Characterisation of Objectively Measured Physical Activity & Self-reported

Status Recruiting

Clinical 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.

Clinical Trial 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

Related Conditions & MeSH terms

Physical Activity

Clinical Trial Details

NCT number	NCT05250700
Study type	Observational
Source	University of Bath
Contact	Liam Beasley, MSc
Phone	07825234936
Email	LAB90@bath.ac.uk
Status	Recruiting
Phase
Start date	November 4, 2020
Completion date	June 1, 2022

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms