Nutrition in People With a Lower Limb Amputation

NCT05747066 | Completed

• 1 other identifier: 10929
• Study Type: observational
• Target: 81
• Locations: 1 country
• Sites: 6

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)?

Conditions

Diet, Food, and Nutrition; Nutrition Disorders; Amputation

Keywords

Nutrition; Malnutrition; Physical activity; Amputation; Outcomes

Outcome Measures

Primary Outcomes (8)

• 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 12 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 12 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 12 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 12 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 12 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 12 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 12 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 12 days post-LLA, at 5 weeks post-LLA, at 6 months post-LLA, at 9 months post-LLA

Secondary Outcomes (5)

• Mortality

  Through study completion, up to 9 months post-LLA

• 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

• 6-minute walk test at each time point and change over time

  At 6 and 9 months post-LLA

Interventions

No intervention OTHER

No intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population will consist of people who have undergone a major dysvascular lower limb amputation.

You may qualify if:

• 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)
• years or older
• Able to collaborate

You may not qualify if:

• Requiring re-amputation
• Severe malabsorption disease

Sponsors & Collaborators

• University Medical Center Groningen: lead

Study Sites (6)

Treant Zorggroep

Emmen, Drenthe, Netherlands

Location

Isala Zwolle

Zwolle, Overijssel, Netherlands

Location

Medisch Centrum Leeuwarden

Leeuwarden, Provincie Friesland, Netherlands

Location

Martini Ziekenhuis Groningen

Groningen, Provincie Groningen, Netherlands

Location

Universitair Medisch Centrum Groningen

Groningen, Provincie Groningen, Netherlands

Location

Ommelander Ziekenhuis Groep

Scheemda, Provincie Groningen, Netherlands

Location

MeSH Terms

Conditions

Nutrition Disorders; Malnutrition; Motor Activity

Condition Hierarchy (Ancestors)

Nutritional and Metabolic Diseases; Behavior

Study Officials

• Jan HB Geertzen

  University Medical Center Groningen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 23, 2023
• First Posted: February 28, 2023
• Study Start: February 21, 2023
• Primary Completion: September 9, 2024
• Study Completion: September 9, 2024
• Last Updated: April 3, 2025

Record last verified: 2024-09

Locations

NL (6)