Older AdultsSTAND-UPNCT02453204
STAND UP - Sedentary Behaviour in Older Adults: Investigating a New Therapeutic Paradigm
A study testing Sitting, Standing and Walking in people with Older Adults, run by University of Leicester at 2 sites in United Kingdom.
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… Read more about this study
- Who is it for?
- Ages 65 to 79 yearsHealthy volunteers can take part
- Conditions the study is for
- Older Adults
- What is being tested?
- Sitting, Standing and Walking
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- Apr 2015to Mar 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 79 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
BHF Glasgow Cardiovascular Research Centre, University of Glasgow, 126 University Avenue
Glasgow, G12 8TA
Leicester Diabetes Centre, Diabetes Research Unit, University of Leicester, Leicester General Hospital
Leicester, LE5 4PW
About this study
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
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.
- Conditions
- Older Adults
- Being tested
- Sitting, Standing, Walking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SittingBehavioural
StandingBehavioural
WalkingBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Sitting | Experimental | 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. Receives: Behavioral: Sitting |
| Standing | Experimental | 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. Receives: Behavioral: Standing |
| Walking | Experimental | 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. Receives: Behavioral: Walking |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 experimental intervention study visits over an estimated period of 1 month
Secondary outcomes (12)
Glucose area under the curve
Measured: 3 experimental intervention study visits over an estimated period of 1 month
Triglyceride area under the curve
Measured: 3 experimental intervention study visits over an estimated period of 1 month
1H NMR Metabolomics spectroscopy
Hydrogen-1 Nuclear Magnetic Resonance assessment undertaken on blood samples collected throughout experimental intervention days
Measured: 3 experimental intervention study visits over an estimated period of 1 month
Blood pressure
Measured: 3 experimental intervention study visits over an estimated period of 1 month
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.
Measured: 3 experimental intervention study visits over an estimated period of 1 month
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.
Measured: 3 experimental intervention study visits over an estimated period of 1 month
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.
Measured: 3 experimental intervention study visits over an estimated period of 1 month
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.
Measured: 3 experimental intervention study visits over an estimated period of 1 month
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).
Measured: 3 experimental intervention study visits over an estimated period of 1 month
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).
Measured: 3 experimental intervention study visits over an estimated period of 1 month
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.
Measured: 3 experimental intervention study visits over an estimated period of 1 month
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.
Measured: 3 experimental intervention study visits over an estimated period of 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2015 (estimated)
- Study startApr 2015
- Primary completionMar 2017
- Study completionMar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Older AdultsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Leicester
- Sponsor type
- University, hospital or other
- Collaborators
- University of Glasgow, National Institute for Health Research, United Kingdom, National Health Service, United Kingdom
- Responsible party
- Sponsor
- Investigators
- Thomas Yates, Principal investigator, University of Leicester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02453204
- Sponsor's protocol ID
- 0482
- Other IDs
- MR/K025090/1, CRN18120, UOLE0482
- Acronym
- STAND-UP
- Status last verified
- Jun 2016
- First submitted
- 12 May 2015
- Last updated
- 30 Jan 2020
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Yates T, Edwardson CL, Celis-Morales C, Biddle SJH, Bodicoat D, Davies MJ, Esliger D, Henson J, Kazi A, Khunti K, Sattar N, Sinclair AJ, Rowlands A, Velayudhan L, Zaccardi F, Gill JMR. Metabolic Effects of Breaking Prolonged Sitting With Standing or Light Walking in Older South Asians and White Europeans: A Randomized Acute Study. J Gerontol A Biol Sci Med Sci. 2020 Jan 1;75(1):139-146. doi: 10.1093/gerona/gly252.
PubMed 30403772
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02453204
- Acronym / sponsor ID
- STAND-UP / 0482
- Conditions
- Older Adults
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- University of LeicesterUniversity, hospital or other
- Collaborators
- University of Glasgow, National Institute for Health Research, United Kingdom, National Health Service, United Kingdom
- Study start
- Apr 2015
- Primary completion
- Mar 2017 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 25 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Sitting | Experimental | Behavioral: SittingParticipants 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. |
| Standing | Experimental | Behavioral: StandingParticipants 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. |
| Walking | Experimental | Behavioral: WalkingThe 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. |
Who may qualify
- Ages
- 65 to 79 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sitting | Behavioural | Sitting |
| Standing | Behavioural | Standing |
| Walking | Behavioural | Walking |
Primary outcome
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.
12 secondary outcomes
Glucose area under the curve
Time frame: 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
1H NMR Metabolomics spectroscopy
Time frame: 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
Felt Arousal Scale (0-5)
Time frame: 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
Semantic Verbal Fluency Test (number of items)
Time frame: 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
Trail Making Tests A (time to complete)
Time frame: 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
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
Karolinska Sleepiness Scale (1-9)
Time frame: 3 experimental intervention study visits over an estimated period of 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2020.
- Derived from this study: PubMed 30403772Yates T, Edwardson CL, Celis-Morales C, Biddle SJH, Bodicoat D, Davies MJ, Esliger D, Henson J, Kazi A, Khunti K, Sattar N, Sinclair AJ, Rowlands A, Velayudhan L, Zaccardi F, Gill JMR. Metabolic Effects of Breaking Prolonged Sitting With Standing or Light Walking in Older South Asians and White Europeans: A Randomized Acute Study. J Gerontol A Biol Sci Med Sci. 2020 Jan 1;75(1):139-146. doi: 10.1093/gerona/gly252.
- NIHR Leicester-Loughborough Diet, Lifestyle and Physical Activity Biomedical Research UnitLink provided by the sponsor.
- Leicester Diabetes CentreLink provided by the sponsor.
- BHF Glasgow Cardiovascular Research CentreLink provided by the sponsor.
Related trials for Older Adults
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Bispectral Index-Guided Propofol Sedation During Endoscopic Retrograde Cholangiopancreatography
Deep Sedation, Endoscopic Retrograde Cholangiopancreatography
Not yet recruiting
Expanded Diagnostic Strategy in Older Adults Hospitalized With Community-Acquired Acute Respiratory Infection
Acute Respiratory Infection
RecruitingObservational study
Effects of Obesity on Physical Abilities and Daily Living Activities in Elderly Adults
Obesity, Sarcopenic Obesity
RecruitingPhase 2
Testing New Therapies for Patients With Acute Myeloid Leukemia Who Are Newly Diagnosed and Have Not Yet Started Treatment (A MyeloMATCH Treatment Trial)
Acute Myeloid Leukemia, Acute Myeloid Leukemia Arising From Previous Myelodysplastic/Myeloproliferative Neoplasm
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas Yates principal investigator
University of Leicester
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sitting, Standing and Walking in people with Older Adults, run by University of Leicester at 2 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Insulin area under the curve (time frame: 3 experimental intervention study visits over an estimated period of 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02453204, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2020.