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Name
UMIN ID

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000048772
Receipt No. R000055564
Scientific Title Physical Fitness Cohort Study of Hemodialysis
Date of disclosure of the study information 2022/08/26
Last modified on 2022/08/26

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Basic information
Public title Physical Fitness Cohort Study of Hemodialysis
Acronym PFCSH
Scientific Title Physical Fitness Cohort Study of Hemodialysis
Scientific Title:Acronym PFCSH
Region
Asia(except Japan)

Condition
Condition Open public recruiting
Classification by specialty
Medicine in general Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The aim of this study was to explore the correlation between physical fitness and nutrition, quality of life, psychological status, cognitive status and mortality in hemodialysis patients.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The aim of this study was to investigate the association between muscle mass, muscle strength as well as physical performance with all-cause mortality in hemodialysis patients.
Key secondary outcomes This study was to explore the association between physical performance (such as sarcopenia) with depression, cognitive impairment, quality of life in hemodialysis patients.

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
18 years-old <
Age-upper limit
90 years-old >=
Gender Male and Female
Key inclusion criteria aged over eighteen receiving maintenance hemodialysis for at least three months, and able to provide informed consent.
Key exclusion criteria patients with hearing impairment, or visual impairment difficulties; presented with an infection, amputated limb, pulmonary edema, or malignancy; unable to communicate with the study staff or provide informed consent.
Target sample size 1500

Research contact person
Name of lead principal investigator
1st name Qi
Middle name
Last name Guo
Organization Shanghai University of Medicine and Health Sciences
Division name China
Zip code 201318
Address 279 Zhouzhu highway , Pudong New District, Shanghai
TEL 15620467578
Email guoqijp@gmail.com

Public contact
Name of contact person
1st name Xiaoyu
Middle name
Last name Chen
Organization Shanghai University of Medicine and Health Sciences
Division name China
Zip code 201318
Address 279 Zhouzhu highway , Pudong New District, Shanghai
TEL 18822002275
Homepage URL
Email 1334427886@qq.com

Sponsor
Institute Department of Rehabilitation Medicine, Shanghai University of Medicine and Health Sciences
Institute
Department

Funding Source
Organization Non
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Shanghai University of Medicine and Health Sciences
Address 279 Zhouzhu highway , Pudong New District, Shanghai
Tel 15620467578
Email guoqijp@gmail.com

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions Shanghai University of Medicine and Health Sciences

Other administrative information
Date of disclosure of the study information
2022 Year 08 Month 26 Day

Related information
URL releasing protocol The relationship between physical performance and depressive symptoms
Publication of results Partially published

Result
URL related to results and publications https://link.springer.com/article/10.1007/s12603-022-1778-8
Number of participants that the trial has enrolled 800
Results Our findings suggest that muscle function rather than muscle mass may contribute substantially to the development of depressive symptoms clusters in the hemodialysis via malnutrition. The malnutrition mediated stronger in the association of muscle function with somatic symptoms. These findings may help guide clinicians to better diagnose and manage depression in the context of concomitant muscle function and malnutrition.
Results date posted
2022 Year 08 Month 26 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics Socioeconomic and health-related characteristics of patients undergoing hemodialysis stratified by depressed status were significant, such as handgrip strength, gait speed,IPAQ, malnutrition and CCI.
Participant flow The final analytic sample consisted of 499 patients (men 312, women 187) after excluding 43 subjects.
Adverse events No
Outcome measures Muscle mass and function; Nutritional Status and depressive symptoms clusters.
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Open public recruiting
Date of protocol fixation
2019 Year 11 Month 01 Day
Date of IRB
2020 Year 07 Month 01 Day
Anticipated trial start date
2020 Year 07 Month 01 Day
Last follow-up date
2025 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information All participants were invited to a face-to-face interview to answer a standardized questionnaire. Baseline date of sociodemographic characteristics, health behaviors, condition of chronic diseases were considered as covariates. Demographic characteristics included age, gender, post-dialysis weight, dialysis vintage, education level. Health behaviors included smoking and drinking habits. Physical activity was assessed using the short form of the International Physical Activity Questionnaire (IPAQ). Charlson comorbidity index (CCI) was used to assess the comorbidity, which accounted for multiple comorbidities by creating a sum score according to the presence of 19 comorbid conditions. In addition, all blood samples were drawn pre-dialysis. Kt/V was used as indicator of dialysis quality and monitored in every dialysis treatment.

Management information
Registered date
2022 Year 08 Month 26 Day
Last modified on
2022 Year 08 Month 26 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055564

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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