Effect of Carbloading and Maltodextrin on the Level of Function in Patients With Apoplexia

Study Overview
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Brief Summary
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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
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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.

Official Title
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Randomized Controlled Trial on the Effect of Carbloading and Maltodextrin on the Level of Function in Patients With Apoplexia

Conditions
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Apoplexy; Brain

Intervention / Treatment
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* Dietary Supplement: Carbloading and maltodextrin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Intervention<br>The intervention consists of a supplement of maltodextrin at training episodes combined with added dietary carbohydrates at all meals | Dietary Supplement: Carbloading and maltodextrin<br>* 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.<br>|
| No Intervention: Control<br>The control receives no intervention. Standard treatment will be administered. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference between inclusion and discharge in score | Measured with Barthel100 by the nursing staff | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of stay (days) | Measured in full days | 8 weeks | 
| Intensity of training (score) | Assessed by the therapists who trained with the patient. | 8 weeks | 
| Duration of training (hours) | Assessed by the therapists after every training. Noted i the same document as intensity of training | 8 weeks | 
| Frequency of training with therapist (episodes/week) | Assessed by the therapists after every training. | 8 weeks | 
| Level of experienced fatique (VAS - score) | Measured by a VAS-fatigue scale. | 8 weeks | 
| Level of experienced post-work out muscle soreness (VAS - score) | Measured by a VAS-pain scale. | 8 weeks | 
| Level of physical activity during hospital admission - daily score | Noted on a document by the patient or the study officials. | 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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carbohydrates, rehabilitation, high-carbohydrate diet