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Effect of SpiroGym App in Patients With Parkinson's Disease (RespPD)

Primary Purpose

Parkinson Disease

Status
Recruiting
Phase
Not Applicable
Locations
Czechia
Study Type
Interventional
Intervention
Expiratory muscle strength training + SpiroGym application
Expiratory muscle strength training
Sponsored by
General University Hospital, Prague
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson Disease focused on measuring Parkinson Disease, Expiratory muscle strength training, Adherence

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Diagnosis of Parkinsons disease Stable dopaminergic medication (stable dose for at least 1 month) Patient in the risk of non-adherence to the home exercise program (SEHEPS questionnaire below 59 points) Exclusion Criteria: Other neurological disorders Difficulty complying due to neuropsychological dysfunction (dementia with a score of less than 19 on the Montreal Cognitive Assessment) Breathing disorders or diseases Smoking in the past 5 years Uncontrolled hypertension

Sites / Locations

  • General University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Expiratory muscle strength training + SpiroGym application

Expiratory muscle strength training

Arm Description

The experimental arm will undergo 24 weeks of expiratory muscle strength training coupled with SpiroGym app.

The experimental arm will undergo 24 weeks of expiratory muscle strength training.

Outcomes

Primary Outcome Measures

Treatment adherence
Adherence will be calculated by comparing the total amount of expiratory maneuvers recorded in the patient training logs (active control group) or in the SpiroGym application (experimental group) to the prescribed amount: 1000 manoeuvres during baseline to week 8 and 800 manoeuvres during weeks 8-24.

Secondary Outcome Measures

Maximum expiratory pressure (MEP)
MEP assessments will be performed in accordance with American Thoracic Society/European Thoracic Society guidelines. Assessments will be performed using a flanged rubber mouthpiece connected to a pressure manometer (Micro RPM, Micro Medical).The maximum value of three expiratory maneuvers that vary by less than 10%. However, results of published studies confirms a learning effect in the MEP measurements. In order to eliminate the learning effect, the patients will be examined twice within one week. The value from the second measurement will be taken as the baseline MEP value. Aditionaly to decrease the test's variability, a 'warm up session' will be incorporated prior to MEP measurements.
The Self-Efficacy scale for home exercise programs
The Self-Efficacy scale for home exercise programs is a tool for evaluating a patient's self-efficacy for home-based exercise programs. The minimum value is 0 and the maximum value is 72. Higher score mean higher self-efficacy for performing home exercise programs.

Full Information

First Posted
January 20, 2023
Last Updated
February 10, 2023
Sponsor
General University Hospital, Prague
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1. Study Identification

Unique Protocol Identification Number
NCT05728099
Brief Title
Effect of SpiroGym App in Patients With Parkinson's Disease
Acronym
RespPD
Official Title
Effect of SpiroGym Mobile Application in Expiratory Muscle Strength Training in Patients With Parkinson's Disease: a Double Blind Randomised Control Trial
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2022 (Actual)
Primary Completion Date
November 1, 2024 (Anticipated)
Study Completion Date
January 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
General University Hospital, Prague

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Airway protective disorders, including swallowing (dysphagia) and cough (dystussia) are common in patients with Parkinson's disease (PD). Disturbances in these protective mechanisms increase the risk of aspiration pneumonia. In fact, aspiration pneumonia is the leading cause of death in individuals with PD. Expiratory muscle strength training (EMST) studies have reported significant improvements in the field of airway protective therapies. EMST represents a treatment that can be quantified and translated into functional outcomes that can directly improve functions related to coughing, swallowing, and speech in patients with PD. However, information about detraining outcomes presented in Troche et al. 2014 highlights the need for the development of long-term maintenance programs to sustain training gains following intensive periods of EMST, especially considering the progressive nature of PD. Low long-term adherence to home exercise is an important issue in many patient groups and may compromise treatment outcomes. In patients with PD, this is further compounded by a wide variety of neuropsychiatric symptoms, such as apathy and depression. Therefore, we developed a mobile phone-based visual feedback application (SpiroGym app.) to keep patients motivated to continue EMST following intensive periods of training. The usability of a SpiroGym app was tested in individuals with PD and the findings indicate that EMST coupled with SpiroGym app is feasible and potentially useful in PD patients. Present study aims to verify and extend the encouraging results of this study which showed a potential self-efficacy benefit of the SpiroGym application.
Detailed Description
Goal 1: To explore effect of the SpiroGym apllication on treatment adherence in 24weeks home expiratory strength training. Hypothesis: Treatment adherence will be higher in the experimental group than in the active control group. Goal 2: To explore self-efficacy effect of the SpiroGym aplication in expiratory muscle training. Hypothesis: The SpiroGym application will increase self-eficacy for expiratory muscle strength training. Goal 3: To explore additional visual feedback effect of the SpiroGym application to increase training effort compared with regular training without immediate visual feedback. Hypothesis: Visual feedback of the SpiroGym application will increase training effort in expiratory muscle strength trainning which will be reflected in the MEP values at 8weeks assessment and 24weeks assessment. Study design: a double blind randomised-controlled trial

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease
Keywords
Parkinson Disease, Expiratory muscle strength training, Adherence

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Participants are randomly assigned to either the experimental or the active control group. A simple computer-generated random allocation sequence was completed before study initiation.
Masking
ParticipantOutcomes Assessor
Masking Description
During the whole study protocol, patients did not receive information about testing the SpiroGym app. They will receive information that we are testing two types of expiratory muscle strength training programs. Outcomes assessors are blinded to treatment group.
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Expiratory muscle strength training + SpiroGym application
Arm Type
Experimental
Arm Description
The experimental arm will undergo 24 weeks of expiratory muscle strength training coupled with SpiroGym app.
Arm Title
Expiratory muscle strength training
Arm Type
Active Comparator
Arm Description
The experimental arm will undergo 24 weeks of expiratory muscle strength training.
Intervention Type
Device
Intervention Name(s)
Expiratory muscle strength training + SpiroGym application
Intervention Description
Participants will performe an intensive home-based expiratory muscle training programme using an Expiratory Muscle Trainer (EMST150; Aspire Products, LLC, United States), which provide a pressure- threshold range from 30 to 150 cmH20. EMST therapy sessions will be completed at home on 5 days of the patients choosing per week. Participants will be instructed to perform five sets of five forceful expirations coupled with SpiroGym app. per training session for 8 weeks (intensive training period). For another 16 weeks (maintenance period) participants will be instructed to perform, at least twice per week, five sets of five forceful expirations coupled with SpiroGym app. per training session .
Intervention Type
Device
Intervention Name(s)
Expiratory muscle strength training
Intervention Description
Participants will performe an intensive home-based expiratory muscle training programme using an Expiratory Muscle Trainer (EMST150; Aspire Products, LLC, United States), which provide a pressure- threshold range from 30 to 150 cmH20. EMST therapy sessions will be completed at home on 5 days of the patients choosing per week. Participants will be instructed to perform five sets of five forceful expirations per training session for 8 weeks (intensive training period). For another 16 weeks (maintenance period) participants will be instructed to perform, at least twice per week, five sets of five forceful expirations per training session. Participants will be given the practice log to track training adherence.
Primary Outcome Measure Information:
Title
Treatment adherence
Description
Adherence will be calculated by comparing the total amount of expiratory maneuvers recorded in the patient training logs (active control group) or in the SpiroGym application (experimental group) to the prescribed amount: 1000 manoeuvres during baseline to week 8 and 800 manoeuvres during weeks 8-24.
Time Frame
Adherence for home exercise programs from baseline to end of the study (24 weeks)
Secondary Outcome Measure Information:
Title
Maximum expiratory pressure (MEP)
Description
MEP assessments will be performed in accordance with American Thoracic Society/European Thoracic Society guidelines. Assessments will be performed using a flanged rubber mouthpiece connected to a pressure manometer (Micro RPM, Micro Medical).The maximum value of three expiratory maneuvers that vary by less than 10%. However, results of published studies confirms a learning effect in the MEP measurements. In order to eliminate the learning effect, the patients will be examined twice within one week. The value from the second measurement will be taken as the baseline MEP value. Aditionaly to decrease the test's variability, a 'warm up session' will be incorporated prior to MEP measurements.
Time Frame
1 week before baseline, baseline, 2 weeks, 4 weeks, 6 weeks, 8 weeks and 24 weeks
Title
The Self-Efficacy scale for home exercise programs
Description
The Self-Efficacy scale for home exercise programs is a tool for evaluating a patient's self-efficacy for home-based exercise programs. The minimum value is 0 and the maximum value is 72. Higher score mean higher self-efficacy for performing home exercise programs.
Time Frame
baseline, 8 weeks
Other Pre-specified Outcome Measures:
Title
MDS-Unified Parkinson's Disease Rating Scale: part III.
Description
This portion of the scale assesses the motor signs of Parkinson´s disease. The minimum value is 0 and the maximum value is 132. Higher score mean The minimum value is 0 and the maximum value is 72. Higher score mean higher patient motor disability.
Time Frame
Baseline, 8 weeks and 24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosis of Parkinsons disease Stable dopaminergic medication (stable dose for at least 1 month) Patient in the risk of non-adherence to the home exercise program (SEHEPS questionnaire below 59 points) Exclusion Criteria: Other neurological disorders Difficulty complying due to neuropsychological dysfunction (dementia with a score of less than 19 on the Montreal Cognitive Assessment) Breathing disorders or diseases Smoking in the past 5 years Uncontrolled hypertension
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Martin Srp, Ph.D.
Phone
+420 224 965 513
Email
martin.srp@vfn.cz
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martin Srp, Ph.D.
Organizational Affiliation
General University Hospital, Prague
Official's Role
Principal Investigator
Facility Information:
Facility Name
General University Hospital
City
Prague
ZIP/Postal Code
120 00
Country
Czechia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Martin Srp, Ph.D.
Phone
+420 224 965 513
Email
martin.srp@vfn.cz

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34631956
Citation
Srp M, Korteova R, Kliment R, Jech R, Ruzicka E, Hoskovcova M. Expiratory Muscle Strength Training in Patients with Parkinson's Disease: A Pilot Study of Mobile Monitoring Application. Mov Disord Clin Pract. 2021 Aug 4;8(7):1148-1149. doi: 10.1002/mdc3.13313. eCollection 2021 Oct. No abstract available.
Results Reference
background
PubMed Identifier
31720808
Citation
Reyes A, Castillo A, Castillo J. Effects of Expiratory Muscle Training and Air Stacking on Peak Cough Flow in Individuals with Parkinson's Disease. Lung. 2020 Feb;198(1):207-211. doi: 10.1007/s00408-019-00291-8. Epub 2019 Nov 12.
Results Reference
background
PubMed Identifier
36345090
Citation
Troche MS, Curtis JA, Sevitz JS, Dakin AE, Perry SE, Borders JC, Grande AA, Mou Y, Vanegas-Arroyave N, Hegland KW. Rehabilitating Cough Dysfunction in Parkinson's Disease: A Randomized Controlled Trial. Mov Disord. 2023 Feb;38(2):201-211. doi: 10.1002/mds.29268. Epub 2022 Nov 7.
Results Reference
background
PubMed Identifier
24933728
Citation
Troche MS, Rosenbek JC, Okun MS, Sapienza CM. Detraining outcomes with expiratory muscle strength training in Parkinson disease. J Rehabil Res Dev. 2014;51(2):305-10. doi: 10.1682/JRRD.2013.05.0101.
Results Reference
background
PubMed Identifier
27050664
Citation
Palazzo C, Klinger E, Dorner V, Kadri A, Thierry O, Boumenir Y, Martin W, Poiraudeau S, Ville I. Barriers to home-based exercise program adherence with chronic low back pain: Patient expectations regarding new technologies. Ann Phys Rehabil Med. 2016 Apr;59(2):107-13. doi: 10.1016/j.rehab.2016.01.009. Epub 2016 Apr 1.
Results Reference
background
PubMed Identifier
29097256
Citation
Chagraoui A, Boukhzar L, Thibaut F, Anouar Y, Maltete D. The pathophysiological mechanisms of motivational deficits in Parkinson's disease. Prog Neuropsychopharmacol Biol Psychiatry. 2018 Feb 2;81:138-152. doi: 10.1016/j.pnpbp.2017.10.022. Epub 2017 Oct 31.
Results Reference
background
PubMed Identifier
31291552
Citation
Picha KJ, Lester M, Heebner NR, Abt JP, Usher EL, Capilouto G, Uhl TL. The Self-Efficacy for Home Exercise Programs Scale: Development and Psychometric Properties. J Orthop Sports Phys Ther. 2019 Sep;49(9):647-655. doi: 10.2519/jospt.2019.8779. Epub 2019 Jul 10.
Results Reference
background
PubMed Identifier
33650729
Citation
Claus I, Muhle P, Czechowski J, Ahring S, Labeit B, Suntrup-Krueger S, Wiendl H, Dziewas R, Warnecke T. Expiratory Muscle Strength Training for Therapy of Pharyngeal Dysphagia in Parkinson's Disease. Mov Disord. 2021 Aug;36(8):1815-1824. doi: 10.1002/mds.28552. Epub 2021 Mar 2.
Results Reference
background
PubMed Identifier
31155431
Citation
Reyes A, Castillo A, Castillo J, Cornejo I, Cruickshank T. The Effects of Respiratory Muscle Training on Phonatory Measures in Individuals with Parkinson's Disease. J Voice. 2020 Nov;34(6):894-902. doi: 10.1016/j.jvoice.2019.05.001. Epub 2019 May 31.
Results Reference
background
PubMed Identifier
19029430
Citation
Pitts T, Bolser D, Rosenbek J, Troche M, Okun MS, Sapienza C. Impact of expiratory muscle strength training on voluntary cough and swallow function in Parkinson disease. Chest. 2009 May;135(5):1301-1308. doi: 10.1378/chest.08-1389. Epub 2008 Nov 24.
Results Reference
background
PubMed Identifier
11223726
Citation
Volianitis S, McConnell AK, Jones DA. Assessment of maximum inspiratory pressure. Prior submaximal respiratory muscle activity ('warm-up') enhances maximum inspiratory activity and attenuates the learning effect of repeated measurement. Respiration. 2001;68(1):22-7. doi: 10.1159/000050458.
Results Reference
background

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Effect of SpiroGym App in Patients With Parkinson's Disease

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