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

NCT ID: NCT04688489

Last Updated: 2020-12-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-08-01

Study Completion Date

2020-12-01

Brief Summary

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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

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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.

Conditions

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Apoplexy; Brain

Keywords

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carbohydrates rehabilitation high-carbohydrate diet

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Intervention

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

Group Type ACTIVE_COMPARATOR

Carbloading and maltodextrin

Intervention Type 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.

Control

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Rigshospitalet, Denmark

OTHER

Sponsor Role collaborator

University of Copenhagen

OTHER

Sponsor Role lead

Responsible Party

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Jens Rikardt Andersen

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Helle Klingenberg Iversen

Role: PRINCIPAL_INVESTIGATOR

Neurologisk Klinik, Rigshospitalet Glostrup

Locations

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Rigshospitalet, Glostrup

Glostrup, Region Sjælland, Denmark

Site Status

Countries

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Denmark

Other Identifiers

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H-20018258

Identifier Type: -

Identifier Source: org_study_id