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

Physical Activity Clinical Trial

Official title:

Characterisation of Objectively Measured Physical Activity and Self-reported Habitual Exercise in Healthy Adults. An Observational Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05250700
• Other study ID #: PA_S1_LAB
• Status: Recruiting
• Start date: November 4, 2020
• Est. completion date: June 1, 2022

Study information

• Verified date: February 2022
• Source: University of Bath
• Contact: Liam Beasley, MSc
• Phone: 07825234936
• Email: LAB90[@]bath.ac.uk
• Is FDA regulated: No
• Study type: Observational

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 66
• Est. completion date: June 1, 2022
• Est. primary completion date: May 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Physical Activity

Locations

Country	Name	City	State
United Kingdom	University of Bath	Bath	Somerset

Sponsors (1)

Lead Sponsor	Collaborator
University of Bath

Country where clinical trial is conducted

United Kingdom, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	6 weeks
Primary	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.	6 weeks