Step, Walk, Bike: Comparisons of Fitness Assessments

Comparison of Submaximal Exercise Tests With Maximal Exercise Test

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)

Study Overview

• Status: Completed
• Conditions: Cardiorespiratory Fitness
• Intervention / Treatment: Behavioral: Exercise

Detailed Description

After enrollment, the subjects will complete each of the following CRF assessments:

Sub-maximal exercise test Six Minute Step Test (6MST): A face mask with the VO2 Master expired gas analysis device will be secured in position with head strap. Subjects will rest seated for 5 minutes prior to the start of the test. The subject will be given a standardized set of instructions on how to complete the test by raising each knee to 90 degrees of hip flexion. The total number of steps completed during the timed 6-minute period will be recorded.

Sub-maximal exercise test Six Minute Walk Test (6MWT): A face mask with the VO2 Master expired gas analysis device will be secured in position with head strap. Subjects will rest seated for 5 minutes prior to the start of the test. A 30-m unobstructed hallway with turning points marked with small cones will be used. The subject will be given a standardized set of instructions on how to complete the test. The total distance walked during the timed 6-minute period will be recorded.

Maximal exercise cardiopulmonary exercise test (CPET): The CPET is performed using an electromagnetically-braked cycle ergometer, 12-lead continuous ECG, continuous pulse oximetry, continuous expired gas analysis (oxygen and carbon dioxide) with ventilation [termed 'metabolic cart'] and intermittent non-invasive blood pressure measurement every 2 minutes. Once the subject is seated comfortably on the bike and adjusted for optimum cycling position, the face mask is fitted. The subjects are instructed on how to perform the incremental ramp test, starting with a baseline rest phase (no leg turnover) for 2 mins followed by reference phase of 2 mins of leg turnover with no resistance (0 watts). The incremental rise in work-rate from baseline is pre-determined by using the equation derived by Wasserman and colleagues in which the same work-rate is increased throughout the test to the limit of tolerance. A work-rate is selected by study staff to aim for a test duration of between 8 and 12 minutes. The subjects are instructed to maintain a cycling cadence of 55 - 65 revolutions per minute (rpm) during the exercise phase. One the limit of tolerance (maximal watts) is reached the resistance on the bike is removed () watts) and the subjects are encouraged to continue cycling for a further 2 mins during the recovery phase.

The order in which 6MST and 6MWT are performed will be randomized. Between test the subjects will be allowed to rest in a chair until the heart rate is within 5 beats per min of resting values and blood pressure in within 10 mmHg of resting values. The CPET will be conducted once both 6MWT and 6MST have been completed. If the subject expresses fatigue after either 6MWT and 6MST, then the subject may elect to re-attend on a separate day to complete the evaluation. At completion of exercise evaluations the subjects will be discharged from study participation. No further follow up will be performed.

Up to 40 subjects aged 18 or older will be enrolled.

Inclusion Criteria:

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

Exclusion Criteria:

• Any exclusion criteria listed in table 8 American Thoracic Society /American College of Chest Physicians Statement on CPET
• Inmate of correctional facility (i.e. prisoner)
• Diagnosed history of dementia
• Inability to ambulate independently
• Considered inappropriate to participate by Principal Investigator

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke University Health System

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Any exclusion criteria listed in table 8 American Thoracic Society /American College of Chest Physicians Statement on CPET
• Inmate of correctional facility (i.e. prisoner)
• Diagnosed history of dementia
• Inability to ambulate independently
• Considered inappropriate to participate by Principal Investigator

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 6MST; Six minute step test	Behavioral: Exercise; Completion of exercise in accordance with assigned protocol
Active Comparator: 6MWT; Six minute walk test	Behavioral: Exercise; Completion of exercise in accordance with assigned protocol
Active Comparator: CPET; Cardiopulmonary exercise test	Behavioral: Exercise; Completion of exercise in accordance with assigned protocol

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total amount of oxygen consumed per minute as measured by wearable face mask	Oxygen measured in mL/min	Up to 15 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total amount of respiratory ventilation per minute as measured by wearable face mask	Respiratory ventilation measured in liters per minute	Up to 15 minutes

Collaborators and Investigators

• Sponsor: Duke University
• Investigators: Principal Investigator: David MacLeod, FRCA, Duke University

Study record dates

Study Major Dates

• Study Start (Actual): April 6, 2022
• Primary Completion (Actual): September 21, 2022
• Study Completion (Actual): September 21, 2022

Study Registration Dates

• First Submitted: March 31, 2021
• First Submitted That Met QC Criteria: March 31, 2021
• First Posted (Actual): April 5, 2021

Study Record Updates

• Last Update Posted (Actual): October 5, 2022
• Last Update Submitted That Met QC Criteria: October 4, 2022
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Keywords: physical activity; exercise capacity; functional capacity; cardiopulmonary exercise testing; aerobic power; CPET; CPEX
• Other Study ID Numbers: Pro00108027

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No