Search MeSH, PubMed DatabaseNCT04721028
A Cross-sectional Study of Sarcopenia in Patients With Parkinson ' s Disease
An observational study of Search MeSH, PubMed Database, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
Parkinson's disease (PD) is the second most common neurodegenerative disease of aging. The average age of PD onset is about 60 years old. Sarcopenia is common in PD patients, and one in five Parkinson's patients is diagnosed with severe sarcopenia. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Search MeSH, PubMed Database
- What is being tested?
- Human body component analyzer
- Type of treatment
- Medical device
- How many people
- 908 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2021to 31 Dec 2023
- How long will I take part?
- 2 Years
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: For PD patients who visited the outpatient and inpatient department of neurology of our hospital on January 1, 2021 and December 31, 2022,
Who may be able to join
- Meets MDS-2015 diagnostic criteria for Parkinson's disease;
- The patient can stand independently;
- Informed consent of patients and their families.
Who cannot join
- Meets MDS-2015 diagnostic criteria for Parkinson's disease;
- The patient can stand independently;
- Informed consent of patients and their families.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
SAHZhejiangU
Hangzhou, Zhejiang, 310000
Jiayan Liu, 13757118366, HREC2013@126.com
About this study
Parkinson's disease (PD) is the second most common neurodegenerative disease of aging. The average age of PD onset is about 60 years old. Sarcopenia is common in PD patients, and one in five Parkinson's patients is diagnosed with severe sarcopenia. The prevalence of Parkinson's disease is expected to increase in the coming decades as the population ages.
Sarcopenia is a syndrome with progressive and widespread loss of skeletal muscle mass and function, resulting in disability, loss of quality of life, and even death. Chronic disease, long-term bedridden, unreasonable diet and drug therapy may be the important factors leading to sarcopenia. China is gradually stepping into an aging society. Sarcopenia, as an age-related disease, lacks effective treatment, and has become a global public health problem and frontier research problem, bringing huge economic burden to families and society. The decline of the musculoskeletal system in the elderly will lead to muscle atrophy and loss of muscle strength, as well as decreased motor ability and balance ability, and ultimately lead to a decline in the quality of life of the elderly. The European Working Group on Sarcopenia recommends routine screening for sarcopenia in older people aged 65 and over in the community. At present, screening for sarcopenia has not received enough attention in China, and there is no unified standard for screening methods. The assessment of sarcopenia mainly focuses on three aspects: muscle mass, muscle strength and muscle function. The main symptoms of Parkinson's disease patients are postural tremor, bradykinesia and stiffness. The existence of sarcopenia may lead to poor treatment control in PD patients, and the recognition of sarcopenia in PD patients may have therapeutic effects.
This project through the cross-sectional survey of Parkinson's disease less muscle disease prevalence situation, further clear according to Parkinson's disease staging classification muscle disease prevalence, less and less by Logistic regression analysis to investigate the muscle disease and Parkinson's disease progression and the correlation between the severity of disease, for the next step nursing intervention strategies for implementation of PD patients less muscle disease provides guidance basis, to prevent and delay the less muscle disease is of great significance.
Read the detailed description
The research content PD patients admitted to the Department of Neurology of our hospital from January 1, 2021 to December 31, 2022 were evaluated according to the assessment criteria for Asian sarcopenia patients (pre-sarcopenia, sarcopenia stage and severe sarcopenia stage), and the muscle mass, muscle strength and functional status of each patient were recorded. To understand the current situation of sarcopenia in PD patients, and to clarify the correlation between sarcopenia and the course and severity of disease in Parkinson's disease patients, and actively look for the influencing factors that can be intervened to guide the development of nursing intervention measures.
The research target This project through the cross-sectional survey of Parkinson's disease less muscle disease prevalence situation, further clear according to Parkinson's disease staging classification muscle disease prevalence, less and less by Logistic regression analysis to investigate the muscle disease and Parkinson's disease progression and the correlation between the severity of disease, for further implementation of PD patients with less muscle disease provide guidance on the basis of nursing intervention strategies.
The problem to be solved Dyskinesia, static tremor, and myotonia are common features of Parkinson's disease, which contribute to the loss of function and independence of Parkinson's patients. The methods used for the assessment of sarcopenia in the general population (such as the inability to measure walking speed and muscle strength) may not be applicable to PD patients, so it is necessary to consult clinical experts and teachers in the implementation process of the project.
Future research ideas
- Through a large sample size cross-sectional survey, this project clarified the prevalence of sarcopenia in Parkinson's disease patients, collected data to clarify related preventive measures to reduce the disease burden, and provided theoretical basis for further implementation of nursing intervention strategies in the future.
- To conduct further multicenter and cross-sectional investigation and study in the future, so as to better define the correlation between Parkinson's disease and sarcopenia.
- To gradually develop sarcopenia assessment criteria for patients with Parkinson's disease.
- Research method, technical route and schedule The research methods Study Design This study was a cross-sectional survey Subjects: PD patients who were admitted to the outpatient and inpatient departments of the Department of Neurology of our hospital on January 1, 2021 and December 31, 2022 were evaluated by H-Y grading scale and UPDRS-3 scale. Obtain basic patient information by consulting patient's medical records or asking patient's family members.
Included in the standard
- Meets MDS-2015 diagnostic criteria for Parkinson's disease; 2) The patient can stand independently; 3) Informed consent of patients and their families. Exclusion criteria
- Parkinson's disease syndrome caused by cerebrovascular diseases, encephalitis and trauma; 2) Progressive nuclear ascending paralysis, multiple system atrophy, Lewy body dementia and other Parkinson's superposition syndrome; 3) severe physical disease; 4) diseases of the digestive system; 5) wasting diseases such as infection and tumor 6) with severe mental illness or cognitive impairment. Withdrawal criteria The patient requested withdrawal. According to the literature, the incidence of sarcopenia in Parkinson's disease patients was 30.6%, the allowable error was 3%, the confidence was 0.95, and the qualified rate of the questionnaire was 90%. Combined with the above data, the sample size was calculated to be 908 cases.
Research tools and evaluation indicators Patients' basic information was obtained by consulting patients' cases or inquiring patients' family members through self-developed patients' basic information table.
- General information: gender, age and course of disease of the patient
- Nutrition status assessment: height, weight, triceps skin fold thickness, leg circumference, diet, MNA scale
- Parkinson's disease symptom assessment H-Y scale, Parkinson's disease non-motor symptom rating scale (NMSS), bell drawing test
- Patients were screened using the calf circumference and SARC-F questionnaire.<SARC-F> is a simple patient-assessed screening questionnaire, which includes 5 items in total, including strength, assisted walking, standing up, stair climbing, and the number of falls in a year. A total score of 4 or more was considered positive. Sarcopenia evaluation
- Evaluation of muscle mass Bioelectrical independence analysis (BIA) was used to evaluate the patient's muscle mass (male <7.0kg/m2, female <5.7kg/m2)
- Muscle strength assessment Hand-held gripper was used to measure the patient's main hand. When measuring grip strength, let the patient exert his hand at a constant speed to the maximum, and avoid visual feedback and verbal stimulation during exertion. Posture: 1) Standing posture: feet naturally on the ground, arms naturally droop; 2) Sitting posture: shoulder adducted neutral position, elbow flexed 90 degrees, upper arm flat with chest, forearm in neutral position; 3) Prostrate: the upper arm ababducts, the elbow is straight, and the body is 30 degrees, the forearm is neutral, the jaws up to hold the gripper, the lower end of the gripper is supported on the bed, the upper limb joints can not be flexed, moved, the gripper can not contact the body or press down. The AWGS 2019 recommended diagnostic threshold for grip strength for sarcopenia is less than 28.0kg for men and less than 18.0kg for women.
- Physical function AWGS recommends the use of the 6M walking test, 5 times sitting up test to assess physical function. The time required to walk 6m at a normal pace from the beginning of the movement, without acceleration or deceleration halfway, and measured at least 2 times to record the average speed. The bound value is 1.0m/s. If the patient was unable to walk independently, a five-time sitting test was used to replace the walking test, with a threshold of ≥12s.
Data statistics
- The prevalence of sarcopenia in PD patients was statistically analyzed; 2) The prevalence of sarcopenia in PD patients stratified by age, sex and H-Y; 3) Correlation between sarcopenia and other factors using Logistic regression model.5. Main innovations
- Currently, there are few studies on the prevalence of sarcopenia in PD patients at home and abroad, and most of them are small sample size studies.
- The prevalence of sarcopenia was determined according to the disease stage of PD patients.
- Expected results and assessment indicators of the project
- The prevalence of sarcopenia in PD patients was determined through a cross-sectional survey of outpatients with PD.
- Logistic regression was used to analyze the correlation between sarcopenia and disease course, disease grade and other factors of Parkinson's disease, and to actively seek potential causes, especially reversible causes, so as to provide guidance for the further implementation of individualized lifestyle intervention (exercise combined nutrition) and related health education for sarcopenia.
Assessment indicators Published 1 paper in the core journal.
- Conditions
- Search MeSH, PubMed Database
- Being tested
- Human body component analyzer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Human body component analyzerDevice
The body composition analyzer is a kind of instrument that can measure the body composition health index. It is composed of professional tester, professional consulting management software, color printer A/B machine and so on.
What is being measured
The primary outcome is the main question the study is designed to answer.
The prevalence of sarcopenia in PD patients
The prevalence of sarcopenia in PD patients was determined through a cross-sectional survey of outpatients with PD.
Measured: 2021.1-2022.12
analyze the correlation between sarcopenia and disease course, disease grade and other factors of Parkinson's disease
Logistic regression was used to analyze the correlation between sarcopenia and disease course, disease grade and other factors of Parkinson's disease, and to actively seek potential causes, especially reversible causes, so as to provide guidance for the further implementation of individualized lifestyle intervention (exercise combined nutrition) and related health education for sarcopenia.
Measured: 2023.1-2023.3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2021
- Study start1 Jan 2021
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Search MeSH, PubMed DatabaseStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe 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
- Case crossover
- Time perspective
- Cross-sectional
- Enrolment
- 908 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04721028
- Sponsor's protocol ID
- 2021437121
- Status last verified
- Jan 2021
- First submitted
- 20 Jan 2021
- Last updated
- 9 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The patient data will be stored in the special PD database by the researchers of this project. All data relating to the subject's identity will be kept confidential and will not be made public except to the extent permitted by applicable laws and/or regulations.
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Cross-sectional Study of Sarcopenia in Patients With Parkinson ' s Disease
- ClinicalTrials.gov ID
- NCT04721028
- Acronym / sponsor ID
- 2021437121
- Conditions
- Search MeSH, PubMed Database
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 908 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 22 Jan 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.
Parkinson's disease (PD) is the second most common neurodegenerative disease of aging. The average age of PD onset is about 60 years old. Sarcopenia is common in PD patients, and one in five Parkinson's patients is diagnosed with severe sarcopenia. The prevalence of Parkinson's disease is expected to increase in the coming decades as the population ages.
Sarcopenia is a syndrome with progressive and widespread loss of skeletal muscle mass and function, resulting in disability, loss of quality of life, and even death. Chronic disease, long-term bedridden, unreasonable diet and drug therapy may be the important factors leading to sarcopenia. China is gradually stepping into an aging society. Sarcopenia, as an age-related disease, lacks effective treatment, and has become a global public health problem and frontier research problem, bringing huge economic burden to families and society. The decline of the musculoskeletal system in the elderly will lead to muscle atrophy and loss of muscle strength, as well as decreased motor ability and balance ability, and ultimately lead to a decline in the quality of life of the elderly. The European Working Group on Sarcopenia recommends routine screening for sarcopenia in older people aged 65 and over in the community. At present, screening for sarcopenia has not received enough attention in China, and there is no unified standard for screening methods. The assessment of sarcopenia mainly focuses on three aspects: muscle mass, muscle strength and muscle function. The main symptoms of Parkinson's disease patients are postural tremor, bradykinesia and stiffness. The existence of sarcopenia may lead to poor treatment control in PD patients, and the recognition of sarcopenia in PD patients may have therapeutic effects.
This project through the cross-sectional survey of Parkinson's disease less muscle disease prevalence situation, further clear according to Parkinson's disease staging classification muscle disease prevalence, less and less by Logistic regression analysis to investigate the muscle disease and Parkinson's disease progression and the correlation between the severity of disease, for the next step nursing intervention strategies for implementation of PD patients less muscle disease provides guidance basis, to prevent and delay the less muscle disease is of great significance.
Detailed description
The research content PD patients admitted to the Department of Neurology of our hospital from January 1, 2021 to December 31, 2022 were evaluated according to the assessment criteria for Asian sarcopenia patients (pre-sarcopenia, sarcopenia stage and severe sarcopenia stage), and the muscle mass, muscle strength and functional status of each patient were recorded. To understand the current situation of sarcopenia in PD patients, and to clarify the correlation between sarcopenia and the course and severity of disease in Parkinson's disease patients, and actively look for the influencing factors that can be intervened to guide the development of nursing intervention measures.
The research target This project through the cross-sectional survey of Parkinson's disease less muscle disease prevalence situation, further clear according to Parkinson's disease staging classification muscle disease prevalence, less and less by Logistic regression analysis to investigate the muscle disease and Parkinson's disease progression and the correlation between the severity of disease, for further implementation of PD patients with less muscle disease provide guidance on the basis of nursing intervention strategies.
The problem to be solved Dyskinesia, static tremor, and myotonia are common features of Parkinson's disease, which contribute to the loss of function and independence of Parkinson's patients. The methods used for the assessment of sarcopenia in the general population (such as the inability to measure walking speed and muscle strength) may not be applicable to PD patients, so it is necessary to consult clinical experts and teachers in the implementation process of the project.
Future research ideas
- Through a large sample size cross-sectional survey, this project clarified the prevalence of sarcopenia in Parkinson's disease patients, collected data to clarify related preventive measures to reduce the disease burden, and provided theoretical basis for further implementation of nursing intervention strategies in the future.
- To conduct further multicenter and cross-sectional investigation and study in the future, so as to better define the correlation between Parkinson's disease and sarcopenia.
- To gradually develop sarcopenia assessment criteria for patients with Parkinson's disease.
- Research method, technical route and schedule The research methods Study Design This study was a cross-sectional survey Subjects: PD patients who were admitted to the outpatient and inpatient departments of the Department of Neurology of our hospital on January 1, 2021 and December 31, 2022 were evaluated by H-Y grading scale and UPDRS-3 scale. Obtain basic patient information by consulting patient's medical records or asking patient's family members.
Included in the standard
- Meets MDS-2015 diagnostic criteria for Parkinson's disease; 2) The patient can stand independently; 3) Informed consent of patients and their families. Exclusion criteria
- Parkinson's disease syndrome caused by cerebrovascular diseases, encephalitis and trauma; 2) Progressive nuclear ascending paralysis, multiple system atrophy, Lewy body dementia and other Parkinson's superposition syndrome; 3) severe physical disease; 4) diseases of the digestive system; 5) wasting diseases such as infection and tumor 6) with severe mental illness or cognitive impairment. Withdrawal criteria The patient requested withdrawal. According to the literature, the incidence of sarcopenia in Parkinson's disease patients was 30.6%, the allowable error was 3%, the confidence was 0.95, and the qualified rate of the questionnaire was 90%. Combined with the above data, the sample size was calculated to be 908 cases.
Research tools and evaluation indicators Patients' basic information was obtained by consulting patients' cases or inquiring patients' family members through self-developed patients' basic information table.
- General information: gender, age and course of disease of the patient
- Nutrition status assessment: height, weight, triceps skin fold thickness, leg circumference, diet, MNA scale
- Parkinson's disease symptom assessment H-Y scale, Parkinson's disease non-motor symptom rating scale (NMSS), bell drawing test
- Patients were screened using the calf circumference and SARC-F questionnaire.<SARC-F> is a simple patient-assessed screening questionnaire, which includes 5 items in total, including strength, assisted walking, standing up, stair climbing, and the number of falls in a year. A total score of 4 or more was considered positive. Sarcopenia evaluation
- Evaluation of muscle mass Bioelectrical independence analysis (BIA) was used to evaluate the patient's muscle mass (male <7.0kg/m2, female <5.7kg/m2)
- Muscle strength assessment Hand-held gripper was used to measure the patient's main hand. When measuring grip strength, let the patient exert his hand at a constant speed to the maximum, and avoid visual feedback and verbal stimulation during exertion. Posture: 1) Standing posture: feet naturally on the ground, arms naturally droop; 2) Sitting posture: shoulder adducted neutral position, elbow flexed 90 degrees, upper arm flat with chest, forearm in neutral position; 3) Prostrate: the upper arm ababducts, the elbow is straight, and the body is 30 degrees, the forearm is neutral, the jaws up to hold the gripper, the lower end of the gripper is supported on the bed, the upper limb joints can not be flexed, moved, the gripper can not contact the body or press down. The AWGS 2019 recommended diagnostic threshold for grip strength for sarcopenia is less than 28.0kg for men and less than 18.0kg for women.
- Physical function AWGS recommends the use of the 6M walking test, 5 times sitting up test to assess physical function. The time required to walk 6m at a normal pace from the beginning of the movement, without acceleration or deceleration halfway, and measured at least 2 times to record the average speed. The bound value is 1.0m/s. If the patient was unable to walk independently, a five-time sitting test was used to replace the walking test, with a threshold of ≥12s.
Data statistics
- The prevalence of sarcopenia in PD patients was statistically analyzed; 2) The prevalence of sarcopenia in PD patients stratified by age, sex and H-Y; 3) Correlation between sarcopenia and other factors using Logistic regression model.5. Main innovations
- Currently, there are few studies on the prevalence of sarcopenia in PD patients at home and abroad, and most of them are small sample size studies.
- The prevalence of sarcopenia was determined according to the disease stage of PD patients.
- Expected results and assessment indicators of the project
- The prevalence of sarcopenia in PD patients was determined through a cross-sectional survey of outpatients with PD.
- Logistic regression was used to analyze the correlation between sarcopenia and disease course, disease grade and other factors of Parkinson's disease, and to actively seek potential causes, especially reversible causes, so as to provide guidance for the further implementation of individualized lifestyle intervention (exercise combined nutrition) and related health education for sarcopenia.
Assessment indicators Published 1 paper in the core journal.
Study design
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
- Target follow-up
- 2 Years
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- For PD patients who visited the outpatient and inpatient department of neurology of our hospital on January 1, 2021 and December 31, 2022,
Key inclusion criteria (3 listed)
- Meets MDS-2015 diagnostic criteria for Parkinson's disease;
- The patient can stand independently;
- Informed consent of patients and their families.
Key exclusion criteria (3 listed)
- Meets MDS-2015 diagnostic criteria for Parkinson's disease;
- The patient can stand independently;
- Informed consent of patients and their families.
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 |
|---|---|---|
| Human body component analyzerThe body composition analyzer is a kind of instrument that can measure the body composition health index. It is composed of professional tester, professional consulting management software, color printer A/B machine and so on. | Device | – |
Primary outcome
The prevalence of sarcopenia in PD patients
Time frame: 2021.1-2022.12
The prevalence of sarcopenia in PD patients was determined through a cross-sectional survey of outpatients with PD.
analyze the correlation between sarcopenia and disease course, disease grade and other factors of Parkinson's disease
Time frame: 2023.1-2023.3
Logistic regression was used to analyze the correlation between sarcopenia and disease course, disease grade and other factors of Parkinson's disease, and to actively seek potential causes, especially reversible causes, so as to provide guidance for the further implementation of individualized lifestyle intervention (exercise combined nutrition) and related health education for sarcopenia.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2021.
- Individual participant dataSharing planned: No. The patient data will be stored in the special PD database by the researchers of this project. All data relating to the subject's identity will be kept confidential and will not be made public except to the extent permitted by applicable laws and/or regulations.
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.
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 Search MeSH, PubMed Database, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
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 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: status not confirmed, as of the sponsor's last update on 9 Feb 2021. 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The prevalence of sarcopenia in PD patients (time frame: 2021.1-2022.12). The study lists 2 primary outcomes in all. 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 9 Feb 2021.