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Completed

NCT Number: NCT02453204

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

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.

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Key information

Conditions

Age range

65 year–79 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

BHF Glasgow Cardiovascular Research Centre, University of Glasgow, 126 University Avenue, Glasgow, United Kingdom

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sitting

Behavioral

Standing

Behavioral

Walking

Behavioral

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of Leicester

Other

Collaborators

  • National Health Service, United Kingdom
  • National Institute for Health Research, United Kingdom
  • University of Glasgow

Registry information

Official study 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

Acronym: STAND-UP

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
May 25, 2015
Registry last updated
Jan 30, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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