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

Not Applicable

Completed

• Conditions: Apoplexy; Brain
• Interventions: Dietary Supplement: Carbloading and maltodextrin

• Registration Number: NCT04688489
• Lead Sponsor: University of Copenhagen

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.

Study Timeline

• Study Start: 2020-08-01
• Study First Submitted: 2020-11-17
• Primary Completion: 2020-11-30
• Status Verified: 2020-12
• Study Completion: 2020-12-01
• Study First Submitted QC: 2020-12-23
• Last Update Submitted: 2020-12-23
• Study First Posted: 2020-12-30
• Last Update Posted: 2020-12-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	Carbloading and maltodextrin	The intervention consists of a supplement of maltodextrin at training episodes combined with added dietary carbohydrates at all meals

Primary Outcome Measures

Name	Time	Method
Difference between inclusion and discharge in score	8 weeks	Measured with Barthel100 by the nursing staff

Secondary Outcome Measures

Name	Time	Method
Length of stay (days)	8 weeks	Measured in full days
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"
Level of experienced fatique (VAS - score)	8 weeks	Measured by a VAS-fatigue scale.
Frequency of training with therapist (episodes/week)	8 weeks	Assessed by the therapists after every training.
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.

Trial Locations

Locations (1)

Rigshospitalet, Glostrup; 🇩🇰 Glostrup, Sjælland, Denmark