Clinical trial NCT02788370: Cardiopulmonary Response to Conical-PEP Breathing During Exercise in Older People.
Official title: Cardiopulmonary Response to Conical Positive Expiratory Breathing During Exercise in Older People.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Aging
Keywords: Positive expiratory pressure
Cardiopulmonary responses
Exercise
Older people
Lead sponsor: Khon Kaen University
Sponsor class: OTHER
Collaborators: name: Thailand Research Fund
First posted: 2016-06-02
Enrollment: 12
Sex: ALL
Minimum age (years): 60
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Aim of this study is to compare cardiopulmonary response to conical-PEP breathing during exercise in older people.

Detailed description: It is known that all most structures and physiological functions deteriorate with age, leading to decrease exercise performance, functional decline and gradual decrease of physical activity in aging.

The most essential change of respiratory physiology are: dilatation of alveoli, enlargement of air space, decrease gas exchange surface area, loss of supporting tissue for distal airway (senile emphysema), decrees of chest wall compliance and decrease of respiratory muscle strength. These changes leading to decrease lung elastic recoil, increase residual volume and functional capacity, and increase work of breathing at rest. In addition, such changes affect respiratory function, especially dynamic hyperinflation (DH) development which could be one of the factors relate to dyspnea during exercise in aging Positive expiratory pressure (PEP) therapy for DH treatment during exercise was reported in several studies.

It is possible that PEP breathing may improve cardiopulmonary response to exercise in older people.

Eligibility criteria: Inclusion Criteria:

* Elder age between 60 to 80 years old with normal spirometry

Exclusion Criteria:

* They are diagnose with cardiovascular disease and, i.e. valvular heart disease, coronary heart disease, congenital heart disease, myocardial heart disease, uncontrolled hypertension, hyperlipidemia; or, present abnormal sign of heart problems previous month, such as chest pain, arrhythmia, abnormal ECG.
* They are impair balance from neuromuscular, musculoskeletal, or vestibular problem affecting cycling and walking.

Primary outcomes:
measure: Change of Inspiratory capacity (IC)
timeFrame: resting, immediate post exercise test and end recovery period of 10 minutes
Secondary outcomes:
measure: Change of Slow vital capacity (SVC)
timeFrame: resting, immediate post exercise test and end recovery period of 10 minutes
measure: Change of respiratory rate (RR)
timeFrame: Resting, during exercise every minute, end exercise test and every minute of recovery period for 10 minutes
measure: Change of hear rate (HR)
timeFrame: Resting, during exercise every minute, end exercise test and every minute of recovery period for 10 minutes
measure: Change of inspiratory time (Ti)
timeFrame: Resting, during exercise every minute, end exercise test and every minute of recovery period for 10 minutes
measure: Change of expiratory time (Te)
timeFrame: Resting, during exercise every minute, end exercise test and every minute of recovery period for 10 minutes
measure: Change of inspiratory and expiratory time ratio (IE ratio)
timeFrame: Resting, during exercise every minute, end exercise test and every minute of recovery period for 10 minutes
measure: Change of tidal volume (VT)
timeFrame: Resting, during exercise every minute, end exercise test and every minute of recovery period for 10 minutes
measure: Change of expiratory minute ventilation (VE)
timeFrame: Resting, during exercise every minute, end exercise test and every minute of recovery period for 10 minutes
measure: Change of mean expiratory flow rate (MEF)
timeFrame: Resting, during exercise every minute, end exercise test and every minute of recovery period for 10 minutes
measure: Change of peak expiratory flow rate (PEF)
timeFrame: Resting, during exercise every minute, end exercise test and every minute of recovery period for 10 minutes
measure: Change of mean expiratory pressure (MEP)
timeFrame: Resting, during exercise every minute, end exercise test and every minute of recovery period for 10 minutes
measure: Change of peak expiratory pressure (PEP)
timeFrame: Resting, during exercise every minute, end exercise test and every minute of recovery period for 10 minutes
measure: Change of pule oxygen saturation (SpO2)
timeFrame: Resting, during exercise every minute, end exercise test and every minute of recovery period for 10 minutes
measure: Change of end tidal carbon dioxide pressure (PetCO2)
timeFrame: Resting, during exercise every minute, end exercise test and every minute of recovery period for 10 minutes
measure: Change of rating perceive of breathlessness (RPB)
timeFrame: resting, during exercise every minute, end exercise test and every minute of recovery period for 10 minutes
measure: Change of leg fatigue
timeFrame: resting, , end exercise test and end recovery period
measure: Change of systolic blood pressure (SBP)
timeFrame: resting, immediate post exercise test and every 2 minutes during recovery period for 10 minutes
measure: Change of diastolic blood pressure (DBP)
timeFrame: resting, immediate post exercise test and every 2 minutes during recovery period for 10 minutes
measure: Change of mean arterial pressure (MAP)
timeFrame: resting, immediate post exercise test and every 2 minutes during recovery period for 10 minutes
Other outcomes:
Locations:
Study officials:
affiliation: School of Physical therapy, Faculty of Associated Medical Sciences, Khon Kaen University
name: Chulee U Jones, Ph.D., PT
role: PRINCIPAL_INVESTIGATOR
References: