UMIN-CTR Clinical Trial

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

hospitalized patients with heart failure

Classification by specialty

Medicine in general	Cardiology	Geriatrics
Rehabilitation medicine

Classification by malignancy

Others

Genomic information

NO

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

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)

Study type

Interventional

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

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

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

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

Email

ma-gotou@hyo-med.ac.jp

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

Email

hi-kondo@hyo-med.ac.jp

Institute

Hyogo Medical University

Institute

Department

Personal name

Hideyuki Kondo

Organization

Hyogo Mdeical University

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Japan

Co-sponsor

Name of secondary funder(s)

Organization

Hyogo Medical University Ethics Review Board

Address

1-1 Mukogawa, Nishinomiya, Hyogo 663-8501, Japan

Tel

+81-798-45-6066

Email

rinri@hyo-med.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

兵庫医科大学ささやま医療センター（兵庫県）

Date of disclosure of the study information

2018

Year

04

Month

01

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Enrolling by invitation

Date of protocol fixation

2018

Year

05

Month

14

Day

Date of IRB

Anticipated trial start date

2018

Year

05

Month

14

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2018

Year

02

Month

23

Day

Last modified on

2023

Year

10

Month

09

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035814