UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047229 |
|---|---|
| Receipt number | R000053863 |
| Scientific Title | Effects of a home-based Radio-Taiso exercise program on health-related quality of life in older adults with frailty: an assessor-blind randomized controlled trial |
| Date of disclosure of the study information | 2022/03/20 |
| Last modified on | 2023/09/19 09:33:36 |
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Basic information
Public title
A randomized, parallel-design trial to examine the effectiveness of Radio-Taiso in older adults with frailty
Acronym
A randomized, parallel-design trial to examine the effectiveness of Radio-Taiso in older adults with frailty
Scientific Title
Effects of a home-based Radio-Taiso exercise program on health-related quality of life in older adults with frailty: an assessor-blind randomized controlled trial
Scientific Title:Acronym
Effects of a home-based Radio-Taiso exercise program on health-related quality of life in older adults with frailty: an assessor-blind randomized controlled trial
Region
| Japan |
Condition
Condition
Frailty
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To test whether older adults with frailty who attend Radio-Taiso exercise program will receive greater benefits on HR-QoL than those who do not.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Phase III
Assessment
Primary outcomes
A mental component summary score of HR-QoL.
Key secondary outcomes
HR-QoL
Physical component summary score, role/social component summary score, and eight subscales of HR-QoL
Physical parameters
Frailty phenotype, agility/dynamic balance, strength, flexibility, aerobic endurance, and posture
Psychophysiological parameters
Attention, executive function, exercise self-efficacy, and depressive symptoms
Biochemical parameters
Brain-derived neurotrophic factor
Sociological parameters
Social network
Habitual lifestyle parameters
Energy intake, physical activity, and sleep conditions
Safety
The number of adverse events that occur during the intervention period will be assessed.
Adherence
Adherence will be assessed by the retention rate during the intervention period and the rate of the practice of the Radio-Taiso exercise program.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
Intervention group (12 weeks)
Radio-Taiso exercise program
1) Five 60-min face-to-face group sessions with a certified instructor and 2) daily practice in participants' homes (3 times/day)
Nutrition program
1) Distribution of a nutrition leaflet (4 times), 2) recording of a dietary variety score (every day), and 3) telephone nutrition counseling (one day per two weeks).
Interventions/Control_2
Control group (12 weeks)
Nutrition program
1) Distribution of a nutrition leaflet (4 times), 2) recording of a dietary variety score (every day), and 3) telephone nutrition counseling (one day per two 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
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Aged 65 years or older
2) Frailty or pre-frailty defined by the revised Japanese version of CHS criteria
Key exclusion criteria
1) Inability to participate in both baseline and follow-up assessments
2) Diagnosed with dementia or prescribed anti-dementia drugs
3) Impaired in basic activities of daily living
4) Not allowed to exercise (except for light-intensity exercise) by the family physician
5) Unstable/severe medical conditions that prevent trial physicians from allowing study participation
6) History of angina pectoris, myocardial infarction, or cardiac surgery for the past 3 months, having a terminal illness, or receiving palliative care
7) Practicing the exercises in Radio-Taiso more than 1 day/week for the past month
8) Participating in a specific rehabilitation program
9) Unable to walk more than 10 m independently
10) Participating or will participate in other clinical trials
11) Not having a television at home
12) Difficulty in communicating in Japanese
13) Judged by the principal investigator/trial physicians to be ineligible
14) Cannot give their consent to participate
Target sample size
226
Research contact person
Name of lead principal investigator
| 1st name | Yosuke |
| Middle name | |
| Last name | Osuka |
Organization
Tokyo Metropolitan Institute of Gerontology
Division name
Research Team for Promoting Independence and Mental Health
Zip code
173-0015
Address
35-2, Sakae-cho, Itabashi-ku, Tokyo
TEL
03-3964-3241
osuka@tmig.or.jp
Public contact
Name of contact person
| 1st name | Yosuke |
| Middle name | |
| Last name | Osuka |
Organization
Tokyo Metropolitan Institute of Gerontology
Division name
Research Team for Promoting Independence and Mental Health
Zip code
173-0015
Address
35-2, Sakae-cho, Itabashi-ku, Tokyo
TEL
03-3964-3241
Homepage URL
osuka@tmig.or.jp
Sponsor or person
Institute
Tokyo Metropolitan Institute of Gerontology
Institute
Department
Personal name
Funding Source
Organization
Japan Post Insurance Co., Ltd
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Tokyo Medical University
Japan Radio-Taiso Federation
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board of Tokyo Metropolitan Geriatric Hospital and Institute of Gerontology
Address
35-2, Sakae-cho, Itabashi-ku, Tokyo
Tel
03-3964-3241
rinsyoushiken@tmghig.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
東京都健康長寿医療センター研究所(東京都)/Tokyo Metropolitan Institute of Gerontology (Tokyo)
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 03 | Month | 20 | Day |
Related information
URL releasing protocol
https://bmjopen.bmj.com/content/12/9/e063201.long
Publication of results
Unpublished
Result
URL related to results and publications
N/A
Number of participants that the trial has enrolled
226
Results
There was no significant difference in the mean changes in the primary outcome (mental domain of the HR-QoL) between the two groups. The intervention group improved greater in the 8-foot up-and-go test(agility/dynamic balance) and the 2-minute step-in-place test (endurance) compared to the control group. The Home-Exercise Barriers Self-Efficacy Scale score in the intervention group declined less than that in the control group.
Results date posted
| 2023 | Year | 09 | Month | 19 | Day |
Results Delayed
| Delay expected |
Results Delay Reason
Due to under review
Date of the first journal publication of results
Baseline Characteristics
Older adults with pre-frailty or frailty
Participant flow
Participants were recruited from the trial-ready cohorts conducted at the Tokyo Metropolitan Institute for Geriatric and Gerontology between October 2021 and February 2022. In April 2022, participants who met the pre-frailty or frailty of the revised J-CHS were sent an invitation to the intervention and a checklist of eligibility criteria. The eligibility criteria are described in the protocol paper. In total, 2005 individuals participated in the trial-ready cohorts. Of these, 1142 who met the pre-frailty or frailty criteria were sent invitations to the trial. Ultimately, 410 individuals participated in the study orientation, and 343 met all eligibility criteria. From this population, 226 were randomly selected and invited for baseline assessment. Finally, 220 (97.3%) participated in the baseline evaluation and were randomly assigned to two pre-determined groups.
Adverse events
The number of adverse events reported by participants was 92 in the intervention group and 94 in the control group. The adverse events included pain (30 in the intervention group and 21 in the control group), falls (4 in the intervention group and 1 in the control group), and other adverse events (58 in the intervention group and 72 in the control group). There was no difference in the incidence of all adverse events between the two groups (intervention group: 47.1%; control group: 40.0%; P = .300). Three adverse events were determined to be possibly related to the Radio-Taiso by trial physicians, but all were mild pain.
Outcome measures
All outcomes listed in the protocol paper were assessed.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2022 | Year | 03 | Month | 18 | Day |
Date of IRB
| 2021 | Year | 12 | Month | 16 | Day |
Anticipated trial start date
| 2022 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 09 | Month | 16 | Day |
Date of closure to data entry
| 2022 | Year | 10 | Month | 14 | Day |
Date trial data considered complete
| 2022 | Year | 10 | Month | 28 | Day |
Date analysis concluded
| 2022 | Year | 11 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2022 | Year | 03 | Month | 19 | Day |
Last modified on
| 2023 | Year | 09 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053863
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