Diet, Food, and NutritionNCT05747066
Nutrition in People With a Lower Limb Amputation
An observational study of Diet, Food, and Nutrition and Nutrition Disorders, run by University Medical Center Groningen at 6 sites in Netherlands.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diet, Food, and Nutrition, Nutrition Disorders, Amputation
- How many people
- 81 participants
- Where
- 6 sitesNetherlands
- Study dates
- 21 Feb 2023to 9 Sep 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population will consist of people who have undergone a major dysvascular lower limb amputation.
Who may be able to join
- 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
Who cannot join
- Requiring re-amputation
- Severe malabsorption disease
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Netherlands6 sites
Treant Zorggroep
Emmen, Drenthe
Martini Ziekenhuis Groningen
Groningen, Provincie Groningen
Universitair Medisch Centrum Groningen
Groningen, Provincie Groningen
Medisch Centrum Leeuwarden
Leeuwarden, Provincie Friesland
Ommelander Ziekenhuis Groep
Scheemda, Provincie Groningen
Isala Zwolle
Zwolle, Overijssel
About this study
Official title: 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)?
Read the 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.
- Conditions
- Diet, Food, and Nutrition, Nutrition Disorders, Amputation
- Being tested
- No intervention
- Keywords
- Nutrition, Malnutrition, Physical activity, Amputation, Outcomes
- Medical subject headings
- Nutrition Disorders, Malnutrition, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Data regarding mortality will be collected from the Statistics Netherlands (Dutch: Centraal Bureau voor de Statistiek).
Measured: Through study completion, up to 9 months post-LLA
Wound healing
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.
Measured: 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
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.
Measured: At 5 weeks, and 6 and 9 months post-LLA
K-level at each time point and change over time
Potential level of functioning will be assessed using the K-level.
Measured: At 6 and 9 months post-LLA
6-minute walk test at each time point and change over time
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.
Measured: At 6 and 9 months post-LLA
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2023
- Study start21 Feb 2023
- Primary completion9 Sep 2024
- Study completion9 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diet, Food, and NutritionStudies of the same condition, open and under way.
- More trials run by University Medical Center GroningenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Medical Center Groningen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jan HB Geertzen, Principal investigator, University Medical Center Groningen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05747066
- Sponsor's protocol ID
- 10929
- Status last verified
- Sep 2024
- First submitted
- 23 Jan 2023
- Last updated
- 3 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Krops LA, Jager-Wittenaar H, Krijnen WP, Dijkstra ML, Keller BPJA, Oskam J, Vierhout B, de Vries JPM, van Walraven L, Geertzen JHB, Dekker R, Kolen AM. Physical activity is associated with positive patient and clinical outcomes following dysvascular major lower limb amputation. J Vasc Surg. 2026 Mar;83(3):866-878. doi: 10.1016/j.jvs.2025.10.040. Epub 2025 Nov 4.
PubMed 41197840
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nutritional Intake, Nutritional Status and Physical Activity Level in People Who Have Undergone a Major Dysvascular Lower Limb Amputation
- ClinicalTrials.gov ID
- NCT05747066
- Acronym / sponsor ID
- 10929
- Conditions
- Diet, Food, and Nutrition, Nutrition Disorders, Amputation
- Keywords
- Nutrition, Malnutrition, Physical activity, Amputation, Outcomes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- University Medical Center GroningenUniversity, hospital or other
- Study start
- 21 Feb 2023 (actual)
- Primary completion
- 9 Sep 2024 (actual)
- Study completion
- 9 Sep 2024 (actual)
- First posted
- 28 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will consist of people who have undergone a major dysvascular lower limb amputation.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- Requiring re-amputation
- Severe malabsorption disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionNo intervention | Other | – |
Primary outcome
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.
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).
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).
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.
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.
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.
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.
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.
5 secondary outcomes
Mortality
Time frame: Through study completion, up to 9 months post-LLA
Wound healing
Time frame: 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
Time frame: At 5 weeks, and 6 and 9 months post-LLA
K-level at each time point and change over time
Time frame: At 6 and 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2025.
- Derived from this study: PubMed 41197840Krops LA, Jager-Wittenaar H, Krijnen WP, Dijkstra ML, Keller BPJA, Oskam J, Vierhout B, de Vries JPM, van Walraven L, Geertzen JHB, Dekker R, Kolen AM. Physical activity is associated with positive patient and clinical outcomes following dysvascular major lower limb amputation. J Vasc Surg. 2026 Mar;83(3):866-878. doi: 10.1016/j.jvs.2025.10.040. Epub 2025 Nov 4.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jan HB Geertzen principal investigator
University Medical Center Groningen
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diet, Food, and Nutrition and Nutrition Disorders, run by University Medical Center Groningen at 6 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05747066, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2025.