UMIN-ICDS Clinical Trial

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

COPD-related sarcopenia patients

Classification by specialty

Pneumology	Geriatrics	Rehabilitation medicine
Adult

Classification by malignancy

Others

Genomic information

NO

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

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.

Study type

Interventional

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

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

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

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

Email

mitsuo-hashimoto@nittai.ac.jp

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

Email

mitsuo-hashimoto@nittai.ac.jp

Institute

Nippon Sport Science University

Institute

Department

Personal name

Organization

Grants-in-Aid for Scientific Research (C)

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization

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)

Organization

Nippon Sport Science University

Address

Faculty of Sport Science, Department of Health Science

Tel

03-5706-0900

Email

souspo@nittai.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

ふくろうクリニック自由が丘

Date of disclosure of the study information

2022

Year

10

Month

13

Day

URL releasing protocol

Publication of results

Unpublished

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

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 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

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/icdr_e/ctr_view.cgi?recptno=R000056033