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Enrolling by invitation NCT06967220

The Impact of Inflammation on Skeletal Muscle Maintenance in Hospitalized Patients

No phase Interventional Disease Related Malnutrition High Systemic Inflammation Geriatric Assessment

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Single leg training.
Who it may be relevant to
Registry conditions: Disease Related Malnutrition, High Systemic Inflammation, Geriatric Assessment. Basic parameters: from 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Denmark
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

The main goal is to elucidate the mechanistic coupling between inflammation and the ability to maintain skeletal muscle through physical exercise while hospitalized. We will investigate protein kinetics in patients who belong to one of three groups 1) high inflammatory state, 2) moderate inflammatory state and 3) low/no inflammation. We will further intervene in group 1 (high inflammatory state) with anti-inflammatory nutrition (primarily green-solution plant-based) to diminish activity in inflammatory pathways. The hypothesis is that inflammation will inhibit protein synthesis in skeletal muscle both in resting muscle and in strength trained skeletal musculature, and that a lowering of the inflammatory status by anti-inflammatory nutrition will enhance the exercise induced formation of new muscle mass. .

Interventions

  • Other Single leg training
    All subjects will train one leg twice daily.

Primary outcome measures

  • FSR in high vs. low inflammation group [Time frame: 7 days (or until hospital discharge)]
Secondary outcome measures (7)
  • Change in muscle size between groups [Time frame: 7 days (or until hospital discharge)]
  • FSR in trained vs. non trained leg [Time frame: 7 days (or until hospital discharge)]
  • Inflammation in regular vs. antiinflammatory diet [Time frame: 7 days (or until hospital discharge)]
  • AA uptake following feeding [Time frame: 7 days (or until hospital discharge)]
  • Muscle size in trained vs. untrained leg [Time frame: 7 days (or until hospital discharge)]
  • Change in muscle strength between groups [Time frame: 7 days (or until discharge)]
  • Muscle strength in trained vs. untrained leg [Time frame: 7 days (or until hospital discharge)]

Eligibility criteria

Inclusion criteria

  • Hospitalised at the geriatric department at Bispebjerg Hospital with an expected admission time of minimum 7 days
  • Have Disease Related Malnutrition (DRM)
  • Able to carry out strength training
  • Able to understand the study information, as assessed by the research team

Exclusion criteria

  • Current use of anti-inflammatory medication
  • Liver failure
  • Short bowel syndrome
  • Chrohn's or colitis
  • Terminally ill

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Basic science

Study locations

Denmark · 1 center
  • Bispebjerg Hospital — Copenhagen

Identifiers

NCT: NCT06967220 · BBH170

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗