Moderate to Severe COPD Receiving Home Exercise TrainingPhase 2NCT01631019
Mobile-phone-based Home Exercise in Chronic Obstructive Pulmonary Disease
A Phase 2 study testing Mobile-phone-based Home Exercise Training Program and Home Exercise Training Program in people with Moderate to Severe COPD Receiving Home Exercise Training, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial summary
Background: Moderate-intensity exercise training improves skeletal muscle aerobic capacity and increased oxidative enzyme activity, as well as exercise tolerance in Chronic Obstructive Pulmonary Disease (COPD) patients. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Moderate to Severe COPD Receiving Home Exercise Training
- What is being tested?
- Mobile-phone-based Home Exercise Training Program and Home Exercise Training Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 26 participants
- Where
- 1 siteTaiwan
- Study dates
- Jan 2007to May 2009
- Phase
- Phase 2
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients with moderate to severe COPD
Who cannot join
- requirement for oxygen therapy;
- presence of symptomatic cardiovascular diseases or severe systemic diseases limiting exercise capacity;
- use of medications affecting exercise responses;
- musculoskeletal conditions with exercise performance limitation; and
- impaired hearing or vision that affects subject's ability to follow the exercise training program.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Influence of Long-term Cell-phone Based Home Exercise on Biomarkers, Skeletal Muscle and Mortality in Patients With COPD
Background: Moderate-intensity exercise training improves skeletal muscle aerobic capacity and increased oxidative enzyme activity, as well as exercise tolerance in Chronic Obstructive Pulmonary Disease (COPD) patients.
Design: To investigate the home-based exercise training program can reduce inflammatory biomarkers in COPD.
Read more
Setting: Conducted from January 2007 to December 2007 at a tertiary medical center, Chang Gung Memorial Hospital, Taiwan.
Patients: Moderate to severe COPD receiving home exercise training, 12 using mobile phone assistance and 14 with free walk, were assessed for 6 months.
Measurements: Incremental shuttle walk test (ISWT), spirometry, strength of limb muscles, C-reactive protein (CRP) and inflammatory cytokines.
Read the detailed description
Exercise training is the cornerstone of comprehensive rehabilitation programs in patients with COPD. Exercise training improves skeletal muscle oxidative capacity and efficiency that leads to a less alveolar ventilation at a given work rate. Patients can tolerate a heavier work load with less dyspnea under exercise. To date, it remains unclear whether and to what extent markers of low-grade systemic inflammation may affect trainability in clinically stable patients. Although specific exercise modalities can be applied to reverse muscle dysfunction, exercise intolerance, and reduced health-related quality of life, there is a substantial heterogeneity in the response to exercise training among patients with clinically stable COPD. Endurance exercise training has been reported to have consistently high clinical efficacy. Most pulmonary rehabilitation programs are hospital based and ask patients with regular supervision and monitoring in order to achieve persistent and optimal physiological benefits. However, compliance and time consuming with regular visits to the hospital or clinics are major stumbling blocks to the success of these programs. Recently, the investigators have developed a home-based exercise training program for stable COPD patients by asking them to walk at a speed controlled by the tempo of music from a program installed in a mobile phone. The tempo of music was set to keep the same walking speed at the intended level for endurance exercise training for all patients. Our mobile phone-based system provides an efficient home endurance exercise training program with good compliance and clinical outcomes in patients with moderate-to-severe COPD. This study was therefore designed to further explore whether the circulating level of inflammatory markers, such as CRP, IL-6, TNF-α, and IL-8, will be reduced in patients with COPD undergoing a mobile-phone assisted home-based exercise training program
- Being tested
- Mobile-phone-based Home Exercise Training Program, Home Exercise Training Program
- Keywords
- Chronic Obstructive Pulmonary Disease, Pulmonary Rehabilitation, Mobile phone, Biomarker
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mobile-phone-based Home Exercise Training ProgramBehavioural
Patients in the mobile phone group were asked to perform daily endurance exercise training under mobile phone guidance, and the adherence was reported back to the central server. The level of endurance walking was re-assessed and re-adjusted initially on regular clinical visits every four weeks during the first three months. During this period of time, the adherence to protocol was reinforced by telephone from health professionals whenever patients missed one day of their walking training detected by the central system. Patients were asked to continue their exercise program at home at a fixed walking speed, and return to the clinic at 1, 2, 3 and 6 months.
Home Exercise Training ProgramBehavioural
all the subjects were assessed by an incremental shuttle walking test (ISWT) (24) for estimation of exercise endurance. Baseline spirometry and body mass index (BMI) were recorded. The adherence and compliance of the home-based exercise training program was assessed by monitoring the frequency of performance and the duration of the endurance walking program recorded on the central system every week. Patients were asked to continue their exercise program at home at a fixed walking speed, and return to the clinic at 1, 2, 3 and 6 months.
| Study group | Role | What they receive |
|---|---|---|
| with mobile phone assistance | Active comparator | In the mobile phone group, patients were asked to continue their exercise program at home at a fixed walking speed. During this period of time, the adherence to protocol was reinforced by telephone from health professionals whenever patients missed one day of their walking training detected by the central system. Patients were asked to continue their exercise program at home at a fixed walking speed, and return to the clinic at 1, 2, 3 and 6 months. Receives: Behavioral: Mobile-phone-based Home Exercise Training Program; Behavioral: Home Exercise Training Program |
| with free walk | Placebo comparator | Patients in the control group were educated the same exercise protocol, but were only verbally asked to freely take the walking exercise training at home. The adherence to the walking exercise at home was reported by the patients themselves at every return visits. All the patients received ISWT, spirometry and blood sample for inflammatory biomarkers at baseline, 1, 2, 3 and 6 months. Receives: Behavioral: Home Exercise Training Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
inflammatory cytokines
IL-8
Measured: 6 months
C-reactive protein (CRP)
CRP as systemic inflamatory status
Measured: 6 months
Incremental shuttle walk test (ISWT)
Distence of shuttle walking test!
Measured: 6 months
spirometry
FEV1 and FEV1/FVC.
Measured: 6 months
strength of limb muscles
upper and lower limbs stregth
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2012 (estimated)
- Study startJan 2007
- Primary completionDec 2007
- Study completionMay 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Moderate to Severe COPD Receiving Home Exercise TrainingStudies 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01631019
- Sponsor's protocol ID
- 95-1401B
- Status last verified
- Jun 2012
- First submitted
- 26 Jun 2012
- Last updated
- 6 Jul 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Wang CH, Chou PC, Joa WC, Chen LF, Sheng TF, Ho SC, Lin HC, Huang CD, Chung FT, Chung KF, Kuo HP. Mobile-phone-based home exercise training program decreases systemic inflammation in COPD: a pilot study. BMC Pulm Med. 2014 Aug 30;14:142. doi: 10.1186/1471-2466-14-142.
PubMed 25175787
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Long-term Cell-phone Based Home Exercise on Biomarkers, Skeletal Muscle and Mortality in Patients With COPD
- ClinicalTrials.gov ID
- NCT01631019
- Acronym / sponsor ID
- 95-1401B
- Keywords
- Chronic Obstructive Pulmonary Disease, Pulmonary Rehabilitation, Mobile phone, Biomarker
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- Jan 2007
- Primary completion
- Dec 2007 (actual)
- Study completion
- May 2009 (actual)
- First posted
- 28 Jun 2012 (estimated)
- 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.
Background: Moderate-intensity exercise training improves skeletal muscle aerobic capacity and increased oxidative enzyme activity, as well as exercise tolerance in Chronic Obstructive Pulmonary Disease (COPD) patients.
Design: To investigate the home-based exercise training program can reduce inflammatory biomarkers in COPD.
Setting: Conducted from January 2007 to December 2007 at a tertiary medical center, Chang Gung Memorial Hospital, Taiwan.
Patients: Moderate to severe COPD receiving home exercise training, 12 using mobile phone assistance and 14 with free walk, were assessed for 6 months.
Measurements: Incremental shuttle walk test (ISWT), spirometry, strength of limb muscles, C-reactive protein (CRP) and inflammatory cytokines.
Detailed description
Exercise training is the cornerstone of comprehensive rehabilitation programs in patients with COPD. Exercise training improves skeletal muscle oxidative capacity and efficiency that leads to a less alveolar ventilation at a given work rate. Patients can tolerate a heavier work load with less dyspnea under exercise. To date, it remains unclear whether and to what extent markers of low-grade systemic inflammation may affect trainability in clinically stable patients. Although specific exercise modalities can be applied to reverse muscle dysfunction, exercise intolerance, and reduced health-related quality of life, there is a substantial heterogeneity in the response to exercise training among patients with clinically stable COPD. Endurance exercise training has been reported to have consistently high clinical efficacy. Most pulmonary rehabilitation programs are hospital based and ask patients with regular supervision and monitoring in order to achieve persistent and optimal physiological benefits. However, compliance and time consuming with regular visits to the hospital or clinics are major stumbling blocks to the success of these programs. Recently, the investigators have developed a home-based exercise training program for stable COPD patients by asking them to walk at a speed controlled by the tempo of music from a program installed in a mobile phone. The tempo of music was set to keep the same walking speed at the intended level for endurance exercise training for all patients. Our mobile phone-based system provides an efficient home endurance exercise training program with good compliance and clinical outcomes in patients with moderate-to-severe COPD. This study was therefore designed to further explore whether the circulating level of inflammatory markers, such as CRP, IL-6, TNF-α, and IL-8, will be reduced in patients with COPD undergoing a mobile-phone assisted home-based exercise training program
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| with mobile phone assistance | Active comparator | Behavioral: Mobile-phone-based Home Exercise Training Program, Behavioral: Home Exercise Training ProgramIn the mobile phone group, patients were asked to continue their exercise program at home at a fixed walking speed. During this period of time, the adherence to protocol was reinforced by telephone from health professionals whenever patients missed one day of their walking training detected by the central system. Patients were asked to continue their exercise program at home at a fixed walking speed, and return to the clinic at 1, 2, 3 and 6 months. |
| with free walk | Placebo comparator | Behavioral: Home Exercise Training ProgramPatients in the control group were educated the same exercise protocol, but were only verbally asked to freely take the walking exercise training at home. The adherence to the walking exercise at home was reported by the patients themselves at every return visits. All the patients received ISWT, spirometry and blood sample for inflammatory biomarkers at baseline, 1, 2, 3 and 6 months. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients with moderate to severe COPD
Key exclusion criteria (5 listed)
- requirement for oxygen therapy;
- presence of symptomatic cardiovascular diseases or severe systemic diseases limiting exercise capacity;
- use of medications affecting exercise responses;
- musculoskeletal conditions with exercise performance limitation; and
- impaired hearing or vision that affects subject's ability to follow the exercise training program.
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 |
|---|---|---|
| Mobile-phone-based Home Exercise Training ProgramPatients in the mobile phone group were asked to perform daily endurance exercise training under mobile phone guidance, and the adherence was reported back to the central server. The level of endurance walking was re-assessed and re-adjusted initially on regular clinical visits every four weeks during the first three months. During this period of time, the adherence to protocol was reinforced by telephone from health professionals whenever patients missed one day of their walking training detected by the central system. Patients were asked to continue their exercise program at home at a fixed walking speed, and return to the clinic at 1, 2, 3 and 6 months. | Behavioural | with mobile phone assistance |
| Home Exercise Training Programall the subjects were assessed by an incremental shuttle walking test (ISWT) (24) for estimation of exercise endurance. Baseline spirometry and body mass index (BMI) were recorded. The adherence and compliance of the home-based exercise training program was assessed by monitoring the frequency of performance and the duration of the endurance walking program recorded on the central system every week. Patients were asked to continue their exercise program at home at a fixed walking speed, and return to the clinic at 1, 2, 3 and 6 months. | Behavioural | with free walk, with mobile phone assistance |
Primary outcome
inflammatory cytokines
Time frame: 6 months
IL-8
C-reactive protein (CRP)
Time frame: 6 months
CRP as systemic inflamatory status
Incremental shuttle walk test (ISWT)
Time frame: 6 months
Distence of shuttle walking test!
spirometry
Time frame: 6 months
FEV1 and FEV1/FVC.
strength of limb muscles
Time frame: 6 months
upper and lower limbs stregth
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 6 Jul 2012.
- Derived from this study: PubMed 25175787Wang CH, Chou PC, Joa WC, Chen LF, Sheng TF, Ho SC, Lin HC, Huang CD, Chung FT, Chung KF, Kuo HP. Mobile-phone-based home exercise training program decreases systemic inflammation in COPD: a pilot study. BMC Pulm Med. 2014 Aug 30;14:142. doi: 10.1186/1471-2466-14-142.
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Mobile-phone-based Home Exercise Training Program and Home Exercise Training Program in people with Moderate to Severe COPD Receiving Home Exercise Training, run by Chang Gung Memorial Hospital 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 1 inclusion and 5 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 6 Jul 2012. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
inflammatory cytokines (time frame: 6 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01631019, which also lists 1 linked publication.
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 6 Jul 2012.