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临床试验/NCT05325697
NCT05325697Unknown不适用

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

University Department of Geriatric Medicine FELIX PLATTER0 个研究点目标入组 15 人开始时间: 2022年4月30日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
15
主要终点
Adherence to the combined exercise program with the oral nutrition supplement: Self-admistered questionnaire

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
65 Years 至 —(Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •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

排除标准

  • •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.

研究组 & 干预措施

Single - Arm

Experimental

12 weeks intervention with a combined physical exercise program (vivifrail) and oral nutritional supplementation (Moltein Plus)

干预措施: Intervention consisting of a multicomponent exercise program combined with an oral nutritional supplement (Combination Product)

结局指标

主要结局

Adherence to the combined exercise program with the oral nutrition supplement: Self-admistered questionnaire

时间窗: 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

时间窗: 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?

Inhibiting factors to follow the combined exercise and nutritional program: Semi-structured phone call interview using a self developed questionnaire

时间窗: 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

时间窗: 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

时间窗: 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?

次要结局

  • Muscle mass(The BIA is measured 12 weeks (84days) after the initiation of the intervention)
  • Changes in nutritional status using the MNA-LF(The MNA-LF is measured 12 weeks (84days) after the initiation of the intervention)
  • Frailty assessment(SPPB is measured 12 weeks (84days) after the initiation of the intervention)
  • Hand grip strenght(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(TUG is assessed 12 weeks (84days) after the initiation of the intervention)
  • EQ-5D-3L Quality of life(Quality of life is measured 12 weeks (84days) after the initiation of the intervention)
  • Changes in nutritional status using the MNA-LF(The MNA-LF is measured at baseline, within one week before hospital discharge)
  • Muscle mass(The BIA at baseline is performed within one week before hospital discharge)
  • EQ-5D-3L Quality of life(Quality of life is measured within one week before hospital discharge)
  • Frailty assessment(SPPB is measured within one week before hospital discharge)
  • Hand grip strenght(Hand grip strength is measured within one week before hospital discharge)
  • Timed up and go assessment to assess functional ability and mobility(TUG is assessed within one week before hospital discharge)

研究者

发起方
University Department of Geriatric Medicine FELIX PLATTER
申办方类型
Other
责任方
Sponsor

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