Skip to main content
OpenTrials
Completed

NCT Number: NCT05747066

Nutrition in People With a 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)?

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Diet, Food, and Nutrition Amputation Behavior Malnutrition Motor Activity Nutrition Disorders Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Treant Zorggroep, Emmen, Drenthe, Netherlands

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

No intervention

Other

No intervention

Primary outcomes

  1. 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.

  2. 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).

  3. 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).

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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

  1. 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).

  2. 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.

  3. 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.

  4. 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.

  5. 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.

Sponsors and collaborators

Lead sponsor

University Medical Center Groningen

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Feb 28, 2023
Registry last updated
Apr 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.