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Bedside Tests of Cardiorespiratory Fitness

Sponsor
University of Nottingham (Other)
Overall Status
Completed
CT.gov ID
NCT06062784
Collaborator
(none)
64
Enrollment
1
Location
36
Actual Duration (Months)
1.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

A study of 64 older adults over the age of 65y to assess the utility of patient characteristics and bedside measures of physical function and muscle size to predict cardiorespiratory fitness.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    A study of 64 older adults over the age of 65y to assess the utility of patient characteristics (age, gender and BMI) and bedside measures of physical function (handgrip strength and step box test) and muscle size (muscle thickness via B-mode ultrasonography (US)) to predict cardiorespiratory fitness (VO2peak and anaerobic threshold) as measured by the gold-standard assessment method, cardiopulmonary exercise testing (CPET).

    Each participant will take part in a single assessment day (after health screening against CPET safety criteria) whereby they will have US measures of the vastus lateralis before completing HGS and step box test assessments, and finally a CPET.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    64 participants
    Observational Model:
    Other
    Time Perspective:
    Other
    Official Title:
    Exploring the Utility of Bedside Tests for Predicting Cardiorespiratory Fitness in Older Adults
    Actual Study Start Date :
    Jan 1, 2019
    Actual Primary Completion Date :
    Dec 31, 2021
    Actual Study Completion Date :
    Dec 31, 2021

    Outcome Measures

    Primary Outcome Measures

    1. Cardiorespiratory fitness (CRF) - VO2 max [Single time-point - 8 to 12 minutes]

      CRF via cardiopulmonary exercise testing (CPET). This includes a measure of maximum oxygen uptake (VO2 max) determined via inline breath gas analysis during an incremental cycle test.

    2. Cardiorespiratory fitness (CRF) - Anaerobic threshold [Single time-point - 8 to 12 minutes]

      CRF via cardiopulmonary exercise testing (CPET). This includes a measure of anaerobic threshold (AT) determined via inline breath gas analysis during an incremental cycle test.

    Secondary Outcome Measures

    1. Muscle architecture - muscle thickness [Single time-point: 10 minutes]

      Analysis of vastus lateralis muscle thickness using b-mode ultrasonography

    2. Muscle architecture - pennation angle [Single time-point: 10 minutes]

      Analysis of vastus lateralis pennation angle using b-mode ultrasonography

    3. Muscle architecture - fascicle length [Single time-point: 10 minutes]

      Analysis of vastus lateralis fascicle length using b-mode ultrasonography

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    65 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • Over 65y

    • Independent, community-dwelling

    Exclusion Criteria:
    • Contraindications to CPET safety criteria

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Centre of Metabolism, Ageing and Physiology (COMAP), University of Nottingham Derby Derbyshire United Kingdom DE22 3DT

    Sponsors and Collaborators

    • University of Nottingham

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University of Nottingham
    ClinicalTrials.gov Identifier:
    NCT06062784
    Other Study ID Numbers:
    • BedTestAge
    First Posted:
    Oct 2, 2023
    Last Update Posted:
    Oct 2, 2023
    Last Verified:
    Sep 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of Oct 2, 2023