outcome measures as of 23/05/2018:
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
3. Subglottic pressure (SGP) and phonation threshold pressure (PTP) were measured during the production of plosives and recorded using a handled battery-operated device (PG-100E, Glottal Enterprises, Canada) connected to a 0.5 inches (inner diameter) silicon tubing and a standard Luer-connector. The opposite end of the silicon tubing was placed between each participant's lips preventing them from
biting the tip of the tubing. Participants were instructed to repeat the syllable /pa/ at a rate of 1.5 to 2 seconds until the pressure tachometer inside the device (PG-100E), reached a 3-second plateau. SGP and PTP measurements were performed at three voice intensities: conversational, lowest possible intensity, and highest possible intensity. SGP and PTP were repeated at least 3 times for each voice intensity. The highest value of each voice intensity record was used for further analysis. Voice production intensity during SGP and PTP measurements
were recorded using a portable digital recorder (Tascam DR40) sampling rate 44kHz/16-bit, placed at 45º and 20 cm from participants’ lips. Voice recordings were further analyzed using Praat software (Phonetic Sciences, University of Amsterdam. The Netherlands). The mean and maximum sound pressure level (SPL) in decibels were extracted for further analysis. For maximum phonation time (MPT) participants were instructed to produce a sustained vowel /a/ sound for as long as possible after a deep inspiration. Three consecutive measures were performed and the highest value was considered for further analysis. MPT was measured with a stopwatch and participants were verbally encouraged during their vocalization. All phonatory measures were performed with participants in the seated position and in a noiseless room.
Phonatory measures were assessed at baseline and after 2 months of respiratory muscle training.

Previous 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

Secondary ID(s)

11160419

Source(s) of Monetary Support

Fondo Nacional de Desarrollo Científico y Tecnológico

Ethics review

Status:
Approval date:
Contact:

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

Results

• Results available: Yes
• Date Completed: 27/11/2017