UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039325 |
|---|---|
| Receipt number | R000044813 |
| Scientific Title | Cluster Randomized Comparative Effectiveness Study of a Remote Exercise Program Based on Cardiac Rehabilitation Methods using ICT for Seniors in Daycare Facilities |
| Date of disclosure of the study information | 2020/03/01 |
| Last modified on | 2021/01/29 10:37:26 |
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Basic information
Public title
Verification of the usefulness of a remote exereise program by coordination of medical team and nursing staff
Acronym
REX-ICT study
Scientific Title
Cluster Randomized Comparative Effectiveness Study of a Remote Exercise Program Based on Cardiac Rehabilitation Methods using ICT for Seniors in Daycare Facilities
Scientific Title:Acronym
REX-ICT study
Region
| Japan |
Condition
Condition
Care-need certificated person who uses daycare facilities
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify effectiveness of a remote exercise program based on cardiac rehabilitation methods using ICT for seniors in daycare facilities
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in peak oxygen uptake (Peak VO2) by cardiopulmonary exercise test (CPX) at 20 weeks from baseline
Key secondary outcomes
Changes from baseline to 20 weeks after intervention for: blood pressure and heart rate, anaerobic metabolic threshold(AT),physical function: SPPB, grip strength, TUG, body composition (limb skeletal muscle mass, weight, muscle quality)
Blood laboratory data: white blood cell count (WBC), red blood cell count (RBC), hemoglobin value (Hb), hematocrit value (Ht), platelet count (PLT), total protein value (TP), albumin value (Alb), LDL calculated value, HDL-C level, TG level, total cholesterol level (Tcho), blood glucose level (Glu), HbA1c level (only those who have diabetes), uric acid level (UA), creatinine level (Cre), serum urea nitrogen level (BUN), eGFR.
Urine collection data: urine general, sodium (Na), potassium (K), creatinine (Cre), estimated NaCl intake
Questionnaire: EQ-5D, Basic Checklist, Barthel Index Scores
Other: Cost-benefit analysis
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
20 weeks for Intervention period.
Instruct the tailor-made exercise prescription based on the concept of interval walking by Physical Therapist(PT) physical evaluation(home exercise and supervised exercise).
Every 4 weeks during the 20-week intervention period, the PT and facility staff will examine the exercise and living guidance of the study subjects Via a web conference and implement remote guidance.
Record blood pressure, pulse rate, weight and accelerometer data at each visit to the facility in LAVITA.
Based on the objective data recorded in LAVITA, prepare Exercise Report and Life Review Sheet and Individual Function Training Addition Plan Provide remote guidance to facility staff.
Subjects with Sarcopenia receive supplemental nutrition after exercise.
A urine Na / K ratio measurement device will be rented from the main hospital to subjects who have been determined to have excessive salt, and the estimated salt intake will be monitored.
Interventions/Control_2
20 weeks for Intervention period.
Only regular outpatient care services without the remote exercis therapg. Based on the care plan, day care facility visits are conducted once or twice a week, and the conventional services such as bathing, desk activity, nap in a lying position, recreation, gymnastics, and individual function training are continued.
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
| 40 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1) Those who have given written consent to participate in the research
(2) Those who are using the facility
(3) Care certification is required for those who need support 1, 2 or nursing care 1
(4) Individuals who can walk indoors independently (Timed Up & Go Test <30 seconds)
(5) Heart disease risk class A to C in AHA exercise standard class classification
(6) Those who are judged to be able to perform exercise therapy according to the judgment of the attending physician
(7) Person who can go to the main hospitals for medical check
(8) Those who can undergo CPX
Key exclusion criteria
(1) Person diagnosed as dementia in care insurance
(2) If the attending physician judgeds inappropriate for conducting this clinical trial
Target sample size
156
Research contact person
Name of lead principal investigator
| 1st name | Takanori |
| Middle name | |
| Last name | Yasu |
Organization
Dokkyo Medical University Nikko Medical Center
Division name
Department of Cadiovasaular Medicine and Nephrology
Zip code
321-2593
Address
632 Takatoku, Nikko City, Tochigi Prefecture
TEL
0288-76-1515
tyasu@dokkyomed.ac.jp
Public contact
Name of contact person
| 1st name | Yuma |
| Middle name | |
| Last name | Tamura |
Organization
Dokkyo Medical University Nikko Medical Center
Division name
Department of Rehabilitation
Zip code
321-2593
Address
632 Takatoku, Nikko City, Tochigi Prefecture
TEL
0288-76-0627
Homepage URL
researcresearchnikko@gmail.com
Sponsor or person
Institute
Dokkyo Medical University Nikko Medical Center
Department of cadio vasaular mcdicine and Nephrology
Institute
Department
Personal name
Funding Source
Organization
Japanese Physical Therapy Association
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
/Dokkyo Medical University Nikko Medical Center Bioethics Committee
Address
632 Takatoku, Nikko City, Tochigi Prefecture
Tel
0288-76-1515
rinshokenkyu@dokkyomed.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
獨協医科大学日光医療センター（栃木県）/Dokkyo Medical University Nikko Medical Center (Tochigi Prefecture)
独協医科大学病院（栃木県）/Dokkyo Medical University Hospital (Tochigi Prefecture)
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 03 | 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
Open public recruiting
Date of protocol fixation
| 2019 | Year | 09 | Month | 24 | Day |
Date of IRB
| 2019 | Year | 10 | Month | 30 | Day |
Anticipated trial start date
| 2020 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2022 | Year | 04 | Month | 30 | Day |
Date trial data considered complete
| 2022 | Year | 05 | Month | 31 | Day |
Date analysis concluded
| 2022 | Year | 06 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2020 | Year | 01 | Month | 30 | Day |
Last modified on
| 2021 | Year | 01 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044813
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