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

Apoplexy; Brain Clinical Trial

— ApoCarb  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04688489
• Other study ID #: H-20018258
• Status: Completed
• Phase: N/A
• Start date: August 1, 2020
• Est. completion date: December 1, 2020

Study information

• Verified date: December 2020
• Source: University of Copenhagen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 1, 2020
• Est. primary completion date: November 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Apoplexy; Brain
• Stroke

Intervention

Dietary Supplement:
• Carbloading 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.

Locations

Country	Name	City	State
Denmark	Rigshospitalet, Glostrup	Glostrup	Sjælland

Sponsors (2)

Lead Sponsor	Collaborator
University of Copenhagen	Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference between inclusion and discharge in score	Measured with Barthel100 by the nursing staff	8 weeks
Secondary	Length of stay (days)	Measured in full days	8 weeks
Secondary	Intensity of training (score)	Assessed by the therapists who trained with the patient.	8 weeks
Secondary	Duration of training (hours)	Assessed by the therapists after every training. Noted i the same document as "intensity of training"	8 weeks
Secondary	Frequency of training with therapist (episodes/week)	Assessed by the therapists after every training.	8 weeks
Secondary	Level of experienced fatique (VAS - score)	Measured by a VAS-fatigue scale.	8 weeks
Secondary	Level of experienced post-work out muscle soreness (VAS - score)	Measured by a VAS-pain scale.	8 weeks
Secondary	Level of physical activity during hospital admission - daily score	Noted on a document by the patient or the study officials.	8 weeks