Implementation of the ProACTIVE Toolkit in the Hospital and Community Setting

NCT04493606 | Unknown DMC

• 1 other identifier: ProACTIVE Implementation
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief Summary

There is a significant drop in physical activity among people with spinal cord injury in the months following discharge from rehabilitation. The ProACTIVE toolkit is a guide to promote physical activity to clients with spinal cord injury that has demonstrated potential to help address this sensitive time frame for physical inactivity. The toolkit was co- developed with 300 physiotherapists, community members with spinal cord injury, and university researchers and has been shown to improve physical activity and fitness in this population. Physiotherapists will refer clients to peer coaches with spinal cord injury who will implement the toolkit. The investigators will assess how well the toolkit is used and its effectiveness to improve physical activity levels.

Conditions

Spinal Cord Injuries

Outcome Measures

Primary Outcomes (1)

• Change from Baseline in Leisure Time Physical Activity at 1 month, 6 months, and 1 year

  Measures include the Leisure Time Physical Activity Questionnaire for People with SCI, which is a self-report measure that assesses minutes of mild, moderate, and vigorous intensity leisure time physical activity (i.e., activity that requires physical exertion and that one chooses to do in their free time) that is broken down into strength training and aerobic activity performed over the past seven days. Lower scores reflect less participation in leisure time physical activity. Support for the Leisure Time Physical Activity Questionnaire's criterion validity and test-retest reliability has been previously demonstrated in a sample of 103 men and women with SCI.

  Baseline, 1 month, 6 month, 1 year

Secondary Outcomes (1)

• Psychosocial predictors of physical activity

  Baseline, 1 month, 6 month, 1 year

Other Outcomes (3)

• Determinants of implementation behaviour for interventionists

  Baseline, 1 month, 6 month, 1 year

• Semi-structured interviews- interventionists

  6 months

• Semi-structured interviews- Patients

  1 year

Study Arms (2)

Intervention Patients

EXPERIMENTAL

SCI patients receiving the physical activity coaching (Objective 1)

Other: SCI ProACTIVE Coaching (objective 1)

Intervention- Interventionists

EXPERIMENTAL

Interventionists receiving physical activity coaching training (Objective 2)

Behavioral: Implementation Intervention (objective 2)

Interventions

SCI ProACTIVE Coaching (objective 1) OTHER

Peer coaches will conduct an assessment to understand patient's readiness, goals, barriers, preferences, and access to physical activity resources and mutually select tailored physical activity-enhancing strategies based on the assessment. These strategies include education (SCI exercise guidelines, safety, benefits, basics of physical activity, behaviour change techniques) and referral to appropriate peers, programs, and organizations. Goals will be based on the SCI Fitness Guidelines (targeting a goal of 20min of moderate to vigorous intensity aerobic exercise + 3 sets of strength training exercises for each major functioning muscle group at a moderate to vigorous intensity each 2x/week) and if ready, the Canadian SCI Physical Activity Guidelines (30 min 3x/week of moderate to vigorous intensity aerobic exercise + strength training 2x/ week). Ten 15-minute, video-conference or telephone sessions will be scheduled in accordance with patient needs and readiness with the peer coaches.

Intervention Patients

Implementation Intervention (objective 2) BEHAVIORAL

A training on how to deliver the ProACTIVE intervention will be delivered. Day 1 training will include an overview of the intervention, demonstration of the delivery of the intervention, and behavioural practice. Interventionists will practice delivering the intervention and record issues or questions to bring to the day 2 training. Day 2 training will include a refresher on intervention content, barriers identified during in-clinic/community practice will be addressed, and further behavioural practice with volunteer clients with additional feedback provided. The trainer (Dr. Jasmin Ma) will provide monitoring and feedback during the first two months of implementation. Community of practice meetings will be held as needed to discuss challenges and facilitators to implementation. Feedback provided during community of practice meetings will be collected and used for iterative quality improvement of the intervention approaches.

Intervention- Interventionists

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• traumatic or non-traumatic spinal cord injury
• do not require ventilatory assistance, and
• have no medical contraindications to exercise identified by the care team

You may not qualify if:

• Uncontrolled symptoms of cardiovascular disease or cardiopulmonary problems/disease.
• Active Stage 3 or 4 pressure ulcer (based on the National Pressure Ulcer Advisory Panel classification)
• Any unstable medical/psychiatric condition or substance abuse disorder that is likely to affect their ability to complete this study.- Any cognitive dysfunction or language barrier that would prevent subjects from following English instructions.
• Participants may be excluded at the discretion of the principal investigator due to other, unforeseen, safety issues.

Sponsors & Collaborators

• University of British Columbia: lead
• Rick Hansen Institute: collaborator

Study Sites (1)

GF Strong Rehabilitation Hospital

Vancouver, British Columbia, V5Z 2G9, Canada

Location

Related Publications (12)

• Bandura, A. (1997). Self-efficacy: The Exercise of Control. New York: W.H. Freeman & Co.

  BACKGROUND

• Brawley LR, Arbour-Nicitopoulos KP, Martin Ginis KA. Developing physical activity interventions for adults with spinal cord injury. Part 3: a pilot feasibility study of an intervention to increase self-managed physical activity. Rehabil Psychol. 2013 Aug;58(3):316-21. doi: 10.1037/a0032814.

  PMID: 23978087 BACKGROUND

• Caspersen CJ, Powell KE, Christenson GM. Physical activity, exercise, and physical fitness: definitions and distinctions for health-related research. Public Health Rep. 1985 Mar-Apr;100(2):126-31.

  PMID: 3920711 BACKGROUND

• Cowan RE, Nash MS, Anderson KD. Exercise participation barrier prevalence and association with exercise participation status in individuals with spinal cord injury. Spinal Cord. 2013 Jan;51(1):27-32. doi: 10.1038/sc.2012.53. Epub 2012 May 15.

  PMID: 22584283 BACKGROUND

• Ma JK, Cheifetz O, Todd KR, Chebaro C, Phang SH, Shaw RB, Whaley KJ, Martin Ginis KA. Co-development of a physiotherapist-delivered physical activity intervention for adults with spinal cord injury. Spinal Cord. 2020 Jul;58(7):778-786. doi: 10.1038/s41393-020-0422-x. Epub 2020 Jan 22.

  PMID: 31969687 BACKGROUND

• Ginis KA, Hicks AL, Latimer AE, Warburton DE, Bourne C, Ditor DS, Goodwin DL, Hayes KC, McCartney N, McIlraith A, Pomerleau P, Smith K, Stone JA, Wolfe DL. The development of evidence-informed physical activity guidelines for adults with spinal cord injury. Spinal Cord. 2011 Nov;49(11):1088-96. doi: 10.1038/sc.2011.63. Epub 2011 Jun 7.

  PMID: 21647164 BACKGROUND

• Martin Ginis KA, Phang SH, Latimer AE, Arbour-Nicitopoulos KP. Reliability and validity tests of the leisure time physical activity questionnaire for people with spinal cord injury. Arch Phys Med Rehabil. 2012 Apr;93(4):677-82. doi: 10.1016/j.apmr.2011.11.005. Epub 2012 Feb 13.

  PMID: 22336103 BACKGROUND

• Sallis JF, Grossman RM, Pinski RB, Patterson TL, Nader PR. The development of scales to measure social support for diet and exercise behaviors. Prev Med. 1987 Nov;16(6):825-36. doi: 10.1016/0091-7435(87)90022-3.

  PMID: 3432232 BACKGROUND

• Scholz, U., Sniehotta, F. F., & Schwarzer, R. (2005). Predicting physical exercise in cardiac rehabilitation: The role of phase-specific self-efficacy beliefs. Journal of Sport and Exercise Psychology, 27(2), 135-151

  BACKGROUND

• Schwarzer R, Lippke S, Luszczynska A. Mechanisms of health behavior change in persons with chronic illness or disability: the Health Action Process Approach (HAPA). Rehabil Psychol. 2011 Aug;56(3):161-70. doi: 10.1037/a0024509.

  PMID: 21767036 BACKGROUND

• Sniehotta, F. F., Scholz, U., & Schwarzer, R. (2005). Bridging the intention-behaviour gap: Planning, self-efficacy, and action control in the adoption and maintenance of physical exercise. Psychology & Health, 20(2), 143-160. https://doi.org/10.1080/08870440512331317670

  BACKGROUND

• Ma JK, Walden K, McBride CB, Le Cornu Levett C, Colistro R, Plashkes T, Thorson T, Shu H, Martin Ginis KA. Implementation of the spinal cord injury exercise guidelines in the hospital and community settings: Protocol for a type II hybrid trial. Spinal Cord. 2022 Jan;60(1):53-57. doi: 10.1038/s41393-021-00685-7. Epub 2021 Aug 10.

  PMID: 34376809 DERIVED

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Kathleen Martin Ginis, PhD

  University of British Columbia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 10, 2020
• First Posted: July 30, 2020
• Study Start: November 19, 2020
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: April 27, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)