Walking Program With Pedometer on Quality of Life in COPD (COPD)
Primary Purpose
Chronic Obstructive Pulmonary Disease
Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
walking program
Sponsored by
About this trial
This is an interventional other trial for Chronic Obstructive Pulmonary Disease focused on measuring COPD, pedometer, physical activity, quality of life
Eligibility Criteria
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
Sites / Locations
- Taoyuan General Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
pedometer
control
Arm Description
walking with pedometer
no intervention
Outcomes
Primary Outcome Measures
tidal volume
the amount of air that moves in or out of the lungs with each respiratory cycle. It is measured by spirometers.
tidal volume
the amount of air that moves in or out of the lungs with each respiratory cycle. It is measured by spirometers.
Short-form 12 questionnaire (SF-12)
The SF-12 is a quality of life questionnaire. The scores range from 0 (worst conceivable QOL) to 100 (best conceivable QOL)
Short-form 12 questionnaire (SF-12)
The SF-12 is a quality of life questionnaire. The scores range from 0 (worst conceivable QOL) to 100 (best conceivable QOL)
6 minute walking test
walking distance
6 minute walking test
walking distance
daily steps
the number of total walking steps per day which is measured by pedometer.
daily steps
the number of total walking steps per day which is measured by pedometer.
Secondary Outcome Measures
Full Information
NCT ID
NCT05251623
First Posted
December 30, 2021
Last Updated
February 10, 2022
Sponsor
Chang Gung University
1. Study Identification
Unique Protocol Identification Number
NCT05251623
Brief Title
Walking Program With Pedometer on Quality of Life in COPD
Acronym
COPD
Official Title
The Effect of Walking Program With Pedometer on Quality-of-life Among Chronic Obstructive Pulmonary Disease Patients
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
March 1, 2018 (Actual)
Primary Completion Date
March 31, 2018 (Actual)
Study Completion Date
March 31, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chang Gung University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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 following measurements were performed: pulmonary function test (PFT), daily steps, Six-Minute Walk Test (6MWT), COPD Assessment Test (CAT), and quality of life questionnaire (SF-12).
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).
.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease
Keywords
COPD, pedometer, physical activity, quality of life
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
45 (Actual)
8. Arms, Groups, and Interventions
Arm Title
pedometer
Arm Type
Experimental
Arm Description
walking with pedometer
Arm Title
control
Arm Type
No Intervention
Arm Description
no intervention
Intervention Type
Other
Intervention Name(s)
walking program
Intervention Description
Subjects in PG walked to target steps daily with pedometer for 6 weeks
Primary Outcome Measure Information:
Title
tidal volume
Description
the amount of air that moves in or out of the lungs with each respiratory cycle. It is measured by spirometers.
Time Frame
week 0
Title
tidal volume
Description
the amount of air that moves in or out of the lungs with each respiratory cycle. It is measured by spirometers.
Time Frame
week 7
Title
Short-form 12 questionnaire (SF-12)
Description
The SF-12 is a quality of life questionnaire. The scores range from 0 (worst conceivable QOL) to 100 (best conceivable QOL)
Time Frame
week 0
Title
Short-form 12 questionnaire (SF-12)
Description
The SF-12 is a quality of life questionnaire. The scores range from 0 (worst conceivable QOL) to 100 (best conceivable QOL)
Time Frame
week 7
Title
6 minute walking test
Description
walking distance
Time Frame
week 0
Title
6 minute walking test
Description
walking distance
Time Frame
week 7
Title
daily steps
Description
the number of total walking steps per day which is measured by pedometer.
Time Frame
week0
Title
daily steps
Description
the number of total walking steps per day which is measured by pedometer.
Time Frame
week 7
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yen-Huey Chen, PhD
Organizational Affiliation
Chang Gung University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Taoyuan General Hospital
City
Taoyuan
ZIP/Postal Code
333
Country
Taiwan
12. IPD Sharing Statement
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Walking Program With Pedometer on Quality of Life in COPD
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