Combining Nutrition Supplementation With an Exercise Program in Elderly Malnourished Frail Patients After Hospital Stay
- Conditions
- Malnutrition; ProteinSarcopeniaFrailty
- Interventions
- Combination Product: Intervention consisting of a multicomponent exercise program combined with an oral nutritional supplement
- Registration Number
- NCT05325697
- Lead Sponsor
- University Department of Geriatric Medicine FELIX PLATTER
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 15
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Single - Arm Intervention consisting of a multicomponent exercise program combined with an oral nutritional supplement 12 weeks intervention with a combined physical exercise program (vivifrail) and oral nutritional supplementation (Moltein Plus)
- Primary Outcome Measures
Name Time Method Adherence to the combined exercise program with the oral nutrition supplement: Self-admistered questionnaire The questionnaire is completed daily from the first day after hospital discharge until the last day of the 12-week intervention (84 days). 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 12 weeks after the initiation of the program (first day after hospital discharge plus 84 days) 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
Name Time Method Muscle mass The BIA is measured 12 weeks (84days) after the initiation of the intervention 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.
Changes in nutritional status using the MNA-LF The MNA-LF is measured 12 weeks (84days) after the initiation of the intervention 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.Frailty assessment SPPB is measured 12 weeks (84days) after the initiation of the intervention 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 measured 12 weeks (84days) after the initiation of the intervention 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 TUG is assessed 12 weeks (84days) after the initiation of the intervention 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.
EQ-5D-3L Quality of life Quality of life is measured 12 weeks (84days) after the initiation of the intervention Quality of life will be measured with the EQ-5D-3L questionnaire intepreted according to the EuroQol guidelines.