Effect of Supplementation With Creatine on the Recovery of Ischemic Stroke: A Randomized Clinical Trial
NCT Number: NCT06576466
Acronym: SUCRE
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Stroke, Ischemic
Interventions: DIETARY_SUPPLEMENT: Creatine monohydrate|OTHER: Placebo
Sponsor: Fundació d'investigació Sanitària de les Illes Balears
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 92
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-09-02
Completion Date: 2027-07-01
Locations: IdISBa, Palma De Mallorca, Illes Balears, 07120, Spain

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.

Primary Outcome Measures: Physical performance, 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)., 3 months, 6 months
Secondary Outcome Measures: Physical performance using Test "timed up and go" (TUG)., Test "timed up and go" (TUG)., 3 months, 6 months|Maximum muscle strength, Maximum muscle strength, measured by manual dynamometer (Kilograms). Grip strength, biceps, triceps, deltoids, psoas, quadriceps and hamstrings will be assessed., 3 months, 6 months|Arm and leg muscle strength, 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., 3 months, 6 months|Balance and stability, 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., 3 months, 6 months|Functional impact, 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, 3 months, 6 months|Performance in basic activities of daily living, 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, 3 and 6 months|Cognitive assessment, 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., 3 months|Quality of life measured by EuroQol 5D, 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., 3 months, 6 months|Anxiety and depression symptoms, 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)., 3 months|Appendicular skeletal muscle mass, 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., 3 months|Total skeletal muscle mass, 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., 3 months|Appendicular body fat, 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., 3 months|Total body fat, 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., 3 months|Nutritional status, 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., 3 months, 6 months|Number of falls., Number of falls since last visit., 3 months, 6 months|Geriatric Nutritional Risk Index (GNRI) score, Geriatric Nutritional Risk Index (GNRI) score. The following formula is used: \[1.489 × serum albumin (g/L)\] + (41.7 × weight (kg)/ideal weight (kg))., 3 months, 6 months|Ventricular strain change, Effect of creatine on cardiac damage secondary to stroke measured using ventricular strain measurement (percentage). A lower strain corresponds to a worse outcome., 3 months|Ejection fraction change, Effect of creatine on cardiac damage secondary to stroke measured using ejection fraction (EF) measurement (percentage). A lower EF corresponds to a worse outcome., 3 months