UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054434 |
|---|---|
| Receipt number | R000062138 |
| Scientific Title | Effects of Home-based Long-term Electrical Muscle Stimulation on Physical Function in Frailty Older Patients with Cardiovascular Disease: a randomized controlled trial |
| Date of disclosure of the study information | 2024/05/19 |
| Last modified on | 2025/10/06 15:10:53 |
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Basic information
Public title
Effects of Home-based Long-term Electrical Muscle Stimulation on Physical Function in Frailty Older Patients with Cardiovascular Disease: a randomized controlled trial
Acronym
FITNESS trial
Scientific Title
Effects of Home-based Long-term Electrical Muscle Stimulation on Physical Function in Frailty Older Patients with Cardiovascular Disease: a randomized controlled trial
Scientific Title:Acronym
FITNESS trial
Region
| Japan |
Condition
Condition
Frailty older patients with cardiovascular disease
Classification by specialty
| Cardiology | Geriatrics | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the efficacy and safety of home-based long-term electrical muscle stimulation on physical function in frailty older patients with cardiovascular disease
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change in quadriceps isometric strength (measurements at baseline and 8 weeks after hospital discharge)
Key secondary outcomes
Change in physical function, body composition, quality of life, and physical activity (measurements at baseline and 8 weeks after discharge)
Improvement in frailty at the end of follow-up
Presence or absence of sarcopenia at the end of follow-up and change in score (measurements at baseline and 8 weeks after discharge)
Change in cognitive function (measurements at baseline and 8 weeks after discharge) and presence or absence of cognitive decline
Recurrence or rehospitalization for cardiovascular disease, all-cause or cardiovascular disease-related deaths, or falls during follow-up
Adherence to intervention, adverse events associated with the intervention, and retention in outpatient rehabilitation
Subgroup analysis (statistical significance level of p-value for interaction: <0.1): age (stratified at median value), gender (male, female), quadriceps isometric strength at baseline (stratified at median value), diagnostic category (heart failure, acute coronary syndrome, other)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
1) Usual cardiac rehabilitation
2) Electrical muscle stimulation training (5 sessions per week for 8 weeks, with each session lasting 20 minutes)
Interventions/Control_2
1) Usual 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
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Patients hospitalized for cardiovascular disease and prescribed cardiac rehabilitation
2) Patients within 7 days of admission
3) Patients aged 65 years or older
4) Patients with frailty (Short Physical Performance Battery score of 4-9)
Key exclusion criteria
1) Patients undergoing hemodialysis
2) Patients with severe aortic stenosis
3) Patients with severe left ventricular outflow tract obstruction
4) Patients with untreated exercise-induced severe arrhythmia (ventricular fibrillation, sustained ventricular tachycardia)
5) Patients with uncontrolled hypertension or diabetes mellitus
6) Peripheral arterial disease (Fontaine classification of III or higher)
7) Patients undergoing home oxygen therapy
8) Unstable angina pectoris (myocardial ischemia induced by exercise less than 3 METs)
9) Patients who have difficulty in giving consent to participate in the study due to cognitive decline
10) Patients who require help in walking before admission
11) Patients with orthopedic conditions that interfere with ambulation
12) Pregnant, lactating, or possibly pregnant patients
13) Patients with a body mass index of 30 kg/m2 or more
14) Known and documented neuromuscular disease
15) Patients with a pacemaker or implantable cardioverter defibrillator (ICD)
16) Patients who are scheduled to be hospitalized within 2 months after discharge for standby surgery, pacemaker or ICD implantation, or for close examination
17) Patients deemed inappropriate by the attending physician
18) Patients who live in a facility or transferred from other hospitals
19) Short life expectancy due to advanced disease such as malignancy other than heart failure
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Kentaro |
| Middle name | |
| Last name | Kamiya |
Organization
Kitasato University
Division name
School of Allied Health Sciences
Zip code
252-0373
Address
1-15-1, Kitasato, Minami-ku, Sagamihara-city, Japan
TEL
042-778-9250
k-kamiya@kitasato-u.ac.jp
Public contact
Name of contact person
| 1st name | Kentaro |
| Middle name | |
| Last name | Kamiya |
Organization
Kitasato University
Division name
School of Allied Health Sciences
Zip code
252-0373
Address
1-15-1, Kitasato, Minami-ku, Sagamihara-city, Japan
TEL
042-778-9250
Homepage URL
k-kamiya@kitasato-u.ac.jp
Sponsor or person
Institute
Kitasato University School of Allied Health Sciences
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Ethics Committee of Kitasato University Hospital
Address
1-15-1, Kitasato, Minami-ku, Sagamihara-city, Japan
Tel
042-778-7756
rinri@med.kitasato-u.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
| 2024 | Year | 05 | Month | 19 | 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
Terminated
Date of protocol fixation
| 2024 | Year | 04 | Month | 17 | Day |
Date of IRB
| 2024 | Year | 06 | Month | 04 | Day |
Anticipated trial start date
| 2024 | Year | 06 | Month | 19 | Day |
Last follow-up date
| 2029 | Year | 04 | 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
| 2024 | Year | 05 | Month | 18 | Day |
Last modified on
| 2025 | Year | 10 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062138
