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The Effect of a Combined Personalized Nutritional Intervention and a Personalized Graded Activity Functional Training Program on Physical Performance in Hospitalized Older Patients, Compared to Usual Care

ConditionOld Age; Atrophy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age65+
SponsorRadboud University Medical Center

About this trial

This project aims to improve physical performance in older patients, by offering a personalized combined nutritional intervention with a physical activity training program. The intervention starts at hospital admittance and is continued after discharge in the home care setting, supported by an e-health application.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Aged ≥65 years

Living within the Nijmegen area (within 40km)

Admitted to clinical ward of Radboudumc or CWZ

Understanding and speaking of the Dutch language

Disqualifiers

Complete use of tube feeding or parenteral nutrition

Renal insufficiency (MDRD-GFR < 30ml/min)

Trial design

Design model

Parallel

Treatments tested in this trial

  • FITFOOD lifestyle intervention

    Behavioral

    Lifestyle intervention with a nutritional and exercise component.

Treatment groups

136 Participants
are divided into 2 treatment groups
Group A: Standard careNo intervention 0 interventions
Group B: FITFOOD lifestyle interventionExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Change in Timed Up & Go

TUG

Time frame
Baseline, 1 day before hospital release, 4 weeks after baseline, 12 weeks after baseline, 24 weeks after baseline.

Secondary outcomes

1

Change in Short Physical Performance Battery

Short Physical Performance Battery (scale: 0-12, a high score indicates no disability, a low score means disabilities may be present or developing).

Time frame
Baseline, 1 day before hospital release, 4 weeks after baseline, 12 weeks after baseline, 24 weeks after baseline.
2

Change in muscle strength

Handgrip strength

Time frame
Baseline, 1 day before hospital release, 12 weeks after baseline, 24 weeks after baseline.
3

Change in muscle mass

BIA

Time frame
Baseline, 1 day before hospital release, 12 weeks after baseline, 24 weeks after baseline.
4

Change in nutritional status

Patient-Generated Subjective Global Assessment (PG-SGA). Scale: 0-49 (low score: no intervention needed. Score\>9: serious indication for intervention)

Time frame
Baseline, 1 day before hospital release, 4 weeks after baseline, 12 weeks after baseline, 24 weeks after baseline.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Radboud University Medical Center

Lead sponsor

Source ClinicalTrials.gov
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