Clinical trial NCT04688489: Effect of Carbloading and Maltodextrin on the Level of Function in Patients With Apoplexia
Official title: Randomized Controlled Trial on the Effect of Carbloading and Maltodextrin on the Level of Function in Patients With Apoplexia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Apoplexy; Brain
Keywords: carbohydrates
rehabilitation
high-carbohydrate diet
Lead sponsor: University of Copenhagen
Sponsor class: OTHER
Collaborators: name: Rigshospitalet, Denmark
First posted: 2020-12-30
Enrollment: 20
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Difference between inclusion and discharge in score
timeFrame: 8 weeks
Secondary outcomes:
measure: Length of stay (days)
timeFrame: 8 weeks
measure: Intensity of training (score)
timeFrame: 8 weeks
measure: Duration of training (hours)
timeFrame: 8 weeks
measure: Frequency of training with therapist (episodes/week)
timeFrame: 8 weeks
measure: Level of experienced fatique (VAS - score)
timeFrame: 8 weeks
measure: Level of experienced post-work out muscle soreness (VAS - score)
timeFrame: 8 weeks
measure: Level of physical activity during hospital admission - daily score
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Glostrup
country: Denmark
facility: Rigshospitalet, Glostrup
state: Sjælland
Study officials:
affiliation: Neurologisk Klinik, Rigshospitalet Glostrup
name: Helle Klingenberg Iversen
role: PRINCIPAL_INVESTIGATOR
References: