UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058886 |
|---|---|
| Receipt number | R000067269 |
| Scientific Title | Effects of Introducing an Activity Diary in Outpatient Pulmonary Rehabilitation on Activity Satisfaction and Sense of Meaning in Life: A Non-Randomized Controlled Trial |
| Date of disclosure of the study information | 2025/10/15 |
| Last modified on | 2025/08/25 13:53:20 |
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Basic information
Public title
Effects of Introducing an Activity Diary in Outpatient Pulmonary Rehabilitation on Activity Satisfaction and Sense of Meaning in Life: A Non-Randomized Controlled Trial
Acronym
Effects of Introducing an Activity Diary in Outpatient Pulmonary Rehabilitation on Activity Satisfaction and Sense of Meaning in Life: A Non-Randomized Controlled Trial
Scientific Title
Effects of Introducing an Activity Diary in Outpatient Pulmonary Rehabilitation on Activity Satisfaction and Sense of Meaning in Life: A Non-Randomized Controlled Trial
Scientific Title:Acronym
Effects of Introducing an Activity Diary in Outpatient Pulmonary Rehabilitation on Activity Satisfaction and Sense of Meaning in Life: A Non-Randomized Controlled Trial
Region
| Japan |
Condition
Condition
Lung disease
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study is to clarify the effects of outpatient pulmonary rehabilitation combined with the use of an activity diary, which records daily activities and occupational experiences, on activity satisfaction, sense of meaning in life, self-efficacy, and health-related quality of life in patients with chronic respiratory diseases undergoing community-based pulmonary rehabilitation.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Activity satisfaction will be assessed using "the activity and dairy life satisfaction scale for the elderly."
The intervention group will be assessed before and after the diary intervention.
The control group will be assessed at baseline and after three months.
Key secondary outcomes
Sense of meaning in life will be measured using the "the K-I scale for the feeling that life is worth living among the aged."
Self-efficacy will be assessed using the "the scale of self-eflicacy on health behavior."
Health-related quality of life will be evaluated using the "SF-12v2 Health Survey (Japanese version)"
The intervention group will be assessed before and after the diary intervention.
The control group will be assessed at baseline and after three months.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
The intervention group will undergo standard outpatient pulmonary rehabilitation primarily consisting of exercise therapy (usual care) once or twice per week, in addition to the introduction of an activity diary, which they will be asked to complete daily for three months. If patients are unable to maintain diary entries independently during the intervention period or require assistance, they will complete the diary with support from an occupational therapist during outpatient pulmonary rehabilitation. Based on the recorded diaries, patients will review their activities with the occupational therapist on a weekly basis. The activity diary will include the most meaningful activity of the day and its related experience, the level of satisfaction with the activity, and goals for the following day (or week). Each diary entry will take approximately five minutes to complete.
Interventions/Control_2
The control group will receive standard outpatient pulmonary rehabilitation primarily consisting of exercise therapy (usual care).
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
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients who have been undergoing outpatient pulmonary rehabilitation at our institution for at least three months and whose condition is clinically stable.
Key exclusion criteria
Patients diagnosed with dementia or suspected dementia who have difficulty completing or reviewing the diary.
Patients who do not provide informed consent to participate in the study.
Target sample size
58
Research contact person
Name of lead principal investigator
| 1st name | Ryuji |
| Middle name | |
| Last name | Kobayashi |
Organization
Hyogo Medical University
Division name
Department of Occupational Therapy, School of Rehabilitation
Zip code
650-8530
Address
1-3-6 Minatojima, Chuo-ku, Kobe, Hyogo, Japan
TEL
078-304-3000
ry-kobayashi@hyo-med.ac.jp
Public contact
Name of contact person
| 1st name | Naoko |
| Middle name | |
| Last name | Sano |
Organization
Hyogo Medical University
Division name
Graduate School of Rehabilitation Science
Zip code
650-8530
Address
1-3-6 Minatojima, Chuo-ku, Kobe, Hyogo, Japan
TEL
078-304-3000
Homepage URL
mhe2505@hyo-med.ac.jp
Sponsor or person
Institute
Hyogo Medical University
Institute
Department
Personal name
Naoko Sano
Funding Source
Organization
No
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
Hyogo Medical University
Address
1-3-6 Minatojima, Chuo-ku, Kobe, Hyogo, Japan
Tel
078-304-3000
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
きだ呼吸器・リハビリクリニック
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 10 | Month | 15 | 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 | 10 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 10 | 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 | 08 | Month | 25 | Day |
Last modified on
| 2025 | Year | 08 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067269
