UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000063532 |
|---|---|
| Receipt number | R000072708 |
| Scientific Title | Verification of a mind-body health promotion program incorporating spiritual care |
| Date of disclosure of the study information | 2026/11/12 |
| Last modified on | 2026/11/05 17:23:11 |
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Basic information
Public title
A study examining the effects of a spirituality-based mind-body health promotion program on the health of community-dwelling older adults
Acronym
Spirituality-Based Health Promotion Program Study for Older Adults
Scientific Title
Verification of a mind-body health promotion program incorporating spiritual care
Scientific Title:Acronym
Exploratory RCT of a spirituality-based health promotion program for older adults
Region
| Japan |
Condition
Condition
Community-dwelling older adults
Classification by specialty
| Nursing | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to implement a mind-body health promotion program incorporating the health concept of spirituality among community-dwelling older adults, with the aim of clarifying the following points:
1. The effect of the program on participants' spirituality
2. Changes in subjective well-being and health-related quality of life
3. The pathway from spirituality through subjective well-being to health-related quality of life
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
Change in spirituality from baseline to post-intervention, assessed using the total score of the 20-item SKY Spirituality Scale (SS-20; range 20-100). Assessments were conducted at baseline and post-intervention (at the end of the waiting period for the control group).
This study was registered retrospectively, and no single primary outcome had been prespecified before the study commenced. For this registration, spirituality was designated as the primary outcome because the intervention was developed as a mind-body health promotion program incorporating spirituality, with spirituality constituting a central concept of the intervention.
Key secondary outcomes
Measured at baseline and post-intervention, and compared between groups:
1. Subjective well-being (single item, 5-point scale, 0-4)
2. Health-related quality of life: SF-8 (Physical and Mental Component Summaries)
3. Cognitive social capital (5 items)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
NO
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
A group-based mind-body health promotion program incorporating the health concept of spirituality was delivered in three sessions, each lasting approximately 90 minutes. The program consisted of health-related education, spirituality-related content, and health-promoting exercises.
Interventions/Control_2
No intervention was provided during the comparison period; participants continued their usual community-based senior club activities. After the comparison period ended, the same program was offered (wait-list control).
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
| 60 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1) Community-dwelling adults aged 60 years or older who were selected from members of senior citizens' clubs affiliated with a local federation of senior citizens' clubs
(2) Individuals with the visual acuity, grip strength, and cognitive level required to complete a self-administered questionnaire
(3) Individuals free from severe illness or symptoms, with the physical capacity to perform exercises such as yoga and rhythmic gymnastics
(4) Individuals who provided written informed consent after receiving an explanation of the study
Key exclusion criteria
(1) Individuals with severe illnesses or symptoms
(2) Individuals without sufficient physical capacity to perform exercises such as yoga and rhythmic gymnastics
Target sample size
148
Research contact person
Name of lead principal investigator
| 1st name | Minako |
| Middle name | |
| Last name | Kobayashi |
Organization
Chukyo Gakuin University
Division name
Faculty of Nursing
Zip code
509-6192
Address
2216 Toki-cho, Mizunami, Gifu 509-6192, Japan
TEL
0572-68-4555
m-kobayashi@chukyogakuin-u.ac.jp
Public contact
Name of contact person
| 1st name | Minako |
| Middle name | |
| Last name | Kobayashi |
Organization
Chukyo Gakuin University
Division name
Faculty of Nursing
Zip code
509-6192
Address
2216 Toki-cho, Mizunami, Gifu 509-6192, Japan
TEL
0572-68-4555
Homepage URL
m-kobayashi@chukyogakuin-u.ac.jp
Sponsor or person
Institute
Heisei College of Health Sciences
Institute
Department
Personal name
Minako Kobayashi
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
JAPAN
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Research Ethics Review Committee, Heisei College of Health Sciences
Address
180 Kurono, Gifu-shi, Gifu 501-1131, Japan
Tel
058-234-3324
info@heisei-iryou.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
| 2026 | Year | 11 | Month | 12 | Day |
Related information
URL releasing protocol
Not applicable
Publication of results
Published
Result
URL related to results and publications
Not applicable
Number of participants that the trial has enrolled
153
Results
The results were presented at the 39th Annual Meeting of the Japan Academy of Nursing Science (2019).
Results date posted
| 2026 | Year | 11 | Month | 05 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Of the 153 randomized participants, 80 were allocated to the intervention group (mean age 75.4 years, SD 4.4) and 73 to the control group (mean age 74.9 years, SD 4.6). No significant between-group differences were found in age, sex, or baseline outcome scores.
Participant flow
Research explanation documents, consent forms, and pre-intervention questionnaires were distributed to 173 eligible members of senior citizens' clubs; 153 returned completed questionnaires and provided written informed consent (response rate 88.4%). All 153 were randomly allocated to the intervention group (n=80) or the control group (n=73), and all were included in the intention-to-treat analyses.
Adverse events
No adverse events or unintended effects were reported during the intervention period.
Outcome measures
For the primary outcome, spirituality (SS-20 total score) showed a significant between-group difference favoring the intervention (adjusted mean difference 2.67, 95% CI 0.53 to 4.81, p=.015). For the secondary outcomes, no significant differences were found in subjective well-being (p=.186), the SF-8 physical component summary (p=.241), or the mental component summary (p=.268). All analyses followed an intention-to-treat framework including all 153 randomized participants, with missing values handled by multiple imputation (m=10) and between-group comparisons made by analysis of covariance adjusting for baseline scores.
Plan to share IPD
The datasets generated and analyzed during the current study are available from the corresponding author on reasonable request.
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2018 | Year | 07 | Month | 03 | Day |
Date of IRB
| 2018 | Year | 07 | Month | 12 | Day |
Anticipated trial start date
| 2019 | Year | 01 | Month | 18 | Day |
Last follow-up date
| 2019 | Year | 02 | Month | 14 | Day |
Date of closure to data entry
| 2019 | Year | 02 | Month | 14 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study was an exploratory intervention study conducted with the approval of the Institutional Research Ethics Review Committee of Heisei College of Health Sciences (approval No. H30-07) in July 2018. Because the trial was not registered in a clinical trial registry at the planning stage, this registration was made after completion of the study. In addition, no single primary outcome had been prespecified before the study commenced.
Management information
Registered date
| 2026 | Year | 11 | Month | 05 | Day |
Last modified on
| 2026 | Year | 11 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072708
