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

Primary Purpose

Apoplexy; Brain

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Carbloading and maltodextrin
Sponsored by
University of Copenhagen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Apoplexy; Brain focused on measuring carbohydrates, rehabilitation, high-carbohydrate diet

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Rigshospitalet, Glostrup

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Intervention

Control

Arm Description

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

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

Outcomes

Primary Outcome Measures

Difference between inclusion and discharge in score
Measured with Barthel100 by the nursing staff

Secondary Outcome Measures

Length of stay (days)
Measured in full days
Intensity of training (score)
Assessed by the therapists who trained with the patient.
Duration of training (hours)
Assessed by the therapists after every training. Noted i the same document as "intensity of training"
Frequency of training with therapist (episodes/week)
Assessed by the therapists after every training.
Level of experienced fatique (VAS - score)
Measured by a VAS-fatigue scale.
Level of experienced post-work out muscle soreness (VAS - score)
Measured by a VAS-pain scale.
Level of physical activity during hospital admission - daily score
Noted on a document by the patient or the study officials.

Full Information

First Posted
November 17, 2020
Last Updated
December 23, 2020
Sponsor
University of Copenhagen
Collaborators
Rigshospitalet, Denmark
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1. Study Identification

Unique Protocol Identification Number
NCT04688489
Brief Title
Effect of Carbloading and Maltodextrin on the Level of Function in Patients With Apoplexia
Acronym
ApoCarb
Official Title
Randomized Controlled Trial on the Effect of Carbloading and Maltodextrin on the Level of Function in Patients With Apoplexia
Study Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
August 1, 2020 (Actual)
Primary Completion Date
November 30, 2020 (Actual)
Study Completion Date
December 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Copenhagen
Collaborators
Rigshospitalet, Denmark

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Apoplexy; Brain
Keywords
carbohydrates, rehabilitation, high-carbohydrate diet

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Active Comparator
Arm Description
The intervention consists of a supplement of maltodextrin at training episodes combined with added dietary carbohydrates at all meals
Arm Title
Control
Arm Type
No Intervention
Arm Description
The control receives no intervention. Standard treatment will be administered.
Intervention Type
Dietary Supplement
Intervention Name(s)
Carbloading and maltodextrin
Intervention Description
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.
Primary Outcome Measure Information:
Title
Difference between inclusion and discharge in score
Description
Measured with Barthel100 by the nursing staff
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Length of stay (days)
Description
Measured in full days
Time Frame
8 weeks
Title
Intensity of training (score)
Description
Assessed by the therapists who trained with the patient.
Time Frame
8 weeks
Title
Duration of training (hours)
Description
Assessed by the therapists after every training. Noted i the same document as "intensity of training"
Time Frame
8 weeks
Title
Frequency of training with therapist (episodes/week)
Description
Assessed by the therapists after every training.
Time Frame
8 weeks
Title
Level of experienced fatique (VAS - score)
Description
Measured by a VAS-fatigue scale.
Time Frame
8 weeks
Title
Level of experienced post-work out muscle soreness (VAS - score)
Description
Measured by a VAS-pain scale.
Time Frame
8 weeks
Title
Level of physical activity during hospital admission - daily score
Description
Noted on a document by the patient or the study officials.
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Helle Klingenberg Iversen
Organizational Affiliation
Neurologisk Klinik, Rigshospitalet Glostrup
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rigshospitalet, Glostrup
City
Glostrup
State/Province
Sjælland
ZIP/Postal Code
2600
Country
Denmark

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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