Piloting an Online Integrated Behaviour Change and Physical Activity Program

Physical Activity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05453149
• Other study ID #: 121214
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 2022
• Est. completion date: December 2022

Study information

• Verified date: July 2022
• Source: Lawson Health Research Institute
• Contact: Swati Mehta, PhD
• Phone: 519-685-8500
• Email: swati.mehta[@]sjhc.london.on.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: December 2022
• Est. primary completion date: December 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Nervous System Diseases
• Neurological Disorder
• Physical Activity

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Lawson Health Research Institute

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Change in Physical Activity	Physical Activity scale for individuals with physical disabilities (PASIPD)	baseline, 10 weeks, 3 months
Primary	Change in Life Participation	NeuroQoL ability to participate; NeuroQoL satisfaction with participation	baseline, 10 weeks, 3 months
Primary	Change in health behaviour	Scale for assessment of implementation planning and coping planning	baseline, 10 weeks, 3 months
Primary	Change in fear of falls	Falls Efficacy Scale - International	baseline, 10 weeks, 3 months
Primary	Change in exercise expectations	Outcome Expectations for Exercise scale	baseline, 10 weeks, 3 months
Primary	Change in Mood	PHQ9	baseline, 10 weeks, 3 months
Primary	Change in Anxiety	GAD7	baseline, 10 weeks, 3 months
Primary	Change in personality	BFI/AAQ	baseline, 10 weeks, 3 months