FrailtyNCT05325697
Combining Nutrition Supplementation With an Exercise Program in Elderly Malnourished Frail Patients After Hospital Stay
A study testing Intervention consisting of a multicomponent exercise program combined with an oral nutritional supplement in people with Frailty and Sarcopenia, run by University Department of Geriatric Medicine FELIX PLATTER.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Frailty, Sarcopenia, Malnutrition; Protein
- What is being tested?
- Intervention consisting of a multicomponent exercise program combined with an oral nutritional supplement
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- No sites listed yet
- Study dates
- 30 Apr 2022to 31 Oct 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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 locations and contacts
No sites are listed yet.
Raphael Banz, Dr. contact
About this study
Official title: Combining Oral Nutrition Supplementation With a Multicomponent Exercise Program in Elderly Malnourished Frail Patients After Hospital Stay A Feasibility Study
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.
Read more
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.
- Conditions
- Frailty, Sarcopenia, Malnutrition; Protein
- Being tested
- Intervention consisting of a multicomponent exercise program combined with an oral nutritional supplement
- Keywords
- Elderly, Exercise program, Oral Nutrition Supplementation
- Medical subject headings
- Frailty, Sarcopenia, Kwashiorkor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention consisting of a multicomponent exercise program combined with an oral nutritional supplementCombination product
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.
| Study group | Role | What they receive |
|---|---|---|
| Single - Arm | Experimental | 12 weeks intervention with a combined physical exercise program (vivifrail) and oral nutritional supplementation (Moltein Plus) Receives: Combination Product: Intervention consisting of a multicomponent exercise program combined with an oral nutritional supplement |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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?
Measured: 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?
Measured: 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?
Measured: 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?
Measured: 12 weeks after the initiation of the program (first day after hospital discharge plus 84 days)
Secondary outcomes (12)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: TUG is assessed 12 weeks (84days) after the initiation of the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2022
- Study start30 Apr 2022 (estimated)
- Primary completion31 Oct 2022 (estimated)
- Study completion31 Oct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FrailtyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single-arm, open label feasibility study.
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Department of Geriatric Medicine FELIX PLATTER
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Reto W Kressig, Prof., Principal investigator, University Department of Geriatric Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05325697
- Sponsor's protocol ID
- 2021-01058
- Status last verified
- Apr 2022
- First submitted
- 23 Feb 2022
- Last updated
- 13 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combining Oral Nutrition Supplementation With a Multicomponent Exercise Program in Elderly Malnourished Frail Patients After Hospital Stay A Feasibility Study
- ClinicalTrials.gov ID
- NCT05325697
- Acronym / sponsor ID
- 2021-01058
- Conditions
- Frailty, Sarcopenia, Malnutrition; Protein
- Keywords
- Elderly, Exercise program, Oral Nutrition Supplementation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- University Department of Geriatric Medicine FELIX PLATTERUniversity, hospital or other
- Study start
- 30 Apr 2022 (estimated)
- Primary completion
- 31 Oct 2022 (estimated)
- Study completion
- 31 Oct 2022 (estimated)
- First posted
- 13 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single-arm, open label feasibility study.
| Arm | Type | Receives |
|---|---|---|
| Single - Arm | Experimental | Combination Product: Intervention consisting of a multicomponent exercise program combined with an oral nutritional supplement12 weeks intervention with a combined physical exercise program (vivifrail) and oral nutritional supplementation (Moltein Plus) |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intervention consisting of a multicomponent exercise program combined with an oral nutritional supplementThe 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. | Combination product | Single - Arm |
Primary outcome
Adherence to the combined exercise program with the oral nutrition supplement: Self-admistered questionnaire
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).
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
Time frame: 1 week after the initiation of the program (first day after hospital discharge plus 7 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?
Inhibiting factors to follow the combined exercise and nutritional program: Semi-structured phone call interview using a self developed questionnaire
Time frame: 4 weeks after the initiation of the program (first day after hospital discharge plus 28 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?
Inhibiting factors to follow the combined exercise and nutritional program: Semi-structured phone call interview using a self developed questionnaire
Time frame: 8 weeks after the initiation of the program (first day after hospital discharge plus 56 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?
Inhibiting factors to follow the combined exercise and nutritional program: Semi-structured phone call interview using a self developed questionnaire
Time frame: 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?
12 secondary outcomes
Changes in nutritional status using the MNA-LF
Time frame: The MNA-LF is measured at baseline, within one week before hospital discharge
Changes in nutritional status using the MNA-LF
Time frame: The MNA-LF is measured 12 weeks (84days) after the initiation of the intervention
Muscle mass
Time frame: The BIA at baseline is performed within one week before hospital discharge
Muscle mass
Time frame: The BIA is measured 12 weeks (84days) after the initiation of the intervention
EQ-5D-3L Quality of life
Time frame: Quality of life is measured within one week before hospital discharge
EQ-5D-3L Quality of life
Time frame: Quality of life is measured 12 weeks (84days) after the initiation of the intervention
Frailty assessment
Time frame: SPPB is measured within one week before hospital discharge
Frailty assessment
Time frame: SPPB is measured 12 weeks (84days) after the initiation of the intervention
Hand grip strenght
Time frame: Hand grip strength is measured within one week before hospital discharge
Hand grip strenght
Time frame: 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
Time frame: TUG is assessed within one week before hospital discharge
Timed up and go assessment to assess functional ability and mobility
Time frame: TUG is assessed 12 weeks (84days) after the initiation of the intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Raphael Banz, Dr. contact
Reto W Kressig, Prof. principal investigator
University Department of Geriatric Medicine
Questions about this trial
What is this clinical trial studying?
A study testing Intervention consisting of a multicomponent exercise program combined with an oral nutritional supplement in people with Frailty and Sarcopenia, run by University Department of Geriatric Medicine FELIX PLATTER.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nadine Beerli, MPH (00413264075, Nadine.Beerli@felixplatter.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adherence to the combined exercise program with the oral nutrition supplement: Self-admistered questionnaire (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).). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2022.