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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02790047
Recruitment Status : Unknown
Verified October 2016 by Chatchai Phimphasak, Khon Kaen University.
Recruitment status was:  Recruiting
First Posted : June 3, 2016
Last Update Posted : October 31, 2016
Sponsor:
Collaborator:
Thailand Research Fund
Information provided by (Responsible Party):
Chatchai Phimphasak, Khon Kaen University

Brief 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.

Condition or disease Intervention/treatment Phase
Chronic Obstructive Pulmonary Disease 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) Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Study Start Date : October 2016
Estimated Primary Completion Date : January 2018
Estimated Study Completion Date : May 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Home-base exercise

Patients 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)
Other: A home-base exercise program

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

Other: Health education

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

Other: ฺBreathing strategies for self secretion clearance

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

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

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)

Experimental: Home-base exercise with a PEP mask

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

Other: A home-base exercise program

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

Other: Health education

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

Other: ฺBreathing strategies for self secretion clearance

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

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

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)




Primary Outcome Measures :
  1. Change of 6 minute walk distance (6MWD) [ Time Frame: baseline, post home-base exercise program at 8th weeks and follow up at 5th months ]
    The 6MWD represents physical performance of COPD pateints.


Secondary Outcome Measures :
  1. Change of St George's Respiratory Questionnaire (SGRQ) score [ Time Frame: baseline, post home-base exercise program at 8th weeks and follow up at 5th months ]
    The SGRQ represents health related quality of life of COPD patients.

  2. Incremental sport marching exercise test (ISMT) [ Time Frame: baseline ]
    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).

  3. Change of endurance exercise time of endurance sport marching exercise test (ESMT) [ Time Frame: baseline, post home-base exercise program at 8th weeks and follow up at 5th months ]
    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.

  4. Change of resting inspiratory capacity (IC) [ Time Frame: baseline, post home-base exercise program at 8th weeks and follow up at 5th months ]
    The resting IC reflects static hyperinflation.

  5. Change of end exercise inspiratory capacity in ESMT (IC-ESMT) [ Time Frame: baseline, post home-base exercise program at 8th weeks and follow up at 5th months ]
    The end exercise IC reflects dynamic hyperinflation. patient will be measured the end exercise IC at immediate post ESMT.

  6. Change of resting slow vital capacity (SVC) [ Time Frame: baseline, post home-base exercise program at 8th weeks and follow up at 5th months ]
    The resting SVC reflect static hyperinflation

  7. Change of end exercise slow vital capacity in ESMT (SVC-ESMT) [ Time Frame: baseline, post home-base exercise program at 8th weeks and follow up at 5th months ]
    The resting SVC reflect dynamic hyperinflation.patient will be measured the end exercise IC at immediate post ESMT.

  8. Change of resting heart rate (HR) [ Time Frame: baseline, post home-base exercise program at 8th weeks and follow up at 5th months ]
    Patients will be measured resting EKG for 20 minutes. the EKG will be analysis to resting HR

  9. Change of resting respiratory rate (RR) [ Time Frame: baseline, post home-base exercise program at 8th weeks and follow up at 5th months ]
    Patients will be measured resting RR for 20 minutes. The RR will be recorded every minute.

  10. Change of resting pulse oxygen saturation (SpO2) [ Time Frame: baseline, post home-base exercise program at 8th weeks and follow up at 5th months ]
    Patients will be measured resting SpO2 for 20 minutes. The SpO2 will be recorded every minute.

  11. Change of resting end tidal carbon dioxide (PetCO2) [ Time Frame: baseline, post home-base exercise program at 8th weeks and follow up at 5th months ]
    Patients will be measured resting PetCO2 for 20 minutes. The PetCO2 will be recorded every minute.

  12. Change of resting systolic blood pressure (SBP) [ Time Frame: baseline, post home-base exercise program at 8th weeks and follow up at 5th months ]
    Patients will be measured resting SBP every 2 minutes for 20 minutes.

  13. Change of resting diastolic blood pressure (DBP) [ Time Frame: baseline, post home-base exercise program at 8th weeks and follow up at 5th months ]
    Patients will be measured resting DBP every 2 minutes for 20 minutes.

  14. Change of resting mean arterial pressure (MAP) [ Time Frame: baseline, post home-base exercise program at 8th weeks and follow up at 5th months ]
    Patients will be measured resting MAP every 2 minutes for 20 minutes.

  15. Change of resting pusle wave velocity (PWV) [ Time Frame: baseline, post home-base exercise program at 8th weeks and follow up at 5th months ]
    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 )

  16. Change of end exercise heart rate in ESMT (HR-ESMT) [ Time Frame: baseline, post home-base exercise program at 8th weeks and follow up at 5th months ]
    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.

  17. Change of end exercise rating perceive of breathlessness in ESMT (RPB-ESMT) [ Time Frame: baseline, post home-base exercise program at 8th weeks and follow up at 5th months ]
    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.

  18. Change of end exercise respiratory rate in ESMT (RR-ESMT) [ Time Frame: baseline, post home-base exercise program at 8th weeks and follow up at 5th months ]
    Patients will be recorded RR at pre-ESMT, during ESMT every minute, end ESMT and every minute in recovery period for 10 minutes.

  19. Change of end exercise tidal volume in ESMT (RR-ESMT) [ Time Frame: baseline, post home-base exercise program at 8th weeks and follow up at 5th months ]
    Patients will be recorded tidal volume at pre-ESMT, end ESMT and end recovery period for 10 minutes.

  20. Change of end exercise minute ventilation in ESMT (RR-ESMT) [ Time Frame: baseline, post home-base exercise program at 8th weeks and follow up at 5th months ]
    Patients will be recorded minute ventilation at pre-ESMT, end ESMT and end recovery period for 10 minutes.

  21. Change of end exercise pulse oxygen saturation in ESMT (SpO2-ESMT) [ Time Frame: baseline, post home-base exercise program at 8th weeks and follow up at 5th months ]
    Patients will be recorded SpO2 at pre-ESMT, during ESMT every minute, end ESMT and every minute in recovery period for 10 minutes.

  22. Change of end exercise end tidal carbon dioxide in ESMT (PetCO2-ESMT) [ Time Frame: baseline, post home-base exercise program at 8th weeks and follow up at 5th months ]
    Patients will be recorded PetCO2 at pre-ESMT, during ESMT every minute, end ESMT and every minute in recovery period for 10 minutes.

  23. Change of end exercise systolic blood pressure in ESMT (SBP-ESMT) [ Time Frame: baseline, post home-base exercise program at 8th weeks and follow up at 5th months ]
    Patients will be recorded SBP at pre-ESMT, immediate end ESMT and every 2 minutes in recovery period for 10 minutes.

  24. Change of end exercise diastolic blood pressure in ESMT (DBP-ESMT) [ Time Frame: baseline, post home-base exercise program at 8th weeks and follow up at 5th months ]
    Patients will be recorded DBP at pre-ESMT, immediate end ESMT and every 2 minutes in recovery period for 10 minutes.

  25. Change of end exercise mean arterial pressure in ESMT (MAP-ESMT) [ Time Frame: baseline, post home-base exercise program at 8th weeks and follow up at 5th months ]
    Patients will be recorded MAP at pre-ESMT, immediate end ESMT and every 2 minutes in recovery period for 10 minutes.

  26. Change of end exercise pulse wave velocity in ESMT (PWV-ESMT) [ Time Frame: baseline, post home-base exercise program at 8th weeks and follow up at 5th months ]
    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 )

  27. Change of end exercise leg fatigue score in ESMT (LEG-ESMT) [ Time Frame: baseline, post home-base exercise program at 8th weeks and follow up at 5th months ]
    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.

  28. Change of end exercise heart rate in 6MWT (HR-6MWT) [ Time Frame: baseline, post home-base exercise program at 8th weeks and follow up at 5th months ]
    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.

  29. Change of end exercise rating perceive of breathlessness in 6MWT (RPB-6MWT) [ Time Frame: baseline, post home-base exercise program at 8th weeks and follow up at 5th months ]
    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.

  30. Change of end exercise respiratory rate in 6MWT (RR-6MWT) [ Time Frame: baseline, post home-base exercise program at 8th weeks and follow up at 5th months ]
    Patients will be recorded RR at pre-6MWT, during 6MWT every minute, end 6MWT and every minute in recovery period for 10 minutes.

  31. Change of end exercise pulse oxygen saturation in 6MWT (SpO2-6MWT) [ Time Frame: baseline, post home-base exercise program at 8th weeks and follow up at 5th months ]
    Patients will be recorded SpO2 at pre-6MWT, during 6MWT every minute, end 6MWT and every minute in recovery period for 10 minutes.

  32. Change of end exercise end tidal carbon dioxide in 6MWT (PetCO2-6MWT) [ Time Frame: baseline, post home-base exercise program at 8th weeks and follow up at 5th months ]
    Patients will be recorded PetCO2 at pre-6MWT, during 6MWT every minute, end 6MWT and every minute in recovery period for 10 minutes.

  33. Change of end exercise systolic blood pressure in 6MWT (SBP-6MWT) [ Time Frame: baseline, post home-base exercise program at 8th weeks and follow up at 5th months ]
    Patients will be recorded SBP at pre-6MWT, immediate end 6MWT and every 2 minutes in recovery period for 10 minutes.

  34. Change of end exercise diastolic blood pressure in 6MWT (DBP-6MWT) [ Time Frame: baseline, post home-base exercise program at 8th weeks and follow up at 5th months ]
    Patients will be recorded DBP at pre-6MWT, immediate end 6MWT and every 2 minutes in recovery period for 10 minutes.

  35. Change of end exercise mean arterial pressure in 6MWT (MAP-6MWT) [ Time Frame: baseline, post home-base exercise program at 8th weeks and follow up at 5th months ]
    Patients will be recorded MAP at pre-6MWT, immediate end 6MWT and every 2 minutes in recovery period for 10 minutes.

  36. Change of end exercise leg fatigue score in 6MWT (LEG-6MWT) [ Time Frame: baseline, post home-base exercise program at 8th weeks and follow up at 5th months ]
    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.

  37. Change of resting heart rate variability (HRV) [ Time Frame: baseline, post home-base exercise program at 8th weeks and follow up at 5th months ]
    Patients will be measured resting EKG for 20 minutes. The EKG will be analysis to HRV

  38. Change of Chronic Obstructive Pulmonary Disease Assessment Test (CAT) score [ Time Frame: baseline, post home-base exercise program at 8th weeks and follow up at 5th months ]
    The CAT is health related quality of life questionnaire.

  39. Change of Modified Medical Research Council Questionnaire (mMRC) score [ Time Frame: baseline, post home-base exercise program at 8th weeks and follow up at 5th months ]
    The mMRC is one of dyspnea parameters. It is ordinal data.

  40. Change of hand grip force [ Time Frame: baseline, post home-base exercise program at 8th weeks and follow up at 5th months ]
    The hand grip force represents general health status of patients. patient will be assessed both dominated and non-dominated hands.

  41. Change of force vital capacity (FVC) and force vital capacity %predicted [ Time Frame: baseline, post home-base exercise program at 8th weeks and follow up at 5th months ]
    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).

  42. Change of force expiratory volume in one second (FEV1) and FEV1%predicted [ Time Frame: baseline, post home-base exercise program at 8th weeks and follow up at 5th months ]
    patient will perform spirometry in FVC maneuver to record post bronco-dilator FEV1 following ATS/ERS statement for spirometry (2005).

  43. Change of FEV1/FVC ratio [ Time Frame: baseline, post home-base exercise program at 8th weeks and follow up at 5th months ]
    patient will perform spirometry in FVC maneuver to record post bronco-dilator FEV1/FVC ratio following ATS/ERS statement for spirometry (2005).

  44. Change of peak expiratory flow rate (PEF) and PEF%predicted [ Time Frame: baseline, post home-base exercise program at 8th weeks and follow up at 5th months ]
    patient will perform spirometry in FVC maneuver to record post bronco-dilator PEF following ATS/ERS statement for spirometry (2005).

  45. Change of Maximum inspiratory pressure (MIP) [ Time Frame: baseline, post home-base exercise program at 8th weeks and follow up at 5th months ]
    Patients will maximum inhale as fast as possible from functional residual capacity (FRC) to total lung capacity (TLC).

  46. Change of Maximum expiratory pressure (MEP) [ Time Frame: baseline, post home-base exercise program at 8th weeks and follow up at 5th months ]
    Patients will maximum exhale as fast as possible from TLC to residual volume (RV).

  47. Change of Baseline Dyspnea Index (BDI) [ Time Frame: baseline, post home-base exercise program at 8th weeks and follow up at 5th months ]
    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.

  48. Change of Transition Dyspnea Index (TDI) [ Time Frame: post home-base exercise program at 8th weeks and follow up at 5th months ]
    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).

  49. Change of number of step per day [ Time Frame: baseline, post home-base exercise program at 8th weeks and follow up at 5th months ]
    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.

  50. Change of rate of using short acting bronco-dilator per week [ Time Frame: baseline, post home-base exercise program at 8th weeks and follow up at 5th months ]
    Patient will be collected the rate of using short acting bronco-dilator per week as 2 months ago of the time frame.

  51. Number of exacerbation event [ Time Frame: Collecting from starting the homes-base exercise program to 5th months follow up. ]
    Definition of exacerbation is a cause of admission to the hospital emergency room or admitting to hospital.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   35 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • COPD patients (with FEV1 ≤70% predicted)

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02790047


Contacts
Contact: Chatchai Phimphasak, M.Sc., PT +66861779571 chatmomo_chai@hotmail.com
Contact: Chulee U jones, Ph.D., PT +66845164169

Locations
Thailand
School of Physical Therapy, Faculty of Associated Medical Sciences Not yet recruiting
Muang Khon Kaen, Khon Kaen, Thailand, 40002
Srinagarind Hospital Recruiting
Muang Khon Kaen, Khon Kaen, Thailand, 40002
Contact: Chatchai Phimphasak, M.Sc. (PT)    +66861779571    chatmomo_chai@hotmail.com   
Sponsors and Collaborators
Khon Kaen University
Thailand Research Fund
Investigators
Study Director: Chulee U Jones, Ph.D., PT Khon Kaen University
Principal Investigator: Chatchai Phimphasak, M.Sc, PT Khon Kaen University

Responsible Party: Chatchai Phimphasak, Principal Investigator, Khon Kaen University
ClinicalTrials.gov Identifier: NCT02790047     History of Changes
Other Study ID Numbers: PHD/0082/2556
First Posted: June 3, 2016    Key Record Dates
Last Update Posted: October 31, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Chatchai Phimphasak, Khon Kaen University:
Chronic Obstructive Pulmonary Disease
Exercise Therapy
Positive Expiratory Pressure
Physical Fitness
Quality of Life

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases