- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05251623
Walking Program With Pedometer on Quality of Life in COPD (COPD)
The Effect of Walking Program With Pedometer on Quality-of-life Among Chronic Obstructive Pulmonary Disease Patients
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Patients with chronic obstructive pulmonary disease (COPD) are suffered from impaired pulmonary function and dyspnea which result to limited level of physical activity, and impaired quality of life. Exercise and regular physical activity have been proven to break the vicious circle. The aim of this study is to investigate the effects of a walking program on exercise capacity and quality of life in patient with COPD. Method: Patients with COPD were randomly assigned to pedometer group (PG) or control group (CON). Subjects in PG walked to target steps daily with pedometer for 6 weeks. Before and after the program, the pulmonary function was assessed by spiromtery test. The exercise capacity were assessed by six-minute walking test, the physical activity level was assessed by daily steps, The quality of life was assessed by COPD Assessment Test (CAT), and quality of life questionnaire (SF-12).
.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Taoyuan, Taiwan, 333
- Taoyuan General Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- diagnosed with COPD
- in a medically stable condition
- able to walk unassisted
- ≥ 40 years of age
Exclusion Criteria:
- oxygen therapy,
- hemodynamic instability,
- signs/symptoms of acute infection
- severe neurological, musculoskeletal, or cardiovascular conditions that affect walking
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: control
no intervention
|
|
Experimental: pedometer
walking with pedometer
|
Subjects in PG walked to target steps daily with pedometer for 6 weeks
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
tidal volume
Time Frame: week 0
|
the amount of air that moves in or out of the lungs with each respiratory cycle.
It is measured by spirometers.
|
week 0
|
tidal volume
Time Frame: week 7
|
the amount of air that moves in or out of the lungs with each respiratory cycle.
It is measured by spirometers.
|
week 7
|
Short-form 12 questionnaire (SF-12)
Time Frame: week 0
|
The SF-12 is a quality of life questionnaire.
The scores range from 0 (worst conceivable QOL) to 100 (best conceivable QOL)
|
week 0
|
Short-form 12 questionnaire (SF-12)
Time Frame: week 7
|
The SF-12 is a quality of life questionnaire.
The scores range from 0 (worst conceivable QOL) to 100 (best conceivable QOL)
|
week 7
|
6 minute walking test
Time Frame: week 0
|
walking distance
|
week 0
|
6 minute walking test
Time Frame: week 7
|
walking distance
|
week 7
|
daily steps
Time Frame: week0
|
the number of total walking steps per day which is measured by pedometer.
|
week0
|
daily steps
Time Frame: week 7
|
the number of total walking steps per day which is measured by pedometer.
|
week 7
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- TYGH106081
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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