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

NCT04688489 | Completed

• 1 other identifier: H-20018258
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Apoplexy; Brain

Keywords

carbohydrates; rehabilitation; high-carbohydrate diet

Outcome Measures

Primary Outcomes (1)

• Difference between inclusion and discharge in score

  Measured with Barthel100 by the nursing staff

  8 weeks

Secondary Outcomes (7)

• Length of stay (days)

  8 weeks

• Intensity of training (score)

  8 weeks

• Duration of training (hours)

  8 weeks

• Frequency of training with therapist (episodes/week)

  8 weeks

• Level of experienced fatique (VAS - score)

  8 weeks

Study Arms (2)

Intervention

ACTIVE COMPARATOR

The intervention consists of a supplement of maltodextrin at training episodes combined with added dietary carbohydrates at all meals

Dietary Supplement: Carbloading and maltodextrin

Control

NO INTERVENTION

The control receives no intervention. Standard treatment will be administered.

Interventions

Carbloading and maltodextrin DIETARY_SUPPLEMENT

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.

Intervention

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Diabetes Mellitus type I og type II
• Enteral nutrition (tube feeding)
• Barthel-100 over 80 points

Sponsors & Collaborators

• University of Copenhagen: lead
• Rigshospitalet, Denmark: collaborator

Study Sites (1)

Rigshospitalet, Glostrup

Glostrup, Region Sjælland, 2600, Denmark

Location

MeSH Terms

Conditions

Stroke

Interventions

maltodextrin

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Helle Klingenberg Iversen

  Neurologisk Klinik, Rigshospitalet Glostrup

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: November 17, 2020
• First Posted: December 30, 2020
• Study Start: August 1, 2020
• Primary Completion: November 30, 2020
• Study Completion: December 1, 2020
• Last Updated: December 30, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)