Stroke, Ischemic
Conditions
Keywords
stroke, creatine, sarcopenia
Brief summary
Stroke is a leading cause of disability and the second leading cause of death worldwide. Most strokes are ischemic, caused by acute arterial occlusion. Post-stroke treatment focuses on secondary prevention and rehabilitation, but few treatments address functional recovery. Creatine, a supplement known for improving physical performance, may aid in the recovery of stroke patients, reducing sarcopenia and improving strength among other effects. This pilot study will investigate the effectiveness of creatine supplementation in enhancing physical and functional recovery in ischemic stroke patients. The study will involve a randomized, double-blind clinical trial comparing creatine monohydrate to a placebo.
Detailed description
Stroke is one of the most impactful health conditions worldwide, currently being the leading cause of disability and the second leading cause of death globally. Approximately 85-90% of strokes are ischemic, primarily caused by acute arterial occlusion, leading to an area of cerebral, spinal, or retinal infarction. The size of the lesion depends on the affected blood vessel and the duration of the occlusion, as well as cerebral autoregulation, blood pressure, blood sugar levels, and many other factors. After the acute phase, treatment is based on secondary prevention and rehabilitation, with few treatments currently available that focus on functional recovery once the infarction has occurred. Stroke survivors experience a loss of functionality, a decline in physical capacity associated with a decrease in muscle mass, sarcopenia, cognitive impairment, and an increase in anxiety and depressive symptoms. Creatine is a widely studied nutritional supplement, mainly in athletes, where it has been shown to improve training adaptation and physical performance. Its effects on energy metabolism, as an anti-inflammatory, and on calcium homeostasis have been described. There are also studies indicating possible musculoskeletal benefits in the elderly population. Given its role in improving physical performance and muscle mass, considering the significant impact of these conditions on patients who have suffered an ischemic stroke, and considering its antioxidant and anti-inflammatory effects, we propose a pilot study to determine the effectiveness of creatine supplementation in stroke patients. This supplementation could potentially lead to greater physical and functional recovery following an ischemic stroke. A randomized, double-blind clinical trial will be conducted. The trial will include a group supplemented with creatine monohydrate at a dose of 0.3 g/kg/day for 7 days, followed by 0.1 g/kg/day for 12 weeks, alongside standard clinical practice; and a control group supplemented with a placebo (corn starch maltodextrin), following the same protocol and doses.
Interventions
DIETARY_SUPPLEMENTCreatine monohydrate
Creatine monohydrate. Guinama brand with CE marking. Code 89823.
OTHERPlacebo
Dextrinomaltose. Guinama brand with CE marking. Code 91146.
Sponsors
Comunidad Autónoma de las Islas Baleares (Dirección General de Investigación en Salud, Formación y Acreditación)
Fundació d'investigació Sanitària de les Illes Balears
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
A professional from the pharmacy service, who will not be involved in data collection or participant care, will handle the blinding. The care staff responsible for patient care will be unaware of each participant's assignment group. Blinding may be broken if a serious adverse effect related to the supplementation is suspected in one of the participants.
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Age between 18 and 80 years * Recent diagnosis of ischemic stroke (from 24 hours to 5 days) . * Neurological deficit due to the stroke that affects mobility (paresis and/or ataxia) and requires motor rehabilitation. * Ability to understand and sign the informed consent form, or failing that, have sufficient support to carry out the correct follow-up of the study.
Exclusion criteria
* Moderate-severe disability prior to stroke, defined by an mRS\>2. * Unstable or severe clinical situation that prevents active rehabilitation. * Neurological deficit due to stroke that prevents walking without help from another person. The use of support with a cane, crutch or walker is permitted. * Moderate or severe dysphagia that makes therapeutic adherence difficult. * Use of creatine supplements in the last 3 months, or use of anabolic products in the last 3 months. * Severe kidney disease (GFR \<30ml/min/1.73 m2). * Musculoskeletal pathology that prevents assessment of muscle strength. For example: fractures, severe osteoarthritis, ligament tears or tendinopathies. * History of allergic reactions to creatine. * Pregnancy or breastfeeding. * Simultaneous participation in another clinical trial.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Physical performance | 3 months, 6 months | To analyze the improvement in physical performance, at 3 months (at the end of the intervention) and at 6 months, measured by the 6-Minute Walking Test (6MW). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Physical performance using Test timed up and go (TUG). | 3 months, 6 months | Test timed up and go (TUG). |
| Maximum muscle strength | 3 months, 6 months | Maximum muscle strength, measured by manual dynamometer (Kilograms). Grip strength, biceps, triceps, deltoids, psoas, quadriceps and hamstrings will be assessed. |
| Arm and leg muscle strength | 3 months, 6 months | Measured by the score on items 5 and 6 of the National institute of Health Stroke Scale (NIHSS) where the score range is from 0 to 4. A higher score corresponds to a worse performance. |
| Balance and stability | 3 months, 6 months | Balance and stability measured using the Postural Assessment Scale for Stroke Patients (PASS). The scale includes 12 items, which are divided into two categories: maintaining a posture (static balance) and changing a posture (dynamic balance). Higher scores indicate better postural control and balance. |
| Performance in basic activities of daily living | 3 and 6 months | Barthel Scale. The Barthel Index is a scale used to measure a person's performance in basic activities of daily living (ADLs) and assess functional independence |
| Cognitive assessment | 3 months | Cognitive assessment using the Montreal cognitive assessment (MoCA) test. The MoCA is a tool used to assess cognitive impairment in various domains, including memory, attention, language, and executive function. A higher score means a better outcome. |
| Quality of life measured by EuroQol 5D | 3 months, 6 months | Quality of life assessment using the EuroQol 5D. EuroQoL 5D is a standardized tool used to assess health-related quality of life. A higher score corresponds to worse quality of life. |
| Anxiety and depression symptoms | 3 months | Assessment of anxiety and depression symptoms using the HADS (Hospital Anxiety and Depression Scale). Both the Anxiety subscale and the Depression subscale range from 0 to 21. Higher scores on either subscale indicate worse outcomes (more severe anxiety or depression). |
| Appendicular skeletal muscle mass | 3 months | Measurement of appendicular (arms and legs) skeletal muscle mass change from baseline, using DXA (dual-energy X-ray absorptiometry) measured in kilograms. A higher skeletal muscle mass means a better outcome. |
| Functional impact | 3 months, 6 months | Functional impact measured by the Modified Rankin Scale (mRS). The mRS is a commonly used scale to measure the degree of disability or dependence in daily activities of people who have suffered a stroke. The mRS is scored on a scale from 0 to 6, with higher scores indicating greater disability |
| Appendicular body fat | 3 months | Measurement of appendicular (arms and legs) and total body fat change from baseline, using DXA (dual-energy X-ray absorptiometry) measured in kilograms. A lower fat mass means a better outcome. |
| Total body fat | 3 months | Measurement of total body fat change from baseline, using DXA (dual-energy X-ray absorptiometry) measured in kilograms. A lower fat mass means a better outcome. |
| Nutritional status | 3 months, 6 months | Measurement of nutritional status change by phase angle using a bioelectrical impedance analysis. A higher phase angle means a better outcome. Outcome units are degrees. |
| Number of falls. | 3 months, 6 months | Number of falls since last visit. |
| Geriatric Nutritional Risk Index (GNRI) score | 3 months, 6 months | Geriatric Nutritional Risk Index (GNRI) score. The following formula is used: \[1.489 × serum albumin (g/L)\] + (41.7 × weight (kg)/ideal weight (kg)). |
| Ventricular strain change | 3 months | Effect of creatine on cardiac damage secondary to stroke measured using ventricular strain measurement (percentage). A lower strain corresponds to a worse outcome. |
| Ejection fraction change | 3 months | Effect of creatine on cardiac damage secondary to stroke measured using ejection fraction (EF) measurement (percentage). A lower EF corresponds to a worse outcome. |
| Adverse events | From enrollment to the end of treatment at 6 months | To assess the occurrence of any adverse events in any of the intervention groups. |
| Total skeletal muscle mass | 3 months | Measurement of total skeletal muscle mass change from baseline, using DXA (dual-energy X-ray absorptiometry) measured in kilograms. A higher skeletal muscle mass means a better outcome. |
Countries
Spain
Contacts
Primary ContactRaquel Delgado Mederos, PhD
Backup ContactEduard Bargay Pizarro, MD
Outcome results
None listed