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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02453204
Recruitment Status : Completed
First Posted : May 25, 2015
Last Update Posted : May 3, 2017
Sponsor:
Collaborators:
University of Glasgow
National Institute for Health Research, United Kingdom
National Health Service, United Kingdom
Information provided by (Responsible Party):
University of Leicester

Brief 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.

Condition or disease Intervention/treatment Phase
Older Adults Behavioral: Sitting Behavioral: Standing Behavioral: Walking Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 76 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
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
Study Start Date : April 2015
Actual Primary Completion Date : March 2017
Actual Study Completion Date : March 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Glucose area under the curve [ Time Frame: 3 experimental intervention study visits over an estimated period of 1 month ]
  2. Triglyceride area under the curve [ Time Frame: 3 experimental intervention study visits over an estimated period of 1 month ]
  3. 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

  4. Blood pressure [ Time Frame: 3 experimental intervention study visits over an estimated period of 1 month ]
  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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).

  10. 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).

  11. 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.

  12. 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.



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Ages Eligible for Study:   65 Years to 79 Years   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02453204


Locations
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United Kingdom
BHF Glasgow Cardiovascular Research Centre, University of Glasgow, 126 University Avenue
Glasgow, United Kingdom, G12 8TA
Leicester Diabetes Centre, Diabetes Research Unit, University of Leicester, Leicester General Hospital
Leicester, United Kingdom, LE5 4PW
Sponsors and Collaborators
University of Leicester
University of Glasgow
National Institute for Health Research, United Kingdom
National Health Service, United Kingdom
Investigators
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Principal Investigator: Thomas Yates University of Leicester

Additional Information:
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Responsible Party: University of Leicester
ClinicalTrials.gov Identifier: NCT02453204     History of Changes
Other Study ID Numbers: REC: CSP152114
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) )
First Posted: May 25, 2015    Key Record Dates
Last Update Posted: May 3, 2017
Last Verified: June 2016