Clinical trial NCT05747066: Nutrition in People With a Lower Limb Amputation
Official title: Nutritional Intake, Nutritional Status and Physical Activity Level in People Who Have Undergone a Major Dysvascular Lower Limb Amputation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diet, Food, and Nutrition
Nutrition Disorders
Amputation
Keywords: Nutrition
Malnutrition
Physical activity
Amputation
Outcomes
Lead sponsor: University Medical Center Groningen
Sponsor class: OTHER
First posted: 2023-02-28
Enrollment: 81
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will consist of people who have undergone a major dysvascular lower limb amputation.

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.

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

Primary outcomes:
measure: Nutritional intake at each time point and change over time
timeFrame: During hospital admission 2 to 12 days post-LLA, at 5 weeks post-LLA, at 6 months post-LLA, at 9 months post-LLA
measure: Diet quality at each time point and change over time
timeFrame: During hospital admission 2 to 12 days post-LLA, at 5 weeks post-LLA, at 6 months post-LLA, at 9 months post-LLA
measure: Patient-Generated Subjective Global Assessment at each time point and change over time
timeFrame: During hospital admission 2 to 12 days post-LLA, at 5 weeks post-LLA, at 6 months post-LLA, at 9 months post-LLA
measure: Muscle mass at each time point and change over time
timeFrame: During hospital admission 2 to 12 days post-LLA, at 5 weeks post-LLA, at 6 months post-LLA, at 9 months post-LLA
measure: Muscle strength at each time point and change over time
timeFrame: During hospital admission 2 to 12 days post-LLA, at 5 weeks post-LLA, at 6 months post-LLA, at 9 months post-LLA
measure: Body mass index at each time point and change over time
timeFrame: During hospital admission 2 to 12 days post-LLA, at 5 weeks post-LLA, at 6 months post-LLA, at 9 months post-LLA
measure: Physical activity level by Activ8 accelerometer at each time point and change over time
timeFrame: During hospital admission 2 to 12 days post-LLA, at 5 weeks post-LLA, at 6 months post-LLA, at 9 months post-LLA
measure: Physical activity level by adapted Short QUestionnaire to ASsess Health-enhancing physical activity at each time point and change over time
timeFrame: 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:
measure: Mortality
timeFrame: Through study completion, up to 9 months post-LLA
measure: Wound healing
timeFrame: At 5 weeks post-LLA
measure: Quality of life assessed by World Health Organization Quality of Life Questionnaire - BREF at each time point and change over time
timeFrame: At 5 weeks, and 6 and 9 months post-LLA
measure: K-level at each time point and change over time
timeFrame: At 6 and 9 months post-LLA
measure: 6-minute walk test at each time point and change over time
timeFrame: At 6 and 9 months post-LLA
Other outcomes:
Locations:
city: Emmen
country: Netherlands
facility: Treant Zorggroep
state: Drenthe
city: Leeuwarden
country: Netherlands
facility: Medisch Centrum Leeuwarden
state: Friesland
city: Scheemda
country: Netherlands
facility: Ommelander Ziekenhuis Groep
state: Groningen
city: Zwolle
country: Netherlands
facility: Isala Zwolle
state: Overijssel
city: Groningen
country: Netherlands
facility: Martini Ziekenhuis Groningen
city: Groningen
country: Netherlands
facility: Universitair Medisch Centrum Groningen
Study officials:
affiliation: University Medical Center Groningen
name: Jan HB Geertzen
role: PRINCIPAL_INVESTIGATOR
References: