Clinical trial NCT05325697: Combining Nutrition Supplementation With an Exercise Program in Elderly Malnourished Frail Patients After Hospital Stay
Official title: Combining Oral Nutrition Supplementation With a Multicomponent Exercise Program in Elderly Malnourished Frail Patients After Hospital Stay A Feasibility Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Frailty
Sarcopenia
Malnutrition; Protein
Keywords: Elderly
Exercise program
Oral Nutrition Supplementation
Lead sponsor: University Department of Geriatric Medicine FELIX PLATTER
Sponsor class: OTHER
First posted: 2022-04-13
Enrollment: 15
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single-arm, open label feasibility study.
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Adherence to the combined exercise program with the oral nutrition supplement: Self-admistered questionnaire
timeFrame: The questionnaire is completed daily from the first day after hospital discharge until the last day of the 12-week intervention (84 days).
measure: Inhibiting factors to follow the combined exercise and nutritional program: Semi-structured phone call interview using a self developed questionnaire
timeFrame: 1 week after the initiation of the program (first day after hospital discharge plus 7 days)
measure: Inhibiting factors to follow the combined exercise and nutritional program: Semi-structured phone call interview using a self developed questionnaire
timeFrame: 4 weeks after the initiation of the program (first day after hospital discharge plus 28 days)
measure: Inhibiting factors to follow the combined exercise and nutritional program: Semi-structured phone call interview using a self developed questionnaire
timeFrame: 8 weeks after the initiation of the program (first day after hospital discharge plus 56 days)
measure: Inhibiting factors to follow the combined exercise and nutritional program: Semi-structured phone call interview using a self developed questionnaire
timeFrame: 12 weeks after the initiation of the program (first day after hospital discharge plus 84 days)
Secondary outcomes:
measure: Changes in nutritional status using the MNA-LF
timeFrame: The MNA-LF is measured at baseline, within one week before hospital discharge
measure: Changes in nutritional status using the MNA-LF
timeFrame: The MNA-LF is measured 12 weeks (84days) after the initiation of the intervention
measure: Muscle mass
timeFrame: The BIA at baseline is performed within one week before hospital discharge
measure: Muscle mass
timeFrame: The BIA is measured 12 weeks (84days) after the initiation of the intervention
measure: EQ-5D-3L Quality of life
timeFrame: Quality of life is measured within one week before hospital discharge
measure: EQ-5D-3L Quality of life
timeFrame: Quality of life is measured 12 weeks (84days) after the initiation of the intervention
measure: Frailty assessment
timeFrame: SPPB is measured within one week before hospital discharge
measure: Frailty assessment
timeFrame: SPPB is measured 12 weeks (84days) after the initiation of the intervention
measure: Hand grip strenght
timeFrame: Hand grip strength is measured within one week before hospital discharge
measure: Hand grip strenght
timeFrame: Hand grip strength is measured 12 weeks (84days) after the initiation of the intervention
measure: Timed up and go assessment to assess functional ability and mobility
timeFrame: TUG is assessed within one week before hospital discharge
measure: Timed up and go assessment to assess functional ability and mobility
timeFrame: TUG is assessed 12 weeks (84days) after the initiation of the intervention
Other outcomes:
Locations:
Study officials:
affiliation: University Department of Geriatric Medicine
name: Reto W Kressig, Prof.
role: PRINCIPAL_INVESTIGATOR
References: