Effect of Home-base Exercise With Conical-PEP Device on Physical Performance and Quality of Life in COPD
HBEcPEP
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
1 other identifier
interventional
50
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable chronic-obstructive-pulmonary-disease
Started Oct 2016
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 2, 2016
CompletedFirst Posted
Study publicly available on registry
June 3, 2016
CompletedStudy Start
First participant enrolled
October 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2018
CompletedOctober 31, 2016
October 1, 2016
1.3 years
February 2, 2016
October 27, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change of 6 minute walk distance (6MWD)
The 6MWD represents physical performance of COPD pateints.
baseline, post home-base exercise program at 8th weeks and follow up at 5th months
Secondary Outcomes (51)
Change of St George's Respiratory Questionnaire (SGRQ) score
baseline, post home-base exercise program at 8th weeks and follow up at 5th months
Incremental sport marching exercise test (ISMT)
baseline
Change of endurance exercise time of endurance sport marching exercise test (ESMT)
baseline, post home-base exercise program at 8th weeks and follow up at 5th months
Change of resting inspiratory capacity (IC)
baseline, post home-base exercise program at 8th weeks and follow up at 5th months
Change of end exercise inspiratory capacity in ESMT (IC-ESMT)
baseline, post home-base exercise program at 8th weeks and follow up at 5th months
- +46 more secondary outcomes
Study Arms (2)
Home-base exercise
ACTIVE 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)
Home-base exercise with a PEP mask
EXPERIMENTALPatients 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)
Interventions
Participant will use a non-re-breathing face mask with conical-PEP device during an interval endurance spot marching exercise.
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 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
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
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)
Eligibility Criteria
You may qualify if:
- COPD patients (with FEV1 ≤70% predicted)
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Khon Kaen Universitylead
- Thailand Research Fundcollaborator
Study Sites (2)
School of Physical Therapy, Faculty of Associated Medical Sciences
Khon Kaen, Changwat Khon Kaen, 40002, Thailand
Srinagarind Hospital
Khon Kaen, Changwat Khon Kaen, 40002, Thailand
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Chulee U Jones, Ph.D., PT
Khon Kaen University
- PRINCIPAL INVESTIGATOR
Chatchai Phimphasak, M.Sc, PT
Khon Kaen University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
February 2, 2016
First Posted
June 3, 2016
Study Start
October 1, 2016
Primary Completion
January 1, 2018
Study Completion
May 1, 2018
Last Updated
October 31, 2016
Record last verified: 2016-10