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

NCT05325697 | Unknown

• 1 other identifier: 2021-01058
• Study Type: interventional
• Target: 15
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Frailty; Sarcopenia; Malnutrition; Protein

Keywords

Elderly; Exercise program; Oral Nutrition Supplementation

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (12)

• Changes in nutritional status using the MNA-LF

  The MNA-LF is measured at baseline, within one week before hospital discharge

• Changes in nutritional status using the MNA-LF

  The MNA-LF is measured 12 weeks (84days) after the initiation of the intervention

• Muscle mass

  The BIA at baseline is performed within one week before hospital discharge

• Muscle mass

  The BIA is measured 12 weeks (84days) after the initiation of the intervention

• EQ-5D-3L Quality of life

  Quality of life is measured within one week before hospital discharge

Study Arms (1)

Single - Arm

EXPERIMENTAL

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

Interventions

Intervention consisting of a multicomponent exercise program combined with an oral nutritional supplement COMBINATION_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.

Single - Arm

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Department of Geriatric Medicine FELIX PLATTER: lead

MeSH Terms

Conditions

Frailty; Sarcopenia; Kwashiorkor

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Signs and Symptoms; Severe Acute Malnutrition; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Study Officials

• Reto W Kressig, Prof.

  University Department of Geriatric Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nadine Beerli, MPH

CONTACT

00413264075; Nadine.Beerli@felixplatter.ch

Raphael Banz, Dr.

CONTACT

raphael.banz@omanda.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single-arm, open label feasibility study.

Study Record Dates

• First Submitted: February 23, 2022
• First Posted: April 13, 2022
• Study Start: April 30, 2022
• Primary Completion: October 31, 2022
• Study Completion: October 31, 2022
• Last Updated: April 13, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share