Combining Nutrition Supplementation With an Exercise Program in Elderly Malnourished Frail Patien… (NCT05325697) | Clinical Trial Compass
UnknownNot Applicable
Combining Nutrition Supplementation With an Exercise Program in Elderly Malnourished Frail Patients After Hospital Stay
15 participantsStarted 2022-04-30
Plain-language 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.
Who can participate
Age range
65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
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).
2
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)
3
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)
4
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)
5
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)
Trial details
NCT IDNCT05325697
SponsorUniversity Department of Geriatric Medicine FELIX PLATTER