Piloting an Online Integrated Behaviour Change and Physical Activity Program

Piloting an Online Integrated Behaviour Change and Physical Activity Program for Those With Neurological Conditions

There is a significant disparity in access to physical activity programs for people with mobility impairments, which greatly impacts mobility, function and long-term wellbeing. This study will test an online, group-based intervention consisting of exercise and behaviour activation strategies targeting these and other outcomes. Importantly, this programming will be applied to patient groups across several clinical programs at Parkwood Institute.

Study Overview

• Status: Not yet recruiting
• Conditions: Physical Activity; Neurological Disorder; Behavioural Change Intervention
• Intervention / Treatment: Behavioral: Integrated Physical Activity and Behavioural Change Intervention

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 18 years of age and over
• Neurological condition (i.e., brain injury, stroke)
• Completed rehabilitation and living in the community
• Participants must have some upper limb function permitting arm movement against gravity
• Physician clearance to participate in the study.

Exclusion Criteria:

• Not cleared by a physician.
• Not able to move upper limbs against gravity.
• No internet access.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Persons with Neurological Conditions

Behavioral: Integrated Physical Activity and Behavioural Change Intervention; Physical Activity (PA) Component: A group-based PA program geared to the level of injury and mobility delivered through web conferencing software. Participants select at three sessions weekly over 10 weeks. Sessions include 45 mins of exercise (i.e boxercise; aerobics; yoga) and 15 mins of social interaction with the group. Behavioural Change Component: Participants will also receive synchronous 1:1 sessions (approximately 20 mins/week) with a trained clinician on behavioural strategies to initiate and maintain engagement in PA over the 10-week period. Content of the sessions includes: providing information on PA and the self-management of impairments and related symptoms; evaluating barriers to engagement (e.g. fear of injury); and behavioural strategies.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Self Efficacy	Self-Efficacy for Managing Chronic Disease 6-item Scale; Scale for the assessement of phase-specific self-efficacy of physical activity	baseline, 10 weeks, 3 months
Change in Physical Activity	Physical Activity scale for individuals with physical disabilities (PASIPD)	baseline, 10 weeks, 3 months
Change in Life Participation	NeuroQoL ability to participate; NeuroQoL satisfaction with participation	baseline, 10 weeks, 3 months
Change in health behaviour	Scale for assessment of implementation planning and coping planning	baseline, 10 weeks, 3 months
Change in fear of falls	Falls Efficacy Scale - International	baseline, 10 weeks, 3 months
Change in exercise expectations	Outcome Expectations for Exercise scale	baseline, 10 weeks, 3 months
Change in Mood	PHQ9	baseline, 10 weeks, 3 months
Change in Anxiety	GAD7	baseline, 10 weeks, 3 months
Change in personality	BFI/AAQ	baseline, 10 weeks, 3 months

Collaborators and Investigators

• Sponsor: Lawson Health Research Institute

Study record dates

Study Major Dates

• Study Start (Anticipated): August 1, 2022
• Primary Completion (Anticipated): December 1, 2022
• Study Completion (Anticipated): December 1, 2022

Study Registration Dates

• First Submitted: July 7, 2022
• First Submitted That Met QC Criteria: July 7, 2022
• First Posted (Actual): July 12, 2022

Study Record Updates

• Last Update Posted (Actual): July 12, 2022
• Last Update Submitted That Met QC Criteria: July 7, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases
• Other Study ID Numbers: 121214

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No