Nutrition in People With a Lower Limb Amputation

March 31, 2025 updated by: University Medical Center Groningen

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

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)?

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

81

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Groningen, Netherlands
        • Universitair Medisch Centrum Groningen
      • Groningen, Netherlands
        • Martini Ziekenhuis Groningen
    • Drenthe
      • Emmen, Drenthe, Netherlands
        • TREANT zorggroep
    • Friesland
      • Leeuwarden, Friesland, Netherlands
        • Medisch Centrum Leeuwarden
    • Groningen
      • Scheemda, Groningen, Netherlands
        • Ommelander Ziekenhuis Groep
    • Overijssel
      • Zwolle, Overijssel, Netherlands
        • Isala Zwolle

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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
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).
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
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).
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
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.
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
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.
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
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.
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
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.
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
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.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mortality
Time Frame: Through study completion, up to 9 months post-LLA
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
6-minute walk test at each time point and change over time
Time Frame: At 6 and 9 months post-LLA
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
Quality of life assessed by World Health Organization Quality of Life Questionnaire - BREF at each time point and change over time
Time Frame: At 5 weeks, and 6 and 9 months post-LLA
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
Wound healing
Time Frame: At 5 weeks post-LLA
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
K-level at each time point and change over time
Time Frame: At 6 and 9 months post-LLA
Potential level of functioning will be assessed using the K-level.
At 6 and 9 months post-LLA

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Medical Center Groningen

Investigators

  • Principal Investigator: Jan HB Geertzen, University Medical Center Groningen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 21, 2023

Primary Completion (Actual)

September 9, 2024

Study Completion (Actual)

September 9, 2024

Study Registration Dates

First Submitted

January 23, 2023

First Submitted That Met QC Criteria

February 16, 2023

First Posted (Actual)

February 28, 2023

Study Record Updates

Last Update Posted (Actual)

April 3, 2025

Last Update Submitted That Met QC Criteria

March 31, 2025

Last Verified

September 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 10929

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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