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

Primary Purpose

Frailty, Sarcopenia, Malnutrition; Protein

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Intervention consisting of a multicomponent exercise program combined with an oral nutritional supplement
Sponsored by
University Department of Geriatric Medicine FELIX PLATTER
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Frailty focused on measuring Elderly, Exercise program, Oral Nutrition Supplementation

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept 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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Single - Arm

    Arm Description

    12 weeks intervention with a combined physical exercise program (vivifrail) and oral nutritional supplementation (Moltein Plus)

    Outcomes

    Primary Outcome Measures

    Adherence to the combined exercise program with the oral nutrition supplement: Self-admistered questionnaire
    Subjects will use a self-admistered questionnaire in paper pencil form consisting of the combined vivifrail passport checklist (provided by the vivifrail program, asking if the exersise program was performed or not and a 3-point likert scale question: "How demanding were the exercises for you?" with the answer options very demanding, moderately demanding and not very demanding) and a oral nutrition checklist (asking if the oral supplementation was consumed or not) to keep record of completed exercise sessions as well as the effort perceived during the activities and the daily intake of the oral nutritional supplementation. Higher scores of absolved exercise sessions with the intake of the oral nutrition mean a better outcome.
    Inhibiting factors to follow the combined exercise and nutritional program: Semi-structured phone call interview using a self developed questionnaire
    The semi-structured phone interviews have the purpose to shed light on the difficulties participants encountered while following the intervention. The self developed questionnaire (adapted from Hoogland J et al. 2019) uses a semi-structured approach and consists of 10 questions: Have you forgotten to consume ONS in the last 7 days? What is the usual dose per day you have taken in the last 7 days? When do you consume the drinkable food? How and when do you usually consume the ONS? Have you forgotten to exercise in the last 7 days? Did you complete the entire exercise session, or did you skip some exercises? What were the reasons that made it difficult to start or finish an exercise session in the last 7 days? How many minutes did it take to do the exercises per day? Do you feel stronger now than before you started the exercise and nutrition program? Do you feel less likely to fall now than before you started the exercise and nutrition program?
    Inhibiting factors to follow the combined exercise and nutritional program: Semi-structured phone call interview using a self developed questionnaire
    The semi-structured phone interviews have the purpose to shed light on the difficulties participants encountered while following the intervention. The self developed questionnaire (adapted from Hoogland J et al. 2019) uses a semi-structured approach and consists of 10 questions: Have you forgotten to consume ONS in the last 7 days? What is the usual dose per day you have taken in the last 7 days? When do you consume the drinkable food? How and when do you usually consume the ONS? Have you forgotten to exercise in the last 7 days? Did you complete the entire exercise session, or did you skip some exercises? What were the reasons that made it difficult to start or finish an exercise session in the last 7 days? How many minutes did it take to do the exercises per day? Do you feel stronger now than before you started the exercise and nutrition program? Do you feel less likely to fall now than before you started the exercise and nutrition program?
    Inhibiting factors to follow the combined exercise and nutritional program: Semi-structured phone call interview using a self developed questionnaire
    The semi-structured phone interviews have the purpose to shed light on the difficulties participants encountered while following the intervention. The self developed questionnaire (adapted from Hoogland J et al. 2019) uses a semi-structured approach and consists of 10 questions: Have you forgotten to consume ONS in the last 7 days? What is the usual dose per day you have taken in the last 7 days? When do you consume the drinkable food? How and when do you usually consume the ONS? Have you forgotten to exercise in the last 7 days? Did you complete the entire exercise session, or did you skip some exercises? What were the reasons that made it difficult to start or finish an exercise session in the last 7 days? How many minutes did it take to do the exercises per day? Do you feel stronger now than before you started the exercise and nutrition program? Do you feel less likely to fall now than before you started the exercise and nutrition program?
    Inhibiting factors to follow the combined exercise and nutritional program: Semi-structured phone call interview using a self developed questionnaire
    The semi-structured phone interviews have the purpose to shed light on the difficulties participants encountered while following the intervention. The self developed questionnaire (adapted from Hoogland J et al. 2019) uses a semi-structured approach and consists of 10 questions: Have you forgotten to consume ONS in the last 7 days? What is the usual dose per day you have taken in the last 7 days? When do you consume the drinkable food? How and when do you usually consume the ONS? Have you forgotten to exercise in the last 7 days? Did you complete the entire exercise session, or did you skip some exercises? What were the reasons that made it difficult to start or finish an exercise session in the last 7 days? How many minutes did it take to do the exercises per day? Do you feel stronger now than before you started the exercise and nutrition program? Do you feel less likely to fall now than before you started the exercise and nutrition program?

    Secondary Outcome Measures

    Changes in nutritional status using the MNA-LF
    Changes in nutritional status will be measured using the MNA-LF(Mini Nutritional Assessment Long Format). The MNA-LF scale ranges from 0-30 points: 24-30 points: normal status, 17-23.5 points: risk for malnutrition, <10 points: malnutrition.
    Changes in nutritional status using the MNA-LF
    Changes in nutritional status will be measured using the MNA-LF(Mini Nutritional Assessment Long Format). The MNA-LF scale ranges from 0-30 points: 24-30 points: normal status, 17-23.5 points: risk for malnutrition, <10 points: malnutrition.
    Muscle mass
    For evaluation of muscle mass, Bioelectrical impedance analysis (BIA) is performed in all included patients using a BIVA 101® (Akern, SMT medical GmbH, Würzburg, Germany). It measures the apendicular muscle mass. The cut-off values for sarcopenia are: ♂< 20 kg, 7 kg/m2, ♀ < 16 kg, 5.5 kg/m2.
    Muscle mass
    For evaluation of muscle mass, Bioelectrical impedance analysis (BIA) is performed in all included patients using a BIVA 101® (Akern, SMT medical GmbH, Würzburg, Germany). It measures the apendicular muscle mass. The cut-off values for sarcopenia are: ♂< 20 kg, 7 kg/m2, ♀ < 16 kg, 5.5 kg/m2.
    EQ-5D-3L Quality of life
    Quality of life will be measured with the EQ-5D-3L questionnaire intepreted according to the EuroQol guidelines.
    EQ-5D-3L Quality of life
    Quality of life will be measured with the EQ-5D-3L questionnaire intepreted according to the EuroQol guidelines.
    Frailty assessment
    The Short Physical Performance Battery (SPPB) is a group of measures that combines the results. of the gait speed, chair stand and 3 balance tests (Guralnik et al., 2000). It has been used as a predictive tool for possible disability and can aid in the monitoring of function in older people. Scores range from 0 to 12 points, ≤ 9 points indicate physical frailty, ≤ 8 points indicate severe sarcopenia, ≤ 3 points indicate severe limitations in the activities of daily living.
    Frailty assessment
    The Short Physical Performance Battery (SPPB) is a group of measures that combines the results. of the gait speed, chair stand and 3 balance tests (Guralnik et al., 2000). It has been used as a predictive tool for possible disability and can aid in the monitoring of function in older people. Scores range from 0 to 12 points, ≤ 9 points indicate physical frailty, ≤ 8 points indicate severe sarcopenia, ≤ 3 points indicate severe limitations in the activities of daily living.
    Hand grip strenght
    Hand grip strength is assessed using a Martin Vigorimeter. The Martin Vigorimeter is a pseudodynamic dynamometer that measures the pressure when subjects press a rubber bulb connected by a tube to a manometer, with pressure being expressed in kiloPascal (kPa). Higher scores mean a better outcome. Cut-off points for poor muscle strength in the assessment for sarcopenia are: female 27 kPa, male 45 kPa.
    Hand grip strenght
    Hand grip strength is assessed using a Martin Vigorimeter. The Martin Vigorimeter is a pseudodynamic dynamometer that measures the pressure when subjects press a rubber bulb connected by a tube to a manometer, with pressure being expressed in kiloPascal (kPa). Higher scores mean a better outcome. Cut-off points for poor muscle strength in the assessment for sarcopenia are: female 27 kPa, male 45 kPa.
    Timed up and go assessment to assess functional ability and mobility
    The timed up and go (TUG) assessment assesses functional ability and mobility. The probands start the assessment in a seated position, then stand up upon the assessor's command, walk 3 meters, turn around, walk back to the chair and sit down. Time measurement (seconds) starts when the back of the participant leaves the backrest and is stopped when is back seated. An older adult who takes ≥12 seconds to complete the TUG is at risk for falling. Lower scores indicate better outcomes. ≥20 seconds to complete the TUG indicate severe sarcopenia.
    Timed up and go assessment to assess functional ability and mobility
    The timed up and go (TUG) assessment assesses functional ability and mobility. The probands start the assessment in a seated position, then stand up upon the assessor's command, walk 3 meters, turn around, walk back to the chair and sit down. Time measurement (seconds) starts when the back of the participant leaves the backrest and is stopped when is back seated. An older adult who takes ≥12 seconds to complete the TUG is at risk for falling. Lower scores indicate better outcomes. ≥20 seconds to complete the TUG indicate severe sarcopenia.

    Full Information

    First Posted
    February 23, 2022
    Last Updated
    April 5, 2022
    Sponsor
    University Department of Geriatric Medicine FELIX PLATTER
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05325697
    Brief Title
    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

    2. Study Status

    Record Verification Date
    April 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    April 30, 2022 (Anticipated)
    Primary Completion Date
    October 31, 2022 (Anticipated)
    Study Completion Date
    October 31, 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University Department of Geriatric Medicine FELIX PLATTER

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Frailty, Sarcopenia, Malnutrition; Protein
    Keywords
    Elderly, Exercise program, Oral Nutrition Supplementation

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Model Description
    Single-arm, open label feasibility study.
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    15 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Single - Arm
    Arm Type
    Experimental
    Arm Description
    12 weeks intervention with a combined physical exercise program (vivifrail) and oral nutritional supplementation (Moltein Plus)
    Intervention Type
    Combination Product
    Intervention Name(s)
    Intervention consisting of a multicomponent exercise program combined with an oral nutritional supplement
    Intervention Description
    The multicomponent exercise program to prevent frailty and risk of falls (Vivifrail) was developed by a European expert group co-funded by the ERASMUS+ programm of the European Union. The program consists of a screening and a subsequent 12-week exercise program. The screening classifies individuals into four categories: disabled, frail, pre-frail, or robust and the difficulty of the program's exercises is adapted to the categories and it includes endurance, balance, and resistance training as well as stretching exercises. This exercise program will be combined with an oral nutritional supplement (Moltein®Plus), which was specifically designed to promote muscle health in elderly people. Moltein®Plus is completely balanced oral nutrition supplement made from whey protein fortified with leucine. Enriching dietary protein with leucine allows to maximize muscle protein synthesis rates without calling for very high protein doses, which are difficult to ingest for older individuals.
    Primary Outcome Measure Information:
    Title
    Adherence to the combined exercise program with the oral nutrition supplement: Self-admistered questionnaire
    Description
    Subjects will use a self-admistered questionnaire in paper pencil form consisting of the combined vivifrail passport checklist (provided by the vivifrail program, asking if the exersise program was performed or not and a 3-point likert scale question: "How demanding were the exercises for you?" with the answer options very demanding, moderately demanding and not very demanding) and a oral nutrition checklist (asking if the oral supplementation was consumed or not) to keep record of completed exercise sessions as well as the effort perceived during the activities and the daily intake of the oral nutritional supplementation. Higher scores of absolved exercise sessions with the intake of the oral nutrition mean a better outcome.
    Time Frame
    The questionnaire is completed daily from the first day after hospital discharge until the last day of the 12-week intervention (84 days).
    Title
    Inhibiting factors to follow the combined exercise and nutritional program: Semi-structured phone call interview using a self developed questionnaire
    Description
    The semi-structured phone interviews have the purpose to shed light on the difficulties participants encountered while following the intervention. The self developed questionnaire (adapted from Hoogland J et al. 2019) uses a semi-structured approach and consists of 10 questions: Have you forgotten to consume ONS in the last 7 days? What is the usual dose per day you have taken in the last 7 days? When do you consume the drinkable food? How and when do you usually consume the ONS? Have you forgotten to exercise in the last 7 days? Did you complete the entire exercise session, or did you skip some exercises? What were the reasons that made it difficult to start or finish an exercise session in the last 7 days? How many minutes did it take to do the exercises per day? Do you feel stronger now than before you started the exercise and nutrition program? Do you feel less likely to fall now than before you started the exercise and nutrition program?
    Time Frame
    1 week after the initiation of the program (first day after hospital discharge plus 7 days)
    Title
    Inhibiting factors to follow the combined exercise and nutritional program: Semi-structured phone call interview using a self developed questionnaire
    Description
    The semi-structured phone interviews have the purpose to shed light on the difficulties participants encountered while following the intervention. The self developed questionnaire (adapted from Hoogland J et al. 2019) uses a semi-structured approach and consists of 10 questions: Have you forgotten to consume ONS in the last 7 days? What is the usual dose per day you have taken in the last 7 days? When do you consume the drinkable food? How and when do you usually consume the ONS? Have you forgotten to exercise in the last 7 days? Did you complete the entire exercise session, or did you skip some exercises? What were the reasons that made it difficult to start or finish an exercise session in the last 7 days? How many minutes did it take to do the exercises per day? Do you feel stronger now than before you started the exercise and nutrition program? Do you feel less likely to fall now than before you started the exercise and nutrition program?
    Time Frame
    4 weeks after the initiation of the program (first day after hospital discharge plus 28 days)
    Title
    Inhibiting factors to follow the combined exercise and nutritional program: Semi-structured phone call interview using a self developed questionnaire
    Description
    The semi-structured phone interviews have the purpose to shed light on the difficulties participants encountered while following the intervention. The self developed questionnaire (adapted from Hoogland J et al. 2019) uses a semi-structured approach and consists of 10 questions: Have you forgotten to consume ONS in the last 7 days? What is the usual dose per day you have taken in the last 7 days? When do you consume the drinkable food? How and when do you usually consume the ONS? Have you forgotten to exercise in the last 7 days? Did you complete the entire exercise session, or did you skip some exercises? What were the reasons that made it difficult to start or finish an exercise session in the last 7 days? How many minutes did it take to do the exercises per day? Do you feel stronger now than before you started the exercise and nutrition program? Do you feel less likely to fall now than before you started the exercise and nutrition program?
    Time Frame
    8 weeks after the initiation of the program (first day after hospital discharge plus 56 days)
    Title
    Inhibiting factors to follow the combined exercise and nutritional program: Semi-structured phone call interview using a self developed questionnaire
    Description
    The semi-structured phone interviews have the purpose to shed light on the difficulties participants encountered while following the intervention. The self developed questionnaire (adapted from Hoogland J et al. 2019) uses a semi-structured approach and consists of 10 questions: Have you forgotten to consume ONS in the last 7 days? What is the usual dose per day you have taken in the last 7 days? When do you consume the drinkable food? How and when do you usually consume the ONS? Have you forgotten to exercise in the last 7 days? Did you complete the entire exercise session, or did you skip some exercises? What were the reasons that made it difficult to start or finish an exercise session in the last 7 days? How many minutes did it take to do the exercises per day? Do you feel stronger now than before you started the exercise and nutrition program? Do you feel less likely to fall now than before you started the exercise and nutrition program?
    Time Frame
    12 weeks after the initiation of the program (first day after hospital discharge plus 84 days)
    Secondary Outcome Measure Information:
    Title
    Changes in nutritional status using the MNA-LF
    Description
    Changes in nutritional status will be measured using the MNA-LF(Mini Nutritional Assessment Long Format). The MNA-LF scale ranges from 0-30 points: 24-30 points: normal status, 17-23.5 points: risk for malnutrition, <10 points: malnutrition.
    Time Frame
    The MNA-LF is measured at baseline, within one week before hospital discharge
    Title
    Changes in nutritional status using the MNA-LF
    Description
    Changes in nutritional status will be measured using the MNA-LF(Mini Nutritional Assessment Long Format). The MNA-LF scale ranges from 0-30 points: 24-30 points: normal status, 17-23.5 points: risk for malnutrition, <10 points: malnutrition.
    Time Frame
    The MNA-LF is measured 12 weeks (84days) after the initiation of the intervention
    Title
    Muscle mass
    Description
    For evaluation of muscle mass, Bioelectrical impedance analysis (BIA) is performed in all included patients using a BIVA 101® (Akern, SMT medical GmbH, Würzburg, Germany). It measures the apendicular muscle mass. The cut-off values for sarcopenia are: ♂< 20 kg, 7 kg/m2, ♀ < 16 kg, 5.5 kg/m2.
    Time Frame
    The BIA at baseline is performed within one week before hospital discharge
    Title
    Muscle mass
    Description
    For evaluation of muscle mass, Bioelectrical impedance analysis (BIA) is performed in all included patients using a BIVA 101® (Akern, SMT medical GmbH, Würzburg, Germany). It measures the apendicular muscle mass. The cut-off values for sarcopenia are: ♂< 20 kg, 7 kg/m2, ♀ < 16 kg, 5.5 kg/m2.
    Time Frame
    The BIA is measured 12 weeks (84days) after the initiation of the intervention
    Title
    EQ-5D-3L Quality of life
    Description
    Quality of life will be measured with the EQ-5D-3L questionnaire intepreted according to the EuroQol guidelines.
    Time Frame
    Quality of life is measured within one week before hospital discharge
    Title
    EQ-5D-3L Quality of life
    Description
    Quality of life will be measured with the EQ-5D-3L questionnaire intepreted according to the EuroQol guidelines.
    Time Frame
    Quality of life is measured 12 weeks (84days) after the initiation of the intervention
    Title
    Frailty assessment
    Description
    The Short Physical Performance Battery (SPPB) is a group of measures that combines the results. of the gait speed, chair stand and 3 balance tests (Guralnik et al., 2000). It has been used as a predictive tool for possible disability and can aid in the monitoring of function in older people. Scores range from 0 to 12 points, ≤ 9 points indicate physical frailty, ≤ 8 points indicate severe sarcopenia, ≤ 3 points indicate severe limitations in the activities of daily living.
    Time Frame
    SPPB is measured within one week before hospital discharge
    Title
    Frailty assessment
    Description
    The Short Physical Performance Battery (SPPB) is a group of measures that combines the results. of the gait speed, chair stand and 3 balance tests (Guralnik et al., 2000). It has been used as a predictive tool for possible disability and can aid in the monitoring of function in older people. Scores range from 0 to 12 points, ≤ 9 points indicate physical frailty, ≤ 8 points indicate severe sarcopenia, ≤ 3 points indicate severe limitations in the activities of daily living.
    Time Frame
    SPPB is measured 12 weeks (84days) after the initiation of the intervention
    Title
    Hand grip strenght
    Description
    Hand grip strength is assessed using a Martin Vigorimeter. The Martin Vigorimeter is a pseudodynamic dynamometer that measures the pressure when subjects press a rubber bulb connected by a tube to a manometer, with pressure being expressed in kiloPascal (kPa). Higher scores mean a better outcome. Cut-off points for poor muscle strength in the assessment for sarcopenia are: female 27 kPa, male 45 kPa.
    Time Frame
    Hand grip strength is measured within one week before hospital discharge
    Title
    Hand grip strenght
    Description
    Hand grip strength is assessed using a Martin Vigorimeter. The Martin Vigorimeter is a pseudodynamic dynamometer that measures the pressure when subjects press a rubber bulb connected by a tube to a manometer, with pressure being expressed in kiloPascal (kPa). Higher scores mean a better outcome. Cut-off points for poor muscle strength in the assessment for sarcopenia are: female 27 kPa, male 45 kPa.
    Time Frame
    Hand grip strength is measured 12 weeks (84days) after the initiation of the intervention
    Title
    Timed up and go assessment to assess functional ability and mobility
    Description
    The timed up and go (TUG) assessment assesses functional ability and mobility. The probands start the assessment in a seated position, then stand up upon the assessor's command, walk 3 meters, turn around, walk back to the chair and sit down. Time measurement (seconds) starts when the back of the participant leaves the backrest and is stopped when is back seated. An older adult who takes ≥12 seconds to complete the TUG is at risk for falling. Lower scores indicate better outcomes. ≥20 seconds to complete the TUG indicate severe sarcopenia.
    Time Frame
    TUG is assessed within one week before hospital discharge
    Title
    Timed up and go assessment to assess functional ability and mobility
    Description
    The timed up and go (TUG) assessment assesses functional ability and mobility. The probands start the assessment in a seated position, then stand up upon the assessor's command, walk 3 meters, turn around, walk back to the chair and sit down. Time measurement (seconds) starts when the back of the participant leaves the backrest and is stopped when is back seated. An older adult who takes ≥12 seconds to complete the TUG is at risk for falling. Lower scores indicate better outcomes. ≥20 seconds to complete the TUG indicate severe sarcopenia.
    Time Frame
    TUG is assessed 12 weeks (84days) after the initiation of the intervention

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Nadine Beerli, MPH
    Phone
    00413264075
    Email
    Nadine.Beerli@felixplatter.ch
    First Name & Middle Initial & Last Name or Official Title & Degree
    Raphael Banz, Dr.
    Email
    raphael.banz@omanda.ch
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Reto W Kressig, Prof.
    Organizational Affiliation
    University Department of Geriatric Medicine
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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

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