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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000009849
Receipt No. R000011526
Scientific Title Clinical evaluation of exercise training for patients with chronic obstructive pulmonary disease - An exploratory study to identify the appropriate evaluation metric -
Date of disclosure of the study information 2013/02/01
Last modified on 2015/07/23

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Basic information
Public title Clinical evaluation of exercise training for patients with chronic obstructive pulmonary disease - An exploratory study to identify the appropriate evaluation metric -
Acronym Appropriate evaluation metric of exercise training for COPD
Scientific Title Clinical evaluation of exercise training for patients with chronic obstructive pulmonary disease - An exploratory study to identify the appropriate evaluation metric -
Scientific Title:Acronym Appropriate evaluation metric of exercise training for COPD
Region
Japan

Condition
Condition Chronic obstructive pulmonary disease
Classification by specialty
Medicine in general Pneumology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To find the appropriate metric to evaluate the effect of exercise training, the exercise training will be performed for 8 weeks in patients with severe to very severe COPD, evaluating the changes in their symptoms, blood biomarkers, nutritional status, and exercise capacities. In addition, in patients with weight loss (body mass index (BMI) of less than 21 kg/m2) and those without weight loss (BMI of 21 kg/m2 or more), whether the evaluation metric affects the outcomes of exercise training will also be investigated.
Basic objectives2 Others
Basic objectives -Others To find the appropriate metric to evaluate the effect of exercise training.
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes The evaluations will be done 3 times:
i) at Week 4,
ii) at Week 8 soon after pulmonary rehabilitation (PR), and
iii) at Week 12 (i.e., 4 weeks after the completion of PR).
As primary outcomes, we will examine the correlation between the change in exercise capacity (peak oxygen uptake) and the plasma ghrelin level.
Key secondary outcomes As secondary outcomes, we will examine the correlations between the changes in exercise capacity (peak oxygen uptake) and i) other blood biomarkers, including plasma vascular endothelial growth factor (VEGF) level, ii) weight, iii) pulmonary function test results, iv) food intake, v) free-living physical activity measured by an accelerometer, vi) DEXA (measurement of lean body mass, body mineral content, and fat mass), vii) symptoms, and viii) respiratory muscle strength.

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 Pulmonary rehabilitation including exercise training for 8 weeks on an outpatient basis. Exercise training will be conducted in 3 sets daily, 3 times a week for 8 weeks (i.e., 24 days) using electromechanically braked cycle ergometers. The initial exercise level of each set will be set for 6 min at the work rate corresponding to 40% of the peak oxygen uptake achieved on the baseline cardiopulmonary exercise testing (CPET). As tolerated by the subject, the exercise duration will be initially increased to 10 min. After that, the training work rate will be increased by 5 W and then extended to the work rate corresponding to 80% of the baseline peak oxygen uptake.
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
20 years-old <=
Age-upper limit
85 years-old >=
Gender Male and Female
Key inclusion criteria 1) Severe to very severe COPD (forced expiratory volume in one second (FEV1)/forced vital capacity (FVC) of less than 70% and FEV1 percent predicted of less than 50%) (after using a bronchodilator)
2) Clinically stable and able to participate in pulmonary rehabilitation
3) Between 20 and 85 years old
4) Signed the agreement for participation in this study
Key exclusion criteria 1) Malignant tumours
2) Active infection
3) Severe heart disease
4) Hepatic dysfunction (serum aspartate aminotransferase and alanine aminotransferase levels at least twice the upper limit of normal)
5) Renal dysfunction (serum creatinine levels of 2.0 mg/dL or more)
6) Asthma (after the inhalation of salbutamol, 12% or more reversibility compared to the FEV1 before inhalation and 200 mL or more improvement of FEV1)
7) Definitely or possibly pregnant
8) Change in drug regimen within 4 weeks before participation in this study
9) Judged to be unable to participate in this study by their physician.
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Ryoji Maekura
Organization National Hospital Organization Toneyama National Hospital, Toyonaka, Japan
Division name Department of Respiratory Medicine, Deputy Director
Zip code
Address 5-1-1 Toneyama, Toyonaka, Osaka, 560-8552, Japan.
TEL 06-6853-2001
Email rmaekura@toneyama.go.jp

Public contact
Name of contact person
1st name
Middle name
Last name Keisuke Miki
Organization National Hospital Organization Toneyama National Hospital, Toyonaka, Japan
Division name Dep. of Respiratory Medicine, and Lab. Chief, Lab. of Respiratory Science, Div. of Clinical Research
Zip code
Address 5-1-1 Toneyama, Toyonaka, Osaka, 560-8552, Japan.
TEL 06-6853-2001
Homepage URL
Email mikisuke@toneyama.go.jp

Sponsor
Institute National Hospital Organization Toneyama National Hospital
Institute
Department

Funding Source
Organization National Hospital Organization
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
Address
Tel
Email

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
2013 Year 02 Month 01 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 Open public recruiting
Date of protocol fixation
2012 Year 12 Month 12 Day
Date of IRB
Anticipated trial start date
2013 Year 02 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2013 Year 01 Month 23 Day
Last modified on
2015 Year 07 Month 23 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011526

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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