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

January 29, 2020 updated by: University of Leicester

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
76

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Glasgow, United Kingdom, G12 8TA
        • BHF Glasgow Cardiovascular Research Centre, University of Glasgow, 126 University Avenue
      • Leicester, United Kingdom, LE5 4PW
        • Leicester Diabetes Centre, Diabetes Research Unit, University of Leicester, Leicester General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

65 years to 79 years (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Sitting
Participants will remain sitting throughout the test period whilst undertaking typical sedentary behaviours such as watching TV, using a computer, reading and writing. Walking and standing will be restricted.
Behavioral: Sitting
Experimental: Standing
Participants will be asked to break their sitting time by standing for five minutes every 30 minutes. Participants will be asked to stand in the same position with no further instructions provided. In total, individuals will accumulate 12 bouts (60 minutes) of standing throughout the test period.
Behavioral: Standing
Experimental: Walking
The walking condition will be identical to standing, but the breaks in sitting time will be punctuated with five minute bouts of self-paced walking rather than standing.
Behavioral: Walking

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Insulin area under the curve
Time Frame: 3 experimental intervention study visits over an estimated period of 1 month
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Glucose area under the curve
Time Frame: 3 experimental intervention study visits over an estimated period of 1 month
3 experimental intervention study visits over an estimated period of 1 month
Triglyceride area under the curve
Time Frame: 3 experimental intervention study visits over an estimated period of 1 month
3 experimental intervention study visits over an estimated period of 1 month
1H NMR Metabolomics spectroscopy
Time Frame: 3 experimental intervention study visits over an estimated period of 1 month
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
Blood pressure
Time Frame: 3 experimental intervention study visits over an estimated period of 1 month
3 experimental intervention study visits over an estimated period of 1 month
Felt Arousal Scale (0-5)
Time Frame: 3 experimental intervention study visits over an estimated period of 1 month
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
Feeling Scale (-5 to +5)
Time Frame: 3 experimental intervention study visits over an estimated period of 1 month
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
Semantic Verbal Fluency Test (number of items)
Time Frame: 3 experimental intervention study visits over an estimated period of 1 month
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
Hopkins Verbal Learning Test (number of words recalled)
Time Frame: 3 experimental intervention study visits over an estimated period of 1 month
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
Trail Making Tests A (time to complete)
Time Frame: 3 experimental intervention study visits over an estimated period of 1 month
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
Trail Making Tests B (time to complete)
Time Frame: 3 experimental intervention study visits over an estimated period of 1 month
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
Rapid Visual Information Processing Test (number of sequences detected and errors)
Time Frame: 3 experimental intervention study visits over an estimated period of 1 month
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
Karolinska Sleepiness Scale (1-9)
Time Frame: 3 experimental intervention study visits over an estimated period of 1 month
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Leicester

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute for Health Research, United Kingdom
National Health Service, United Kingdom
University of Glasgow

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Thomas Yates, University of Leicester

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 12, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 20, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 25, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 30, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 29, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2016

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 0482
  • MR/K025090/1 (Other Grant/Funding Number: UK Medical Research Council)
  • CRN18120 (Registry Identifier: UK Clinical Research Network)
  • UOLE0482 (Other Identifier: University of Leicester (Sponsor ID))

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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