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NCT05951790: LOPD01
Inspiratory Muscle Training (IMT) in Adult People With Pompe Disease
NA trial testing Inspiratory Muscle Training (IMT) in Glycogen Storage Disease Type II in 20 participants. Status unknown.
1 June 2023
Quick facts
| Lead sponsor | Fondazione Don Carlo Gnocchi Onlus |
|---|---|
| Phase | NA |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 20 |
| Start date | 1 March 2023 |
| Primary completion | 1 June 2023 |
| Estimated completion | 1 April 2024 |
| Sites | 1 location across Italy |
Drugs / interventions tested
- Inspiratory Muscle Training (IMT)
- Inspiratory Muscle Training (IMT) + Air Stacking
Conditions studied
- Glycogen Storage Disease Type II — all drugs for Glycogen Storage Disease Type II →
- Pompe Disease (Late-onset) — all drugs for Pompe Disease (Late-onset) →
Sponsor
Fondazione Don Carlo Gnocchi Onlus — full company profile →
Who can join
18 and older, any sex, with Glycogen Storage Disease Type II or Pompe Disease (Late-onset). Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The goal of this multicentre, randomized and controlled cross-over trial is to evaluate the efficacy of a programme of Inspiratory Muscle Training in subjects with Late On-set Pompe Disease (LOPD). The main question is to: * verify changes in Forced Vital Capacity, Postural Drop, Maximal Inspiratory Pressure, Maximal Expiratory Pressure, Peak expiratory cough pressure, Maximal Inspiratory Capacity, six- minute walk test and or 6-minute pegboard ring test.- * measure changes in some questionnaries investigating dispnoea and quality of life (Short-Form 36, Individualized-Neuromuscular-Quality-of-Life, Maugeri-Respiratory-Failure 28, Borg scale, Dispnoea 12, Mulditimensional Dispnea Profile, modified Medical Research Council, Fatigue Severity Scale, Epsworth Scale, Visual Analogue Scale). Measurement will take place at baseline and after one, three, four, six and twelve months. Participants will undergo a specific treatment consisting of aerobic exercise and Inspiratory Muscle Training with Powerbreathe device or Air-Stacking. Researchers will study if Powerbreathe device is more effective than Air-stacking maneuvres
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT05951790
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Inspiratory Muscle Training (IMT)
Trials testing the same drug.
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- NCT04566172 — Preoperative Optimization to Improve Functional Status · NA · withdrawn
- NCT06576297 — Novel Respiratory Training as Part of Palliative Care for Older Adults With Heart Failure · NA · active not recruiting
- NCT06286553 — Rehabilitation of Abdominal Diastasis After Childbirth: Trunk and Inspiratory Muscle Training · NA · recruiting
Other recruiting trials for Glycogen Storage Disease Type II
Currently open trials in the same condition.
- NCT06666413 — China Post-approval Commitment (PAC) Study of Avalglucosidase Alfa in Participants With IOPD · Phase 4 · recruiting
- NCT05164055 — Avalglucosidase Alfa French Post-trial Access for Participants With Pompe Disease (PTA Avalglucosidase) · Phase 4 · active not recruiting
- NCT04910776 — Clinical Study for Treatment-naïve IOPD Babies to Evaluate Efficacy and Safety of ERT With Avalglucosidase Alfa · Phase 3 · active not recruiting
- NCT04848779 — A Prospective Study to Observe & Describe Clinical Outcomes of Alglucosidase Alfa Treatment in Patients ≤6 Months of Age · active not recruiting
- NCT00231400 — Pompe Disease Registry Protocol · recruiting
Other Fondazione Don Carlo Gnocchi Onlus trials
Trials by the same sponsor.
- NCT07252856 — Transcultural Digital Solutions in Phase III Cardiac Rehabilitation · NA · not yet recruiting
- NCT07290218 — Tridimensional Robotic Assessment of Neglect in Brain Injured Patients · not yet recruiting
- NCT07064226 — Validation of a Digital Intervention to Rehabilitate Cognitive Resources · NA · recruiting
- NCT07130929 — Functional Electrical Stimulation to Treat Critical Neuromyopathy After Severe Stroke: a Pilot Study. · NA · recruiting
- NCT07159854 — Telerehabilitation in Central and Peripheral Neurological Sequelae From Chemotherapy · NA · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05951790 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Fondazione Don Carlo Gnocchi Onlus
- Last refreshed: 19 July 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05951790.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing