Piloting an Online Integrated Behaviour Change and Physical Activity Program

• Sponsor: Lawson Health Research Institute (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05453149
• Collaborator: (none)
• Enrollment: 20
• Arm: 1
• Anticipated Duration (Months): 4

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Neurological Disorder; Behavioural Change Intervention; Physical Activity	Behavioral: Integrated Physical Activity and Behavioural Change Intervention	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 20 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: Piloting an Online Integrated Behaviour Change and Physical Activity Program for Those With Neurological Conditions
• Anticipated Study Start Date: Aug 1, 2022
• Anticipated Primary Completion Date: Dec 1, 2022
• Anticipated Study Completion Date: Dec 1, 2022

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Change in Self Efficacy [baseline, 10 weeks, 3 months]

   Self-Efficacy for Managing Chronic Disease 6-item Scale; Scale for the assessement of phase-specific self-efficacy of physical activity

2. Change in Physical Activity [baseline, 10 weeks, 3 months]

   Physical Activity scale for individuals with physical disabilities (PASIPD)

3. Change in Life Participation [baseline, 10 weeks, 3 months]

   NeuroQoL ability to participate; NeuroQoL satisfaction with participation

4. Change in health behaviour [baseline, 10 weeks, 3 months]

   Scale for assessment of implementation planning and coping planning

5. Change in fear of falls [baseline, 10 weeks, 3 months]

   Falls Efficacy Scale - International

6. Change in exercise expectations [baseline, 10 weeks, 3 months]

   Outcome Expectations for Exercise scale

7. Change in Mood [baseline, 10 weeks, 3 months]

   PHQ9

8. Change in Anxiety [baseline, 10 weeks, 3 months]

   GAD7

9. Change in personality [baseline, 10 weeks, 3 months]

   BFI/AAQ

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Lawson Health Research Institute

Investigators

• Principal Investigator: Swati Mehta, PhD, Lawson Health Research Institute

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Lawson Health Research Institute
• ClinicalTrials.gov Identifier: NCT05453149
• Other Study ID Numbers: 121214
• First Posted: Jul 12, 2022
• Last Update Posted: Jul 12, 2022
• Last Verified: Jul 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Nervous System Diseases

Study Results

No Results Posted as of Jul 12, 2022