UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047893 |
|---|---|
| Receipt number | R000054579 |
| Scientific Title | Survey of Frailty in Older Patients with Heart Failure |
| Date of disclosure of the study information | 2022/05/30 |
| Last modified on | 2024/12/03 14:02:11 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Survey of Frailty in Older Patients with Heart Failure
Acronym
Survey of Frailty in Older Patients with Heart Failure
Scientific Title
Survey of Frailty in Older Patients with Heart Failure
Scientific Title:Acronym
Survey of Frailty in Older Patients with Heart Failure
Region
| Japan |
Condition
Condition
Older Heart failure
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
(1) To determine the prevalence of frailty in heart failure patients undergoing cardiovascular physical therapy.
(2) To determine the proportion of heart failure patients who are discharged from the hospital without recovering to their pre-hospital physical function.
(3) To investigate the prognosis of older heart failure patients and its related factors.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Prognosis after 1 year of hospital discharge
Key secondary outcomes
Daily function (Kihon checklist)
Physical function (Short Physical Performance Battery, grip strength, walking speed, upper arm and lower leg circumference)
Barthel Index, Functional Independence Measure) and frailty (Japanese version of Cardiovascular Health Study Index)
Physical therapy content (duration, number of units, and content of physical therapy)
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
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients 65 years of age or older with heart failure who required hospitalization for treatment of heart failure and for whom physiotherapy was prescribed during hospitalization.
Key exclusion criteria
Patients who were deemed inappropriate by the attending physician.
Patients who were bedridden prior to hospitalization (Patients with a disability of at least rank C in the level of independence from daily living [bedridden level] for the disabled elderly).
Target sample size
10000
Research contact person
Name of lead principal investigator
| 1st name | Tetsuya |
| Middle name | |
| Last name | Takahashi |
Organization
Juntendo University
Division name
Faculty of Health Science, Department of Physical Therapy
Zip code
1130033
Address
Hongo 3-2-12, Bunkyo-ku, 113-0033, TOKYO, JAPAN
TEL
0358020425
te-takahashi@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | Tetsuya |
| Middle name | |
| Last name | Takahashi |
Organization
Juntendo University
Division name
Faculty of Health Science, Department of Physical Therapy
Zip code
1130033
Address
Hongo 3-2-12, Bunkyo-ku, 113-0033, TOKYO, JAPAN
TEL
0358020425
Homepage URL
te-takahashi@juntendo.ac.jp
Sponsor or person
Institute
Faculty of Health Science, Department of Physical Therapy
Juntendo University
Institute
Department
Personal name
Tetsuya Takahashi
Funding Source
Organization
Japanese Society of Cardiovascular Physical Therapy
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Juntendo University Faculty of Health Sciences Research Ethics Committee
Address
Hongo 3-2-12, Bunkyo-ku, 113-0033, TOKYO, JAPAN
Tel
03-3812-1780
c.matsuno.vg@juntendo.ac.jp
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
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 05 | Month | 30 | Day |
Related information
URL releasing protocol
https://www.jstage.jst.go.jp/article/circj/88/5/88_CJ-23-0722/_article
Publication of results
Partially published
Result
URL related to results and publications
https://www.jstage.jst.go.jp/article/circj/88/5/88_CJ-23-0722/_article
Number of participants that the trial has enrolled
9403
Results
Of the 9,403 patients (median age 83.0 years, 50.9% male), 3,488 (37.1%) had HAD. The HAD group was older and had higher rates of hypertension, chronic kidney disease, and cerebrovascular disease comorbidity. The HAD group also had a significantly lower Barthel Index and a significantly higher Kihon checklist score before admission.
Results date posted
| 2024 | Year | 05 | Month | 30 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2024 | Year | 05 | Month | 01 | Day |
Baseline Characteristics
J-Proof HF is a prospective nationwide multicenter cohort registry of patients with heart failure in Japan. Ninety-six institutions across Japan employing members of the Japanese Society of Cardiovascular Physical Therapy participated in the registry. From December 2020 to March 2022, consecutive patients aged over 65 years who were prescribed physical rehabilitation by their physician during hospitalization after the onset of heart failure were enrolled in the J-Proof HF Registry.
Participant flow
Ninety-six institutions across Japan employing members of the Japanese Society of Cardiovascular Physical Therapy participated in the registry. From December 2020 to March 2022, consecutive patients aged over 65 years who were prescribed physical rehabilitation by their physician during hospitalization after the onset of heart failure were enrolled in the J-Proof HF Registry. Exclusion criteria were as follows: death during hospitalization, invasive treatment (transcatheter aortic valve implantation, MitraClip, surgery) during hospitalization, and acute coronary syndrome. Patients who were bedridden prior to admission were also excluded.
Adverse events
NA
Outcome measures
Patient demographic data, diagnoses, comorbidities, cardiac function based on echocardiography at admission, New York Heart Association (NYHA) classification at admission, laboratory data at admission (B-type natriuretic peptide [BNP], estimated glomerular filtration rate, albumin, hemoglobin concentration) were recorded. The prehospital Barthel Index and the Kihon checklist of the Ministry of Health, Labour and Welfare, were also recorded. Prescribed medications, the Short Physical Performance Battery (SPPB), grip strength, upper arm and lower leg circumference, and the Japanese Cardiovascular Health Study Index (to assess physical frailty) were assessed at hospital discharge. Cognitive function was assessed at baseline using either the Hasegawa Dementia Scale (HDS-R), Mini-Mental State Examination (MMSE), Mini-Cognitive Assessment Instrument (Mini-Cog), or the Japanese version of the Montreal Cognitive Assessment (MoCA-J). In this study, cognitive decline was defined as <21 points on the HDS-R, <24 points on the MMSE, <3 points on the Mini-Cog, and <26 points on the MoCA-J. We then examined rehabilitation content during hospitalization (duration of rehabilitation, number of rehabilitation units [20 min/unit], and physical therapy content) and the discharge destination. The Functional Independence Measure (FIM) was also measured at discharge whenever possible.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2020 | Year | 12 | Month | 15 | Day |
Date of IRB
| 2020 | Year | 05 | Month | 25 | Day |
Anticipated trial start date
| 2020 | Year | 05 | Month | 25 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2024 | Year | 06 | Month | 30 | Day |
Date trial data considered complete
| 2024 | Year | 06 | Month | 30 | Day |
Date analysis concluded
| 2026 | Year | 03 | Month | 31 | Day |
Other
Other related information
Non
Management information
Registered date
| 2022 | Year | 05 | Month | 30 | Day |
Last modified on
| 2024 | Year | 12 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054579
