Nutrition in People With a Lower Limb Amputation

Sponsor

University Medical Center Groningen (Other)

Overall Status

Recruiting

CT.gov ID

NCT05747066

Collaborator

(none)

Enrollment

Locations

16.3

Anticipated Duration (Months)

13.8

Patients Per Site

0.8

Patients Per Site Per Month

Study Details

Study Description

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 3 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)?

Condition or Disease	Intervention/Treatment	Phase
Diet, Food, and Nutrition Nutrition Disorders Amputation	Other: No intervention

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 Design

Study Type:

Observational

Anticipated Enrollment :

69 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Feb 21, 2023

Anticipated Primary Completion Date :

Jul 1, 2024

Anticipated Study Completion Date :

Jul 1, 2024

Outcome Measures

Primary Outcome Measures

Nutritional intake at each time point and change over time [During hospital admission 5 to 10 days post-LLA, at 3 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, fat, and micronutrients, and will be classified as adequate/inadequate intake.
Diet quality at each time point and change over time [During hospital admission 5 to 10 days post-LLA, at 3 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).
Patient-Generated Subjective Global Assessment at each time point and change over time [During hospital admission 5 to 10 days post-LLA, at 3 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 mass at each time point and change over time [During hospital admission 5 to 10 days post-LLA, at 3 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.
Muscle strength at each time point and change over time [During hospital admission 5 to 10 days post-LLA, at 3 weeks post-LLA, at 6 months post-LLA, at 9 months post-LLA]
Muscle strength will be determined by the handgrip strength, in kgf.
Body mass index at each time point and change over time [During hospital admission 5 to 10 days post-LLA, at 3 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.
Physical activity level by Activ8 accelerometer at each time point and change over time [During hospital admission 5 to 10 days post-LLA, at 3 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 7 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.
Physical activity level by adapted Short QUestionnaire to ASsess Health-enhancing physical activity at each time point and change over time [During hospital admission 5 to 10 days post-LLA, at 3 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 Outcome Measures

Mortality [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).
Wound healing [At 3 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.
Quality of life assessed by World Health Organization Quality of Life Questionnaire - BREF at each time point and change over time [At 3 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.
Walking with a prosthesis at each time point and change over time [At 6 and 9 months post-LLA]
Physical functiononing will be assessed by walking with a prosthesis yes/no.
6-minute walk test at each time point and change over time [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Undergoing or recently (i.e., within the last five 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

Contacts and Locations

Locations

	Site	City	State	Country
1	Ommelander Ziekenhuis Groep	Scheemda	Groningen	Netherlands
2	Isala Zwolle	Zwolle	Overijssel	Netherlands
3	Martini Ziekenhuis Groningen	Groningen		Netherlands
4	Universitair Medisch Centrum Groningen	Groningen		Netherlands
5	Medisch Centrum Leeuwarden	Leeuwarden		Netherlands