Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT04721028 |
| Other study ID # |
2021437121 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
January 1, 2021 |
| Est. completion date |
December 31, 2023 |
Study information
| Verified date |
January 2021 |
| Source |
Second Affiliated Hospital, School of Medicine, Zhejiang University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational [Patient Registry]
|
Clinical 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. 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.
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
1. 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.
2. 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.
3. To gradually develop sarcopenia assessment criteria for patients with Parkinson's
disease.
1. 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
1) 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
1) 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.
1. General information: gender, age and course of disease of the patient
2. Nutrition status assessment: height, weight, triceps skin fold thickness, leg
circumference, diet, MNA scale
3. Parkinson's disease symptom assessment H-Y scale, Parkinson's disease non-motor symptom
rating scale (NMSS), bell drawing test
4. Patients were screened using the calf circumference and SARC-F questionnaire. 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
5. 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)
6. 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.
7. 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
1) 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
1. 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.
2. The prevalence of sarcopenia was determined according to the disease stage of PD
patients.
6. Expected results and assessment indicators of the project
1. The prevalence of sarcopenia in PD patients was determined through a cross-sectional
survey of outpatients with PD.
2. 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.
