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

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

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.

Study Overview

• Status: Completed
• Conditions: Apoplexy; Brain
• Intervention / Treatment: Dietary supplement: Carbloading and maltodextrin

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 Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Sjælland
    • Glostrup, Sjælland, Denmark, 2600
      • Rigshospitalet, Glostrup

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Intervention; The intervention consists of a supplement of maltodextrin at training episodes combined with added dietary carbohydrates at all meals	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.
No Intervention: Control; The control receives no intervention. Standard treatment will be administered.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Copenhagen
• Collaborators: Rigshospitalet, Denmark
• Investigators: Principal Investigator: Helle Klingenberg Iversen, Neurologisk Klinik, Rigshospitalet Glostrup

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2020
• Primary Completion (Actual): November 30, 2020
• Study Completion (Actual): December 1, 2020

Study Registration Dates

• First Submitted: November 17, 2020
• First Submitted That Met QC Criteria: December 23, 2020
• First Posted (Actual): December 30, 2020

Study Record Updates

• Last Update Posted (Actual): December 30, 2020
• Last Update Submitted That Met QC Criteria: December 23, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Keywords: rehabilitation; carbohydrates; high-carbohydrate diet
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: H-20018258

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No