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

Study Overview
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Brief Summary
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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.

Official Title
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Combining Oral Nutrition Supplementation With a Multicomponent Exercise Program in Elderly Malnourished Frail Patients After Hospital Stay A Feasibility Study

Conditions
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Frailty, Sarcopenia, Malnutrition; Protein

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


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Single-arm, open label feasibility study.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Single - Arm<br>12 weeks intervention with a combined physical exercise program (vivifrail) and oral nutritional supplementation (Moltein Plus) | Combination Product: Intervention consisting of a multicomponent exercise program combined with an oral nutritional supplement<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | The questionnaire is completed daily from the first day after hospital discharge until the last day of the 12-week intervention (84 days). | 
| 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? | 1 week after the initiation of the program (first day after hospital discharge plus 7 days) | 
| 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? | 4 weeks after the initiation of the program (first day after hospital discharge plus 28 days) | 
| 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? | 8 weeks after the initiation of the program (first day after hospital discharge plus 56 days) | 
| 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? | 12 weeks after the initiation of the program (first day after hospital discharge plus 84 days) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | The MNA-LF is measured at baseline, within one week before hospital discharge | 
| 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. | The MNA-LF is measured 12 weeks (84days) after the initiation of the intervention | 
| 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. | The BIA at baseline is performed within one week before hospital discharge | 
| 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. | The BIA is measured 12 weeks (84days) after the initiation of the intervention | 
| EQ-5D-3L Quality of life | Quality of life will be measured with the EQ-5D-3L questionnaire intepreted according to the EuroQol guidelines. | Quality of life is measured within one week before hospital discharge | 
| EQ-5D-3L Quality of life | Quality of life will be measured with the EQ-5D-3L questionnaire intepreted according to the EuroQol guidelines. | Quality of life is measured 12 weeks (84days) after the initiation of the intervention | 
| 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. | SPPB is measured within one week before hospital discharge | 
| 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. | SPPB is measured 12 weeks (84days) after the initiation of the intervention | 
| 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 strength is measured within one week before hospital discharge | 
| 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 strength is measured 12 weeks (84days) after the initiation of the intervention | 
| 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. | TUG is assessed within one week before hospital discharge | 
| 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. | TUG is assessed 12 weeks (84days) after the initiation of the intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Elderly, Exercise program, Oral Nutrition Supplementation