Robot-based Intervention to Improve Physical Activity in Older Adults

February 27, 2025 updated by: Kayne Park, University of Ottawa

Retraining Automatic Attitudes Towards Physical Activity and Sedentary Behaviour in Adults 60 Years of Age or Older

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.

Study Overview

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.

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

    • Ontario
      • Ottawa, Ontario, Canada, K1S5S9
        • Recruiting
        • Faculty of Health Sciences
        • Contact:
        • Contact:
        • Contact:
          • Kayne Park, PhD
        • Contact:
          • Matthieu Boisgontier, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Interventional Group: Responses Biased towards Visual Stimulus
Successfully recruited individuals will be performing the JOGGNG Task on the Kinarm Endpoint Laboratory. This task requires participants to quickly make a reaching movement to manipulate a virtual avatar that is jogging across a field. During this, a frisbee will move towards the avatar and will tilt clockwise or counterclockwise. Participants have been instructed to either reach quickly to grab the frisbee from the air during clockwise tilts or to not move during counterclockwise tilts. This tilt/movement associated is reversed to control for potential bias in tilt angle and movement. An image of physical activity or sedentary behaviour will appear inside of the frisbee but participants are not told that it is associated with any of the tilts. For the Interventional Group, the tilt associated with movement will have an image of physical activity appear 90% of the time and the tilt associated with no movement will have an image of sedentary behaviour 90% of the time.
Recruited participants will be performing the JOGGNG Task on the Kinarm Endpoint Laboratory. This task requires participants to control a robotic handle to manipulate a virtual avatar that looks as if it is jogging across a field. During the jogging, a frisbee will appear and quickly move towards the avatar, eventually tilting clockwise or counterclockwise. Participants are required to either reach quickly to grab the frisbee from the air during clockwise tilts or to not move during counterclockwise tilts. This tilt/movement associated is reversed to control for a potential bias in tilt angle and movement. An image of physical activity or sedentary behaviour will appear inside of the frisbee but participants are not told that it is associated with any of the tilts. Each trial consists of one frisbee and participants will complete a total of 3 blocks of 360 trials each which will take approximately 30 minutes to complete.
Sham Comparator: Control Group: Responses Randomly Assigned to Visual Stimulus
Recruited participants will be performing the JOGGNG Task on the Kinarm Endpoint Laboratory. This task requires participants to quickly make a reaching movement to manipulate a virtual avatar that is jogging across a field. During this, a frisbee will move towards the avatar and will tilt clockwise or counterclockwise. Participants have been instructed to either reach quickly to grab the frisbee from the air during clockwise tilts or to not move during counterclockwise tilts. This tilt/movement associated is reversed to control for potential bias in tilt angle and movement. An image of physical activity or sedentary behaviour will appear inside of the frisbee but participants are not told that it is associated with any of the tilts. For the Control Group, the tilt associated with movement will have an image of physical activity appear 50% of the time and the tilt associated with no movement will have an image of sedentary behaviour 50% of the time.
Recruited participants will be performing the JOGGNG Task on the Kinarm Endpoint Laboratory. This task requires participants to control a robotic handle to manipulate a virtual avatar that looks as if it is jogging across a field. During the jogging, a frisbee will appear and quickly move towards the avatar, eventually tilting clockwise or counterclockwise. Participants are required to either reach quickly to grab the frisbee from the air during clockwise tilts or to not move during counterclockwise tilts. This tilt/movement associated is reversed to control for a potential bias in tilt angle and movement. An image of physical activity or sedentary behaviour will appear inside of the frisbee but participants are not told that it is associated with any of the tilts. Each trial consists of one frisbee and participants will complete a total of 3 blocks of 360 trials each which will take approximately 30 minutes to complete.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Determinants of Protocol Feasibility: Recruitment Rate and Retention Rate
Time Frame: From enrollment to the end of recruitment at 7 months
The main purpose of this study is to determine whether the intervention protocol is feasible and thus the primary outcomes are recruitment rates, retention rates, and reasons for study dropout.
From enrollment to the end of recruitment at 7 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Actigraph wGT3X-BT accelerometers for measuring daily step count
Time Frame: From enrollment to the end of recruitment at 7 months
Participants will wear the a small research grade accelerometer on their right hip with support hardware supplied by the researchers to measure their daily step count. As a key measure of physical activity, this device will be worn for 1 week before intervention, after intervention, and once more 1 month after the intervention.
From enrollment to the end of recruitment at 7 months
Approach Avoidance Task
Time Frame: From enrollment to the end of recruitment at 7 months
The manikin approach avoidance task has been previously used to determine automatic attitudes towards physical activity and sedentary behaviour. It is a laptop-based task where participants move an avatar towards or away from an image of physical activity or sedentary behaviour. The task measures the reaction time that participants respond to each image type to determine whether they have biased tendencies towards a certain image.
From enrollment to the end of recruitment at 7 months
6 Minute Walk Test
Time Frame: From enrollment to the end of recruitment at 7 months
The 6 Minute Walk Test is a common measure to assess walking ability. The test is conducted by having the participant walk as far as possible on a 30m flat indoor course for a period of 6 minutes. Standardized encouragement will be provided at each minute. Total distance walked (meters) in 6 minutes will be documented. The major outcome is the distance walked during the 6 minutes.
From enrollment to the end of recruitment at 7 months
Hand Dynamometer for Grip Strength
Time Frame: From enrollment to the end of recruitment at 7 months
Grip strength will be assessed with the JAMAR Hand Dynamometer. Participants will perform the test using their reported dominant hand in a seated position with their elbow flexed 90 degrees. Two tests would be performed by each participant and the higher value (Kilogram*Force) will be recorded as hand grip strength.
From enrollment to the end of recruitment at 7 months
World Health Organization Quality of Life Questionnaire (WHOQOL)
Time Frame: From enrollment to the end of recruitment at 7 months
The scale assesses quality of life (QoL) over four domains: Physical Health (seven items), Psychological Health (six items), Social Relationships (three items), and Environmental Health (eight items). Scores for each item can range from one to five with higher scores indicating better QoL.
From enrollment to the end of recruitment at 7 months
Physical Effort Scale (PES)
Time Frame: From enrollment to the end of recruitment at 7 months
This questionnaire asks about the participant's perceptions about physical effort, which is usually associated with increased heart rate and breathing. It consists of eight items ranging from one to five with higher scores indicating greater agreement.
From enrollment to the end of recruitment at 7 months
Affective and Instrumental Attitude Scale (ASIS)
Time Frame: From enrollment to the end of recruitment at 7 months
This scale assesses participants' attitudes towards physical activity. It has four questions scored from one to seven assessing affective and instrumental attitudes. Scores nearer 1 indicate less affective/instrumental attitudes while scores nearer 7 indicate greater affective/instrumental attitudes.
From enrollment to the end of recruitment at 7 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Matthieu P Boisgontier, PhD, University of Ottawa
  • Principal Investigator: Kayne Park, PhD, University of Ottawa

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 1, 2025

Primary Completion (Estimated)

September 30, 2025

Study Completion (Estimated)

September 30, 2025

Study Registration Dates

First Submitted

February 7, 2025

First Submitted That Met QC Criteria

February 18, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 27, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • H-01-25-11168

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All data from participants that were included in the final study report will be shared on an online repository.

IPD Sharing Time Frame

The IPD and supporting information will be available for an indefinite time on an online repository once the data collection is complete.

IPD Sharing Access Criteria

All data of participants with full datasets collected in this study will be accessible after the data collection has completed.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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