SarcopeniaNCT05141981
Sarcopenia and Its Associated Factors Among Hip Fractures Patients
An observational study of Sarcopenia, run by Assiut University at 1 site in Egypt.
Trial summary
1. Asses the prevalence of sarcopenia in hip fracture patients in Truama hospital at Assuit University 2. To study the associated factors of sarcopenia in hip fracture patients in Trauma hospital at Assuit University Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Sarcopenia
- What is being tested?
- inbody device
- Type of treatment
- Medical device
- How many people
- 135 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Nov 2021to 10 Sep 2023
- 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 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: admitted patients in Assiut university Trauma hospital
Who may be able to join
- old patients >50 years with hip fracture attending assuit university hospital
Who cannot join
- patients with dementia ,muscle disease and neurological disease
- Patients who are unwilling to participate
- Patients>80 years due to uncooperate at this age to answer the questionnaire
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Sarcopenia and Its Associated Factors Among Hip Fracture Patients in Assuit University Trauma Hospital
- Asses the prevalence of sarcopenia in hip fracture patients in Truama hospital at Assuit University
- To study the associated factors of sarcopenia in hip fracture patients in Trauma hospital at Assuit University
Read the detailed description
Skeletal muscle is the largest body compartment in most adults with the exception of an enlarged adipose tissue mass in the presence of obesity. Skeletal muscles grow in size from birth onward, reaching peak mass in the third decade. Many factors determine an individual adult's total body skeletal muscle mass and include their size(height),magnitude of adiposity, race, genetic factors, activity, hormone levels and diet. By the fourth decade populations and individuals begin to show a gradual loss in skeletal muscle mass and the rate of atrophy appears to accelerate beyond the seventh decade. The senescence-related changes in skeletal muscle are, in turn, associated with adverse out- comes such as pathological bone fractures and even death. The term sarcopenia, from the Greek roots is widely used to describe the age-associated decrease in muscle mass observed in several cross-sectional and longitudinal studies. Interest in sarcopenia mainly results from its linkage with unfavorable outcomes, including mobility disorders, increased risk of falling, reduced ability to function in activities of daily living, loss of independence, poor quality of life, and reduced life expectancy. Measuring skeletal muscle mass, composition, strength and physical performance is thus a vital part of not only studying sarcopenia, but also of growing importance in clinically evaluating and monitoring the greatly increasing population of ageing at risk adults in most countries. Our report highlights aspects of evaluating these features of skeletal muscle and expands on earlier methodological and historical reviews. While the main phenotypic feature of sarcopenia is loss of lean tissue, notably skeletal muscle, there is growing recognition that sarcopenia can co-exist in the presence of obesity. A skeletal muscle compartment reduced in mass may thus be masked by the presence of excess fat. Diagnosing sarcopenia-obesity may thus include measures beyond that of skeletal muscle mass such as BMI and total body fat, topics that we will allude to in the review that follows. Loss of skeletal muscle also plays an important role in two other conditions, cachexia and frailty, creating a spectrum of phenotypes and clinical conditions that encompass sarcopenia There are two main factors for Skeletal muscle evaluation, skeletal muscle mass and composition, are the main determinants of global muscle metabolic function, strength and physical performance. Vascular and neurological integrity are also essential components that ultimately contribute to a skeletal muscle's metabolic and mechanical functionality. The'quality' of a skeletal muscle is a loosely defined concept that broadly includes aspects of anatomic structure, chemical composition and metabolic and mechanical performance. Our review encompasses aspects of measuring skeletal muscle mass, composition and function in relation to the evaluation of individuals and groups for the presence of sarcopenia and related conditions. Multiple methods of measuring skeletal muscle mass are available for research and clinical purposes that vary in cost, complexity and availability. A high prevalence of low muscle mass in hip-fracture patients has been shown. Hip fractures carry a high risk of both death and disability with a 8-36 % excess mortality within 1 year and more than 50 % of the survivors not regaining their own pre-injury level of independence. Sarcopenia may worsen the functional prognosis after hip fracture occurrence, but the association between reduced muscle mass and functional ability remains unclear in this group of older and frail persons. Conversely, muscle strength has been indicated as a strong independent predictor of the functional outcome, whereas lower-limb performance is usually not accessible at an early stage, because of the direct consequences of the hip fracture on ambulation. There are no available studies in our locality about sarcopenia and its related factors
- Conditions
- Sarcopenia
- Being tested
- inbody device
- Keywords
- sarcopenia and hip fracture
- Medical subject headings
- Sarcopenia, Hip Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
inbody deviceDevice
measure muscle mass
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of Sarcopenia among Hip fracture patients in Assuit University Truama hospital
by inbody device
Measured: 20 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2021
- Study start20 Nov 2021
- Primary completion10 Aug 2023
- Study completion10 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SarcopeniaStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 135 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, AHAbdelhafeez, Assiut University
- Investigators
- Osama Ahmad, prof, Study chair, assuit yniversity
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05141981
- Sponsor's protocol ID
- sarcopenia and hip fracure
- Status last verified
- Jun 2024
- First submitted
- 20 Sep 2021
- Last updated
- 14 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sarcopenia and Its Associated Factors Among Hip Fracture Patients in Assuit University Trauma Hospital
- ClinicalTrials.gov ID
- NCT05141981
- Acronym / sponsor ID
- sarcopenia and hip fracure
- Conditions
- Sarcopenia
- Keywords
- sarcopenia and hip fracture
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 135 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 20 Nov 2021 (actual)
- Primary completion
- 10 Aug 2023 (actual)
- Study completion
- 10 Sep 2023 (actual)
- First posted
- 2 Dec 2021 (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.
- Asses the prevalence of sarcopenia in hip fracture patients in Truama hospital at Assuit University
- To study the associated factors of sarcopenia in hip fracture patients in Trauma hospital at Assuit University
Detailed description
Skeletal muscle is the largest body compartment in most adults with the exception of an enlarged adipose tissue mass in the presence of obesity. Skeletal muscles grow in size from birth onward, reaching peak mass in the third decade. Many factors determine an individual adult's total body skeletal muscle mass and include their size(height),magnitude of adiposity, race, genetic factors, activity, hormone levels and diet. By the fourth decade populations and individuals begin to show a gradual loss in skeletal muscle mass and the rate of atrophy appears to accelerate beyond the seventh decade. The senescence-related changes in skeletal muscle are, in turn, associated with adverse out- comes such as pathological bone fractures and even death. The term sarcopenia, from the Greek roots is widely used to describe the age-associated decrease in muscle mass observed in several cross-sectional and longitudinal studies. Interest in sarcopenia mainly results from its linkage with unfavorable outcomes, including mobility disorders, increased risk of falling, reduced ability to function in activities of daily living, loss of independence, poor quality of life, and reduced life expectancy. Measuring skeletal muscle mass, composition, strength and physical performance is thus a vital part of not only studying sarcopenia, but also of growing importance in clinically evaluating and monitoring the greatly increasing population of ageing at risk adults in most countries. Our report highlights aspects of evaluating these features of skeletal muscle and expands on earlier methodological and historical reviews. While the main phenotypic feature of sarcopenia is loss of lean tissue, notably skeletal muscle, there is growing recognition that sarcopenia can co-exist in the presence of obesity. A skeletal muscle compartment reduced in mass may thus be masked by the presence of excess fat. Diagnosing sarcopenia-obesity may thus include measures beyond that of skeletal muscle mass such as BMI and total body fat, topics that we will allude to in the review that follows. Loss of skeletal muscle also plays an important role in two other conditions, cachexia and frailty, creating a spectrum of phenotypes and clinical conditions that encompass sarcopenia There are two main factors for Skeletal muscle evaluation, skeletal muscle mass and composition, are the main determinants of global muscle metabolic function, strength and physical performance. Vascular and neurological integrity are also essential components that ultimately contribute to a skeletal muscle's metabolic and mechanical functionality. The'quality' of a skeletal muscle is a loosely defined concept that broadly includes aspects of anatomic structure, chemical composition and metabolic and mechanical performance. Our review encompasses aspects of measuring skeletal muscle mass, composition and function in relation to the evaluation of individuals and groups for the presence of sarcopenia and related conditions. Multiple methods of measuring skeletal muscle mass are available for research and clinical purposes that vary in cost, complexity and availability. A high prevalence of low muscle mass in hip-fracture patients has been shown. Hip fractures carry a high risk of both death and disability with a 8-36 % excess mortality within 1 year and more than 50 % of the survivors not regaining their own pre-injury level of independence. Sarcopenia may worsen the functional prognosis after hip fracture occurrence, but the association between reduced muscle mass and functional ability remains unclear in this group of older and frail persons. Conversely, muscle strength has been indicated as a strong independent predictor of the functional outcome, whereas lower-limb performance is usually not accessible at an early stage, because of the direct consequences of the hip fracture on ambulation. There are no available studies in our locality about sarcopenia and its related factors
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- admitted patients in Assiut university Trauma hospital
Key inclusion criteria (1 listed)
- old patients >50 years with hip fracture attending assuit university hospital
Key exclusion criteria (3 listed)
- patients with dementia ,muscle disease and neurological disease
- Patients who are unwilling to participate
- Patients>80 years due to uncooperate at this age to answer the questionnaire
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 |
|---|---|---|
| inbody devicemeasure muscle mass | Device | – |
Primary outcome
Prevalence of Sarcopenia among Hip fracture patients in Assuit University Truama hospital
Time frame: 20 minutes
by inbody device
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 14 Jun 2024.
Related trials for Sarcopenia
Enrolling by invitation
Online Exercise Program for Transplant Patients: A Pilot Study
Kidney Transplantation, Physical Function
Not yet recruitingPhase 2
A Study of Bimagrumab in Participants With HFpEF
Heart Failure, Diastolic, Diastolic Heart Failure
Not yet recruiting
The Aim of the Study is to Decipher the Alterations in Signalling Pathways of Skeletal Muscle Stem Cells (Satellite Cells (SCs)) in Individuals With COPD, as Well as to Examine the Effect of Exercise Training on SCs.
COPD (Chronic Obstructive Pulmonary Disease), Sarcopenia in Elderly
Not yet recruitingPhase 2
MF-300 for Treatment of Age-Related Sarcopenia
Sarcopenia in Elderly
Not yet recruitingObservational study
Validation of Uzbek SARC-F and IPAQ-SF Questionnaires in Adults With and Without Hypothyroidism
Hypothyroidism, Psychometrics
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.
Osama Ahmad, prof study chair
assuit yniversity
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sarcopenia, run by Assiut University at 1 site in Egypt.
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 1 inclusion and 3 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 14 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. 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?
Prevalence of Sarcopenia among Hip fracture patients in Assuit University Truama hospital (time frame: 20 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Jun 2024.