Clinical trial NCT02790047: Effect of Home-base Exercise With Conical-PEP Device on Physical Performance and Quality of Life in COPD
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 type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: Chronic Obstructive Pulmonary Disease
Exercise Therapy
Positive Expiratory Pressure
Physical Fitness
Quality of Life
Lead sponsor: Khon Kaen University
Sponsor class: OTHER
Collaborators: name: Thailand Research Fund
First posted: 2016-06-03
Enrollment: 50
Sex: ALL
Minimum age (years): 35
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility 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.

Primary outcomes:
measure: Change of 6 minute walk distance (6MWD)
timeFrame: baseline, post home-base exercise program at 8th weeks and follow up at 5th months
Secondary outcomes:
measure: Change of St George's Respiratory Questionnaire (SGRQ) score
timeFrame: baseline, post home-base exercise program at 8th weeks and follow up at 5th months
measure: Incremental sport marching exercise test (ISMT)
timeFrame: baseline
measure: Change of endurance exercise time of endurance sport marching exercise test (ESMT)
timeFrame: baseline, post home-base exercise program at 8th weeks and follow up at 5th months
measure: Change of resting inspiratory capacity (IC)
timeFrame: baseline, post home-base exercise program at 8th weeks and follow up at 5th months
measure: Change of end exercise inspiratory capacity in ESMT (IC-ESMT)
timeFrame: baseline, post home-base exercise program at 8th weeks and follow up at 5th months
measure: Change of resting slow vital capacity (SVC)
timeFrame: baseline, post home-base exercise program at 8th weeks and follow up at 5th months
measure: Change of end exercise slow vital capacity in ESMT (SVC-ESMT)
timeFrame: baseline, post home-base exercise program at 8th weeks and follow up at 5th months
measure: Change of resting heart rate (HR)
timeFrame: baseline, post home-base exercise program at 8th weeks and follow up at 5th months
measure: Change of resting respiratory rate (RR)
timeFrame: baseline, post home-base exercise program at 8th weeks and follow up at 5th months
measure: Change of resting pulse oxygen saturation (SpO2)
timeFrame: baseline, post home-base exercise program at 8th weeks and follow up at 5th months
measure: Change of resting end tidal carbon dioxide (PetCO2)
timeFrame: baseline, post home-base exercise program at 8th weeks and follow up at 5th months
measure: Change of resting systolic blood pressure (SBP)
timeFrame: baseline, post home-base exercise program at 8th weeks and follow up at 5th months
measure: Change of resting diastolic blood pressure (DBP)
timeFrame: baseline, post home-base exercise program at 8th weeks and follow up at 5th months
measure: Change of resting mean arterial pressure (MAP)
timeFrame: baseline, post home-base exercise program at 8th weeks and follow up at 5th months
measure: Change of resting pusle wave velocity (PWV)
timeFrame: baseline, post home-base exercise program at 8th weeks and follow up at 5th months
measure: Change of end exercise heart rate in ESMT (HR-ESMT)
timeFrame: baseline, post home-base exercise program at 8th weeks and follow up at 5th months
measure: Change of end exercise rating perceive of breathlessness in ESMT (RPB-ESMT)
timeFrame: baseline, post home-base exercise program at 8th weeks and follow up at 5th months
measure: Change of end exercise respiratory rate in ESMT (RR-ESMT)
timeFrame: baseline, post home-base exercise program at 8th weeks and follow up at 5th months
measure: Change of end exercise tidal volume in ESMT (RR-ESMT)
timeFrame: baseline, post home-base exercise program at 8th weeks and follow up at 5th months
measure: Change of end exercise minute ventilation in ESMT (RR-ESMT)
timeFrame: baseline, post home-base exercise program at 8th weeks and follow up at 5th months
measure: Change of end exercise pulse oxygen saturation in ESMT (SpO2-ESMT)
timeFrame: baseline, post home-base exercise program at 8th weeks and follow up at 5th months
measure: Change of end exercise end tidal carbon dioxide in ESMT (PetCO2-ESMT)
timeFrame: baseline, post home-base exercise program at 8th weeks and follow up at 5th months
measure: Change of end exercise systolic blood pressure in ESMT (SBP-ESMT)
timeFrame: baseline, post home-base exercise program at 8th weeks and follow up at 5th months
measure: Change of end exercise diastolic blood pressure in ESMT (DBP-ESMT)
timeFrame: baseline, post home-base exercise program at 8th weeks and follow up at 5th months
measure: Change of end exercise mean arterial pressure in ESMT (MAP-ESMT)
timeFrame: baseline, post home-base exercise program at 8th weeks and follow up at 5th months
measure: Change of end exercise pulse wave velocity in ESMT (PWV-ESMT)
timeFrame: baseline, post home-base exercise program at 8th weeks and follow up at 5th months
measure: Change of end exercise leg fatigue score in ESMT (LEG-ESMT)
timeFrame: baseline, post home-base exercise program at 8th weeks and follow up at 5th months
measure: Change of end exercise heart rate in 6MWT (HR-6MWT)
timeFrame: baseline, post home-base exercise program at 8th weeks and follow up at 5th months
measure: Change of end exercise rating perceive of breathlessness in 6MWT (RPB-6MWT)
timeFrame: baseline, post home-base exercise program at 8th weeks and follow up at 5th months
measure: Change of end exercise respiratory rate in 6MWT (RR-6MWT)
timeFrame: baseline, post home-base exercise program at 8th weeks and follow up at 5th months
measure: Change of end exercise pulse oxygen saturation in 6MWT (SpO2-6MWT)
timeFrame: baseline, post home-base exercise program at 8th weeks and follow up at 5th months
measure: Change of end exercise end tidal carbon dioxide in 6MWT (PetCO2-6MWT)
timeFrame: baseline, post home-base exercise program at 8th weeks and follow up at 5th months
measure: Change of end exercise systolic blood pressure in 6MWT (SBP-6MWT)
timeFrame: baseline, post home-base exercise program at 8th weeks and follow up at 5th months
measure: Change of end exercise diastolic blood pressure in 6MWT (DBP-6MWT)
timeFrame: baseline, post home-base exercise program at 8th weeks and follow up at 5th months
measure: Change of end exercise mean arterial pressure in 6MWT (MAP-6MWT)
timeFrame: baseline, post home-base exercise program at 8th weeks and follow up at 5th months
measure: Change of end exercise leg fatigue score in 6MWT (LEG-6MWT)
timeFrame: baseline, post home-base exercise program at 8th weeks and follow up at 5th months
measure: Change of resting heart rate variability (HRV)
timeFrame: baseline, post home-base exercise program at 8th weeks and follow up at 5th months
measure: Change of Chronic Obstructive Pulmonary Disease Assessment Test (CAT) score
timeFrame: baseline, post home-base exercise program at 8th weeks and follow up at 5th months
measure: Change of Modified Medical Research Council Questionnaire (mMRC) score
timeFrame: baseline, post home-base exercise program at 8th weeks and follow up at 5th months
measure: Change of hand grip force
timeFrame: baseline, post home-base exercise program at 8th weeks and follow up at 5th months
measure: Change of force vital capacity (FVC) and force vital capacity %predicted
timeFrame: baseline, post home-base exercise program at 8th weeks and follow up at 5th months
measure: Change of force expiratory volume in one second (FEV1) and FEV1%predicted
timeFrame: baseline, post home-base exercise program at 8th weeks and follow up at 5th months
measure: Change of FEV1/FVC ratio
timeFrame: baseline, post home-base exercise program at 8th weeks and follow up at 5th months
measure: Change of peak expiratory flow rate (PEF) and PEF%predicted
timeFrame: baseline, post home-base exercise program at 8th weeks and follow up at 5th months
measure: Change of Maximum inspiratory pressure (MIP)
timeFrame: baseline, post home-base exercise program at 8th weeks and follow up at 5th months
measure: Change of Maximum expiratory pressure (MEP)
timeFrame: baseline, post home-base exercise program at 8th weeks and follow up at 5th months
measure: Change of Baseline Dyspnea Index (BDI)
timeFrame: baseline, post home-base exercise program at 8th weeks and follow up at 5th months
measure: Change of Transition Dyspnea Index (TDI)
timeFrame: post home-base exercise program at 8th weeks and follow up at 5th months
measure: Change of number of step per day
timeFrame: baseline, post home-base exercise program at 8th weeks and follow up at 5th months
measure: Change of rate of using short acting bronco-dilator per week
timeFrame: baseline, post home-base exercise program at 8th weeks and follow up at 5th months
measure: Number of exacerbation event
timeFrame: Collecting from starting the homes-base exercise program to 5th months follow up.
Other outcomes:
Locations:
city: Muang Khon Kaen
country: Thailand
facility: School of Physical Therapy, Faculty of Associated Medical Sciences
state: Khon Kaen
city: Muang Khon Kaen
country: Thailand
facility: Srinagarind Hospital
state: Khon Kaen
Study officials:
affiliation: Khon Kaen University
name: Chulee U Jones, Ph.D., PT
role: STUDY_DIRECTOR
affiliation: Khon Kaen University
name: Chatchai Phimphasak, M.Sc, PT
role: PRINCIPAL_INVESTIGATOR
References: