NCT06949839Toborzás még nem indult
Effectiveness of Therapeutic Exercise Combined With Respiratory Muscle Training in Patients With Subacute Stroke
Effectiveness of a Therapeutic Exercise Program Combined With Respiratory Muscle Training in Patients With Subacute Stroke: a Randomized Clinical Trial
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2025. ápr. 29. · Több mint 12 hónapja nem frissült - kérdezd meg a helyszínt, nyitott-e még
Rövid összefoglaló (regiszter, angolul)
Stroke has a significant impact on morbidity, mortality and healthcare expenditure globally. In addition to the motor and cognitive consequences, as well as on functional independence and social participation, it can produce alterations in the respiratory function. Scientific evidence supports the application of both therapeutic exercise programs and respiratory muscle training (RMT). However, studies that combine both interventions are limited, and to date no study has been published that examines the effectiveness of this combination in the subacute phase of stroke, which is the one that presents the widest range of neuroplasticity. Objectives: To analyze the effects of a combined therapeutic exercise and RMT program, compared to the therapeutic exercise and sham RMT program, on different variables related to functional, respiratory, swallowing and speech/voice capacity, in patients in the subacute phase of a stroke. Type of research: double-blind randomized controlled clinical trial. Design: The study will be carried out at the University Hospital Complex of A Coruña (CHUAC), where 64 patients with more than three and less than six months of evolution after a stroke will be recruited. Participants will be randomly assigned to two groups: the intervention group will perform a combined therapeutic exercise and RMT program, while the control group will combine the same therapeutic exercise program and sham RMT. The duration of the intervention will be eight weeks. The therapeutic exercise program will be carried out three days per week and will consist of a cardiovascular exercise part and a strength-endurance part. The RMT protocol will involve both the inspiratory and expiratory muscles, using the Orygen-Dual Valve® device. The control group will use the same valve but without resistance, generating a sham RMT. It will have a frequency of five days per week and will be carried out at the home of each patient. Additionally, half the subjects in the intervention group will continue the RMT protocol once the eight-week period has ended, with a frequency of two days per week, until the six-month follow-up. Possible differences between groups will be analyzed before and after the intervention, and at three and six months of follow-up, in relation to the following domains: functional capacity, functional independence, lung and respiratory muscle function, swallowing and speech/voice function, respiratory signs and symptoms, and quality of life.
- Állapot (regiszter)
- Toborzás még nem indult
- Vizsgálattípus
- Beavatkozással járó
- Résztvevők száma
- 64 (tervezett)
- Első benyújtás
- 2025. ápr. 8.
- Kezdés
- 2025. ápr.
- Elsődleges befejezés
- 2027. máj.
- Fő szponzor
- Ana Lista Paz
- Betegségek
- Stroke (szélütés)
- NCT-szám
- NCT06949839
Mit vállalsz
- Vizsgálat típusa: Beavatkozással járó
- Tervezett résztvevők: 64
- 2025. ápr. és az elsődleges befejezés (2027. máj.) között
- 1 helyszín, 1 országban
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
A(z) ClinicalTrials.gov regisztermezőiből összeállítva. A vizsgálat felépítését írja le.
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Korábbi kezelés
- Those with other underlying neurological diseases with impaired functionality prior to the stroke.
- Those with a prior participation in a RMT program.
Más betegség
- Those with recurrent stroke.
- Those with a history of chronic respiratory disease.
- Those with other cardiovascular or metabolic diseases in an unstable phase.
Egyéb
- Those with severe cognitive deficits that impede understanding of the assessment tests and/or the intervention.
- Those with severe facial paralysis that impedes proper performance of pulmonary function and respiratory muscle strength tests.
- Those who participate in a cardiovascular and/or strength-endurance training program at the time of the study.
- Those with any of the contraindications to performing the tests included in the study protocol: spirometry, respiratory muscle strength and endurance tests, and 6MWT.
- Those with any of the contraindications to physical exercise.
Kiket keres a vizsgálat
- Those diagnosed with a first stroke occurring three to six months after the onset (subacute phase).
- Those aged 18 years or older.
- Those able to walk at least 10 meters, with or without walking aids and/or physical assistance from another person.
Életkor a regiszterben: 18 év – - · Nem: nők és férfiak · Egészséges önkénteseket nem fogad
Helyszínek (1)
Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.
| Helyszín | Város | Ország | Helyszín állapota |
|---|---|---|---|
| University Hospital of A Coruña (CHUAC) | A Coruña | Spanyolország | Ismeretlen állapot |
Ez az oldal tájékoztatás, nem orvosi tanács. Bármely vizsgálatról az orvosoddal beszélj.