Step, Walk, Bike: Comparisons of Fitness Assessments

NCT ID: NCT04830306

Last Updated: 2022-10-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-04-06
• Study Completion Date: 2022-09-21

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)

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

Conditions

Cardiorespiratory Fitness

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

6MST

Six minute step test

Group Type: ACTIVE_COMPARATOR

Exercise

Intervention Type: BEHAVIORAL

Completion of exercise in accordance with assigned protocol

6MWT

Six minute walk test

Group Type: ACTIVE_COMPARATOR

Exercise

Intervention Type: BEHAVIORAL

Completion of exercise in accordance with assigned protocol

CPET

Cardiopulmonary exercise test

Group Type: ACTIVE_COMPARATOR

Exercise

Intervention Type: BEHAVIORAL

Completion of exercise in accordance with assigned protocol

Interventions

Exercise

Completion of exercise in accordance with assigned protocol

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Duke University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David MacLeod, FRCA

Role: PRINCIPAL_INVESTIGATOR

Duke University

Locations

Duke University Health System

Durham, North Carolina, United States

Countries

United States

Other Identifiers

Pro00108027

Identifier Type: -

Identifier Source: org_study_id