UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031444 |
|---|---|
| Receipt number | R000035814 |
| Scientific Title | Therapeutic effects of thermotherapy combined with exercise training on physical activity in hospitalized aged patients with decompensated heart failure. |
| Date of disclosure of the study information | 2018/04/01 |
| Last modified on | 2025/03/28 15:08:49 |
* 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
Therapeutic effects of thermotherapy combined with exercise training on physical activity in hospitalized aged patients with decompensated heart failure.
Acronym
Combined effects of thermotherapy and exercise training in patients with heart failure.
Scientific Title
Therapeutic effects of thermotherapy combined with exercise training on physical activity in hospitalized aged patients with decompensated heart failure.
Scientific Title:Acronym
Combined effects of thermotherapy and exercise training in patients with heart failure.
Region
| Japan |
Condition
Condition
hospitalized patients with heart failure
Classification by specialty
| Medicine in general | Cardiology | Geriatrics |
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify therapeutic effects of thermotherapy with cardiac rehabilitation on physical activity in patients with heart failure.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Peak oxygen consumption (VO2) post treatment
Key secondary outcomes
All values are post treatment.
1) VE/VCO2 slope
2) Anaerobic Threshold (AT) point
3) Serum IGF-1 levels
4) Serum TNF alpha levels
5) Plasma Noradrenaline levels
6) Plasma BNP levels
7) Plasma plasminogen activator inhibitor-1 levels
8) Left ventricular end-diastolic diameter by cardiac ultrasound
9) Left arterial diameter or volume by cardiac ultrasound
10) Sleep quality assessed by St. Mary's Hospital Sleep Questionnaire
11) Worsening congestive heart failure
12) Death from any cause
13) Adverse event (e.g. accidental burns, falling accident)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Pseudo-randomization
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment | Maneuver |
Interventions/Control_1
Hyperthermia therapy using far infrared rays (One or twice treatment session a day, 5 days per week for a month or during hospitalization). It combines with ordinary cardiac rehabilitation.
Interventions/Control_2
Only traditional cardiac 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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients met all of following criterion are enrolled.
1) Written informed consent obtained from subject or legal representative.
2) >20 years of age.
3) Hospitalization for heart failure with New York Heart Association (NYHA) class 3 to 4 symptoms.
4) Heart failure defined as patients with either left ventricular ejection fraction of 40% or less, maximal oxygen consumption (peak VO2) of 80% or less, or plasma BNP levels of 80 pg/ml or less.
Key exclusion criteria
Patients met either of following criterion are not enrolled.
1) Acute inflammatory diseases such as bacterial infection or thrombophlebitis.
2) Paresthesia of legs.
3) Uncontrollable bleeding or known bleeding diathesis with active bleeding.
4) Patients with cancers.
5) Patients who have condition or factor serves as a reason to withhold hyperthermia therapy.
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Masashi |
| Middle name | |
| Last name | Goto |
Organization
Hyogo Medical University Sasayama medical center
Division name
Department of General Medicine and Community Health Science
Zip code
669-2321
Address
5 Kurooka, Sasayama, Hyogo 669-2321, Japan
TEL
+81-79-552-1181
ma-gotou@hyo-med.ac.jp
Public contact
Name of contact person
| 1st name | Hideyuki |
| Middle name | |
| Last name | Kondo |
Organization
Hyogo College of Medicine Sasayama Medical Center
Division name
Department of General Medicine and Community Health Science
Zip code
669-2321
Address
5 Kurooka, Sasayama, Hyogo 669-2321, Japan
TEL
+81-79-552-1181
Homepage URL
hi-kondo@hyo-med.ac.jp
Sponsor or person
Institute
Hyogo Medical University
Institute
Department
Personal name
Hideyuki Kondo
Funding Source
Organization
Hyogo Mdeical University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Hyogo Medical University Ethics Review Board
Address
1-1 Mukogawa, Nishinomiya, Hyogo 663-8501, Japan
Tel
+81-798-45-6066
rinri@hyo-med.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
兵庫医科大学ささやま医療センター（兵庫県）
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 04 | Month | 01 | 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
Enrolling by invitation
Date of protocol fixation
| 2018 | Year | 05 | Month | 14 | Day |
Date of IRB
| 2018 | Year | 08 | Month | 14 | Day |
Anticipated trial start date
| 2018 | Year | 05 | Month | 14 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 02 | Month | 23 | Day |
Last modified on
| 2025 | Year | 03 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035814
