Clinical trial NCT06843161: Robot-based Intervention to Improve Physical Activity in Older Adults
Official title: Retraining Automatic Attitudes Towards Physical Activity and Sedentary Behaviour in Adults 60 Years of Age or Older
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Physical Inactivity
Aging
Sedentary Behaviors
Bias, Implicit
Cognition
Lead sponsor: University of Ottawa
Sponsor class: OTHER
Collaborators: name: Banting Research Foundation
name: Mitacs
name: Perley Health
First posted: 2025-02-24
Enrollment: 40
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Physical inactivity is considered a global pandemic negatively impacting the health of over 60% of older adults in America. Interventions aimed at improving physical activity in older adults focus on training reflective processes such as providing information on health benefits of physical activity. These interventions generally find that participants improved their intentions to be physically active rather than supporting actual change in behaviours to become physically active.

There is growing support for the idea that human behaviour is the result of a combination of quick automatic processes and slower reflective processes. Interventional studies have used cognitive bias modification tasks that target the quick automatic processes to retrain participant's bias. Such studies find that participant's bias towards diet, alcohol, and phobias can be altered using these cognitive bias modification tasks.

In this study, the investigators developed a new training task using a robotic device that aims to retrain automatic bias towards physical activity and sedentary behaviours. The robotic device allows greater immersive environments for participants to interact with and be more engaged with the cognitive bias modification task. This interventional study is testing whether this new robot-based training and the protocol for assessing physical activity is feasible for retraining older adults' bias towards physical activity and sedentary behaviour. Participants will be examined on their daily physical activity using an accelerometer, their physical ability using functional tests, and their perceptions on physical activity using questionnaires. To determine whether this protocol is feasible, the investigators will examine participant recruitment and retention rates.

Detailed description: Over the past two decades, society has encouraged people to be more physically active. As a result, most individuals are now aware of the positive effects of regular physical activity and have the intention to exercise. Yet, this intention is not sufficient, as exercise plans are often not executed. Despite gradually scaling up actions that promote physical activity over the years, people are actually becoming less active. From 2010 to 2016, the number of inactive adults has increased by 5% worldwide, currently affecting more than 1 in 4 adults (1.4 billion people). This gap between intention and action is a challenge that health professionals need to address in order to counteract the pandemic of physical inactivity.

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 across several physiological systems. Physical activity can reduce and delay the impact of this age-related deterioration in health and functional independence. However, in the Americas, more than 60% of older adults are physically inactive.

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. From this perspective, changing conscious goals should lead to substantial behavioural change. Yet, meta-analyses indicate that these interventions are more effective in changing intentions than actual behaviour. Thus, new interventions targeting alternative processes are necessary to explore.

Recent work highlights that engagement in physical activity is governed not only by reflective processes, but also by automatic processes acting outside conscious awareness. For example, in active individuals, stimuli associated with physical activity attract attention, trigger positive affective reactions, and activate approach tendencies. These automatic reactions are thought to facilitate the translation of intention into action. From this perspective, physical inactivity is the result of an imbalance between strong negative automatic reactions to stimuli associated with physical activity and a relatively weaker intention to be physically active. This imbalance between reflective and automatic processes can be particularly pronounced in older adults, who are more likely to spontaneously associate physical activity with fear, pain, or discomfort felt during physical exercise. Therefore, older adults could be particularly responsive to and benefit the most from an intervention targeting the automatic reactions to physical activity and sedentary stimuli.

Interventions targeting automatic reactions to health-related stimuli have already proven to be successful in changing behaviour. For example, interventions have been used to retrain the automatic reaction to alcohol. Using a joystick, patients were repeatedly asked to avoid pictures on a screen that were related to alcohol and to approach pictures unrelated to alcohol. Results showed that adding to a regular treatment an intervention targeting cognitive bias reduced the relapse rates one year after treatment discharge by 9% to 13%. These interventions have also proven to be useful in impacting smoking, social anxiety, and eating behaviour.

Eligibility criteria: Inclusion Criteria:

* 60 years of age or older
* Able to walk
* Able to communicate in English
* Able to travel to the University of Ottawa Lees Campus

Exclusion Criteria:

* Diagnosed neurological or psychiatric disorder
* Impaired motor function of the upper limbs
* Unable to understand task instructions

Primary outcomes:
measure: Determinants of Protocol Feasibility: Recruitment Rate and Retention Rate
timeFrame: From enrollment to the end of recruitment at 7 months
Secondary outcomes:
measure: Actigraph wGT3X-BT accelerometers for measuring daily step count
timeFrame: From enrollment to the end of recruitment at 7 months
measure: Approach Avoidance Task
timeFrame: From enrollment to the end of recruitment at 7 months
measure: 6 Minute Walk Test
timeFrame: From enrollment to the end of recruitment at 7 months
measure: Hand Dynamometer for Grip Strength
timeFrame: From enrollment to the end of recruitment at 7 months
measure: World Health Organization Quality of Life Questionnaire (WHOQOL)
timeFrame: From enrollment to the end of recruitment at 7 months
measure: Affective and Instrumental Attitude Scale (ASIS)
timeFrame: From enrollment to the end of recruitment at 7 months
measure: Physical Effort Scale (PES)
timeFrame: From enrollment to the end of recruitment at 7 months
Other outcomes:
Locations:
city: Ottawa
country: Canada
facility: Faculty of Health Sciences
state: Ontario
Study officials:
affiliation: University of Ottawa
name: Kayne Park, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Ottawa
name: Matthieu P Boisgontier, PhD
role: PRINCIPAL_INVESTIGATOR
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