NCT02788370

Brief Summary

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2016

Status
unknown

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

May 26, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 2, 2016

Completed
29 days until next milestone

Study Start

First participant enrolled

July 1, 2016

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2016

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

August 22, 2017

Status Verified

August 1, 2017

Enrollment Period

4 months

First QC Date

May 26, 2016

Last Update Submit

August 17, 2017

Conditions

Aging

Keywords

Positive expiratory pressureCardiopulmonary responsesExerciseOlder people

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (19)

  • Change of Slow vital capacity (SVC)

    resting, immediate post exercise test and end recovery period of 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 hear rate (HR)

    Resting, during exercise every minute, end exercise test and every minute of recovery period for 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 expiratory time (Te)

    Resting, during exercise every minute, end exercise test and every minute of recovery period for 10 minutes

  • +14 more secondary outcomes

Study Arms (2)

Sham-PEP breathing

SHAM COMPARATOR

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

Other: Constant work load cycling test

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.

Device: a conical positive expiratory pressure deviceOther: Constant work load cycling test

Interventions

a conical positive expiratory pressure deviceDEVICE

The CPEP device will be connected to respiratory transducer for generating positive expiratory pressure with therapeutic rang (5 to 20 cm H2O).

Also known as: CPEP deice
Conical-PEP breathing
Constant work load cycling testOTHER

Participants will per form constant work load cycling test until symptom limit with 50 to 60 rpm. The termination criteria include 1. sever breathlessness (\>5 /10 score of modified Borg scale) 2. leg fatigue (can not maintain speed between 50 to 60 rpm) 3. Hear rate (HR) \>80 % age-predicted maximum HR 4. Exercise time up to 10 minutes 5. Other symptom that stated by American thoracic Society(2002)

Conical-PEP breathingSham-PEP breathing

Eligibility Criteria

Age60 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Chulee U Jones, Ph.D., PT

    School of Physical therapy, Faculty of Associated Medical Sciences, Khon Kaen University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
School of Physical Therapy, Faculty of Associated Medical Sciences

Study Record Dates

First Submitted

May 26, 2016

First Posted

June 2, 2016

Study Start

July 1, 2016

Primary Completion

November 1, 2016

Study Completion

December 1, 2017

Last Updated

August 22, 2017

Record last verified: 2017-08