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Chronic Obstructive Pulmonary DiseaseHBEcPEPNCT02790047

Effect of Home-base Exercise With Conical-PEP Device on Physical Performance and Quality of Life in COPD

A study testing A non-re-breathing face mask with conical-PEP device, A home-base exercise program and Health education in people with Chronic Obstructive Pulmonary Disease, run by Khon Kaen University at 2 sites in Thailand.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The aim of this study to investigate the efficacy of a home-base exercise program with a new conical PEP device on physical performance and health related quality of life in COPD patients. Read more about this study

Who is it for?
Ages 35 to 80 years
Conditions the study is for
Chronic Obstructive Pulmonary Disease
What is being tested?
A non-re-breathing face mask with conical-PEP device, A home-base exercise program and Health education
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
2 sitesThailand
Study dates
Oct 2016to May 2018
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 35 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • COPD patients (with FEV1 ≤70% predicted)

Who cannot join

  • Exacerbate within a month prior, which was a cause of admission to the hospital emergency room or been admitted to hospital.
  • Are changed medicines within a month ago.
  • Have been used home oxygen therapy.
  • Have musculoskeletal or neuromuscular problem affecting balance and walking. and spot marching exercise.
  • Using walking aid device.

Trial locations and contacts

2 sites in 1 country.

Chatchai Phimphasak, M.Sc., PT contact

+66861779571

chatmomo_chai@hotmail.com

Chulee U jones, Ph.D., PT contact

+66845164169

Thailand2 sites, 2 recruiting

  • School of Physical Therapy, Faculty of Associated Medical Sciences

    Khon Kaen, Changwat Khon Kaen, 40002

    Not yet recruiting

  • Srinagarind Hospital

    Khon Kaen, Changwat Khon Kaen, 40002

    Chatchai Phimphasak, M.Sc. (PT), +66861779571, chatmomo_chai@hotmail.com

    Recruiting

Other trials in Thailand

About this study

Official title: Effect of Home-base Exercise Program With a Conical Positive Expiratory Pressure Device on Physical Performance and Health Related Quality of Life in Patients With Chronic Obstructive Pulmonary Disease

The aim of this study to investigate the efficacy of a home-base exercise program with a new conical PEP device on physical performance and health related quality of life in COPD patients.

Read the detailed description

The key pathophysiology of COPD is expiratory flow limit and hyperinflation that is a major factor related exertional dyspnea and exercise limitation. When expiratory minute volume( V ̇E) raise up while exercise, respiratory response by increase respiratory rate (RR) and tidal volume (VT), force exhalation occur lead to develop premature airway closer. These generate dynamic air tapping breath by breath and result in dynamic hyperinflation (DH). The DH limits VT expansion, increase respiratory muscle load, and it is a major cause related dyspnea and exercise termination. Furthermore, Pre-inflammatory products from the COPD lung contribute to another system, and provoke systemic inflammation lead to nutritional abnormalities, weight loss, skeletal muscle dysfunction, osteo-skeletal effect, cardiovascular effect and psychological effect. All of these affect the exercise tolerance and gradually affect physical activity and health-related quality of life (HRQL) as well.

COPD GOLD guideline states that goal for treatments of stable COPD comprise of relive symptoms, improve exercise tolerance, improve health status, prevent disease progression and reduce mortality. Several evidences have suggested an effect of pulmonary rehabilitation (PR) in patient with stable COPD and following acute exacerbation. Strong evidences reported that the PR program could improve exercise tolerance, reduce dyspnea, decrease fatigue and improve health-related quality of life.

The core stone of PR is an exercise program. Several types of exercise were published such as endurance exercise, interval exercise, strengthening exercise, respiratory muscle strengthening and breathing exercise. Most COPD patient stop exercise causes from dyspnea that related DH development during exercise. Previous studies reported various strategies to reduce DH development during exercise for extending exercise time or increase exercise capacity in immediate effect such as bronchodilators , hyperoxic breathing, heliox breathing, positive pressure therapy by non-invasive positive pressure ventilation (NIPPV), by pursed lip breathing (PLB) and by positive expiratory pressure (PEP) device.

The PEP therapy have been conventionally using for reduce premature airway closer by moving equal pressure point from distal to proximal, improve gas exchange and improve secretion clearance. In the past decade, the knowledge of dynamic hyperinflation in COPD patient has rapidly glowed up. The PEP device and PLB have used to reduce DH development during exercise that reported in only 5 studies. They expected that delay DH development, it may delay exertional dyspnea, and may result in improve exercise capacity.

Three studies reported DH parameter at pre and post exercise. Results indicated that using the PEP device can reduce DH when measuring immediate post exercise. However, effects of positive pressure therapy (PEP device and PLB) on exercise capacity were also inconclusive. But three studies showed positive effect of PEP therapy on exercise capacity.

Training effect of PEP therapy on physical performance and quality of life was present in two studies. The first study showed the benefit of breathing retraining (including PLB, and other breathing techniques) that were integrated to all daily activities and exercise program, superior than control group in peak oxygen consumption after 7th week of exercise program. The second study applied PLB to reduce DH during exercise program. They found that after ten sessions (within 3 to 4 weeks) of program, both PLB and control groups significantly improve 6 minute walk distance and quality of life, but non-significant effect between groups. To date there was only two studies of PEP therapy applying to exercise program, and results were not conclusive.

In spite of the PLB was wildly used, but positive pressure from this technique was reported about 5 cm H2O, it is lower boundary of therapeutic pressure range (5 to 20 cm H2O), this may result in a non-success of DH reduction. Consequently, The PEP device may be a convenient alternative way to generate positive pressure within therapeutic range for reduces DH during exercise or daily activities living. This may increase patient's physical performance and quality of life greater that exercise alone.

Being tested
A non-re-breathing face mask with conical-PEP device, A home-base exercise program, Health education, ฺBreathing strategies for self secretion clearance, The medication following the COPD GOLD guidelines (2015)
Keywords
Chronic Obstructive Pulmonary Disease, Exercise Therapy, Positive Expiratory Pressure, Physical Fitness, Quality of Life
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.

  • A non-re-breathing face mask with conical-PEP deviceDevice

    Participant will use a non-re-breathing face mask with conical-PEP device during an interval endurance spot marching exercise.

  • A home-base exercise programOther

    Duration of the program is 8 weeks A frequency of exercise session is 3 to 5 sessions per week A content of each exercise session includes

    1. Stretching exercise (shoulder, trunk and leg muscles) to warm up for 5 to 10 minutes
    2. Interval endurance exercise using a spot marching movement for 30 to 40 minutes. In each phase of spot marching exercise, patients will perform the exercise from 0 to 3 or 4 score of 10 score of a modified dyspnea Borg scale, they will record exercise the exercise duration time. Then, they will be required to rest until a modified dyspnea Borg scale < 1 score. Next, they will perform the next interval of spot marching exercise with the same protocol.
    3. Stretching exercise (shoulder, trunk and leg muscles) to cool down for 5 to 10 minutes

  • Health educationOther

    Health education include

    1. Knowledge of COPD disease
    2. Smoking status and smoking cessation
    3. Medication correctly
    4. Self dyspnea management
    5. Basic nutrition for COPD

  • ฺBreathing strategies for self secretion clearanceOther

    Using a modified active cycle breathing technique (mACBT) include

    1. Control breathing
    2. Pursed lip breathing (PLB)
    3. Slow inhale with sustain thoracic expansion for 3 sec and exhale with PLB technique
    4. Force expiratory technique (FET) with low to medium lung volume
    5. Huffing or coughing

  • The medication following the COPD GOLD guidelines (2015)Drug

    Patients will receive medications following the COPD GOLD guidelines (2015). The medication names were listed below

    1. Bata 2 agonist (short acting); Salbutamol (oral or inhaler), Terbutaline (oral)
    2. Bata 2 agonist (long acting); Bambuterol (oral), Procaterol (oral), Salmeterol (inhaler), Formoterol (inhaler)
    3. Xanthine derivative (sustained release theophylline)
    4. Anticholinergic; Tiotropium(inhaler), Ipratropium bromide (inhaler)
    5. Corticosteroids; Beclomethasone (inhaler), Budesonide(inhaler), Fluticasone(inhaler)
    6. Combined anticholinergic+ Beta 2-agonist; Ipratropium+fenoterol (inhaler), Ipratropium+salbutamol (inhaler)
    7. Combined Beta 2-agonist+ corticosteroids; Formoterol+ Budesonide(inhaler), Salmeterol+ Fluticasone(inhaler)
Study groups in NCT02790047
Study groupRoleWhat they receive
Home-base exerciseActive comparatorPatients will receive intervention as following 1. A home-base exercise program 2. Health education 3. Breathing strategies for self secretion clearance 4. The medication following the COPD GOLD guidelines (2015)
Receives: Other: A home-base exercise program; Other: Health education; Other: ฺBreathing strategies for self secretion clearance; Drug: The medication following the COPD GOLD guidelines (2015)
Home-base exercise with a PEP maskExperimentalPatients will receive intervention as following 1. A home-base exercise program with using a non-re-breathing face mask with conical-PEP device during an interval endurance spot marching exercise 2. Health education 3. Breathing strategies for self secretion clearance 4. The medication following the COPD GOLD guidelines (2015)
Receives: Device: A non-re-breathing face mask with conical-PEP device; Other: A home-base exercise program; Other: Health education; Other: ฺBreathing strategies for self secretion clearance; Drug: The medication following the COPD GOLD guidelines (2015)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change of 6 minute walk distance (6MWD)

    The 6MWD represents physical performance of COPD pateints.

    Measured: baseline, post home-base exercise program at 8th weeks and follow up at 5th months

Secondary outcomes (51)

  1. Change of St George's Respiratory Questionnaire (SGRQ) score

    The SGRQ represents health related quality of life of COPD patients.

    Measured: baseline, post home-base exercise program at 8th weeks and follow up at 5th months

  2. Incremental sport marching exercise test (ISMT)

    The ISMT is combination movement of high arm and leg raising on the spot . Patient will start ISMT with 60 or 70 steps/minute and increase 10 to 20 steps/minute every 2 minutes until symptom limited. Aim of this test is to fine maximum step rate and step rate which patient perceive at least moderate dyspnea or breathlessness. The proper step rate will use in endurance spot marching exercise test (ESMT).

    Measured: baseline

  3. Change of endurance exercise time of endurance sport marching exercise test (ESMT)

    The ESMT is a physical performance parameter. The exercise capacity of this test is endurance exercise time. Patents will perform ESMT with constant step rate until symptom limit or exercise time up to 25 minute.

    Measured: baseline, post home-base exercise program at 8th weeks and follow up at 5th months

  4. Change of resting inspiratory capacity (IC)

    The resting IC reflects static hyperinflation.

    Measured: baseline, post home-base exercise program at 8th weeks and follow up at 5th months

  5. Change of end exercise inspiratory capacity in ESMT (IC-ESMT)

    The end exercise IC reflects dynamic hyperinflation. patient will be measured the end exercise IC at immediate post ESMT.

    Measured: baseline, post home-base exercise program at 8th weeks and follow up at 5th months

  6. Change of resting slow vital capacity (SVC)

    The resting SVC reflect static hyperinflation

    Measured: baseline, post home-base exercise program at 8th weeks and follow up at 5th months

  7. Change of end exercise slow vital capacity in ESMT (SVC-ESMT)

    The resting SVC reflect dynamic hyperinflation.patient will be measured the end exercise IC at immediate post ESMT.

    Measured: baseline, post home-base exercise program at 8th weeks and follow up at 5th months

  8. Change of resting heart rate (HR)

    Patients will be measured resting EKG for 20 minutes. the EKG will be analysis to resting HR

    Measured: baseline, post home-base exercise program at 8th weeks and follow up at 5th months

  9. Change of resting respiratory rate (RR)

    Patients will be measured resting RR for 20 minutes. The RR will be recorded every minute.

    Measured: baseline, post home-base exercise program at 8th weeks and follow up at 5th months

  10. Change of resting pulse oxygen saturation (SpO2)

    Patients will be measured resting SpO2 for 20 minutes. The SpO2 will be recorded every minute.

    Measured: baseline, post home-base exercise program at 8th weeks and follow up at 5th months

  11. Change of resting end tidal carbon dioxide (PetCO2)

    Patients will be measured resting PetCO2 for 20 minutes. The PetCO2 will be recorded every minute.

    Measured: baseline, post home-base exercise program at 8th weeks and follow up at 5th months

  12. Change of resting systolic blood pressure (SBP)

    Patients will be measured resting SBP every 2 minutes for 20 minutes.

    Measured: baseline, post home-base exercise program at 8th weeks and follow up at 5th months

  13. Change of resting diastolic blood pressure (DBP)

    Patients will be measured resting DBP every 2 minutes for 20 minutes.

    Measured: baseline, post home-base exercise program at 8th weeks and follow up at 5th months

  14. Change of resting mean arterial pressure (MAP)

    Patients will be measured resting MAP every 2 minutes for 20 minutes.

    Measured: baseline, post home-base exercise program at 8th weeks and follow up at 5th months

  15. Change of resting pusle wave velocity (PWV)

    Patients will be continuously measured resting EKG and photoplethysmography (PPG) for 20 minutes. The pulse transit time will be collected from EKG and PPG, then the pulse transit time in each patient will divide by a length of their arm (from jugular notch to tip of index finger )

    Measured: baseline, post home-base exercise program at 8th weeks and follow up at 5th months

  16. Change of end exercise heart rate in ESMT (HR-ESMT)

    Patients will be continuously measured EKG during ESMT. The investigators will collect end exercise HR at immediate post ESMT and every minute in recovery period for 10 minutes.

    Measured: baseline, post home-base exercise program at 8th weeks and follow up at 5th months

  17. Change of end exercise rating perceive of breathlessness in ESMT (RPB-ESMT)

    Patients will rate their breathlessness using 10 scale of modified Borg dyspnea scale at pre-ESMT, during ESMT every minute, end ESMT and every minute in recovery period for 10 minute.

    Measured: baseline, post home-base exercise program at 8th weeks and follow up at 5th months

  18. Change of end exercise respiratory rate in ESMT (RR-ESMT)

    Patients will be recorded RR at pre-ESMT, during ESMT every minute, end ESMT and every minute in recovery period for 10 minutes.

    Measured: baseline, post home-base exercise program at 8th weeks and follow up at 5th months

  19. Change of end exercise tidal volume in ESMT (RR-ESMT)

    Patients will be recorded tidal volume at pre-ESMT, end ESMT and end recovery period for 10 minutes.

    Measured: baseline, post home-base exercise program at 8th weeks and follow up at 5th months

  20. Change of end exercise minute ventilation in ESMT (RR-ESMT)

    Patients will be recorded minute ventilation at pre-ESMT, end ESMT and end recovery period for 10 minutes.

    Measured: baseline, post home-base exercise program at 8th weeks and follow up at 5th months

  21. Change of end exercise pulse oxygen saturation in ESMT (SpO2-ESMT)

    Patients will be recorded SpO2 at pre-ESMT, during ESMT every minute, end ESMT and every minute in recovery period for 10 minutes.

    Measured: baseline, post home-base exercise program at 8th weeks and follow up at 5th months

  22. Change of end exercise end tidal carbon dioxide in ESMT (PetCO2-ESMT)

    Patients will be recorded PetCO2 at pre-ESMT, during ESMT every minute, end ESMT and every minute in recovery period for 10 minutes.

    Measured: baseline, post home-base exercise program at 8th weeks and follow up at 5th months

  23. Change of end exercise systolic blood pressure in ESMT (SBP-ESMT)

    Patients will be recorded SBP at pre-ESMT, immediate end ESMT and every 2 minutes in recovery period for 10 minutes.

    Measured: baseline, post home-base exercise program at 8th weeks and follow up at 5th months

  24. Change of end exercise diastolic blood pressure in ESMT (DBP-ESMT)

    Patients will be recorded DBP at pre-ESMT, immediate end ESMT and every 2 minutes in recovery period for 10 minutes.

    Measured: baseline, post home-base exercise program at 8th weeks and follow up at 5th months

  25. Change of end exercise mean arterial pressure in ESMT (MAP-ESMT)

    Patients will be recorded MAP at pre-ESMT, immediate end ESMT and every 2 minutes in recovery period for 10 minutes.

    Measured: baseline, post home-base exercise program at 8th weeks and follow up at 5th months

  26. Change of end exercise pulse wave velocity in ESMT (PWV-ESMT)

    Patients will be continuously measured EKG and photoplethysmography (PPG) at pre ESMT during ESMT and recovery period for 10 minutes. The pulse transit time will be collected from EKG and PPG at end of ESMT, then the pulse transit time in each patient will divide by a length of their arm (from jugular notch to tip of index finger )

    Measured: baseline, post home-base exercise program at 8th weeks and follow up at 5th months

  27. Change of end exercise leg fatigue score in ESMT (LEG-ESMT)

    Patients will rate their leg fatigue using 10 scale of modified Borg leg fatigue scale at pre-ESMT, during ESMT every minute, end ESMT and every minute in recovery period for 10 minute.

    Measured: baseline, post home-base exercise program at 8th weeks and follow up at 5th months

  28. Change of end exercise heart rate in 6MWT (HR-6MWT)

    Patients will be continuously measured HR during 6MWT. The investigators will collect end exercise HR at immediate post 6MWT and every minute in recovery period for 10 minutes.

    Measured: baseline, post home-base exercise program at 8th weeks and follow up at 5th months

  29. Change of end exercise rating perceive of breathlessness in 6MWT (RPB-6MWT)

    Patients will rate their breathlessness using 10 scale of modified Borg dyspnea scale at pre-6MWT, during 6MWT every minute, end 6MWT and every minute in recovery period for 10 minute.

    Measured: baseline, post home-base exercise program at 8th weeks and follow up at 5th months

  30. Change of end exercise respiratory rate in 6MWT (RR-6MWT)

    Patients will be recorded RR at pre-6MWT, during 6MWT every minute, end 6MWT and every minute in recovery period for 10 minutes.

    Measured: baseline, post home-base exercise program at 8th weeks and follow up at 5th months

  31. Change of end exercise pulse oxygen saturation in 6MWT (SpO2-6MWT)

    Patients will be recorded SpO2 at pre-6MWT, during 6MWT every minute, end 6MWT and every minute in recovery period for 10 minutes.

    Measured: baseline, post home-base exercise program at 8th weeks and follow up at 5th months

  32. Change of end exercise end tidal carbon dioxide in 6MWT (PetCO2-6MWT)

    Patients will be recorded PetCO2 at pre-6MWT, during 6MWT every minute, end 6MWT and every minute in recovery period for 10 minutes.

    Measured: baseline, post home-base exercise program at 8th weeks and follow up at 5th months

  33. Change of end exercise systolic blood pressure in 6MWT (SBP-6MWT)

    Patients will be recorded SBP at pre-6MWT, immediate end 6MWT and every 2 minutes in recovery period for 10 minutes.

    Measured: baseline, post home-base exercise program at 8th weeks and follow up at 5th months

  34. Change of end exercise diastolic blood pressure in 6MWT (DBP-6MWT)

    Patients will be recorded DBP at pre-6MWT, immediate end 6MWT and every 2 minutes in recovery period for 10 minutes.

    Measured: baseline, post home-base exercise program at 8th weeks and follow up at 5th months

  35. Change of end exercise mean arterial pressure in 6MWT (MAP-6MWT)

    Patients will be recorded MAP at pre-6MWT, immediate end 6MWT and every 2 minutes in recovery period for 10 minutes.

    Measured: baseline, post home-base exercise program at 8th weeks and follow up at 5th months

  36. Change of end exercise leg fatigue score in 6MWT (LEG-6MWT)

    Patients will rate their leg fatigue using 10 scale of modified Borg leg fatigue scale at pre-6MWT, during 6MWT every minute, end 6MWT and every minute in recovery period for 10 minute.

    Measured: baseline, post home-base exercise program at 8th weeks and follow up at 5th months

  37. Change of resting heart rate variability (HRV)

    Patients will be measured resting EKG for 20 minutes. The EKG will be analysis to HRV

    Measured: baseline, post home-base exercise program at 8th weeks and follow up at 5th months

  38. Change of Chronic Obstructive Pulmonary Disease Assessment Test (CAT) score

    The CAT is health related quality of life questionnaire.

    Measured: baseline, post home-base exercise program at 8th weeks and follow up at 5th months

  39. Change of Modified Medical Research Council Questionnaire (mMRC) score

    The mMRC is one of dyspnea parameters. It is ordinal data.

    Measured: baseline, post home-base exercise program at 8th weeks and follow up at 5th months

  40. Change of hand grip force

    The hand grip force represents general health status of patients. patient will be assessed both dominated and non-dominated hands.

    Measured: baseline, post home-base exercise program at 8th weeks and follow up at 5th months

  41. Change of force vital capacity (FVC) and force vital capacity %predicted

    patient will perform spirometry in FVC maneuver to record post bronco-dilator force vital capacity following American Thoracic Society (ATS) /European Respiratory Society (ERS) statement for spirometry (2005).

    Measured: baseline, post home-base exercise program at 8th weeks and follow up at 5th months

  42. Change of force expiratory volume in one second (FEV1) and FEV1%predicted

    patient will perform spirometry in FVC maneuver to record post bronco-dilator FEV1 following ATS/ERS statement for spirometry (2005).

    Measured: baseline, post home-base exercise program at 8th weeks and follow up at 5th months

  43. Change of FEV1/FVC ratio

    patient will perform spirometry in FVC maneuver to record post bronco-dilator FEV1/FVC ratio following ATS/ERS statement for spirometry (2005).

    Measured: baseline, post home-base exercise program at 8th weeks and follow up at 5th months

  44. Change of peak expiratory flow rate (PEF) and PEF%predicted

    patient will perform spirometry in FVC maneuver to record post bronco-dilator PEF following ATS/ERS statement for spirometry (2005).

    Measured: baseline, post home-base exercise program at 8th weeks and follow up at 5th months

  45. Change of Maximum inspiratory pressure (MIP)

    Patients will maximum inhale as fast as possible from functional residual capacity (FRC) to total lung capacity (TLC).

    Measured: baseline, post home-base exercise program at 8th weeks and follow up at 5th months

  46. Change of Maximum expiratory pressure (MEP)

    Patients will maximum exhale as fast as possible from TLC to residual volume (RV).

    Measured: baseline, post home-base exercise program at 8th weeks and follow up at 5th months

  47. Change of Baseline Dyspnea Index (BDI)

    The BDI is one of dyspnea parameters (questionnaire). Three dimension questions include; 1.effect of daily function on dyspnea, 2. effect of magnitude of task on dyspnea and 3. effect of magnitude off effort on dyspnea.

    Measured: baseline, post home-base exercise program at 8th weeks and follow up at 5th months

  48. Change of Transition Dyspnea Index (TDI)

    The TDI assesses change of dyspnea perception from the BDI in each dimensions. Patient will rate score from -6 to +6 (positive score reflect improve of dyspnea and negative score reflect worse dyspnea).

    Measured: post home-base exercise program at 8th weeks and follow up at 5th months

  49. Change of number of step per day

    The number of step per day represents physical activity using a pedometer. Patient will contact the pedometer from early wake up to go to bed with 10 day hours for 14 day before starting the home-base exercise program, post the home-base exercise program and 5th months . The researcher will record the regular step per day for 7 days to analysis.

    Measured: baseline, post home-base exercise program at 8th weeks and follow up at 5th months

  50. Change of rate of using short acting bronco-dilator per week

    Patient will be collected the rate of using short acting bronco-dilator per week as 2 months ago of the time frame.

    Measured: baseline, post home-base exercise program at 8th weeks and follow up at 5th months

  51. Number of exacerbation event

    Definition of exacerbation is a cause of admission to the hospital emergency room or admitting to hospital.

    Measured: Collecting from starting the homes-base exercise program to 5th months follow up.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Jun 2016 (estimated)
  2. Study startOct 2016
  3. Primary completionJan 2018 (estimated)
  4. Study completionMay 2018 (estimated)

Resources

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
Double blind
Who is masked
Participant, Investigator
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02790047
Sponsor's protocol ID
PHD/0082/2556
Acronym
HBEcPEP
Status last verified
Oct 2016
First submitted
2 Feb 2016
Last updated
31 Oct 2016
Results posted
No
Data monitoring committee
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A study testing A non-re-breathing face mask with conical-PEP device, A home-base exercise program and Health education in people with Chronic Obstructive Pulmonary Disease, run by Khon Kaen University at 2 sites in Thailand.

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: status not confirmed, as of the sponsor's last update on 31 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Thailand. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Chatchai Phimphasak, M.Sc., PT (+66861779571, chatmomo_chai@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change of 6 minute walk distance (6MWD) (time frame: baseline, post home-base exercise program at 8th weeks and follow up at 5th months). 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 NCT02790047.

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 31 Oct 2016.

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