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AgingNCT05704660

Automatic Reaction to Physical Activity and Sedentary Stimuli in Aging

A study testing Adjusted Cognitive-biased modification task and Cognitive-biased modification task in people with Aging, run by University of Ottawa.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Most individuals are aware of the benefits to health of regular physical activity and have good intentions to exercise. Yet, 1.4 billion people worldwide are inactive, which suggests that turning intention into action can be challenging. Read more about this study

Who is it for?
Ages 60 years and olderHealthy volunteers can take part
Conditions the study is for
Aging
What is being tested?
Adjusted Cognitive-biased modification task and Cognitive-biased modification task
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
216 participants
Where
No sites listed yet
Study dates
Sep 2023to Sep 2025
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 60 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 60 years of age or older and able to understand instructions in English.

Who cannot join

  • Diagnosed psychiatric disorders or neurological condition (e.g., stork, Parkinson's disease, Alzheimer's disease, dementia)
  • Unable to carry out the training program
  • Unable to understand the protocol
  • Motor deficit preventing physical activity without external help
  • Physical health status preventing physical activity
  • Alcohol or substance dependence.

Trial locations and contacts

No sites are listed yet.

Matthieu P. Boisgontier, PhD contact

6135625408

matthieu.boisgontier@uottawa.ca

Ataallah Farajzadeh, MSc contact

3439870216

afara098@uottawa.ca

About this study

Official title: Retraining the Automatic Reaction to Physical Activity and Sedentary Stimuli in Adults 60 Years of Age or Older

Most individuals are aware of the benefits to health of regular physical activity and have good intentions to exercise. Yet, 1.4 billion people worldwide are inactive, which suggests that turning intention into action can be challenging. Recent findings show that the intention-action gap could be explained by negative automatic reactions (which is a component of dual-task theory) to stimuli associated with physical activity. This gap is particularly concerning in older adults, who are more likely to spontaneously associate physical activity with fear, pain, or discomfort. To promote physical activity, the current project proposes to train older adults to suppress their automatic attraction toward sedentary stimuli and to respond positively to physical-activity stimuli. This evidence-based and low-cost intervention aims to improve physical functioning and quality of life for these population. The results will inform public-health policies and improve clinical interventions that aim to counteract a global health problem: the pandemic of physical inactivity.

Read the detailed description

Physical activity is one of the top contributors to health, reducing rates of cardiovascular disease, cancer, hypertension, diabetes, obesity, and depression. This wide spectrum of benefits is particularly important for older adults, who often suffer structural and functional deterioration in several physiological systems. Physical activity can reduce and delay the impact of this age-related deterioration in health and functional independence. Current interventions to enhance physical activity in older adults rely mainly on reflective processes by providing rational information about the health benefits of a physically active lifestyle. While these interventions successfully increase intention, their effect on actual behavior is weak. That is, most individuals are now aware of the positive effects of regular physical activity and have the intention to exercise. However, this intention is not sufficient and exercise plans are often not executed. This gap between intention and action is a challenge that health professionals need to address to counteract the pandemic of physical inactivity. Recent findings suggest that this inability to turn the intention into action is explained by negative automatic reactions to stimuli associated with physical activity. These automatic reactions could be particularly strong in older adults, who are more likely to associate physical activity with fear, pain, or discomfort. This study aims to test the effect of an intervention that targets the automatic processes underlying physical inactivity in older adults. The intervention is expected to reduce physical inactivity during the intervention and at follow-up, thereby improving physical functioning and quality of life.

Conditions
Aging
Being tested
Adjusted Cognitive-biased modification task, Cognitive-biased modification task
Keywords
Attentional Bias, Exercise, Sedentary Behavior
Medical subject headings
Motor Activity, Sedentary Behavior

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Adjusted Cognitive-biased modification taskBehavioural

    The intervention of the proposed project is based on a go/no-go task in which older adults need to quickly decide whether or not they should react to the stimulus. A rectangle containing an image, or a word will be presented on a screen. In the intervention group, older adults will be instructed to restrain their actions when the rectangle is tilted to the right and to react by pressing a key on the keyboard when the rectangle is tilted to the left, irrespective of the content of the rectangle (because the training is meant to be implicit). In order to train inhibitory processes counteracting the automatic attraction to sedentary behavior, 90% of the rectangles tilted to the right (counterbalanced across participants) will contain a picture or a word related to sedentary behavior. To foster the automatic attraction toward physical activity, 90% of the rectangles tilted to the left will contain a picture or a word related to physical activity.

  • Cognitive-biased modification taskBehavioural

    In the comparison group, instructions will be identical, but the percentage of physical activity and sedentary stimuli will be equal in each tilt condition (i.e., 50% sedentary stimuli and 50% physical activity stimuli in both right- and left-tilted rectangles)

Study groups in NCT05704660
Study groupRoleWhat they receive
Adjusted and modified Cognitive-Biased Modification TaskExperimentalThe intervention is based on a Go/No-Go task.
Receives: Behavioral: Adjusted Cognitive-biased modification task
Normal Cognitve-Biased modification TaskPlacebo comparatorThe Sham-intervention is based on a Go/No-Go task.
Receives: Behavioral: Cognitive-biased modification task

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Physical activity Tracker

    Assessing the number of step.

    Measured: "7 days", at least "7 hours" per day (not to used it during shower or when they sleep at night).

Secondary outcomes (6)
  1. International Physical Activity Questionnaire (Short Form)

    The usual level of moderate-to-vigorous physical activity in minutes per week will be assessed.

    Measured: Before and after intervention ("10 minutes" to fill out)

  2. Six-Minute Walk Test

    Total distance walked in "6 minutes" will be documented. The outcome is the distance walked during the "6 minutes".

    Measured: Before and after intervention ("6 minutes" to carry out)

  3. Hand grip strength

    The grip strength will be evaluated using a dynamometer. The higher the value obtained by the participant, the stronger the grip.

    Measured: Before and after intervention ( "One minute" to carry out)

  4. World Health Organization Quality of Life (BREF)

    Assessing quality of life over four domains. Scores for each domain can range from zero to 100, with higher scores indicating better quality of life.

    Measured: Before and after intervention ( "20 minutes" to carry out)

  5. Approach-avoidance task

    To measure automatic approach and avoidance tendencies toward physical activity and sedentary behaviors. Faster and the more accurate reaction toward a stimuli (e.g., physical activity) indicates a stronger tendency to approach that specific stimuli.

    Measured: Before and after intervention, and at the beginning of each intervention session ("30 minutes" to carry out)

  6. Explicit Affective Attitude Toward Physical Activity

    Mean of two items based on two "7-point" scales (unpleasant-pleasant; unenjoyable-enjoyable). A higher score indicates more positive attitudes toward physical activity.

    Measured: Before and after intervention ("2-5 minute" to carry out)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Jan 2023
  2. Study startSep 2023 (estimated)
  3. Primary completionSep 2024 (estimated)
  4. Study completionSep 2025 (estimated)

Resources

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
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
216 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05704660
Sponsor's protocol ID
H-09-22-8453
Status last verified
Jan 2023
First submitted
10 Jan 2023
Last updated
30 Jan 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Guthold R, Stevens GA, Riley LM, Bull FC. Worldwide trends in insufficient physical activity from 2001 to 2016: a pooled analysis of 358 population-based surveys with 1.9 million participants. Lancet Glob Health. 2018 Oct;6(10):e1077-e1086. doi: 10.1016/S2214-109X(18)30357-7. Epub 2018 Sep 4.

    PubMed 30193830
  • Kohl HW 3rd, Craig CL, Lambert EV, Inoue S, Alkandari JR, Leetongin G, Kahlmeier S; Lancet Physical Activity Series Working Group. The pandemic of physical inactivity: global action for public health. Lancet. 2012 Jul 21;380(9838):294-305. doi: 10.1016/S0140-6736(12)60898-8.

    PubMed 22818941
  • Cheval B, Boisgontier MP. The Theory of Effort Minimization in Physical Activity. Exerc Sport Sci Rev. 2021 Jul 1;49(3):168-178. doi: 10.1249/JES.0000000000000252.

    PubMed 34112744
  • Wiers RW, Eberl C, Rinck M, Becker ES, Lindenmeyer J. Retraining automatic action tendencies changes alcoholic patients' approach bias for alcohol and improves treatment outcome. Psychol Sci. 2011 Apr;22(4):490-7. doi: 10.1177/0956797611400615. Epub 2011 Mar 9.

    PubMed 21389338
  • Wittekind CE, Feist A, Schneider BC, Moritz S, Fritzsche A. The approach-avoidance task as an online intervention in cigarette smoking: a pilot study. J Behav Ther Exp Psychiatry. 2015 Mar;46:115-20. doi: 10.1016/j.jbtep.2014.08.006. Epub 2014 Sep 16.

    PubMed 25306247
  • Taylor CT, Amir N. Modifying automatic approach action tendencies in individuals with elevated social anxiety symptoms. Behav Res Ther. 2012 Sep;50(9):529-36. doi: 10.1016/j.brat.2012.05.004. Epub 2012 May 23.

    PubMed 22728645
  • Aulbach MB, Knittle K, Haukkala A. Implicit process interventions in eating behaviour: a meta-analysis examining mediators and moderators. Health Psychol Rev. 2019 Jun;13(2):179-208. doi: 10.1080/17437199.2019.1571933. Epub 2019 Feb 6.

    PubMed 30676235
  • Cheval B, Radel R, Neva JL, Boyd LA, Swinnen SP, Sander D, Boisgontier MP. Behavioral and Neural Evidence of the Rewarding Value of Exercise Behaviors: A Systematic Review. Sports Med. 2018 Jun;48(6):1389-1404. doi: 10.1007/s40279-018-0898-0.

    PubMed 29556981
  • Cheval B, Tipura E, Burra N, Frossard J, Chanal J, Orsholits D, Radel R, Boisgontier MP. Avoiding sedentary behaviors requires more cortical resources than avoiding physical activity: An EEG study. Neuropsychologia. 2018 Oct;119:68-80. doi: 10.1016/j.neuropsychologia.2018.07.029. Epub 2018 Jul 26.

    PubMed 30056055
  • Bull FC, Al-Ansari SS, Biddle S, Borodulin K, Buman MP, Cardon G, Carty C, Chaput JP, Chastin S, Chou R, Dempsey PC, DiPietro L, Ekelund U, Firth J, Friedenreich CM, Garcia L, Gichu M, Jago R, Katzmarzyk PT, Lambert E, Leitzmann M, Milton K, Ortega FB, Ranasinghe C, Stamatakis E, Tiedemann A, Troiano RP, van der Ploeg HP, Wari V, Willumsen JF. World Health Organization 2020 guidelines on physical activity and sedentary behaviour. Br J Sports Med. 2020 Dec;54(24):1451-1462. doi: 10.1136/bjsports-2020-102955.

    PubMed 33239350
  • Haseler C, Crooke R, Haseler T. Promoting physical activity to patients. BMJ. 2019 Sep 17;366:l5230. doi: 10.1136/bmj.l5230. No abstract available.

    PubMed 31530549
  • Rhodes RE, Dickau L. Experimental evidence for the intention-behavior relationship in the physical activity domain: a meta-analysis. Health Psychol. 2012 Nov;31(6):724-7. doi: 10.1037/a0027290. Epub 2012 Mar 5.

    PubMed 22390739
  • Calitri R, Lowe R, Eves FF, Bennett P. Associations between visual attention, implicit and explicit attitude and behaviour for physical activity. Psychol Health. 2009 Nov;24(9):1105-23. doi: 10.1080/08870440802245306.

    PubMed 20205048
  • Conroy DE, Hyde AL, Doerksen SE, Ribeiro NF. Implicit attitudes and explicit motivation prospectively predict physical activity. Ann Behav Med. 2010 May;39(2):112-8. doi: 10.1007/s12160-010-9161-0.

    PubMed 20140542
  • Cheval B, Sarrazin P, Isoard-Gautheur S, Radel R, Friese M. Reflective and impulsive processes explain (in)effectiveness of messages promoting physical activity: a randomized controlled trial. Health Psychol. 2015 Jan;34(1):10-9. doi: 10.1037/hea0000102. Epub 2014 Aug 18.

    PubMed 25133840

Questions about this trial

What is this clinical trial studying?

A study testing Adjusted Cognitive-biased modification task and Cognitive-biased modification task in people with Aging, run by University of Ottawa.

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 1 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 30 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Matthieu P. Boisgontier, PhD (6135625408, matthieu.boisgontier@uottawa.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Physical activity Tracker (time frame: "7 days", at least "7 hours" per day (not to used it during shower or when they sleep at night).). 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 NCT05704660, which also lists 15 linked publications.

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 2023.

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