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NCT Number: NCT04688489

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.

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Key information

Conditions

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

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rigshospitalet, Glostrup

Glostrup, Region Sjælland, 2600, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Difference between inclusion and discharge in score

    Time frame: 8 weeks

    Measured with Barthel100 by the nursing staff

Secondary outcomes

  1. Length of stay (days)

    Time frame: 8 weeks

    Measured in full days

  2. Intensity of training (score)

    Time frame: 8 weeks

    Assessed by the therapists who trained with the patient.

  3. Duration of training (hours)

    Time frame: 8 weeks

    Assessed by the therapists after every training. Noted i the same document as "intensity of training"

  4. Frequency of training with therapist (episodes/week)

    Time frame: 8 weeks

    Assessed by the therapists after every training.

  5. Level of experienced fatique (VAS - score)

    Time frame: 8 weeks

    Measured by a VAS-fatigue scale.

  6. Level of experienced post-work out muscle soreness (VAS - score)

    Time frame: 8 weeks

    Measured by a VAS-pain scale.

  7. Level of physical activity during hospital admission - daily score

    Time frame: 8 weeks

    Noted on a document by the patient or the study officials.

Sponsors and collaborators

Lead sponsor

University of Copenhagen

Other

Collaborators

  • Rigshospitalet, Denmark

Registry information

Official study title

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

Acronym: ApoCarb

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Dec 30, 2020
Registry last updated
Dec 30, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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