NCT04830306

Brief Summary

To compare cardiorespiratory fitness parameters (oxygen consumption and respiratory ventilation) measured during two sub-maximal exercise tests (six minute step test, 6MST \& six minute walk test, 6 MWT) with maximal exercise test (cardiopulmonary exercise test, CPET)

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

March 31, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 5, 2021

Completed
1 year until next milestone

Study Start

First participant enrolled

April 6, 2022

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 21, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 21, 2022

Completed
Last Updated

October 5, 2022

Status Verified

November 1, 2021

Enrollment Period

6 months

First QC Date

March 31, 2021

Last Update Submit

October 4, 2022

Conditions

Cardiorespiratory Fitness

Keywords

aerobic powerCPETCPEXcardiopulmonary exercise testingexercise capacityfunctional capacityphysical activity

Outcome Measures

Primary Outcomes (1)

  • Total amount of oxygen consumed per minute as measured by wearable face mask

    Oxygen measured in mL/min

    Up to 15 minutes

Secondary Outcomes (1)

  • Total amount of respiratory ventilation per minute as measured by wearable face mask

    Up to 15 minutes

Study Arms (3)

6MST

ACTIVE COMPARATOR

Six minute step test

Behavioral: Exercise

6MWT

ACTIVE COMPARATOR

Six minute walk test

Behavioral: Exercise

CPET

ACTIVE COMPARATOR

Cardiopulmonary exercise test

Behavioral: Exercise

Interventions

ExerciseBEHAVIORAL

Completion of exercise in accordance with assigned protocol

6MST6MWTCPET

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18 and older
  • Able to speak English
  • Ambulatory \[assistive devices ok\]
  • Able to provide informed consent

You may not qualify if:

  • Inmate of correctional facility (i.e. prisoner)
  • Diagnosed history of dementia
  • Inability to ambulate independently
  • Considered inappropriate to participate by Principal Investigator

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Duke University Health System

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • David MacLeod, FRCA

    Duke University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
CROSSOVER
Model Details: All subjects will be asked to complete the three exercise tests
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 31, 2021

First Posted

April 5, 2021

Study Start

April 6, 2022

Primary Completion

September 21, 2022

Study Completion

September 21, 2022

Last Updated

October 5, 2022

Record last verified: 2021-11

Data Sharing

IPD Sharing
Will not share

Locations

US(1)