AgingNCT06062784
Bedside Tests of Cardiorespiratory Fitness
An observational study of Aging, run by University of Nottingham at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Aging
- How many people
- 64 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Jan 2019to 31 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Study population: Community dwelling adults over the age of 65y who were able to provide written, informed consent and had no contraindications to exercise testing.
Who may be able to join
- Over 65y
- Independent, community-dwelling
Who cannot join
- Contraindications to CPET safety criteria
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Centre of Metabolism, Ageing and Physiology (COMAP), University of Nottingham
Derby, Derbyshire, DE22 3DT
About this study
Official title: Exploring the Utility of Bedside Tests for Predicting Cardiorespiratory Fitness in Older Adults
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.
Read the 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 (HGS) 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.
- Conditions
- Aging
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiorespiratory fitness (CRF) - VO2 max
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.
Measured: Single time-point - 8 to 12 minutes
Cardiorespiratory fitness (CRF) - Anaerobic threshold
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.
Measured: Single time-point - 8 to 12 minutes
Secondary outcomes (3)
Muscle architecture - muscle thickness
Analysis of vastus lateralis muscle thickness using b-mode ultrasonography
Measured: Single time-point: 10 minutes
Muscle architecture - pennation angle
Analysis of vastus lateralis pennation angle using b-mode ultrasonography
Measured: Single time-point: 10 minutes
Muscle architecture - fascicle length
Analysis of vastus lateralis fascicle length using b-mode ultrasonography
Measured: Single time-point: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2023
- Study start1 Jan 2019
- Primary completion31 Dec 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AgingStudies of the same condition, open and under way.
- More trials run by University of NottinghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nottingham
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06062784
- Sponsor's protocol ID
- BedTestAge
- Status last verified
- Aug 2025
- First submitted
- 7 Sep 2023
- Last updated
- 3 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring the Utility of Bedside Tests for Predicting Cardiorespiratory Fitness in Older Adults
- ClinicalTrials.gov ID
- NCT06062784
- Acronym / sponsor ID
- BedTestAge
- Conditions
- Aging
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- University of NottinghamUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 2 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 (HGS) 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
- Observational model
- Other
- Time perspective
- Other
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- Study population
- Community dwelling adults over the age of 65y who were able to provide written, informed consent and had no contraindications to exercise testing.
Key inclusion criteria (2 listed)
- Over 65y
- Independent, community-dwelling
Key exclusion criteria (1 listed)
- Contraindications to CPET safety criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Cardiorespiratory fitness (CRF) - VO2 max
Time frame: 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.
Cardiorespiratory fitness (CRF) - Anaerobic threshold
Time frame: 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.
3 secondary outcomes
Muscle architecture - muscle thickness
Time frame: Single time-point: 10 minutes
Muscle architecture - pennation angle
Time frame: Single time-point: 10 minutes
Muscle architecture - fascicle length
Time frame: Single time-point: 10 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aging, run by University of Nottingham at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiorespiratory fitness (CRF) - VO2 max (time frame: Single time-point - 8 to 12 minutes). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2025.