Cardiopulmonary Response to Conical-PEP Breathing During Exercise in Older People. (CPEPolder)

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

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

Study Overview

• Status: Unknown
• Conditions: Aging
• Intervention / Treatment: Other: Constant work load cycling test; Device: a conical positive expiratory pressure device

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 Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
SHAM_COMPARATOR: Sham-PEP breathing; Patients will perform a constant work load cycling test with sham-positive expiratory pressure breathing util symptom limit.	Other: Constant work load cycling test; Participants will per form constant work load cycling test until symptom limit with 50 to 60 rpm. The termination criteria include; sever breathlessness (>5 /10 score of modified Borg scale); leg fatigue (can not maintain speed between 50 to 60 rpm); Hear rate (HR) >80 % age-predicted maximum HR; Exercise time up to 10 minutes; Other symptom that stated by American thoracic Society(2002)
EXPERIMENTAL: Conical-PEP breathing; Patients will perform a constant work load cycling test with positive expiratory pressure breathing using a conical positive expiratory pressure device until symptom limit.	Other: Constant work load cycling test; Participants will per form constant work load cycling test until symptom limit with 50 to 60 rpm. The termination criteria include; sever breathlessness (>5 /10 score of modified Borg scale); leg fatigue (can not maintain speed between 50 to 60 rpm); Hear rate (HR) >80 % age-predicted maximum HR; Exercise time up to 10 minutes; Other symptom that stated by American thoracic Society(2002); Device: a conical positive expiratory pressure device; The CPEP device will be connected to respiratory transducer for generating positive expiratory pressure with therapeutic rang (5 to 20 cm H2O).; Other Names: CPEP deice

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of Inspiratory capacity (IC)	Participants will be measured IC with slow vital capacity maneuver following American thoracic Society (ATS) and European Respiratory Society (ERS) statement for spirometry (2005).	resting, immediate post exercise test and end recovery period of 10 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of Slow vital capacity (SVC)	Participants will be measured SVC with slow vital capacity maneuver following American thoracic Society (ATS) and European Respiratory Society (ERS) statement for spirometry (2005).	resting, immediate post exercise test and end recovery period of 10 minutes
Change of respiratory rate (RR)	The RR will be measured by a flow transducer of BioPAC system MP 36. The RR will continuously measure throughout resting, during exercise, end exercise and recovery period fro 10 minute	Resting, during exercise every minute, end exercise test and every minute of recovery period for 10 minutes
Change of hear rate (HR)	Participants will be continuously recorded EKG by the BioPAC system MP 36 The HR will be collected from EKG. Moreover, real time EKG with HR will be measured by bedside monitor for termination criteria .	Resting, during exercise every minute, end exercise test and every minute of recovery period for 10 minutes
Change of inspiratory time (Ti)	The Ti will measure by a flow transducer of BioPAC system MP 36. The Ti will continuously measure throughout resting, during exercise, end exercise and recovery period fro 10 minute	Resting, during exercise every minute, end exercise test and every minute of recovery period for 10 minutes
Change of expiratory time (Te)	The Te will measure by a flow transducer of BioPAC system MP 36. The Te will continuously measure throughout resting, during exercise, end exercise and recovery period fro 10 minute	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)	The IE ratio will measure by a flow transducer of BioPAC system MP 36. The IE ratio will continuously measure throughout resting, during exercise, end exercise and recovery period fro 10 minute	Resting, during exercise every minute, end exercise test and every minute of recovery period for 10 minutes
Change of tidal volume (VT)	The VT will measure by a flow transducer of BioPAC system MP 36. The VT will continuously measure throughout resting, during exercise, end exercise and recovery period fro 10 minute	Resting, during exercise every minute, end exercise test and every minute of recovery period for 10 minutes
Change of expiratory minute ventilation (VE)	The VE will calculate from RR and VT and will present at resting, during exercise every minute, end exercise and every minute in recovery period for 10 minute	Resting, during exercise every minute, end exercise test and every minute of recovery period for 10 minutes
Change of mean expiratory flow rate (MEF)	The MEF will measure by a flow transducer of BioPAC system MP 36. The MEF will continuously measure throughout resting, during exercise, end exercise and recovery period fro 10 minute.	Resting, during exercise every minute, end exercise test and every minute of recovery period for 10 minutes
Change of peak expiratory flow rate (PEF)	The PEF will measure by a flow transducer of BioPAC system MP 36. The PEF will continuously measure throughout resting, during exercise, end exercise and recovery period fro 10 minute.	Resting, during exercise every minute, end exercise test and every minute of recovery period for 10 minutes
Change of mean expiratory pressure (MEP)	The MEP will measure by a pressure transducer of BioPAC system MP 36. The MEP will continuously measure throughout resting, during exercise, end exercise and recovery period fro 10 minute.	Resting, during exercise every minute, end exercise test and every minute of recovery period for 10 minutes
Change of peak expiratory pressure (PEP)	The PEP will measure by a pressure transducer of BioPAC system MP 36. The PEP will continuously measure throughout resting, during exercise, end exercise and recovery period fro 10 minute.	Resting, during exercise every minute, end exercise test and every minute of recovery period for 10 minutes
Change of pule oxygen saturation (SpO2)	Participants will be continuously measured SpO2 throughout the test. Researcher will collect SpO2 at resting, every minute during exercise, end exercise test and every minute of recovery period for 10 minutes.	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)	Participants will be continuously measured PetCO2 throughout the test. Researcher will collect PetCO2 at resting, every minute during exercise, end exercise test and every minute of recovery period for 10 minutes.	Resting, during exercise every minute, end exercise test and every minute of recovery period for 10 minutes
Change of rating perceive of breathlessness (RPB)	Participant will rate RPB using a modified Borg dyspnea 10 scale at resting, during exercise every minute, end exercise test and every minute of recovery period for 10 minutes.	resting, during exercise every minute, end exercise test and every minute of recovery period for 10 minutes
Change of leg fatigue	Participant will rate their leg fatigue using a visual analog scale at resting, end exercise test and end recovery period for 10 minutes.	resting, , end exercise test and end recovery period
Change of systolic blood pressure (SBP)	The SBP will be measured by a bedside monitor at resting, immediate post exercise test and every 2 minutes during recovery period for 10 minutes.	resting, immediate post exercise test and every 2 minutes during recovery period for 10 minutes
Change of diastolic blood pressure (DBP)	The SBP will be measured by a bedside monitor at resting, immediate post exercise test and every 2 minutes during recovery period for 10 minutes.	resting, immediate post exercise test and every 2 minutes during recovery period for 10 minutes
Change of mean arterial pressure (MAP)	The MAP will be measured by a bedside monitor at resting, immediate post exercise test and every 2 minutes during recovery period for 10 minutes.	resting, immediate post exercise test and every 2 minutes during recovery period for 10 minutes

Collaborators and Investigators

• Sponsor: Khon Kaen University
• Collaborators: Thailand Research Fund
• Investigators: Principal Investigator: Chulee U Jones, Ph.D., PT, School of physical therapy, Faculty of Associated medical sciences, Khon Kaen University

Study record dates

Study Major Dates

• Study Start: July 1, 2016
• Primary Completion (ACTUAL): November 1, 2016
• Study Completion (ANTICIPATED): December 1, 2017

Study Registration Dates

• First Submitted: May 26, 2016
• First Submitted That Met QC Criteria: May 26, 2016
• First Posted (ESTIMATE): June 2, 2016

Study Record Updates

• Last Update Posted (ACTUAL): August 22, 2017
• Last Update Submitted That Met QC Criteria: August 17, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Keywords: Exercise; Older people; Positive expiratory pressure; Cardiopulmonary responses
• Other Study ID Numbers: PHD/0082/2556.1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED