Spinal Cord InjuriesNCT04493606
Implementation of the ProACTIVE Toolkit in the Hospital and Community Setting
A study testing SCI ProACTIVE Coaching (objective 1) and Implementation Intervention (objective 2) in people with Spinal Cord Injuries, run by University of British Columbia at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Spinal Cord Injuries
- What is being tested?
- SCI ProACTIVE Coaching (objective 1) and Implementation Intervention (objective 2)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteCanada
- Study dates
- 19 Nov 2020to Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- traumatic or non-traumatic spinal cord injury
- do not require ventilatory assistance, and
- have no medical contraindications to exercise identified by the care team
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Canada1 site
GF Strong Rehabilitation Hospital
Vancouver, British Columbia, V5Z 2G9
About this study
Official title: Implementation of the ProACTIVE Toolkit in the Hospital and Community Setting to Improve Physical Activity Among People With Spinal Cord Injury
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.
Read the detailed description
Purpose 1 (arms 1 and 2): To evaluate the effect of referral to peer-led coaching, guided by the ProACTIVE SCI intervention, on physical activity behaviour, health, and quality of life outcomes among people with SCI.
Procedure overview: Participants will complete survey measures (~45 minutes) at baseline/discharge, 2 months, 6 months post discharge, and 1-year follow-up. Participants will also complete a semi-structured interview to assess satisfaction with the intervention at 6 months. Participants in the intervention group will receive an initial assessment (~1 hour) and 10 physical activity coaching sessions (~15 minutes each). A total time commitment of ~6.5 hours is expected over one year.
Design: For pragmatic and ethical reasons, single-group, repeated measures design will be used where interested participants will receive the intervention.
Procedure: Patients who are interested in participating will be enrolled in the intervention and will receive the ProACTIVE SCI intervention coaching. Patients who are not interested in participating will be re-contacted before discharge and/or at 3 months post-discharge to gauge interest. For those who consent during their hospital stay, a two-page quick-sheet will be filled out at discharge to record any physical activity coaching information collected during their hospital stay as part of usual care. (Please see Section 9 for the "GF Strong inpatient/ form" and "GF Strong outpatient form" that is currently used in practice). The quick-sheet and any exercise prescriptions developed will be transferred to the SCI BC peers. If possible, SCI BC peers will contact the client in-person or over video-conference before discharge to begin coaching, otherwise SCI BC peers will contact the patient to begin coaching sessions in the community post-discharge. SCI BC peers will carry out the physical activity coaching sessions guided by the ProACTIVE SCI intervention with the exception that exercise prescriptions cannot be made by the peers. If exercise prescriptions are needed, referral to an adapted personal trainer in the community will be made. Coaching sessions will be provided either in-person, using video teleconferencing technology or telephone if needed. Ten 15-minute sessions will be scheduled in accordance with patient needs and readiness, however, as a general structure, one coaching session will be provided each month for months 1-3, two coaching sessions per month in months 4-6, with a follow-up before one year. The peer coaches will make up to 5 attempts to reschedule a missed coaching session.
Sample size estimate: Based on feasibility estimates calculated using number of patients admitted yearly to GF Strong (n=100), an estimated 70% discharged to home (n=70; remaining 30% discharged to long-term care or other), approximately 55% of patients willing to consent over the 3 month follow-up period, and a 20% dropout estimate (based on previous experience in conducting studies in this population) an estimated n=30 individuals will be recruited to the intervention group (see Figure 2).
To ensure the sample size based on feasibility is adequately powered to detect an effect on physical activity, the investigators conducted a power calculation based on a previous randomized controlled trial in the in-patient setting with individuals with spinal cord injury. Physiotherapists delivered a bi-weekly behavioural coaching intervention to 39 individuals with SCI and physical activity was assessed at baseline, discharge, 6-months, and one-year post-discharge. A large-sized effect was observed at 6 months (d=0.89) for self-reported physical activity. Given the quasi-experimental design, the investigators are powering for a more modest between groups difference (d = .75). Eight participants/condition (N = 16) are needed to yield a significant effect of this magnitude in a repeated measures ANOVA, with β = .80 and α = .05. Thus, the feasibility-based projected sample size is adequate to detect a significant effect of the intervention on physical activity in this context.
Statistical Analysis: One-way repeated measures ANOVA
Purpose 2 (arm 3): Evaluate, understand, and document the implementation process of physiotherapists and peers with SCI delivering the ProACTIVE SCI intervention
Procedure overview: Clinicians and SCI BC Peers will receive a two-day training (2 hours each day) on how to deliver the ProACTIVE intervention. Clinicians and SCI BC Peers will be supported with monitoring and feedback for the first two months of delivering the intervention to clients and community of practice meetings as needed. 20-minute surveys will be administered before and immediately after training, as well as at 2 months and 6 months after starting implementation. One-hour semi-structured interviews will be conducted at 6 months. A total time commitment of ~18.5 hours is expected over one year for the clinicians. SCI BC Peers will deliver 10x15 minute coaching sessions to ~ 10 participants each for a total time commitment of 43.5 hours over one year.
Design: Within-subject, repeated measures.
Participants: As the aim of this project is to deliver the intervention using a pragmatic approach, volunteer physiotherapists from GF Strong and SCI BC peer coordinators who are interested in delivering the ProACTIVE SCI intervention will be included in this objective.
Sample size estimate: The study is powered to detect a significant within-subject effect over time on the theoretical domains framework (TDF) measures. A previous evaluation of the ProACTIVE implementation training amongst physiotherapists, when using within subject pre-post analyses, demonstrated a very large effect size across TDF outcomes (f=.867). A minimum of five participants are needed to yield a significant effect of this magnitude in a within-subject, repeated measures ANOVA (4 time points), with β = .80, α = .05, and a conservative 0.25 correlation among repeated measures.
Statistical Analysis: One-way repeated measure ANOVA.
- Conditions
- Spinal Cord Injuries
- Being tested
- SCI ProACTIVE Coaching (objective 1), Implementation Intervention (objective 2)
- Medical subject headings
- Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
Implementation Intervention (objective 2)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Patients | Experimental | SCI patients receiving the physical activity coaching (Objective 1) Receives: Other: SCI ProACTIVE Coaching (objective 1) |
| Intervention- Interventionists | Experimental | Interventionists receiving physical activity coaching training (Objective 2) Receives: Behavioral: Implementation Intervention (objective 2) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 1 month, 6 month, 1 year
Secondary outcomes (1)
Psychosocial predictors of physical activity
Psychosocial predictors of physical activity will be assessed using a survey based on the Health Action Process Approach (HAPA) model. Measures of the HAPA constructs are drawn from existing measures and previous SCI studies where possible. All items are assessed on a 7-point Likert scale ranging from 1='strongly disagree' to 7='strongly agree'. The survey will be recorded either electronically or with pen and paper depending on the respondent's preference. Survey will take approximately 25 minutes to complete, and will assess constructs related to exercise such as perceived risks, self- efficacy, planning, and social support. The demographics questionnaire will also be administered with this measure.
Measured: Baseline, 1 month, 6 month, 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2020
- Study start19 Nov 2020
- Primary completionDec 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Spinal Cord InjuriesStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- Rick Hansen Institute
- Responsible party
- Principal investigator, Kathleen Martin Ginis, University of British Columbia
- Investigators
- Kathleen Martin Ginis, PhD, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04493606
- Sponsor's protocol ID
- ProACTIVE Implementation
- Status last verified
- Apr 2023
- First submitted
- 10 Jul 2020
- Last updated
- 27 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bandura, A. (1997). Self-efficacy: The Exercise of Control. New York: W.H. Freeman & Co.
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.
PubMed 23978087Caspersen 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.
PubMed 3920711Cowan 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.
PubMed 22584283Ma 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.
PubMed 31969687Ginis 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.
PubMed 21647164Martin 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.
PubMed 22336103Sallis 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.
PubMed 3432232Scholz, 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
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.
PubMed 21767036Sniehotta, 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
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.
PubMed 34376809
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation of the ProACTIVE Toolkit in the Hospital and Community Setting to Improve Physical Activity Among People With Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT04493606
- Acronym / sponsor ID
- ProACTIVE Implementation
- Conditions
- Spinal Cord Injuries
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 38 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Collaborators
- Rick Hansen Institute
- Study start
- 19 Nov 2020 (actual)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 30 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Purpose 1 (arms 1 and 2): To evaluate the effect of referral to peer-led coaching, guided by the ProACTIVE SCI intervention, on physical activity behaviour, health, and quality of life outcomes among people with SCI.
Procedure overview: Participants will complete survey measures (~45 minutes) at baseline/discharge, 2 months, 6 months post discharge, and 1-year follow-up. Participants will also complete a semi-structured interview to assess satisfaction with the intervention at 6 months. Participants in the intervention group will receive an initial assessment (~1 hour) and 10 physical activity coaching sessions (~15 minutes each). A total time commitment of ~6.5 hours is expected over one year.
Design: For pragmatic and ethical reasons, single-group, repeated measures design will be used where interested participants will receive the intervention.
Procedure: Patients who are interested in participating will be enrolled in the intervention and will receive the ProACTIVE SCI intervention coaching. Patients who are not interested in participating will be re-contacted before discharge and/or at 3 months post-discharge to gauge interest. For those who consent during their hospital stay, a two-page quick-sheet will be filled out at discharge to record any physical activity coaching information collected during their hospital stay as part of usual care. (Please see Section 9 for the "GF Strong inpatient/ form" and "GF Strong outpatient form" that is currently used in practice). The quick-sheet and any exercise prescriptions developed will be transferred to the SCI BC peers. If possible, SCI BC peers will contact the client in-person or over video-conference before discharge to begin coaching, otherwise SCI BC peers will contact the patient to begin coaching sessions in the community post-discharge. SCI BC peers will carry out the physical activity coaching sessions guided by the ProACTIVE SCI intervention with the exception that exercise prescriptions cannot be made by the peers. If exercise prescriptions are needed, referral to an adapted personal trainer in the community will be made. Coaching sessions will be provided either in-person, using video teleconferencing technology or telephone if needed. Ten 15-minute sessions will be scheduled in accordance with patient needs and readiness, however, as a general structure, one coaching session will be provided each month for months 1-3, two coaching sessions per month in months 4-6, with a follow-up before one year. The peer coaches will make up to 5 attempts to reschedule a missed coaching session.
Sample size estimate: Based on feasibility estimates calculated using number of patients admitted yearly to GF Strong (n=100), an estimated 70% discharged to home (n=70; remaining 30% discharged to long-term care or other), approximately 55% of patients willing to consent over the 3 month follow-up period, and a 20% dropout estimate (based on previous experience in conducting studies in this population) an estimated n=30 individuals will be recruited to the intervention group (see Figure 2).
To ensure the sample size based on feasibility is adequately powered to detect an effect on physical activity, the investigators conducted a power calculation based on a previous randomized controlled trial in the in-patient setting with individuals with spinal cord injury. Physiotherapists delivered a bi-weekly behavioural coaching intervention to 39 individuals with SCI and physical activity was assessed at baseline, discharge, 6-months, and one-year post-discharge. A large-sized effect was observed at 6 months (d=0.89) for self-reported physical activity. Given the quasi-experimental design, the investigators are powering for a more modest between groups difference (d = .75). Eight participants/condition (N = 16) are needed to yield a significant effect of this magnitude in a repeated measures ANOVA, with β = .80 and α = .05. Thus, the feasibility-based projected sample size is adequate to detect a significant effect of the intervention on physical activity in this context.
Statistical Analysis: One-way repeated measures ANOVA
Purpose 2 (arm 3): Evaluate, understand, and document the implementation process of physiotherapists and peers with SCI delivering the ProACTIVE SCI intervention
Procedure overview: Clinicians and SCI BC Peers will receive a two-day training (2 hours each day) on how to deliver the ProACTIVE intervention. Clinicians and SCI BC Peers will be supported with monitoring and feedback for the first two months of delivering the intervention to clients and community of practice meetings as needed. 20-minute surveys will be administered before and immediately after training, as well as at 2 months and 6 months after starting implementation. One-hour semi-structured interviews will be conducted at 6 months. A total time commitment of ~18.5 hours is expected over one year for the clinicians. SCI BC Peers will deliver 10x15 minute coaching sessions to ~ 10 participants each for a total time commitment of 43.5 hours over one year.
Design: Within-subject, repeated measures.
Participants: As the aim of this project is to deliver the intervention using a pragmatic approach, volunteer physiotherapists from GF Strong and SCI BC peer coordinators who are interested in delivering the ProACTIVE SCI intervention will be included in this objective.
Sample size estimate: The study is powered to detect a significant within-subject effect over time on the theoretical domains framework (TDF) measures. A previous evaluation of the ProACTIVE implementation training amongst physiotherapists, when using within subject pre-post analyses, demonstrated a very large effect size across TDF outcomes (f=.867). A minimum of five participants are needed to yield a significant effect of this magnitude in a within-subject, repeated measures ANOVA (4 time points), with β = .80, α = .05, and a conservative 0.25 correlation among repeated measures.
Statistical Analysis: One-way repeated measure ANOVA.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Patients | Experimental | Other: SCI ProACTIVE Coaching (objective 1)SCI patients receiving the physical activity coaching (Objective 1) |
| Intervention- Interventionists | Experimental | Behavioral: Implementation Intervention (objective 2)Interventionists receiving physical activity coaching training (Objective 2) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- traumatic or non-traumatic spinal cord injury
- do not require ventilatory assistance, and
- have no medical contraindications to exercise identified by the care team
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SCI ProACTIVE Coaching (objective 1)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. | Other | Intervention Patients |
| Implementation Intervention (objective 2)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. | Behavioural | Intervention- Interventionists |
Primary outcome
Change from Baseline in Leisure Time Physical Activity at 1 month, 6 months, and 1 year
Time frame: Baseline, 1 month, 6 month, 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.
1 secondary outcome
Psychosocial predictors of physical activity
Time frame: Baseline, 1 month, 6 month, 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2023.
- BackgroundBandura, A. (1997). Self-efficacy: The Exercise of Control. New York: W.H. Freeman & Co.
- Background: PubMed 23978087Brawley 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.
- Background: PubMed 3920711Caspersen 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.
- Background: PubMed 22584283Cowan 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.
- Background: PubMed 31969687Ma 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.
- Background: PubMed 21647164Ginis 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.
- Background: PubMed 22336103Martin 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.
- Background: PubMed 3432232Sallis 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.
- BackgroundScholz, 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: PubMed 21767036Schwarzer 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.
- BackgroundSniehotta, 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
- Derived from this study: PubMed 34376809Ma 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.
- Individual participant dataSharing planned: No
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Spinal Cord Injuries
Not yet recruiting
Evaluating the Effect of the Zeen Mobility Device on Clinical Practicality, Safety, and Impact (Via Assessments of Walking, Standing Tolerance, Balance, Endurance, Effort, and Participation in Daily Tasks) in an Outpatient Rehabilitation Setting for Individuals With Mobility Impairments.
Stroke, Parkinson's Disease (PD)
RecruitingPhase 3
A Trial Investigating the Efficacy and Safety of NVG-291 in Subjects With Chronic Spinal Cord Injury
Chronic Spinal Cord Injury
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kathleen Martin Ginis, PhD principal investigator
University of British Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SCI ProACTIVE Coaching (objective 1) and Implementation Intervention (objective 2) in people with Spinal Cord Injuries, run by University of British Columbia at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in Leisure Time Physical Activity at 1 month, 6 months, and 1 year (time frame: Baseline, 1 month, 6 month, 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04493606, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2023.