Physical ActivityNCT05250700
Characterisation of Objectively Measured Physical Activity and Self-reported Habitual Exercise
An observational study of Physical Activity, run by University of Bath at 1 site in United Kingdom.
Trial summary
This study aims to observe participants' physical activity (PA) using a blinded multisensor physical activity monitor as they go about their typical daily physical activities across a 6-week time frame. Participants will also complete a subjective, self-reported, online form to denote structured activities undertaken. Read more about this study
- Who is it for?
- Ages 40 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Physical Activity
- How many people
- 66 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 4 Nov 2020to 1 Jun 2022
- 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 40 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Participants will be recruited from Bath and surrounding areas (South West, England) although participants able and willing to travel from further afield may be recruited. All participants are aged 40-70 years and healthy (non-clinical sample).
Who may be able to join
- Healthy adults aged 40-70.
- Available to attend Department for Health, University of Bath, Bath, UK.
- Capable of conducting typical daily task (e.g., housework, walking etc.).
- Willingness to wear a PA monitor for 24hr for a total of 42 days.
Who cannot join
- No cold/flu-like symptoms within the last month.
- Smokers.
- Known history of cardiac or circulatory dysfunction.
- Known to live with diabetes or other metabolic disorders.
- Known to live with severe visual or audio impairment.
- Known to live with epilepsy or have seizures.
- Known disabilities that impede daily physical activity.
- Known allergy to nickel.
Trial locations and contacts
1 site in 1 country.
Dylan Thompson, PhD contact
United Kingdom1 site, 1 recruiting
- Recruiting
University of Bath
Bath, Somerset, BA2 7AY
Liam Beasley, 07825234936, LAB90@bath.ac.uk
About this study
Official title: Characterisation of Objectively Measured Physical Activity and Self-reported Habitual Exercise in Healthy Adults. An Observational Trial
This study aims to observe participants' physical activity (PA) using a blinded multisensor physical activity monitor as they go about their typical daily physical activities across a 6-week time frame. Participants will also complete a subjective, self-reported, online form to denote structured activities undertaken.
Read the detailed description
This study will observe participants' objectively measured PA and energy expenditure in a naturalistic manner. Individuals expressing interest will be invited to attend an online familiarisation meeting to assess eligibility for the study - procedures will be presented/explained in detail before participants are given a chance to question and discuss any concerns. Once aware of the requirements, participants will be asked if they wish to take part in the main trial and asked for written informed consent.
In Visit 1 (Day 0) willing participants will then undergo a familiarisation of protocol components, and they will be provided with the SenseWear armband to be worn, constantly, over a 42-day period (except during water-based activities such as showering and swimming). The device does not include a display and so participants are blinded to the measurement. Participants will be instructed to continue with their normal lifestyles and not make any changes. On or around day 43, participants will be asked to return the device (Visit 2).
During visit 1 and visit 2 participants will be measured and weighed using a stadiometer and floor scale. Throughout the trial, weekly reminder emails will be distributed by the research team to all participants reminding them of the study requirements and providing them with an additional opportunity to raise concerns. Due to the data storage capacity of the devices, new monitors will be distributed and used monitors returned remotely via post at weeks 2 and 4.
Additionally, during this period of objective PA measurement, participants will be invited to note the start and end time of any 'structured exercise' - defined as any PA that is "planned, structured, repetitive and aimed at improving or maintaining physical fitness (Caspersen, Powell and Christenson 1985 cited by Simmich, Deacon and Russell 2019)". Participants will also be required to note time spent sleeping. Data from this self-report component of the trial will be used to demarcate bouts of purposeful, structured exercise as well as total self-reported waking time.
- Conditions
- Physical Activity
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Adults (40-70yrs) | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total energy expenditure [kilocalories per minute]
24-hour energy expenditure will be assessed via a wearable device enabling the estimation of total daily kilocalorie expenditure.
Measured: 6 weeks
Domain specific energy expenditure [kilocalories per minute].
24-hour energy expenditure will be assessed via a wearable device enabling the estimation of kilocalorie expenditure during sedentary (<1.5 metabolic equivalents) , light (1.5 - 3 metabolic equivalents), moderate (3-6 metabolic equivalents), vigorous (>6 metabolic equivalents) activities.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2022
- Study start4 Nov 2020
- Primary completion1 May 2022 (estimated)
- Study completion1 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Physical ActivityStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Bath
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Liam Beasley, University of Bath
- Investigators
- Liam Beasley, MSc, Principal investigator, University of Bath
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05250700
- Sponsor's protocol ID
- PA_S1_LAB
- Status last verified
- Feb 2022
- First submitted
- 1 Feb 2022
- Last updated
- 22 Feb 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Caspersen CJ, Powell KE, Christenson GM. Physical activity, exercise, and physical fitness: definitions and distinctions for health-related research. Public Health Rep. 1985 Mar-Apr;100(2):126-31.
PubMed 3920711Simmich J, Deacon AJ, Russell TG. Active Video Games for Rehabilitation in Respiratory Conditions: Systematic Review and Meta-Analysis. JMIR Serious Games. 2019 Feb 25;7(1):e10116. doi: 10.2196/10116.
PubMed 30801256
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterisation of Objectively Measured Physical Activity and Self-reported Habitual Exercise in Healthy Adults. An Observational Trial
- ClinicalTrials.gov ID
- NCT05250700
- Acronym / sponsor ID
- PA_S1_LAB
- Conditions
- Physical Activity
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- University of BathUniversity, hospital or other
- Study start
- 4 Nov 2020 (actual)
- Primary completion
- 1 May 2022 (estimated)
- Study completion
- 1 Jun 2022 (estimated)
- First posted
- 22 Feb 2022 (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.
This study aims to observe participants' physical activity (PA) using a blinded multisensor physical activity monitor as they go about their typical daily physical activities across a 6-week time frame. Participants will also complete a subjective, self-reported, online form to denote structured activities undertaken.
Detailed description
This study will observe participants' objectively measured PA and energy expenditure in a naturalistic manner. Individuals expressing interest will be invited to attend an online familiarisation meeting to assess eligibility for the study - procedures will be presented/explained in detail before participants are given a chance to question and discuss any concerns. Once aware of the requirements, participants will be asked if they wish to take part in the main trial and asked for written informed consent.
In Visit 1 (Day 0) willing participants will then undergo a familiarisation of protocol components, and they will be provided with the SenseWear armband to be worn, constantly, over a 42-day period (except during water-based activities such as showering and swimming). The device does not include a display and so participants are blinded to the measurement. Participants will be instructed to continue with their normal lifestyles and not make any changes. On or around day 43, participants will be asked to return the device (Visit 2).
During visit 1 and visit 2 participants will be measured and weighed using a stadiometer and floor scale. Throughout the trial, weekly reminder emails will be distributed by the research team to all participants reminding them of the study requirements and providing them with an additional opportunity to raise concerns. Due to the data storage capacity of the devices, new monitors will be distributed and used monitors returned remotely via post at weeks 2 and 4.
Additionally, during this period of objective PA measurement, participants will be invited to note the start and end time of any 'structured exercise' - defined as any PA that is "planned, structured, repetitive and aimed at improving or maintaining physical fitness (Caspersen, Powell and Christenson 1985 cited by Simmich, Deacon and Russell 2019)". Participants will also be required to note time spent sleeping. Data from this self-report component of the trial will be used to demarcate bouts of purposeful, structured exercise as well as total self-reported waking time.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adults (40-70yrs) | – | – |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Participants will be recruited from Bath and surrounding areas (South West, England) although participants able and willing to travel from further afield may be recruited. All participants are aged 40-70 years and healthy (non-clinical sample).
Key inclusion criteria (4 listed)
- Healthy adults aged 40-70.
- Available to attend Department for Health, University of Bath, Bath, UK.
- Capable of conducting typical daily task (e.g., housework, walking etc.).
- Willingness to wear a PA monitor for 24hr for a total of 42 days.
Key exclusion criteria (8 listed)
- No cold/flu-like symptoms within the last month.
- Smokers.
- Known history of cardiac or circulatory dysfunction.
- Known to live with diabetes or other metabolic disorders.
- Known to live with severe visual or audio impairment.
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
Total energy expenditure [kilocalories per minute]
Time frame: 6 weeks
24-hour energy expenditure will be assessed via a wearable device enabling the estimation of total daily kilocalorie expenditure.
Domain specific energy expenditure [kilocalories per minute].
Time frame: 6 weeks
24-hour energy expenditure will be assessed via a wearable device enabling the estimation of kilocalorie expenditure during sedentary (<1.5 metabolic equivalents) , light (1.5 - 3 metabolic equivalents), moderate (3-6 metabolic equivalents), vigorous (>6 metabolic equivalents) activities.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2022.
- Background: PubMed 3920711Caspersen CJ, Powell KE, Christenson GM. Physical activity, exercise, and physical fitness: definitions and distinctions for health-related research. Public Health Rep. 1985 Mar-Apr;100(2):126-31.
- Background: PubMed 30801256Simmich J, Deacon AJ, Russell TG. Active Video Games for Rehabilitation in Respiratory Conditions: Systematic Review and Meta-Analysis. JMIR Serious Games. 2019 Feb 25;7(1):e10116. doi: 10.2196/10116.
- Individual participant dataSharing planned: No
Related trials for Physical Activity
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruiting
Feasibility of a Robot-Guided Active Play Intervention for Children With Cerebral Palsy
Cerebral Palsy
Enrolling by invitation
Online Exercise Program for Transplant Patients: A Pilot Study
Kidney Transplantation, Physical Function
Recruiting
Effect of a Brief Daily Digital Meditation on Well-Being in US Young Adults (BEGIN II)
Mental Health and General Well-being
RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life(COREVIVE-HFrEF)
Heart Failure With Reduced Ejection Fraction, Iron Deficiency
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.
Dylan Thompson, PhD contact
Liam Beasley, MSc principal investigator
University of Bath
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 Physical Activity, run by University of Bath 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 4 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 22 Feb 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Liam Beasley, MSc (07825234936, LAB90@bath.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total energy expenditure [kilocalories per minute] (time frame: 6 weeks). 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?
On the ClinicalTrials.gov record for NCT05250700, which also lists 2 linked publications.
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 22 Feb 2022.