UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058175 |
|---|---|
| Receipt number | R000062979 |
| Scientific Title | A Randomized Clinical Trial of the Safety, Efficacy, and Prognosis of Upper Extremity Resistance Training in Hospitalized Elderly Heart Failure Patients |
| Date of disclosure of the study information | 2025/06/28 |
| Last modified on | 2025/06/28 13:39:50 |
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Basic information
Public title
Safety, Efficacy, and Prognosis of Upper Extremity Resistance Training in Hospitalized Elderly Heart Failure Patients: A Randomized Clinical Trial
Acronym
Safety, Efficacy, and Prognosis of Upper Extremity Resistance Training in Hospitalized Elderly Heart Failure Patients: A Randomized Clinical Trial
Scientific Title
A Randomized Clinical Trial of the Safety, Efficacy, and Prognosis of Upper Extremity Resistance Training in Hospitalized Elderly Heart Failure Patients
Scientific Title:Acronym
ULRT-EHF Study (Upper Limb Resistance Training in Elderly Heart Failure)
Region
| Japan |
Condition
Condition
Heart failure in the elderly
Classification by specialty
| Cardiology | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
A Study on the Safety and Effectiveness of Upper Extremity Resistance Training in Hospitalized Older Patients with Heart Failure
Basic objectives2
Others
Basic objectives -Others
To evaluate the safety and efficacy of upper limb resistance training and its impact on prognosis in elderly patients with heart failure.
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Safety, effectiveness, quality of life, and prognosis with upper extremity resistance training
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Treatment Group: Group that undergoes upper limb resistance training
Interventions/Control_2
Control Group: Group that undergoes standard rehabilitation
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
| 99 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Elderly heart failure patients aged 65 years older who are hospitalized for acute exacerbation of heart failure and for whom a rehabilitation order has been prescribed by a physician will be randomly assigned to two groups in the order of the physician's rehabilitation order. Patients assigned to the upper limbs resistance training (URT) group will be randomly assigned to the URT group, and those assigned to the ADL group will be randomly assigned to the ADL group. The following four criteria will be used as references: European Society of Cardiology statement, AHA scientific statement, Japanese Society of Cardiology guidelines, contraindications to resistance training in heart failure, and the REHAB-HF Trial. The following four conditions should be checked: controlled heart failure and NYHA classification I-III, no congestive symptoms (orthopnea, ascites, jugular venous distention, extreme edema), systolic blood pressure greater than 80 mmHg without orthostatic hypotension, ability to walk 4 m or more (regardless of whether or not a walking aid is used). The patient's condition is not a contraindication to URT, but the following 9 criteria should be confirmed. The following 9 conditions are not contraindicated for URT: NYHA classification IV, left ventricular outflow tract stenosis, noncompensated heart failure, uncontrolled arrhythmia, severe and symptomatic aortic stenosis, uncontrolled diabetes, uncontrolled hypertension (Blood pressure 180/110 mm Hg or higher), severe pulmonary hypertension (Mean pulmonary artery pressure 55 mm Hg or higher), acute myocardial infarction.
Key exclusion criteria
Patients who are scheduled to receive intravenous continuous inotropic therapy after discharge from the hospital, patients with an artificial heart or who are scheduled to receive one within the next 6 months (heart transplant candidates), patients who cannot receive URT due to severe orthopedic disease or stroke, patients with severe dementia who cannot proceed with rehabilitation, patients who need treatment in the ICU, and upper limb Patients who cannot consent to resistance training are excluded.
Target sample size
128
Research contact person
Name of lead principal investigator
| 1st name | Masami |
| Middle name | |
| Last name | Inokuma |
Organization
Gunma Prefectural Cardiovascular Center
Division name
Division of Rehabilitation Medicine
Zip code
371-004
Address
3-12 Kou, Kameizumi-cho, Maebashi, Gunma
TEL
0272697455
inokuma-m@cvc.pref.gunma.jp
Public contact
Name of contact person
| 1st name | Masami |
| Middle name | |
| Last name | Inokuma |
Organization
Gunma Prefectural Cardiovascular Center
Division name
Division of Rehabilitation Medicine
Zip code
371-0004
Address
3-12 Kou, Kameizumi-cho, Maebashi, Gunma
TEL
0272697455
Homepage URL
inokuma-m@cvc.pref.gunma.jp
Sponsor or person
Institute
other
Institute
Department
Personal name
Masami Inokuma
Funding Source
Organization
nothing
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Gunma Cardiovascular Center Ethics Review Committee
Address
3-12 Kou, Kameizumi-cho, Maebashi, Gunma
Tel
0272697455
inokuma-m@cvc.pref.gunma.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
| 2025 | Year | 06 | Month | 28 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Open public recruiting
Date of protocol fixation
| 2024 | Year | 07 | Month | 30 | Day |
Date of IRB
| 2024 | Year | 05 | Month | 17 | Day |
Anticipated trial start date
| 2024 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
| 2025 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 06 | Month | 14 | Day |
Last modified on
| 2025 | Year | 06 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062979
