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Clinical Trials/NCT02788370
NCT02788370UnknownNot Applicable

Cardiopulmonary Response to Conical Positive Expiratory Breathing During Exercise in Older People.

Khon Kaen University0 sites12 target enrollmentStarted: July 1, 2016Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Enrollment
12
Primary Endpoint
Change of Inspiratory capacity (IC)

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover
Primary Purpose
Treatment
Masking
Double (Participant, Outcomes Assessor)

Eligibility Criteria

Ages
60 Years to 80 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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.

Arms & Interventions

Sham-PEP breathing

Sham Comparator

Patients will perform a constant work load cycling test with sham-positive expiratory pressure breathing util symptom limit.

Intervention: Constant work load cycling test (Other)

Conical-PEP breathing

Experimental

Patients will perform a constant work load cycling test with positive expiratory pressure breathing using a conical positive expiratory pressure device until symptom limit.

Intervention: a conical positive expiratory pressure device (Device)

Conical-PEP breathing

Experimental

Patients will perform a constant work load cycling test with positive expiratory pressure breathing using a conical positive expiratory pressure device until symptom limit.

Intervention: Constant work load cycling test (Other)

Outcomes

Primary Outcomes

Change of Inspiratory capacity (IC)

Time Frame: resting, immediate post exercise test and end recovery period of 10 minutes

Participants will be measured IC with slow vital capacity maneuver following American thoracic Society (ATS) and European Respiratory Society (ERS) statement for spirometry (2005).

Secondary Outcomes

  • Change of peak expiratory flow rate (PEF)(Resting, during exercise every minute, end exercise test and every minute of recovery period for 10 minutes)
  • Change of respiratory rate (RR)(Resting, during exercise every minute, end exercise test and every minute of recovery period for 10 minutes)
  • Change of Slow vital capacity (SVC)(resting, immediate post exercise test and end recovery period of 10 minutes)
  • Change of inspiratory time (Ti)(Resting, during exercise every minute, end exercise test and every minute of recovery period for 10 minutes)
  • Change of hear rate (HR)(Resting, during exercise every minute, end exercise test and every minute of recovery period for 10 minutes)
  • Change of inspiratory and expiratory time ratio (IE ratio)(Resting, during exercise every minute, end exercise test and every minute of recovery period for 10 minutes)
  • Change of expiratory minute ventilation (VE)(Resting, during exercise every minute, end exercise test and every minute of recovery period for 10 minutes)
  • Change of diastolic blood pressure (DBP)(resting, immediate post exercise test and every 2 minutes during recovery period for 10 minutes)
  • Change of expiratory time (Te)(Resting, during exercise every minute, end exercise test and every minute of recovery period for 10 minutes)
  • Change of tidal volume (VT)(Resting, during exercise every minute, end exercise test and every minute of recovery period for 10 minutes)
  • Change of mean expiratory flow rate (MEF)(Resting, during exercise every minute, end exercise test and every minute of recovery period for 10 minutes)
  • Change of peak expiratory pressure (PEP)(Resting, during exercise every minute, end exercise test and every minute of recovery period for 10 minutes)
  • Change of rating perceive of breathlessness (RPB)(resting, during exercise every minute, end exercise test and every minute of recovery period for 10 minutes)
  • Change of leg fatigue(resting, , end exercise test and end recovery period)
  • Change of systolic blood pressure (SBP)(resting, immediate post exercise test and every 2 minutes during recovery period for 10 minutes)
  • Change of mean expiratory pressure (MEP)(Resting, during exercise every minute, end exercise test and every minute of recovery period for 10 minutes)
  • Change of end tidal carbon dioxide pressure (PetCO2)(Resting, during exercise every minute, end exercise test and every minute of recovery period for 10 minutes)
  • Change of mean arterial pressure (MAP)(resting, immediate post exercise test and every 2 minutes during recovery period for 10 minutes)
  • Change of pule oxygen saturation (SpO2)(Resting, during exercise every minute, end exercise test and every minute of recovery period for 10 minutes)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Chatchai Phimphasak

School of Physical Therapy, Faculty of Associated Medical Sciences

Khon Kaen University

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