Nutrition in People With a Lower Limb Amputation

Study Overview
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Brief Summary
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The goal of this prospective longitudinal observational cohort study is to determine the nutritional intake, nutritional status, and physical activity level in people who have undergone a major dysvascular lower limb amputation (LLA) at different moments post-LLA (during hospital admission several days post-LLA, and at 5 weeks, 6 months, and 9 months post-LLA). The main questions this study aims to answer are: What is the nutritional intake, nutritional status, and physical activity level at different moments post-LLA? What is the association between nutritional intake and physical activity level, and nutritional status? What is the association between nutritional intake, nutritional status and physical activity level and clinical outcomes (mortality, wound healing, quality of life, physical functioning)?

Detailed Description
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People requiring an LLA are at high risk for adverse clinical outcomes. Undernutrition and low physical activity level may affect clinical outcomes negatively. However, little is known about the nutritional intake, nutritional status and physical activity level in the LLA population, and their association with clinical outcomes.

Official Title
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Nutritional Intake, Nutritional Status and Physical Activity Level in People Who Have Undergone a Major Dysvascular Lower Limb Amputation

Conditions
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Diet, Food, and Nutrition, Nutrition Disorders, Amputation

Intervention / Treatment
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* Other: No intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Undergoing or recently (i.e., within the last seven weeks) having undergone a major dysvascular lower limb amputation (i.e., Syme amputation or more proximal level) 18 years or older Able to collaborate Exclusion Criteria: Requiring re-amputation Severe malabsorption disease

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: No intervention|No intervention|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nutritional intake at each time point and change over time | Nutritional intake will be assessed by a 24h recall. Nutritional intake includes intake of energy, protein, carbohydrates, and fat, and will be classified as adequate/inadequate intake. | During hospital admission 2 to 10 days post-LLA, at 5 weeks post-LLA, at 6 months post-LLA, at 9 months post-LLA | 
| Diet quality at each time point and change over time | The Dutch Healthy Diet Index will be calculated on the data of the 24h recall. The 15 components of the Dutch Healthy Diet Index represent the 15 food-based Dutch dietary guidelines of 2015. The score ranges from 0 to 10 for each component, giving a total score between 0 (no adherence) and 150 (complete adherence). | During hospital admission 2 to 10 days post-LLA, at 5 weeks post-LLA, at 6 months post-LLA, at 9 months post-LLA | 
| Patient-Generated Subjective Global Assessment at each time point and change over time | Nutritional status will be determined based on the use of the Patient-Generated Subjective Global Assessment (PG-SGA). Completing the PG-SGA will result in a numerical score (0-52), as well as categorization of nutritional status (PG-SGA Stage A = well nourished, PG SGA Stage B = moderate or suspected undernutrition, PG-SGA Stage C = severely undernourished). | During hospital admission 2 to 10 days post-LLA, at 5 weeks post-LLA, at 6 months post-LLA, at 9 months post-LLA | 
| Muscle mass at each time point and change over time | Muscle mass will be determined by measuring the mid-upper arm circumference and the triceps skinfold, in mm. | During hospital admission 2 to 10 days post-LLA, at 5 weeks post-LLA, at 6 months post-LLA, at 9 months post-LLA | 
| Muscle strength at each time point and change over time | Muscle strength will be determined by the handgrip strength, in kgf. | During hospital admission 2 to 10 days post-LLA, at 5 weeks post-LLA, at 6 months post-LLA, at 9 months post-LLA | 
| Body mass index at each time point and change over time | Body mass index will be determined based on weight and height, and adjusted for LLA level, in kg/m^2. | During hospital admission 2 to 10 days post-LLA, at 5 weeks post-LLA, at 6 months post-LLA, at 9 months post-LLA | 
| Physical activity level by Activ8 accelerometer at each time point and change over time | Physical activity level will be determined based on data from the Activ8 accelerometer. The Activ8 is a tri-axis accelerometer (2M Engineering, Valkenswaard, The Netherlands) which determines the time spent lying/sitting, standing, walking, running, and cycling for at least 3 consecutive days. The following outcome variables will be calculated: percentage of time spent active, intensity of behavior (counts/min), average number of active bouts, and mean duration of active bouts. | During hospital admission 2 to 10 days post-LLA, at 5 weeks post-LLA, at 6 months post-LLA, at 9 months post-LLA | 
| Physical activity level by adapted Short QUestionnaire to ASsess Health-enhancing physical activity at each time point and change over time | Physical activity level will be determined based on the adapted Short QUestionnaire to ASsess Health-enhancing physical activity (Adapted-SQUASH). The Adapted-SQUASH is a 19-item self-reported recall questionnaire designed to assess physical activity among persons with disabilities. Total activity score will be calculated (minutes x intensity) together with total minutes of activity/week, and total minutes of light, moderate or vigorous activity/week. | During hospital admission 2 to 10 days post-LLA, at 5 weeks post-LLA, at 6 months post-LLA, at 9 months post-LLA | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality | Data regarding mortality will be collected from the Statistics Netherlands (Dutch: Centraal Bureau voor de Statistiek). | Through study completion, up to 9 months post-LLA | 
| Wound healing | Wound healing will be classified as healed wound or open wound. Healed wound is defined as closed wound, i.e., skin is intact and the underneath tissue is not exposed. Furthermore, the TIME criteria will be assessed. | At 5 weeks post-LLA | 
| Quality of life assessed by World Health Organization Quality of Life Questionnaire - BREF at each time point and change over time | Quality of life will be assessed by the World Health Organization Quality of Life Questionnaire - BREF. This is a self-reported instrument. Possible scores range from 0 to 100. A higher score indicates a better quality of life. | At 5 weeks, and 6 and 9 months post-LLA | 
| K-level at each time point and change over time | Potential level of functioning will be assessed using the K-level. | At 6 and 9 months post-LLA | 
| 6-minute walk test at each time point and change over time | Physical functioning will be assessed by the 6-minute walk test. More distance covered during the 6-minute walk test indicates a better physical function. | At 6 and 9 months post-LLA | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Nutrition, Malnutrition, Physical activity, Amputation, Outcomes