UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030761 |
|---|---|
| Receipt number | R000035081 |
| Scientific Title | Effects of cyborg-type robot suit HAL on exercise therapy in patients with chronic heart failure |
| Date of disclosure of the study information | 2018/02/01 |
| Last modified on | 2023/01/15 13:22:23 |
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Basic information
Public title
Effects of cyborg-type robot suit HAL on exercise therapy in patients with chronic heart failure
Acronym
Effects of HAL on exercise therapy in CHF patients
Scientific Title
Effects of cyborg-type robot suit HAL on exercise therapy in patients with chronic heart failure
Scientific Title:Acronym
Effects of HAL on exercise therapy in CHF patients
Region
| Japan |
Condition
Condition
patients with chronic heart failure
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to clarify the followings in patients with chronic heart failure;
1) Motion assistance of HAL during exercise therapy could lead to effective reduction of cardiopulmonary burden.
2) HAL could lead to early getting out of bed and early discharge from hospital.
3) HAL could lead to reduce the hospitalization by heart failure and cardiovascular death after discharge.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
heart rate, blood pressure, and symptom during exercise therapy
Key secondary outcomes
1) days from the start of exercise therapy until the walking by oneself
2) days from the start of exercise therapy until the discharge from hospital
3) adverse events
4) prognosis during 1 year from discharge
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
YES
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Wearing of Robot suit HAL
Interventions/Control_2
Time: 5-30 minutes /day
Frequency: 3-5 days /week
Duration: approximately 2 weeks
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
A patient with chronic heart failure who meets the criteria of exercise therapy (cardiac rehabilitation) by health insurance
Key exclusion criteria
A patient who correspond to contraindication to exercise therapy
Target sample size
90
Research contact person
Name of lead principal investigator
| 1st name | Akira |
| Middle name | |
| Last name | Koike |
Organization
Faculty of Medicine, University of Tsukuba
Division name
Department of Cardiology
Zip code
305-8575
Address
1-1-1 Tennodai, Tsukuba, Ibaraki
TEL
029-853-3210
koike@md.tsukuba.ac.jp
Public contact
Name of contact person
| 1st name | Akira |
| Middle name | |
| Last name | Koike |
Organization
Faculty of Medicine, University of Tsukuba
Division name
Department of Cardiology
Zip code
305-8575
Address
1-1-1 Tennodai, Tsukuba, Ibaraki
TEL
029-853-3210
Homepage URL
koike@md.tsukuba.ac.jp
Sponsor or person
Institute
Department of Cardiology, Faculty of Medicine, University of Tsukuba
Institute
Department
Personal name
Funding Source
Organization
MEXT
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee, University of Tsukuba Hospital
Address
Amakubo 2-1-1, Tsukuba-shi, ibaraki
Tel
029-853-3914
rinshokenkyu@un.tsukuba.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
筑波大学附属病院／University of Tsukuba Hospital
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 02 | Month | 01 | Day |
Related information
URL releasing protocol
DOI: 10.1253/circj.CJ-21-0381
Publication of results
Published
Result
URL related to results and publications
DOI: 10.1253/circj.CJ-21-0381
Number of participants that the trial has enrolled
28
Results
Motion assistance from HAL during the sit-tostand exercise significantly improved muscle strength in heart failure patients. The lumbartype HAL may be an effective tool for frailty, a predictor of poor prognosis in heart failure.
Results date posted
| 2023 | Year | 01 | Month | 15 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Mean age was 71.0 years in the HAL group (n =13) and 75.2 years in the control group (n = 11), and gender (male/female) was 7/6 in the HAL group and 6/5 in the control group.
Participant flow
Twenty-four of 28 patients completed all protocol-specified assessments and
interventions (13 in the HAL group and 11 in the control group). Three of the four dropouts were
discontinued by early discharge due to the patient's own circumstances or medical reasons,
and one was discontinued due to death judged to be unrelated to this clinical study.
Adverse events
No adverse events occurred in all cases.
Outcome measures
Heart rate and blood pressure at the final exercise session
The number of days from the start of exercise therapy before the patient could walk
The number of days from the start of exercise therapy to discharge
BNP
The knee extensor muscle strength
The 30-s chair-stand test(CS-30)
6-minute walking distance (6MWD)
Short physical performance battery (SPPB)
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2017 | Year | 12 | Month | 20 | Day |
Date of IRB
| 2018 | Year | 01 | Month | 22 | Day |
Anticipated trial start date
| 2018 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 09 | Month | 30 | 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 | 01 | Month | 11 | Day |
Last modified on
| 2023 | Year | 01 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035081
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