Chronic Obstructive Pulmonary DiseaseCOPDNCT05251623
Walking Program With Pedometer on Quality of Life in COPD
A study testing walking program in people with Chronic Obstructive Pulmonary Disease, run by Chang Gung University at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- walking program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Mar 2018to 31 Mar 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- diagnosed with COPD
- in a medically stable condition
- able to walk unassisted
- ≥ 40 years of age
Who cannot join
- oxygen therapy,
- hemodynamic instability,
- signs/symptoms of acute infection
- severe neurological, musculoskeletal, or cardiovascular conditions that affect walking
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Walking Program With Pedometer on Quality-of-life Among Chronic Obstructive Pulmonary Disease Patients
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).
Read the 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).
.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- walking program
- Keywords
- COPD, pedometer, physical activity, quality of life
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
walking programOther
Subjects in PG walked to target steps daily with pedometer for 6 weeks
| Study group | Role | What they receive |
|---|---|---|
| pedometer | Experimental | walking with pedometer Receives: Other: walking program |
| control | No intervention | no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
tidal volume
the amount of air that moves in or out of the lungs with each respiratory cycle. It is measured by spirometers.
Measured: week 0
tidal volume
the amount of air that moves in or out of the lungs with each respiratory cycle. It is measured by spirometers.
Measured: week 7
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)
Measured: week 0
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)
Measured: week 7
6 minute walking test
walking distance
Measured: week 0
6 minute walking test
walking distance
Measured: week 7
daily steps
the number of total walking steps per day which is measured by pedometer.
Measured: week0
daily steps
the number of total walking steps per day which is measured by pedometer.
Measured: week 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2022
- Study start1 Mar 2018
- Primary completion31 Mar 2018
- Study completion31 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chang Gung University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chen Yen-Huey, Chang Gung University
- Investigators
- Yen-Huey Chen, PhD, Principal investigator, Chang Gung University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05251623
- Sponsor's protocol ID
- TYGH106081
- Acronym
- COPD
- Status last verified
- Feb 2022
- First submitted
- 30 Dec 2021
- Last updated
- 23 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Walking Program With Pedometer on Quality-of-life Among Chronic Obstructive Pulmonary Disease Patients
- ClinicalTrials.gov ID
- NCT05251623
- Acronym / sponsor ID
- COPD / TYGH106081
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- COPD, pedometer, physical activity, quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Chang Gung UniversityUniversity, hospital or other
- Study start
- 1 Mar 2018 (actual)
- Primary completion
- 31 Mar 2018 (actual)
- Study completion
- 31 Mar 2019 (actual)
- First posted
- 23 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| pedometer | Experimental | Other: walking programwalking with pedometer |
| control | No intervention | –no intervention |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- diagnosed with COPD
- in a medically stable condition
- able to walk unassisted
- ≥ 40 years of age
Key exclusion criteria (4 listed)
- oxygen therapy,
- hemodynamic instability,
- signs/symptoms of acute infection
- severe neurological, musculoskeletal, or cardiovascular conditions that affect walking
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| walking programSubjects in PG walked to target steps daily with pedometer for 6 weeks | Other | pedometer |
Primary outcome
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.
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.
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)
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)
6 minute walking test
Time frame: week 0
walking distance
6 minute walking test
Time frame: week 7
walking distance
daily steps
Time frame: week0
the number of total walking steps per day which is measured by pedometer.
daily steps
Time frame: week 7
the number of total walking steps per day which is measured by pedometer.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yen-Huey Chen, PhD principal investigator
Chang Gung University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing walking program in people with Chronic Obstructive Pulmonary Disease, run by Chang Gung University at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
tidal volume (time frame: week 0). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2022.