Apoplexy; Brain
Conditions
Keywords
carbohydrates, rehabilitation, high-carbohydrate diet
Brief summary
The study will investigate the potential effect of a supplement of maltodextrin and added dietary carbohydrates on the level of function in patients with apoplexia. The study has an intervention group and a control group. The study is randomized, but not blinded. The primary outcome is level of function measured with Barthel-100. Besides the primary outcome there are several secondary outcomes (see detailed description). All patients are recruited from Rigshospitalet, Glostrup.
Detailed description
The study will investigate the potential effect of a supplement of maltodextrin (20 g for women and 30 g for men) and added dietary carbohydrates on the level of function in patients with apoplexia. The study has an intervention group and a control group. The study is randomized, but not blinded. The primary outcome is level of function measured with Barthel-100. Secondary outcomes are: training intensity, duration and frequency; length of stay; self-training (training without a therapist) and patient's experienced fatigue; and patient's experienced pain. All patients are recruited from Rigshospitalet, Glostrup. The supplement will be administered before and after each training session with a therapist. The supplement is a powder desolved in a glass of juice. The nursing staff will add extra carbohydrates to the patient's meals in the form of potatoes, rice, bread, fruit or other carbohydrate rich food items. All meals will be noted daily and validated the following day by the primary investigators.
Interventions
DIETARY_SUPPLEMENTCarbloading and maltodextrin
The intervention is a dietary intervention that consists of a supplement of maltodextrin and added dietary carbohydrates. The supplement (20 g for women and 30 g for men) will be given to patients before and after a scheduled training, while the carbohydrates are given with meals. The extra carbohydrates given at meal time consists of extra potatoes, rice, bread, fruit, juice or other carbohydrate-rich food items.
Sponsors
Rigshospitalet, Denmark
University of Copenhagen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients with apoplexia who are declared suited for rehabilitation at Afs. Neurologisk Afdeling N 35 - Apopleksi or Afs. Neurologisk Afdeling N 45 - Apopleksi, Rigshospitalet, Glostrup * Patient must be able to consent participation * Age 50+ years * Must be able to understand danish * Must be relevant for physio- or occupational therapy
Exclusion criteria
* Diabetes Mellitus type I og type II * Enteral nutrition (tube feeding) * Barthel-100 over 80 points
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Difference between inclusion and discharge in score | 8 weeks | Measured with Barthel100 by the nursing staff |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Intensity of training (score) | 8 weeks | Assessed by the therapists who trained with the patient. |
| Duration of training (hours) | 8 weeks | Assessed by the therapists after every training. Noted i the same document as intensity of training |
| Frequency of training with therapist (episodes/week) | 8 weeks | Assessed by the therapists after every training. |
| Length of stay (days) | 8 weeks | Measured in full days |
| Level of experienced post-work out muscle soreness (VAS - score) | 8 weeks | Measured by a VAS-pain scale. |
| Level of physical activity during hospital admission - daily score | 8 weeks | Noted on a document by the patient or the study officials. |
| Level of experienced fatique (VAS - score) | 8 weeks | Measured by a VAS-fatigue scale. |
Countries
Denmark
Outcome results
None listed