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Combining Nutrition Supplementation With an Exercise Program in Elderly Malnourished Frail Patients After Hospital Stay

U

University Department of Geriatric Medicine FELIX PLATTER

Status

Unknown

Conditions

Malnutrition; Protein
Frailty
Sarcopenia

Treatments

Combination Product: Intervention consisting of a multicomponent exercise program combined with an oral nutritional supplement

Study type

Interventional

Funder types

Other

Identifiers

NCT05325697
2021-01058

Details and patient eligibility

About

The objective of this study is to investigate the feasibility of a combined nutritional and home-based exercise intervention in elderly, malnourished, frail patients after hospital discharge.

Adherence to exercise program, adherence to oral nutrition supplement, potential inhibiting factors to follow exercise program, changes in nutritional status, muscle mass and function, quality of life are outcome factors.

The intervention consists of 12 weeks with a physical exercise program (vivifrail) and oral nutritional supplementation (Moltein Plus).

The investigators hypothesize that 12 weeks of a combined nutritional and home-based multicomponent exercise program is feasible for frail elderly patients after hospital discharge, meaning that ≥70% of the exercise sessions will be completed and oral supplements will be consumed by the participants.

Enrollment

15 estimated patients

Sex

All

Ages

65+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Age ≥ 65
  • Malnutrition: Nutrition Risk Screening ≥3
  • Frail/pre-frail status according Fried Frailty Phenotype: 1-2 criteria present = pre frail, > 2 criteria present = frail
  • Frailty status according to SPPB: A: 0-3 points = disabled, B (B+): 4-6 points = frail (at risk of falls), C (C+): 7-10 points = pre-frail (at risk of falls), D: 10-12 points = robust.
  • Ability to sit
  • Consent to participate in the study
  • Ability to follow the instructions of the vivifrail program
  • Prescription for use of an ONS

Exclusion criteria

  • Severe acute cardiovascular issues: eg. unstable angina pectoris, uncontrolled arrhythmia, uncontrolled arterial hypertension or unstable cardiovascular disease or other unstable medical condition.
  • Persisting oedema and/or ascites
  • Contraindication for the protein-rich ONS (e.g. cow's milk allergy, end stage renal disease without renal replacement therapy) or dysphagia for liquids
  • non-removable plasters or bandages at feet or hands aggravating body impedance analysis (BIA), implanted defibrillation device
  • Parenteral/tube feeding
  • No access to telephone or severe hearing loss
  • Terminal illness
  • Hospitalized due to pulmonary thromboembolism
  • Considerable cognitive impairment: Mini-mental score < 18 or advice of healthcare professionals against inclusion due to cognitive or psychological reasons.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

15 participants in 1 patient group

Single - Arm
Experimental group
Description:
12 weeks intervention with a combined physical exercise program (vivifrail) and oral nutritional supplementation (Moltein Plus)
Treatment:
Combination Product: Intervention consisting of a multicomponent exercise program combined with an oral nutritional supplement

Trial contacts and locations

0

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Central trial contact

Raphael Banz, Dr.; Nadine Beerli, MPH

Data sourced from clinicaltrials.gov

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