An interventional study of Expiratory Muscle Strength Training (EMST) in PARKINSON DISEASE (Disorder), sponsored by Karolinska Institutet. Recruiting at 1 site in Sweden. Per ClinicalTrials.gov, last updated 2026-11-12.
Sponsored by Karolinska Institutet · Not applicable, Interventional, and Treatment
Among 10 studies in Parkinson Disease by Karolinska Institutet — 3 open to participants now, 3 under way, none of them phase 3. Parkinson Disease · Karolinska Institutet.
Among the 10 studies in Parkinson Disease by Karolinska Institutet, this one is the only one that started in 2024, is one of 5 with no phase, and was the 10th registered.
4,576 studies on the registry are indexed under Parkinson Disease; 1,087 are open to participants now.
Browse Parkinson Disease studies →3 of the 10 studies in Parkinson Disease by Karolinska Institutet are open now, in 1 country. Recruiting first, the newest first:
Karolinska Institutet · Sites in Sweden
Ages 18+
Karolinska Institutet · Sites in Sweden
By country, each count listing its studies:
Of the 749 Parkinson Disease studies recruiting now, 311 (42%) set no upper age limit and 127 (17%) stop at 75 or younger; 64 take children under 18; 189 take healthy volunteers.
This study: all sexes · no healthy volunteers.
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10 studies; the count open now beside each. This study's row is marked.
First in 2004; this study’s year is marked. 1 started in 2024.
This study's planned enrollment of 80 is above the median of 40 across 3,355 interventional studies indexed under Parkinson Disease.
Median enrollment 106 across the 6 interventional studies, 292 across the 4 observational. Of the 6 that completed or were terminated, 2 (33%) have results posted.
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Karolinska Institutet is the lead sponsor of 1,149 studies on the registry; 277 are open to participants now.
1 of the studies in Parkinson Disease by Karolinska Institutet that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06901869Karolinska InstitutetPhysical Activity in Persons With Parkinson's Disease | 2026-12 |
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Among the 10 studies in Parkinson Disease by Karolinska Institutet, from their registry updates:
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This study is a Post-Market Clinical Follow-up (PMCF) randomized controlled trial of a CE-marked device used in routine clinical practice. The goal of this study is to investigate whether Expiratory Muscle Strength Training (EMST) improves voice, speech, breathing, and swallowing function in people with Parkinson's disease.
The research questions are:
Does EMST improve voice, speech, breathing, and swallowing in people with Parkinson's disease, as measured by clinical tests, immediately after the training period and three months later? Does EMST lead to meaningful improvements in voice, speech, breathing, and swallowing problems as reported by people with Parkinson's disease immediately after the training period and three months later? Do the effects of EMST differ according to disease severity?
Researchers will compare participants who receive EMST with participants in a passive control group to determine whether EMST improves voice, speech, breathing, and swallowing function.
Participants will:
Be randomly assigned to either an EMST group or a passive control group. Complete a structured EMST training program, if assigned to the intervention group.
Attend study visits for assessments of voice, speech, breathing, and swallowing function.
Undergo clinical tests and complete study-related evaluations throughout the study.
Be monitored for any device-related or study-related adverse events.
Parkinson's disease (PD) is associated with impairments in respiratory, phonatory, speech, and swallowing functions that can negatively affect communication, nutritional status, and quality of life. Expiratory Muscle Strength Training (EMST) is a device-based intervention that targets expiratory and submental muscle strength and has shown potential benefits for respiratory function, swallowing safety, and vocal performance in individuals with PD.
This study is designed as a prospective, single-blind, randomized controlled trial with two parallel study arms: (A) an intervention group receiving EMST and (B) a passive control group. The aim of the study is to investigate the effects of EMST on respiratory, phonatory, speech, and swallowing functions in individuals with PD. Participants assigned to the intervention group will complete a 5-week EMST training program. Assessments will be conducted at baseline, immediately following the training period, and after a 3-month detraining period to evaluate both short- and long-term effects of the intervention.
Note: This study was registered retrospectively due to an administrative oversight. The Clinical Investigation Plan (CIP), including all intervention procedures and outcome measures, was finalized and locked prior to participant enrollment. The CIP was approved by the Swedish Medical Products Agency on 2024-02-18 (CIV-ID; CIV-23-12-045455, approval number 5.1-2024-16540) and has remained unchanged since study initiation.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
MMSE and MoCA
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will perform Expiratory Muscle Strength Training (EMST) using a CE-marked, calibrated handheld threshold device routinely used in clinical practice. The training protocol consists of 5 sets of 5 breaths per day, 5 days per week, for 5 weeks. Training resistance will be individually adjusted on a weekly basis according to participant performance and established EMST training recommendations.
Device: Expiratory Muscle Strength Training (EMST)
Participants assigned to the passive control group will not receive the EMST intervention during the study period. No sham intervention will be provided. Following completion of all study assessments, including the 3-month follow-up, participants will be offered the opportunity to receive the EMST intervention.
Expiratory Muscle Strength Training (EMST) will be performed using a CE-marked, calibrated handheld threshold device that provides a fixed expiratory resistance. Participants will complete 5 sets of 5 forceful expiratory breaths per day, 5 days per week, for 5 weeks. The training load will be individually calibrated and adjusted weekly based on each participant's performance to maintain an appropriate training intensity. The intervention is designed to strengthen expiratory and submental muscles involved in respiration, phonation, speech, and swallowing.
Sound Pressure Level/SPL
Sound pressure level (SPL) will be assessed from audio recordings obtained in a sound-treated studio using calibrated recording equipment. Recordings will be made with a head-mounted omnidirectional microphone positioned at a fixed distance from the mouth. Speech samples will be collected using a Speech Range Profile (SRP), a two-dimensional graphical representation of vocal performance, with fundamental frequency (Hz) on the x-axis and vocal intensity (dB) on the y-axis. Participants will read a standardized text and produce spontaneous speech based on a standardized picture-sequence task. Data will be collected both at habitual speaking loudness and during exposure to white noise (70 dB) presented via headphones. SPL will be quantified in decibels \[dB\] and analyzed on an interval scale (minimum, maximum, and equivalent continuous sound level \[Leq SPL\]). Higher SPL values indicate greater vocal intensity.
Time frame: Assessment Time-points: (i) Baseline (two baseline measurements obtained 5 weeks apart), (ii) immediately post-intervention, and (iii) 3-month follow-up.
Maximum Phonation Time (MPT)
Maximum phonation time (MPT) will be assessed from audio recordings obtained in a sound-treated studio using calibrated recording equipment and a head-mounted omnidirectional microphone positioned at a fixed distance from the mouth. Participants will sustain the vowel /a/ for as long as possible following a maximal inhalation. Three trials will be performed with approximately 15-second intervals between attempts. Data will be collected both at habitual speaking loudness and during exposure to white noise (70 dB) presented via headphones. MPT will be quantified in seconds \[s\] and analyzed on a ratio scale. The highest value obtained under each condition will be used for analysis. Higher MPT values indicate better phonatory performance, reflecting more efficient respiratory support and vocal fold function, whereas lower values may indicate reduced respiratory support and impaired vocal fold function.
Time frame: Assessment Time-p.oints: (i) Baseline (two baseline measurements obtained 5 weeks apart), (ii) immediately post-intervention, and (iii) 3-month follow-up.
Speech Range
Speech range (fundamental frequency, F0) will be assessed using a Speech Range Profile (SRP), a two-dimensional graphical representation of vocal performance, with fundamental frequency \[Hz\] on the x-axis and vocal intensity \[dB\] on the y-axis. Participants will read a standardized text and produce spontaneous speech based on a standardized picture-sequence task. Data will be collected both at habitual speaking loudness and during exposure to white noise (70 dB) presented via headphones. Speech range will be quantified in Hertz \[Hz\] and analyzed on a ratio scale (minimum, maximum, mean, modal frequency, and range in semitones). A reduced speech range indicates limited pitch variation and reduced prosodic variation during connected speech.
Time frame: Assessment Time-points: (i) Baseline (two baseline measurements obtained 5 weeks apart), (ii) immediately post-intervention, and (iii) 3-month follow-up.
Phrase length
Phrase length will be assessed from audio recordings obtained in a sound-treated studio using calibrated recording equipment and a head-mounted omnidirectional microphone positioned at a fixed distance from the mouth. Participants will read a standardized text. Data will be collected both at habitual speaking loudness and during exposure to white noise (70 dB) presented via headphones. Phrase length will be quantified as the mean number of syllables per breath group and analyzed on a ratio scale (mean). Higher values indicate more efficient speech breathing, whereas lower values may indicate reduced speech breathing efficiency.
Time frame: Assessment Time-points: (i) Baseline (two baseline measurements obtained 5 weeks apart), (ii) immediately post-intervention, and (iii) 3-month follow-up.
Maximum Expiratory Pressure (MEP)
Maximal expiratory pressure (MEP) will be obtained using the MicroRPM respiratory pressure meter. Following a maximal inhalation, participants will exhale as forcefully as possible into the device mouthpiece. To ensure reliable measurements, the procedure will be repeated until three values within 10% of each other have been recorded. MEP will be quantified in cmH₂O and analyzed on a ratio scale. The highest value will be used for analysis. Lower MEP values indicate reduced expiratory muscle strength and impaired respiratory function, whereas higher MEP values indicate greater expiratory muscle strength and better respiratory function.
Time frame: Assessment Time-points: (i) Baseline (two baseline measurements obtained 5 weeks apart), (ii) immediately post-intervention, and (iii) 3-month follow-up.
Swallowing Capacity
Swallowing capacity will be assessed using the Timed Water Swallow Test. Participants are instructed to drink a glass of still water as quickly and safely as possible without interruption. The time in seconds \[s\] from initial contact of the water with the lips to completion of the final swallow is recorded. To ensure accurate measurement, participants' mouth and neck regions are video-recorded during the assessment. Swallowing capacity is calculated by subtracting any residual volume from the initial volume and dividing the resulting volume by the recorded time. Swallowing capacity will be quantified in milliliters per second \[mL/s\] and analyzed on a ratio scale. Lower swallowing capacity values indicate reduced swallowing efficiency and poorer swallowing performance, whereas higher values indicate greater swallowing efficiency and better swallowing performance.
Time frame: Assessment Time-points: (i) Baseline (two baseline measurements obtained 5 weeks apart), (ii) immediately post-intervention, and (iii) 3-month follow-up.
Patient Reported Outcome; Respiratory Functioning
To assess participants' perceived respiratory functioning and breathing-related disability, the Dyspnea Index (DI) will be used. DI is a patient-reported outcome measure (PROM) designed to assess the severity of upper airway-related dyspnea. It consists of 10 items, each rated on a 5-point Likert scale (0-4), yielding a total score ranging from 0 to 40. Higher scores indicate more severe dyspnea symptoms and a greater impact on daily functioning and quality of life.
Time frame: Assessment Time-points: (i) Baseline (two baseline measurements obtained 5 weeks apart), (ii) immediately post-intervention, and (iii) 3-month follow-up.
Patient Reported Outcome; Voice Functioning
To assess participants' perceived voice functioning and the impact of voice problems on daily life, the Voice Handicap Index (VHI) will be administered. The VHI is a patient-reported outcome measure that evaluates the functional, physical, and emotional consequences of voice disorders. Higher scores indicate a greater perceived voice-related handicap and poorer voice functioning.
Time frame: Assessment Time-points: (i) Baseline (two baseline measurements obtained 5 weeks apart), (ii) immediately post-intervention, and (iii) 3-month follow-up.
Patient Reported Outcome; Speech and Communication Functioning
To assess participants' perceived speech functioning and communication-related difficulties, the Self-report Questionnaire on Acquired Speech Difficulties (SOFT) will be administered. The SOFT is a patient-reported outcome measure consisting of items rated on a 4-point Likert scale, yielding a mean score ranging from 0 to 3. Higher scores indicate a greater perceived impact of speech and communication difficulties on daily life.
Time frame: Assessment Time-points: (i) Baseline (two baseline measurements obtained 5 weeks apart), (ii) immediately post-intervention, and (iii) 3-month follow-up.
Patient Reported Outcome; Swallowing Functioning
To assess participants' perceived swallowing functioning and the impact of swallowing difficulties on daily life, the Sydney Swallow Questionnaire (SSQ) will be administered. The SSQ is a patient-reported outcome measure that assesses self-perceived swallowing difficulties using visual analogue scales, yielding a total score ranging from 0 to 1700. Higher scores indicate greater perceived swallowing impairment and swallowing-related disability.
Time frame: Assessment Time-points: (i) Baseline (two baseline measurements obtained 5 weeks apart), (ii) immediately post-intervention, and (iii) 3-month follow-up.
Dysarthria severity
The participant's level of functioning will be evaluated within the framework of the International Classification of Functioning, Disability and Health (ICF) using validated Therapy Outcome Measures (TOM). Likert scale, score range 0-5. Higher scores indicate better functioning, participation, and well-being, as well as reduced disability related to dysarthria.
Time frame: Assessment Time-points: (i) Baseline (two baseline measurements obtained 5 weeks apart), (ii) immediately post-intervention, and (iii) 3-month follow-up.
Dysphagia severity
The participant's level of functioning will be evaluated within the framework of the International Classification of Functioning, Disability and Health (ICF) using validated Therapy Outcome Measures (TOM). The participant's level of functioning will be evaluated within the framework of the International Classification of Functioning, Disability and Health (ICF) using validated Therapy Outcome Measures (TOM). Likert scale, score range 0-5. Higher scores indicate better functioning, participation, and well-being, as well as reduced disability related to dysphagia.
Time frame: Assessment Time-points: (i) Baseline (two baseline measurements obtained 5 weeks apart), (ii) immediately post-intervention, and (iii) 3-month follow-up.
Functional oral intake
Measured using the International Dysphagia Diet Standardisation Initiative Functional Diet Scale (IDDSI-FDS). Ordinal scale, score range 0-7. Higher scores indicate better swallowing-related dietary function and fewer dietary restrictions.
Time frame: Assessment Time-points: (i) Baseline (two baseline measurements obtained 5 weeks apart), (ii) immediately post-intervention, and (iii) 3-month follow-up.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No — The datasets generated and/or analysed during the current study will not be stored on an external site, however will be available from the corresponding author upon reasonable request.
Started Apr 2024 (actual). Primary completion is estimated for Sep 2028, 53 months after the start.
Of 1,293 non-industry interventional studies with no phase under Parkinson Disease, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 44. This study's planned 53 months is above that.
Counting every sponsor, half of 1,369 studies reached it within 25 months; a quarter within 12 and three quarters within 44.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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