Chronic Obstructive Pulmonary Disease (COPD)NCT02200549
Effects of Combined Cycle Training and Inspiratory Muscle Training in Patients With COPD
A study testing calibrated cycle ergometer and calibrated cycle ergometer and threshold loading device in people with Chronic Obstructive Pulmonary Disease (COPD), run by Zhujiang Hospital at 1 site in China.
Trial summary
Chronic Obstructive Pulmonary Disease (COPD) ，the fourth leading cause of death in the world, represents an important public health challenge. It is also a major cause of chronic morbidity, mortality and disability throughout the world, leading to a heavy social and economic burden. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease (COPD)
- What is being tested?
- calibrated cycle ergometer and calibrated cycle ergometer and threshold loading device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteChina
- Study dates
- Dec 2014to Jan 2017
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients between 40 and 75 years of age were eligible if they met the following criteria:
- moderate to severe airflow obstruction (30≤ Forced Expiratory Volume At One Second(FEV1) <80% predicted and Forced Expiratory Volume At One Second/Forced Vital Capacity(FEV1/FVC)<70%)
- Complaints of dyspnea on exertion
- Clinically stable condition
- No participation in a pulmonary rehabilitation program in the last year.
Who cannot join
- Patients were excluded if they had evidence of asthma and/or had experienced a major exacerbation in the 2 months before enrollment
- Required home oxygen therapy or experienced oxyhemoglobin desaturation below 85% with exercise
- And/or had other health problems that would interfere with exercise.
Trial locations and contacts
1 site in 1 country.
China1 site
Zhujiang Hospital,Southern Medical Universtiy
Guangzhou, Guangdong, 510282
About this study
Official title: Effects of Combined Cycle Training and Inspiratory Muscle Training on Exercise Performance ,Health-related Quality,Dyspnoea ,Body Composition,Depressive Symptomatology in Patients With Chronic Obstructive Pulmonary Disease(COPD)
Chronic Obstructive Pulmonary Disease (COPD) ，the fourth leading cause of death in the world, represents an important public health challenge. It is also a major cause of chronic morbidity, mortality and disability throughout the world, leading to a heavy social and economic burden. For a long time, treatment of COPD mainly focus on drug therapy. Recently, pulmonary rehabilitation is recognized as a core component of the management of individuals with chronic respiratory disease, which has been clearly demonstrated to reduce dyspnea, increase exercise capacity, and improve quality of life.
Exercise training, widely regarded as the cornerstone of pulmonary rehabilitation , is one of the best available means of improving muscle function in COPD.The most commonly form is cycle training. Inspiratory Muscle Training (IMT) as an adjunct to exercise training has an additional benefit on inspiratory muscle strength, endurance and exercise capacity in patient with COPD.
There is insufficient evidence demonstrate greater benefits from combined inspiratory muscle training and cycle training. This study will evaluate the effects of combined inspiratory muscle training and cycle training in patients with COPD.
Read the detailed description
The patients with COPD will participate in a rehabilitation program for 8 weeks. Participants in the proposed study will be randomly programmed into one of three intervention groups:
- Cycle training program alone (performing on calibrated stationary cycle ergometer).
- Combined cycle training and inspiratory muscle training(performing on calibrated stationary cycle ergometer and threshold loading device).
- Neither cycle training nor inspiratory muscle training.
- Being tested
- Control group, calibrated cycle ergometer, calibrated cycle ergometer and threshold loading device
- Keywords
- pulmonary rehabilitation, inspiratory muscle training, exercise training
- 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.
Control groupDevice
Neither cycle training nor inspiratory muscle training.
calibrated cycle ergometerDevice
The most common device to proform cycle training is calibrated cycle ergometer.
calibrated cycle ergometer and threshold loading deviceDevice
Combined cycle training and inspiratory muscle training.The threshold loading device is composed of a mouth -piece attached to a small plastic cylinder that contains a spring-loaded poppet value. The valve opens to permit inspiratory flow only once the person has generated adequate negative intrathoracic pressure to condense the spring.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Experimental | Neither cycle training nor inspiratory muscle training. Receives: Device: Control group |
| Cycle training group | Experimental | A 30-minute cycling training session is performed 3 days a week using calibrated cycle ergometer. Receives: Device: calibrated cycle ergometer |
| Combined group | Experimental | A 30-minute Combined training session is performed 3 days a week using calibrated cycle ergometer and threshold loading device. Receives: Device: calibrated cycle ergometer and threshold loading device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Exercise Performance (composite outcome measure)
Exercise performance tests include field walking tests and cycle ergometer tests.
Measured: The groups will be assessed at baseline (time zero) and at the end of the training protocol (week 8)
Secondary outcomes (3)
Health-related quality (composite outcome measure)
Health-related quality is a component of the broader concept of quality of life and is defined as satisfaction with health.The St. George's Respiratory Questionnaire (SGRQ) and Chronic Respiratory Disease Questionnaire (CRQ）; and its self-reported version are the most widely used disease-specific questionnaires.
Measured: The groups will be assessed at baseline (time zero) and at the end of the training protocol (week 8)
inspiratory muscle function (composite outcome measure)
Currently, a variety of methods can be used to evaluate respiratory muscle function, including maximal inspiratory (PImax)，expiratory pressures(PEmax) and inspiratory muscle endurance.
Measured: The groups will be assessed at baseline (time zero) and at the end of the training protocol (week 8)
Symptom Evaluation (composite outcome measure)
Individuals with chronic respiratory disease often have symptoms such as dyspnea, fatigue, cough, weakness, sleeplessness,and psychological distress.Instruments for assessment of multiple symptoms include COPD Assessment Test (CAT) and Modified Medical British Research Council Scale(mMRC).
Measured: The groups will be assessed at baseline (time zero) and at the end of the training protocol (week 8)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2014 (estimated)
- Study startDec 2014
- Primary completionJan 2017
- Study completionJan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary Disease (COPD)Studies of the same condition, open and under way.
- More trials run by Zhujiang HospitalThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zhujiang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xin Chen, Doctor, Principal investigator, Zhujiang Hospital,Southern Medical Unversity
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02200549
- Sponsor's protocol ID
- CX13902205193
- Status last verified
- Mar 2016
- First submitted
- 20 Jul 2014
- Last updated
- 18 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Combined Cycle Training and Inspiratory Muscle Training on Exercise Performance ,Health-related Quality,Dyspnoea ,Body Composition,Depressive Symptomatology in Patients With Chronic Obstructive Pulmonary Disease(COPD)
- ClinicalTrials.gov ID
- NCT02200549
- Acronym / sponsor ID
- CX13902205193
- Keywords
- pulmonary rehabilitation, inspiratory muscle training, exercise training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Zhujiang HospitalUniversity, hospital or other
- Study start
- Dec 2014
- Primary completion
- Jan 2017 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 25 Jul 2014 (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.
Chronic Obstructive Pulmonary Disease (COPD) ，the fourth leading cause of death in the world, represents an important public health challenge. It is also a major cause of chronic morbidity, mortality and disability throughout the world, leading to a heavy social and economic burden. For a long time, treatment of COPD mainly focus on drug therapy. Recently, pulmonary rehabilitation is recognized as a core component of the management of individuals with chronic respiratory disease, which has been clearly demonstrated to reduce dyspnea, increase exercise capacity, and improve quality of life.
Exercise training, widely regarded as the cornerstone of pulmonary rehabilitation , is one of the best available means of improving muscle function in COPD.The most commonly form is cycle training. Inspiratory Muscle Training (IMT) as an adjunct to exercise training has an additional benefit on inspiratory muscle strength, endurance and exercise capacity in patient with COPD.
There is insufficient evidence demonstrate greater benefits from combined inspiratory muscle training and cycle training. This study will evaluate the effects of combined inspiratory muscle training and cycle training in patients with COPD.
Detailed description
The patients with COPD will participate in a rehabilitation program for 8 weeks. Participants in the proposed study will be randomly programmed into one of three intervention groups:
- Cycle training program alone (performing on calibrated stationary cycle ergometer).
- Combined cycle training and inspiratory muscle training(performing on calibrated stationary cycle ergometer and threshold loading device).
- Neither cycle training nor inspiratory muscle training.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control group | Experimental | Device: Control groupNeither cycle training nor inspiratory muscle training. |
| Cycle training group | Experimental | Device: calibrated cycle ergometerA 30-minute cycling training session is performed 3 days a week using calibrated cycle ergometer. |
| Combined group | Experimental | Device: calibrated cycle ergometer and threshold loading deviceA 30-minute Combined training session is performed 3 days a week using calibrated cycle ergometer and threshold loading device. |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients between 40 and 75 years of age were eligible if they met the following criteria:
Key exclusion criteria (3 listed)
- Patients were excluded if they had evidence of asthma and/or had experienced a major exacerbation in the 2 months before enrollment
- Required home oxygen therapy or experienced oxyhemoglobin desaturation below 85% with exercise
- And/or had other health problems that would interfere with exercise.
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 |
|---|---|---|
| Control groupNeither cycle training nor inspiratory muscle training. | Device | Control group |
| calibrated cycle ergometerThe most common device to proform cycle training is calibrated cycle ergometer. | Device | Cycle training group |
| calibrated cycle ergometer and threshold loading deviceCombined cycle training and inspiratory muscle training.The threshold loading device is composed of a mouth -piece attached to a small plastic cylinder that contains a spring-loaded poppet value. The valve opens to permit inspiratory flow only once the person has generated adequate negative intrathoracic pressure to condense the spring. | Device | Combined group |
Primary outcome
Exercise Performance (composite outcome measure)
Time frame: The groups will be assessed at baseline (time zero) and at the end of the training protocol (week 8)
Exercise performance tests include field walking tests and cycle ergometer tests.
3 secondary outcomes
Health-related quality (composite outcome measure)
Time frame: The groups will be assessed at baseline (time zero) and at the end of the training protocol (week 8)
inspiratory muscle function (composite outcome measure)
Time frame: The groups will be assessed at baseline (time zero) and at the end of the training protocol (week 8)
Symptom Evaluation (composite outcome measure)
Time frame: The groups will be assessed at baseline (time zero) and at the end of the training protocol (week 8)
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 18 May 2017.
- Individual participant dataSharing planned: No
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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.
Xin Chen, Doctor principal investigator
Zhujiang Hospital,Southern Medical Unversity
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing calibrated cycle ergometer and calibrated cycle ergometer and threshold loading device in people with Chronic Obstructive Pulmonary Disease (COPD), run by Zhujiang Hospital at 1 site in China.
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 5 inclusion and 3 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 18 May 2017. 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 China. 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?
Exercise Performance (composite outcome measure) (time frame: The groups will be assessed at baseline (time zero) and at the end of the training protocol (week 8)). 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 18 May 2017.