UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046033 |
|---|---|
| Receipt number | R000052214 |
| Scientific Title | Effects of combination therapy with cognitive behavioral therapy and exercise on physical function in older adults with sarcopenia: an open-label pilot study |
| Date of disclosure of the study information | 2021/11/11 |
| Last modified on | 2022/03/29 19:46:49 |
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Basic information
Public title
Physical function improvement effects of combination therapy with psychotherapy for behavior change and exercise in older adults with muscle weakness
Acronym
Physical function improvement effects of combination therapy with psychotherapy and exercise in older adults
Scientific Title
Effects of combination therapy with cognitive behavioral therapy and exercise on physical function in older adults with sarcopenia: an open-label pilot study
Scientific Title:Acronym
Effects of combination therapy with cognitive behavioral therapy and exercise on physical function in older adults with sarcopenia
Region
| Japan |
Condition
Condition
Sarcopenia
Classification by specialty
| Medicine in general | Geriatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To estimate the effects of combined cognitive behavioral therapy and exercise therapy on increasing physical activity and improving physical function in community-dwelling older people with sarcopenia
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
Short Physical Performance Battery (at 4 weeks after the start of intervention)
Key secondary outcomes
Short form of International Physical Activity Questionnaire
Self-efficacy for exercise
Steps
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Intervention sessions combining cognitive behavioral therapy to increase physical activity, exercise, and health lectures on sarcopenia will be conducted once a week for a total of four weeks.
Interventions/Control_2
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
Community dwelling
Sarcopenia diagnosed by criteria of Asian working group for sarcopenia
Able to walk on own or with the use of a walking aid
Key exclusion criteria
Patients with Cardiac pacemakers, implantable cardioverter defibrillators, etc.
Have a metal device (e.g., ) in the body.
Decreased cognitive function (score below 23 on Mini-Mental State Examination)
Prohibited from exercising for medical reasons by family physician.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Toshiaki |
| Middle name | A. |
| Last name | Furukawa |
Organization
Kyoto University Graduate School of Medicine
Division name
Departments of Health Promotion and Human Behavior
Zip code
606-8501
Address
Yoshida-Konoe-cho, Sakyo-ku, Kyoto
TEL
075-753-9491
furukawa@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Noboru |
| Middle name | |
| Last name | Horinouchi |
Organization
Kyoto University Graduate School of Medicine
Division name
Departments of Health Promotion and Human Behavior
Zip code
606-8501
Address
Yoshida-Konoe-cho, Sakyo-ku, Kyoto
TEL
075-753-9491
Homepage URL
horinouchi.noboru.36w@st.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto University Graduate School of Medicine
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
Tsukumi Central Hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kyoto University Graduate School and Faculty of Medicine, Ethics Committee
Address
Yoshida-Konoe-cho, Sakyo-ku, Kyoto 606-8501
Tel
075-753-4680
ethcom@kuhp.kyoto-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
津久見市医師会立津久見中央病院（大分県）/Tsukumi Central Hospital(Oita)
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 11 | Month | 11 | 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
6
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
No longer recruiting
Date of protocol fixation
| 2021 | Year | 10 | Month | 22 | Day |
Date of IRB
| 2021 | Year | 11 | Month | 05 | Day |
Anticipated trial start date
| 2021 | Year | 11 | Month | 11 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 10 | Day |
Date of closure to data entry
| 2022 | Year | 03 | Month | 10 | Day |
Date trial data considered complete
| 2022 | Year | 03 | Month | 17 | Day |
Date analysis concluded
| 2022 | Year | 03 | Month | 24 | Day |
Other
Other related information
Management information
Registered date
| 2021 | Year | 11 | Month | 11 | Day |
Last modified on
| 2022 | Year | 03 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052214
