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Clinical Trials/NCT05747066
NCT05747066
Completed
Not Applicable

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

University Medical Center Groningen6 sites in 1 country81 target enrollmentFebruary 21, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Diet, Food, and Nutrition
Sponsor
University Medical Center Groningen
Enrollment
81
Locations
6
Primary Endpoint
Body mass index at each time point and change over time
Status
Completed
Last Updated
last year

Overview

Brief Summary

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

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.

Registry
clinicaltrials.gov
Start Date
February 21, 2023
End Date
September 9, 2024
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Body mass index at each time point and change over time

Time Frame: During hospital admission 2 to 12 days post-LLA, at 5 weeks post-LLA, at 6 months post-LLA, at 9 months post-LLA

Body mass index will be determined based on weight and height, and adjusted for LLA level, in kg/m\^2.

Muscle mass at each time point and change over time

Time Frame: During hospital admission 2 to 12 days post-LLA, at 5 weeks post-LLA, at 6 months post-LLA, at 9 months post-LLA

Muscle mass will be determined by measuring the mid-upper arm circumference and the triceps skinfold, in mm.

Nutritional intake at each time point and change over time

Time Frame: During hospital admission 2 to 12 days post-LLA, at 5 weeks post-LLA, at 6 months post-LLA, at 9 months post-LLA

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.

Diet quality at each time point and change over time

Time Frame: During hospital admission 2 to 12 days post-LLA, at 5 weeks post-LLA, at 6 months post-LLA, at 9 months post-LLA

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).

Physical activity level by Activ8 accelerometer at each time point and change over time

Time Frame: During hospital admission 2 to 12 days post-LLA, at 5 weeks post-LLA, at 6 months post-LLA, at 9 months post-LLA

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.

Patient-Generated Subjective Global Assessment at each time point and change over time

Time Frame: During hospital admission 2 to 12 days post-LLA, at 5 weeks post-LLA, at 6 months post-LLA, at 9 months post-LLA

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).

Muscle strength at each time point and change over time

Time Frame: During hospital admission 2 to 12 days post-LLA, at 5 weeks post-LLA, at 6 months post-LLA, at 9 months post-LLA

Muscle strength will be determined by the handgrip strength, in kgf.

Physical activity level by adapted Short QUestionnaire to ASsess Health-enhancing physical activity at each time point and change over time

Time Frame: During hospital admission 2 to 12 days post-LLA, at 5 weeks post-LLA, at 6 months post-LLA, at 9 months post-LLA

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.

Secondary Outcomes

  • Wound healing(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(At 5 weeks, and 6 and 9 months post-LLA)
  • K-level at each time point and change over time(At 6 and 9 months post-LLA)
  • Mortality(Through study completion, up to 9 months post-LLA)
  • 6-minute walk test at each time point and change over time(At 6 and 9 months post-LLA)

Study Sites (6)

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