Dysphagic stroke Circulatory System Dysphagic stroke
Conditions
Interventions
A 12 weeks study to investigate the use of respiratory exercises in 60 dysphagic stroke patients. The various interventions are:
1. Expiratory Muscle Training (EMT) will be undertaken using a handheld
Sponsors
King's College Hospital NHS Trust (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Ischemic stroke patients aged between 50 and 80 years with: 1.1. First ever stroke 1.2. Within 1 week of stroke onset 1.3. Moderate severity, defined as NIH stroke scale of 520 2. Videofluoroscopic evidence of aspiration 3. Ability to maintain sitting balance 4. Adequate communication to follow instructions 5. Able to comply with respiratory muscle testing procedures 6. Consent to participation
Exclusion criteria
Exclusion criteria: 1. Suboptimal blood pressure control (BP greater than 180/100 mm Hg on 3 occasions in last 24 hours) 2. Myocardial infarction, angina or heart failure in the last 3 months 3. Features of raised intracranial pressure on CT scan 4. Pulmonary, neurological (other than stroke) or orthopaedic conditions that adversely affected the respiratory muscle pump
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Assessments of patient outcomes will be undertaken at baseline, completion of training (4 weeks) and at 3 months to assess sustainability of effect. These will include: 1. Assessment of aspiration: Aspiration will be assessed using videofluoroscopy (VF) undertaken by a speech and language therapist blinded to patient allocation. Patients will be seated in an upright position and different consistencies of food/liquid impregnated with barium will be used. Imaging will be done using lateral projection from the teeth anteriorly to the posterior pharyngeal wall posteriorly. Patients will be scored according to their most unsafe swallow and categorised as: safe (no penetration or aspiration), penetration (entry of material into the laryngeal vestibule without passage through the (true vocal cords), silent aspiration (passage through the cords without cough or accompanying distress) or overt aspiration. The proportion of patients with silent or over aspiration who fail to clear their airways with cough will be used for analysis. Assessment of aspiration will be undertaken in all patients at 4 weeks. Assessment at 3 months will be undertaken only in patients still aspirating at 4 weeks to limit radiation risk. 2. Assessment of function: Dependence in activities of daily living will be measured using the Nottingham Extended Activities of Daily Living Index, which has been validated in stroke patients. 3. Assessment of respiratory function: Respiratory assessments will be undertaken masked to allocation. Subjects will be propped up to 45 degrees to ensure that the abdominal muscles are not being used to maintain posture and will wear a nose clip to prevent air leakage. Measurements will be undertaken in accordance with American Thoracic Society and European Respiratory Society guidelines. Forced expiratory volume in the first second (FEV1), forced vital capacity (FVC) and peak expiratory flow rate (PEFR) will be measured using a handheld spirometer and values will be obta | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Assessment of participation, acceptability and safety 1.1. Data on the number of stroke patients admitted during the study, and the numbers screened, eligible and participating in the study will be collected. The reasons for exclusion or non participation will be recorded. 1.2. Data on the training provided and difficulties experienced during training instruction or use of equipment will be collected in the trainer?s log. Information on training pressure thresholds, total number of training sets and repetitions per set will be recorded in the patient log. 1.3. Pre and post training session blood pressure, heart rate and oxygen saturations and adverse events will be collected from the patient training log. | — |
Countries
United Kingdom
Outcome results
None listed