NCT05704660

Brief 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. 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
216

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2023

Typical duration for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 10, 2023

Completed
20 days until next milestone

First Posted

Study publicly available on registry

January 30, 2023

Completed
7 months until next milestone

Study Start

First participant enrolled

September 1, 2023

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2024

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2025

Completed
Last Updated

January 30, 2023

Status Verified

January 1, 2023

Enrollment Period

1 year

First QC Date

January 10, 2023

Last Update Submit

January 26, 2023

Conditions

Keywords

Attentional BiasExerciseSedentary Behavior

Outcome Measures

Primary Outcomes (1)

  • Physical activity Tracker

    Assessing the number of step.

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

Secondary Outcomes (6)

  • International Physical Activity Questionnaire (Short Form)

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

  • Six-Minute Walk Test

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

  • Hand grip strength

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

  • World Health Organization Quality of Life (BREF)

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

  • Approach-avoidance task

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

  • +1 more secondary outcomes

Study Arms (2)

Adjusted and modified Cognitive-Biased Modification Task

EXPERIMENTAL

The intervention is based on a Go/No-Go task.

Behavioral: Adjusted Cognitive-biased modification task

Normal Cognitve-Biased modification Task

PLACEBO COMPARATOR

The Sham-intervention is based on a Go/No-Go task.

Behavioral: Cognitive-biased modification task

Interventions

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.

Adjusted and modified Cognitive-Biased Modification Task

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)

Normal Cognitve-Biased modification Task

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (15)

  • 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.

    PMID: 30193830BACKGROUND
  • 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.

    PMID: 22818941BACKGROUND
  • 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.

    PMID: 34112744BACKGROUND
  • 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.

    PMID: 21389338BACKGROUND
  • 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.

    PMID: 25306247BACKGROUND
  • 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.

    PMID: 22728645BACKGROUND
  • 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.

    PMID: 30676235BACKGROUND
  • 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.

    PMID: 29556981BACKGROUND
  • 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.

    PMID: 30056055BACKGROUND
  • 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.

    PMID: 33239350BACKGROUND
  • 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.

    PMID: 31530549BACKGROUND
  • 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.

    PMID: 22390739BACKGROUND
  • 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.

    PMID: 20205048BACKGROUND
  • 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.

    PMID: 20140542BACKGROUND
  • 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.

    PMID: 25133840BACKGROUND

MeSH Terms

Conditions

Motor ActivitySedentary Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Matthieu P Boisgontier, PhD

    University of Ottawa

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Matthieu P. Boisgontier, PhD

CONTACT

Ataallah Farajzadeh, MSc

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
Participants and research assistant will be blinded to the groups' allocation. The participant blinding success will be appraised by asking them to guess in what group there were at the trial termination. Besides, the research assistant blinding success will be appraised via detecting the group allocation (Experimental vs. Control) by research assistant at the end of data collection phase. The randomization will be generated on a computer and an independent coworker will carry out the randomization. The participant's identification number will be used to determine the sequence of randomization. Participants will be randomized in a 1:1 ratio between the intervention and active control condition.
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 10, 2023

First Posted

January 30, 2023

Study Start

September 1, 2023

Primary Completion

September 1, 2024

Study Completion

September 1, 2025

Last Updated

January 30, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share