UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057913 |
|---|---|
| Receipt number | R000066203 |
| Scientific Title | The effect of High-Intensity Interval Training Intervention on exercise tolerance in maintenance elderly outpatient cardiac rehabilitation patients with Frailty :a randomized controlled trial |
| Date of disclosure of the study information | 2025/07/01 |
| Last modified on | 2025/05/20 01:38:20 |
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Basic information
Public title
The effect of High-Intensity Interval Training Intervention on exercise tolerance in maintenance elderly outpatient cardiac rehabilitation patients with Frailty :a randomized controlled trial
Acronym
High Intensity Interval Training for maintenance elderly ambulatory cardiac rehabilitation patients presenting with Frailty
Scientific Title
The effect of High-Intensity Interval Training Intervention on exercise tolerance in maintenance elderly outpatient cardiac rehabilitation patients with Frailty :a randomized controlled trial
Scientific Title:Acronym
High Intensity Interval Training for maintenance elderly ambulatory cardiac rehabilitation patients presenting with Frailty
Region
| Japan |
Condition
Condition
Cardiovascular patients
Classification by specialty
| Cardiology | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The effect of High-Intensity Interval Training on exercise tolerance and clinical outcomes in maintenance elderly outpatient cardiac rehabilitation patients presenting with Frailty
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change in peak VO2 and peak Work rate in Cardiopulmonary exercise test(CPET) before and after intervention
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Intervention group performed supervised high-intensity interval training once a week for 12 weeks.
Interventions/Control_2
The control group will perform the same aerobic exercise as before.
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
| 70 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.Cardiovascular patients 70 years of age or older who continue to receive outpatient cardiac rehabilitation in the maintenance phase
2.Patients who are frail or pre frail
3.Patients who have been performing the same aerobic exercise as before in outpatient cardiac rehabilitation for more than 3 months and whose peak VO2 was measured by CPET within the last month
4.Patients who have given verbal explanations using written explanations and obtained written consent
Key exclusion criteria
1.Patients with unstable hemodynamics
2.Patients with when ischemic changes are observed on CPET
3.Patients with severe aortic stenosis
4.Patients with active inflammatory disease
5.Patients with malignancy under treatment
6.Patients with severe chronic obstructive pulmonary disease
7.Patients with chronic renal failure undergoing hemodialysis
8.Patients with pain appears in the hip , knee and ankle joints
9.Patients with motor paralysis
10.Patients with when severe malnutrition disorders
11.Patients with those unable to perform the exercise as instructed due to poor comprehension
Target sample size
35
Research contact person
Name of lead principal investigator
| 1st name | Ryota |
| Middle name | |
| Last name | Matsuzawa |
Organization
Hyogo Medical University
Division name
Department of Physical Therapy School of Rehabilitation
Zip code
650-8530
Address
1-3-6 Minatojima, Chuo-ku, Kobe, Hyogo
TEL
078-304-3181
ri-matsuzawa@hyo-med.ac.jp
Public contact
Name of contact person
| 1st name | Ryota |
| Middle name | |
| Last name | Matsuzawa |
Organization
Hyogo Medical University
Division name
Department of Physical Therapy School of Rehabilitation
Zip code
650-8530
Address
1-3-6 Minatojima, Chuo-ku, Kobe, Hyogo
TEL
078-304-3181
Homepage URL
ri-matsuzawa@hyo-med.ac.jp
Sponsor or person
Institute
Department of Physical Therapy School of Rehabilitation, Hyogo Medical University, Kobe, Hyogo, Japan
Institute
Department
Personal name
Funding Source
Organization
Department of Physical Therapy School of Rehabilitation, Hyogo Medical University, Kobe, Hyogo, Japan
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
The Ethics Review Board of Hyogo Medical University
Address
1-1 Mukogawa-cho, Nishinomiya, Hyogo, 663-8501
Tel
0798-45-6066
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
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 07 | 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 05 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2028 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 05 | Month | 20 | Day |
Last modified on
| 2025 | Year | 05 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066203
