Clinical evaluation of exercise training for patients with chronic obstructive pulmonary disease - An exploratory study to identify the appropriate evaluation metric -

Clinical evaluation of exercise training for patients with chronic obstructive pulmonary disease - An exploratory study to identify the appropriate evaluation metric - - Appropriate evaluation metric of exercise training for COPD

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000009849

Enrollment

Registered

2013-02-01

Start date

2013-02-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic obstructive pulmonary disease

Interventions

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 electrome

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
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.	—

Secondary

Measure	Time frame
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.	—

Measure

Time frame

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.

—

Countries

Japan

Contacts

Public ContactKeisuke Miki

National Hospital Organization Toneyama National Hospital, Toyonaka, Japan Dep. of Respiratory Medicine, and Lab. Chief, Lab. of Respiratory Science, Div. of Clinical Research

mikisuke@toneyama.go.jp06-6853-2001

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026