STAND UP - Sedentary Behaviour in Older Adults: Investigating a New Therapeutic Paradigm

Older Adults Clinical Trial

— STAND-UP  

Official title:

STAND UP - Sedentary Behaviour in Older Adults: Investigating a New Therapeutic Paradigm Work Package 3: Investigating the Effect of Sedentary Time, Reduced Sedentary Time and Increased Light-intensity Physical Activity on Metabolic and Psychological Health in Older Adults

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02453204
• Other study ID #: 0482
• Secondary ID: MR/K025090/1CRN1
• Status: Completed
• Phase: N/A
• Start date: April 2015
• Est. completion date: March 2017

Study information

• Verified date: June 2016
• Source: University of Leicester
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Research has shown that reducing the time spent sitting can reduce the risk of many diseases, such as diabetes and heart disease, and improve health. It is estimated that many older adults typically spend 70% of their waking day sitting, but little is known about whether reducing sitting promotes health and well-being in this age group. The aim of this research is to investigate the health effects of reducing sitting time by replacing it with short periods of standing or walking in adults over the age of 65.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 76
• Est. completion date: March 2017
• Est. primary completion date: March 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years to 79 Years

Eligibility

Inclusion Criteria:

• Adults aged between 65 to 79 years inclusive

• Able to walk (without any assistive devices and not requiring assistance from another person)

• Ability to communicate in and understand English to participate in the informed consent process.

Exclusion Criteria:

• Regular purposeful exercise (=75 minutes of self-reported vigorous exercise per week)

• Inability to stand or undertake light ambulation

• Psychological condition which limits participation in the study (e.g. dementia)

• Inability to communicate or understand English

• Steroid use

• Use of glucose lowering medication

• Inability to give informed consent

Related Conditions & MeSH terms

• Older Adults

Intervention

Behavioral:
• Sitting

• Standing

• Walking

Locations

Country	Name	City	State
United Kingdom	BHF Glasgow Cardiovascular Research Centre, University of Glasgow, 126 University Avenue	Glasgow
United Kingdom	Leicester Diabetes Centre, Diabetes Research Unit, University of Leicester, Leicester General Hospital	Leicester

Sponsors (4)

Lead Sponsor	Collaborator
University of Leicester	National Health Service, United Kingdom, National Institute for Health Research, United Kingdom, University of Glasgow

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Insulin area under the curve	Samples will be batched and analysed at the end of the study within a certified research laboratory at the Institute of Cardiovascular and Medical Sciences (ICAMS), University of Glasgow. Samples collected at the Leicester Diabetes Centre will be sent by courier in specialist containers and packed with dry ice.	3 experimental intervention study visits over an estimated period of 1 month
Secondary	Glucose area under the curve		3 experimental intervention study visits over an estimated period of 1 month
Secondary	Triglyceride area under the curve		3 experimental intervention study visits over an estimated period of 1 month
Secondary	1H NMR Metabolomics spectroscopy	Hydrogen-1 Nuclear Magnetic Resonance assessment undertaken on blood samples collected throughout experimental intervention days	3 experimental intervention study visits over an estimated period of 1 month
Secondary	Blood pressure		3 experimental intervention study visits over an estimated period of 1 month
Secondary	Felt Arousal Scale (0-5)	Positive affect and mood measured using the 6-point Likert Felt Arousal scale (0 = "low arousal" to 5 = "high arousal") that will be used to assess arousal.	3 experimental intervention study visits over an estimated period of 1 month
Secondary	Feeling Scale (-5 to +5)	Positive affect and mood measured using the 11-point Likert Feeling Scale (-5 = "very bad" to +5 = "very good") will be used to assess affective valence.	3 experimental intervention study visits over an estimated period of 1 month
Secondary	Semantic Verbal Fluency Test (number of items)	The Semantic Verbal Fluency Test assesses semantic memory and language, and participants will be asked to name as many items as they can that belong to a particular category. The categories selected for each of the experimental days will be clothing and animals.	3 experimental intervention study visits over an estimated period of 1 month
Secondary	Hopkins Verbal Learning Test (number of words recalled)	The Hopkins Verbal Learning Test assesses verbal learning and working memory and requires immediate and delayed recall of a series of 12 words over three learning trials. Participants will be requested to undertake the delayed recall component at the end of the first set of cognitive function tests and during the second set of cognitive function tests on experimental intervention days.	3 experimental intervention study visits over an estimated period of 1 month
Secondary	Trail Making Tests A (time to complete)	The Trail Making Tests A assesses cognitive flexibility and requires connecting randomly located numbers in numerical order (e.g. 1,2,3,4).	3 experimental intervention study visits over an estimated period of 1 month
Secondary	Trail Making Tests B (time to complete)	The Trail Making Tests B assesses cognitive flexibility and requires connecting randomly located numbers and letters in numerical and alphabetical order alternately (e.g. 1,A,2,B,3,C).	3 experimental intervention study visits over an estimated period of 1 month
Secondary	Rapid Visual Information Processing Test (number of sequences detected and errors)	The Rapid Visual Information Processing Test assesses sustained visual attention using numbers and requires both selective attention and working memory. This test displays a number on screen that changes between odd and even digits and individuals must detect target sequences of three odd or three even consecutive digits.	3 experimental intervention study visits over an estimated period of 1 month
Secondary	Karolinska Sleepiness Scale (1-9)	Sleep quality measured using the 9-point Likert Karolinska Sleepiness Scale (1= "very alert" to 9= "very sleepy, fighting sleep, an effort to keep awake") based on a self-reported subjective assessment of the participant's level of drowsiness at the time.	3 experimental intervention study visits over an estimated period of 1 month

External Links

•   BHF Glasgow Cardiovascular Research Centre
•   Leicester Diabetes Centre
•   NIHR Leicester-Loughborough Diet, Lifestyle and Physical Activity Biomedical Research Unit