Characterisation of Objectively Measured Physical Activity and Self-reported Habitual Exercise

NCT ID: NCT05250700

Last Updated: 2022-02-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

66 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-11-04

Study Completion Date

2022-06-01

Brief Summary

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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

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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

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Physical Activity

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Adults (40-70yrs)

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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.
Minimum Eligible Age

40 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Bath

OTHER

Sponsor Role lead

Responsible Party

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Liam Beasley

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Liam Beasley, MSc

Role: PRINCIPAL_INVESTIGATOR

University of Bath

Locations

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University of Bath

Bath, Somerset, United Kingdom

Site Status RECRUITING

Countries

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United Kingdom

Central Contacts

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Liam Beasley, MSc

Role: CONTACT

07825234936

Dylan Thompson, PhD

Role: CONTACT

Facility Contacts

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Liam Beasley

Role: primary

07825234936

References

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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.

Reference Type BACKGROUND
PMID: 3920711 (View on PubMed)

Simmich 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.

Reference Type BACKGROUND
PMID: 30801256 (View on PubMed)

Other Identifiers

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PA_S1_LAB

Identifier Type: -

Identifier Source: org_study_id

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