UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049202 |
|---|---|
| Receipt number | R000056033 |
| Scientific Title | The efficacy of respiratory rehabilitation for COPD-related sarcopenia: a randomized controlled trial |
| Date of disclosure of the study information | 2022/10/13 |
| Last modified on | 2023/02/10 16:37:32 |
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Basic information
Public title
The efficacy of respiratory rehabilitation for COPD-related sarcopenia: a randomized controlled trial
Acronym
Respiratory rehabilitation for COPD-related sarcopenia
Scientific Title
The efficacy of respiratory rehabilitation for COPD-related sarcopenia: a randomized controlled trial
Scientific Title:Acronym
Respiratory rehabilitation for COPD-related sarcopenia
Region
| Japan |
Condition
Condition
COPD-related sarcopenia patients
Classification by specialty
| Pneumology | Geriatrics | Rehabilitation medicine |
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim is to conduct a multicenter randomized controlled trial using the PROBE method to prove that the combination of weekly respiratory rehabilitation at a community clinic and home exercise in patients with COPD-related sarcopenia leads to improved exercise tolerance and physical activity compared to those who receive conditioning therapy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Phase III
Assessment
Primary outcomes
The total walking distance by shuttle walking (Compare after 3-month rehabilitation)
Key secondary outcomes
1. Improvements in sarcopenia indicators such as SMI and grip strength, quadriceps maximum voluntary contraction, 4-m gait speed, and 5-repetition sit-to-stand test.
(Compare after 3-month rehabilitation)
2. respiratory muscle strength (Pimax, Pemax) (Compare after 3-month rehabilitation)
3. Questionnaire such as CAT, kihon check list (Compare after 3-month rehabilitation)
4. Eat-10 questionnaire
(Compare after 3-month rehabilitation)
5. measurement of tongue pressure
(Compare after 3-month rehabilitation)
6. MMSE and HADS Questionnaire
(Compare after 3-month rehabilitation)
7. J-CHS assessment
(Compare after 3-month rehabilitation)
8. Physical activity measured by a 3-axis accelerometer(step counts, METS/day, Time in LPA, MPA and VPA)
(Compare after 3-month rehabilitation)
9. Measurements done three months and six months after rehabilitation will also be compared.
10. Highly sensitive Elisa measurement of sarcopenia-related proteins in urinary exosomes (parkin, Activin RIIA, Myostatin).
These results will be reported separately.
11. Walking analysis (stride, Pronation, impact on landing, etc.)
These results will be reported separately.
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
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
In addition to nutritional therapy and psychotherapy, conditioning is performed on an outpatient basis once a week for 40 minutes.
(Three months rehabilitation period)
Interventions/Control_2
In addition to nutritional therapy and psychotherapy, exercise therapy is performed once a week on an outpatient basis for 1 hour, and home exercise is used in combination twice a week.
(Three months rehabilitation period)
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. COPD patients aged more than 40 years old
2. had 10-pack years of smoking history
3. diagnosed as sarcopenia using AWGS 2019 guideline
Key exclusion criteria
1. history of respiratory rehabilitation within one year.
2. history of acute exacerbation within one month.
3. patients using oxygen therapy.
4. patients receiving chemotherapy.
5. Severe diabetes mellitus (retinopathy, fundus hemorrhage, during dialysis, the complication of peripheral neuropathy)
6. Severe heart disease (acute myocardial infarction, pacemaker wearer, unstable angina, uncontrolled heart failure, advanced obstructive hypertrophic cardiomyopathy, acute embolism, acute infectious diseases (pericarditis, myocarditis)
Target sample size
160
Research contact person
Name of lead principal investigator
| 1st name | Mitsuo |
| Middle name | |
| Last name | Hashimoto |
Organization
Nippon Sport Science University
Division name
Faculty of Sport Science, Department of Health Science
Zip code
158-0081
Address
7-1-1 Fukasawa, Setagaya-ku, Tokyo
TEL
81-3-5706-0862
mitsuo-hashimoto@nittai.ac.jp
Public contact
Name of contact person
| 1st name | Mitsuo |
| Middle name | |
| Last name | Hashimoto |
Organization
Nippon Sport Science University
Division name
Faculty of Sport Science, Department of Health Science
Zip code
158-0081
Address
7-1-1 Fukasawa, Setagaya-ku, Tokyo
TEL
81-3-5706-0862
Homepage URL
mitsuo-hashimoto@nittai.ac.jp
Sponsor or person
Institute
Nippon Sport Science University
Institute
Department
Personal name
Funding Source
Organization
Grants-in-Aid for Scientific Research (C)
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Department of respiratory medicine at
1. Kanto central hospital
2. National Hospital Organization Tokyo Medical Center
3. Teikyo University Hospital, Mizonokuchi
4. Tamagawa Hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nippon Sport Science University
Address
Faculty of Sport Science, Department of Health Science
Tel
03-5706-0900
souspo@nittai.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
ふくろうクリニック自由が丘
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 10 | Month | 13 | 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
| 2022 | Year | 10 | Month | 12 | Day |
Date of IRB
| 2022 | Year | 08 | Month | 04 | Day |
Anticipated trial start date
| 2022 | Year | 10 | Month | 15 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Efficacy analyses will be conducted in all randomly assigned participants according to the intention-to-treat principle.
For missing values, the multiple imputation method will be used.
The superiority of the exercise therapy group over the conditioning group in the primary endpoint and the main secondary endpoints will be tested in a prespecified hierarchical order.
First, the primary endpoint will be analyzed, and if the P value is less than 0.05, the secondary endpoints will be analyzed sequentially in the following order.
1. Improvements in the quadriceps maximum voluntary contraction test immediately after 3-month rehabilitation (after 3-month rehabilitation).
2. Improvements in the Handgrip test (after 3-month rehabilitation).
3. Improvements in the SPPB test (after 3-month rehabilitation).
4. Improvements in the CAT and kihon check list questionnaire (after 3-month rehabilitation).
5. Improvements in the Physical activity measured by a 3-axis accelerometer (step counts, METS/day, Time in LPA, MPA and VPA) (after 3-month rehabilitation).
6. Improvements in the respiratory muscle strength (Pimax, Pemax) (after 3-month rehabilitation).
7. Improvements in the MMSE and HADS Questionnaire (after 3-month rehabilitation).
8. Measurements done three months and six months after rehabilitation will also be compared.
All comparisons will be performed using a two-sided alpha level of 0.05.
The comparison of the primary endpoint and the secondary endpoints between the exercise therapy group and the conditioning group will be analyzed using a t-test or Mann-Whitney test.
For the analysis of # 8 measurement, Generalized Linear Mixed Effects Model will be used.
Following results will be reported separately.
1. Eat-10 questionnaire and tongue pressure
2.Elisa measurement of urinary exosomes (parkin, Activin RIIA, Myostatin).
3. Walking analysis
Management information
Registered date
| 2022 | Year | 10 | Month | 12 | Day |
Last modified on
| 2023 | Year | 02 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056033
