UMIN-CTR Clinical Trial

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