UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048772 |
|---|---|
| Receipt number | 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 18:34:10 |
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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
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
1334427886@qq.com
Sponsor or person
Institute
Department of Rehabilitation Medicine, Shanghai University of Medicine and Health Sciences
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055564
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