Spinal Cord InjuriesNCT03111030
ProACTIVE SCI Physical Activity Intervention
A study testing ProacTive SCI in people with Spinal Cord Injuries, run by University of British Columbia at 2 sites in Canada.
Trial summary
This study will employ a randomized, wait-list controlled trial. A total of 30 participants (15 experimental, 15 wait-list control) between 18-65 years of age who have chronic SCI ≥ 1 year prior will be recruited. 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?
- ProacTive SCI
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 2 sitesCanada
- Study dates
- 28 Apr 2017to 1 Aug 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Individuals must be competent to give informed consent,
- be able to propel an arm ergometer.
Who cannot join
- History and/or symptoms of CVD or cardiopulmonary problems/disease.
- Major trauma or surgery within the last 6 months.
- Active Stage 3 or 4 pressure ulcer (based on the National Pressure Ulcer Advisory Panel classification)
- Recent (within 1 year) history of lower-extremity or non-union fracture
- Any unstable medical/psychiatric condition or substance abuse disorder that is likely to affect their ability to complete this study.
- Individuals with active medical issues such as pressure sores, urinary tract infections, hypertension, or heart disorders.
- Any cognitive dysfunction or language barrier that would prevent subjects from following English instructions.
- Subjects may be excluded at the discretion of the principal investigator due to other, unforeseen, safety issues.
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
University of British Columbia Okanagan
Kelowna, British Columbia, V1V 1V7
International Collaboration on Repair Discoveries
Vancouver, British Columbia, V5Z 1M9
About this study
Official title: ProACTIVE SCI Physical Activity Coaching Intervention
This study will employ a randomized, wait-list controlled trial. A total of 30 participants (15 experimental, 15 wait-list control) between 18-65 years of age who have chronic SCI ≥ 1 year prior will be recruited. Physical activity measures will be taken using wrist-based accelerometers and the Leisure Time Physical Activity Questionnaire for people with SCI (LTPAQ). Psychosocial factors will be evaluated through questionnaires. The primary health outcome measure (aPWV), and secondary cardiovascular parameters will be assessed using a combination of echocardiography and ultrasound. Fitness will be determined using a peak oxygen consumption test on an arm-cycle ergometer. All measurement will be taken at baseline and after 9 weeks following intervention commencement. Physical activity will also be sampled mid-intervention at 4 and 7 weeks. Training will involve weekly, 10-15 minute coaching sessions for 9 weeks. All pre- and post-assessments will take place at the Blusson Spinal Cord Centre at ICORD. Intervention content will be delivered in-person, over Skype or phone, and the wrist- worn accelerometers will be delivered and picked up from the participant's home during the intervention.
Read the detailed description
A randomized, wait-list controlled trial will be used to compare the effects of tailored PA coaching sessions versus no coaching on PA behaviour, psychosocial factors, and health outcomes. Eligible individuals will be randomly assigned (1:1) to either the experimental (PA coaching sessions) or wait-list control condition. Matched randomization based on baseline physical activity levels will be used. The randomization sequence will be generated by a research assistant independent of the trial.
Day 1 testing measures include vascular measures (arterial pulse wave velocity, arterial structure; 30 minutes), cardiac structure and function measures (30 minutes), a peak oxygen uptake test (60 minutes), for a total duration of 2 hours. Participants will be given an accelerometer to wear for the 6-day monitoring period (6.1.2) after which they will return for Day 2 testing.
Day 2 testing measures include administration of the LTPAQ (5 minutes), administration of the demographics and Health Action Process Approach model questionnaire (25 minutes), and a measurement of energy expenditure at different sub-maximal wheeling speeds to calibrate MVPA cut-points (30 minutes) and at baseline, the first PA coaching session will be administered (60 minutes) whereas at post-test a semi-structured interview will be administered (60 minutes). Total duration of day 2 testing will be 2 hours. The intervention protocol is described below. During the intervention, physical activity will be sampled at two time points; accelerometer and PARA SCI data will be taken during week 4 and week 7.
INTERVENTION
Intervention Protocol:
Experimental participants will receive weekly PA coaching sessions. Each session will be 10-15 minutes in duration and delivered either face to face, over Skype, or when the former modes are unavailable, over the phone. Additionally, supplemental resources may be emailed to the participants based on need throughout the intervention.
Participants' motivation to exercise will first be determined according to stages of the HAPA model. Those who identify as pre-intenders (no intention to exercise) will receive intervention strategies that focus on changing motivation to be physically active. Those identified as intenders (willing to exercise but have not started) will focus on providing resources and behavioural strategies to commence physical activity. Lastly, those identified as actors (already exercising) will receive intervention strategies that help participants maintain or improve PA behaviour.
For those in the intender or actor stage, the intervention aims to promote the international SCI PA guidelines to promote fitness (at least 20 minutes of moderate vigorous aerobic activity twice/week and strength training twice/week). For those exceeding the fitness guidelines, the international SCI PA guidelines to promote health are promoted (at least 30 minutes of moderate to vigorous aerobic activity three times/week and strength training twice/week). However, these aims will be modified based on the individual's baseline PA. During the first visit, participants' baseline PA levels will be reviewed and an appropriate PA goal to achieve in the following month will be formed. Ultimately, the goal is the decision of the participant.
Following goal setting, barriers to participating in PA will be identified. The interventionist will select intervention strategies based on the identified barriers. A pre-formed chart of corresponding intervention strategies (e.g. use of behaviour change techniques, referral to facilities or peers, suggesting at-home exercises) was developed to aid this pairing process (Appendix A). These intervention strategies are accompanied by a comprehensive toolkit based from the HAPA model (Appendix B). In brief, the toolkit advises on three key strategies for promoting PA to people with SCI: i) education, ii) referral, iii) tailored PA prescription.
Remaining weekly coaching sessions will review participants' progress and barriers to discuss new goals and strategies as outlined above.
Control Participants:
Control participants will complete baseline and post-testing only. Following completion of post-test measures they will be administered the same PA coaching session as the intervention group, with post-test measures being repeated upon intervention completion.
- Conditions
- Spinal Cord Injuries
- Being tested
- ProacTive SCI
- 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.
ProacTive SCIBehavioural
Participants will receive weekly physical activity coaching sessions. Each session will be 10-15 minutes, delivered either face to face, over Skype, or over the phone. Additional resources may be emailed to participants based on need throughout the intervention (for example, a goal, list of places to exercise, contact information to reach mentoring services). A typical session may include:
- An assessment of motivated the participant is to be physically active
- A: If motivated, a physical activity goal will be set, strategies will be reviewed, and resources to accomplish that goal will be provided. B: If not motivated, questions will be asked to understand why the reasons for lack of motivation. If it is for any reasons including barriers, fear, confidence, or knowledge, the interventionist will discuss strategies to overcome these obstacles.
- Progress and barriers will be reassessed and discussed.
| Study group | Role | What they receive |
|---|---|---|
| ProacTive SCI | Experimental | Individualized physical activity coaching sessions Receives: Behavioral: ProacTive SCI |
| Wait-list control | No intervention | Standard care, receiving physical activity coaching sessions after completing post-testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Physical Activity: Leisure Time Physical Activity Questionnaire for People With SCI (LTPAQ)
Participants will be asked to complete a questionnaire, guided by the co-investigator (Jasmin Ma), that asks the participant to recall in the last 7 days how many days and for how long leisure time physical activity was performed. The recall assessment will take approximately 5 minutes to complete.
Measured: Baseline, week 4, week 7, week 10, 6 month follow up
Change in Total Accelerometer Count as a Measure of Change in Physical Activity: 6-day Physical Activity Monitoring Period
Participants will be fitted with a wrist-based tri-axial accelerometer to be worn 24 hours a day for 6 days in order to determine intensity and amount of PA. They will keep a detailed PA diary recording all leisure time PA performed during the day. The primary outcome will be total vector magnitude (VM) accelerometer counts from a tri-axial wrist-worn accelerometer (GT9X, ActiGraph LLC, FL). During the intervention, the accelerometer will be picked up and dropped off to the participant's home to decrease burden. Text or email reminders (i.e. "Please don't forget to wear your accelerometer today") will be used to promote adherence to accelerometer wear.
Measured: Baseline, week 4, week 7, week 10
Secondary outcomes (14)
Change in Health Action Process Approach Model Measure
This survey will examine psychological factors that may affect PA participation. 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. All items will be assessed on a 7-point Likert scale ranging from 1 = "strongly disagree" to 7 = "strongly agree". Higher scores indicate a better outcome.
Measured: Baseline, 9 weeks from intervention start (week 10)
Number of Participants Participating in Qualitative Interviews
A semi-structured interview will be conducted at the end of the intervention to understand what components were and were not effective. Data will not be recorded. This feedback will be used to improve future iterations of the intervention. There is no associated scale with this measurement.
Measured: 9 weeks from intervention start (week 10)
Change in Pulse Wave Velocity
aPWV (cm/s) is calculated by dividing the distance between measurement sites, by the pulse transit time. Distance between the carotid and femoral arteries will be measured using measuring tape along the surface of the body, held parallel to the testing table. The pulse transit is determined from the arterial blood pressure waves, which are collected at each arterial site. A pen-like device (model SPT-301; Millar Instruments Inc., Houston, TX) will be applied to the carotid and femoral arterial sites using a light pressure to obtain arterial pressure waves. Heart rate will be recorded using a single-lead (lead I) electrocardiogram (ECG) (model ML 123, ADInstruments Inc., Colorado Springs, CO).
Measured: Baseline, 9 weeks from intervention start (week 10)
Change in Arterial Structure: Wall Thickness
Common carotid arterial images will be collected using B-mode ultrasound (INFO) for 10 cardiac cycles. Images will be analyzed using internal ultrasound software to determine lumen diameter and intima-media thickness.
Measured: Baseline, 9 weeks from intervention start (week 10)
Change in End Systolic Volume
Cardiac image will be collected non-invasively using Doppler ultrasound (Vivid q, GE Healthcare, Buckinghamshire, UK). Image will be collected and stored on the ultrasound for offline analysis.
Measured: Baseline, 9 weeks from intervention start (week 10)
Change in End Diastolic Volume
Cardiac image will be collected non-invasively using Doppler ultrasound (Vivid q, GE Healthcare, Buckinghamshire, UK). Image will be collected and stored on the ultrasound for offline analysis.
Measured: Baseline, 9 weeks from intervention start (week 10)
Change in Intraventricular Septum Diameter
Cardiac image will be collected non-invasively using Doppler ultrasound (Vivid q, GE Healthcare, Buckinghamshire, UK). Image will be collected and stored on the ultrasound for offline analysis.
Measured: Baseline, 9 weeks from intervention start (week 10)
Change in Ventricular Internal Diameter
Cardiac image will be collected non-invasively using Doppler ultrasound (Vivid q, GE Healthcare, Buckinghamshire, UK). Image will be collected and stored on the ultrasound for offline analysis.
Measured: Baseline, 9 weeks from intervention start (week 10)
Change in Systolic Function
Cardiac image will be collected non-invasively using Doppler ultrasound (Vivid q, GE Healthcare, Buckinghamshire, UK). Image will be collected and stored on the ultrasound for offline analysis. LV stroke volume will be used to measure change in systolic function.
Measured: Baseline, 9 weeks from intervention start (week 10)
Change in Ejection Fraction
Cardiac image will be collected non-invasively using Doppler ultrasound (Vivid q, GE Healthcare, Buckinghamshire, UK). Image will be collected and stored on the ultrasound for offline analysis.
Measured: Baseline, 9 weeks from intervention start (week 10)
Change in Cardiac Output
Cardiac image will be collected non-invasively using Doppler ultrasound (Vivid q, GE Healthcare, Buckinghamshire, UK). Image will be collected and stored on the ultrasound for offline analysis.
Measured: Baseline, 9 weeks from intervention start (week 10)
Change in Fractional Shortening
Cardiac image will be collected non-invasively using Doppler ultrasound (Vivid q, GE Healthcare, Buckinghamshire, UK). Image will be collected and stored on the ultrasound for offline analysis. Longitudinal strain will be used to measure change in fractional shortening.
Measured: Baseline, 9 weeks from intervention start (week 10)
Change in Diastolic Function
Cardiac image will be collected non-invasively using Doppler ultrasound (Vivid q, GE Healthcare, Buckinghamshire, UK). Image will be collected and stored on the ultrasound for offline analysis. E'/A' (ratio between early diastolic septal tissue velocity and late diastolic septal tissue velocity) will be used to measure change in diastolic function.
Measured: Baseline, 9 weeks from intervention start (week 10)
Aerobic Fitness Evaluation: Peak Oxygen Uptake Test (VO2peak)
Participants will perform a graded arm ergometer test on an electronically braked arm ergometer. For participants with tetraplegia who have limited handgrip function, gloves will be used to secure hands to the ergometer handles. Participants will be instructed to maintain a cycling rate of 50 revolutions per minute (rpm) for the duration of the test. After an initial warm-up at 0W, power output will be increased each minute at a rate of 2-5 W/min for participants with tetraplegia, or 10 W/min for participants with paraplegia, until volitional exhaustion (i.e. dropping below 30 rpm). Oxygen consumption will be recorded on a breath-by-breath basis for the duration of the test and reported as rolling 30-second averages sampled at 5-second intervals as per consensus recommendations.
All outcome data are reported here: https://doi.org/10.1007/s40279-019-01118-5
Measured: Baseline, 9 weeks from intervention start (week 10)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2017
- Study start28 Apr 2017
- Primary completion1 Aug 2018
- Study completion1 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- Rick Hansen Institute, Ontario Neurotrauma Foundation, International Collaboration on Repair Discoveries
- Responsible party
- Principal investigator, Kathleen Martin Ginis, University of British Columbia
- Investigators
- Kathleen Martin Ginis, PhD, Principal investigator, University of British Columbia- Okanagan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03111030
- Sponsor's protocol ID
- H17-00559
- Status last verified
- Dec 2024
- First submitted
- 16 Mar 2017
- Last updated
- 5 Dec 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hoekstra F, Martin Ginis KA, Collins D, Dinwoodie M, Ma JK, Gaudet S, Rakiecki D; SCI Exercise Counselling Panel; Gainforth HL. Applying state space grids methods to characterize counsellor-client interactions in a physical activity behavioural intervention for adults with disabilities. Psychol Sport Exerc. 2023 Mar;65:102350. doi: 10.1016/j.psychsport.2022.102350. Epub 2022 Dec 9.
PubMed 37665832Dinwoodie M, Hoekstra F, Stelzer S, Ma JK, Martin Ginis KA. A dynamic analysis of physical activity barriers experienced by adults with spinal cord injury. Spinal Cord Ser Cases. 2022 Mar 29;8(1):37. doi: 10.1038/s41394-022-00504-y.
PubMed 35351871Hoekstra F, Collins D, Dinwoodie M, Ma JK, Martin Ginis KA. Measuring behavior change technique delivery and receipt in physical activity behavioral interventions. Rehabil Psychol. 2022 May;67(2):128-138. doi: 10.1037/rep0000440. Epub 2022 Mar 17.
PubMed 35298203Ma JK, West CR, Martin Ginis KA. The Effects of a Patient and Provider Co-Developed, Behavioral Physical Activity Intervention on Physical Activity, Psychosocial Predictors, and Fitness in Individuals with Spinal Cord Injury: A Randomized Controlled Trial. Sports Med. 2019 Jul;49(7):1117-1131. doi: 10.1007/s40279-019-01118-5.
PubMed 31119717
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ProACTIVE SCI Physical Activity Coaching Intervention
- ClinicalTrials.gov ID
- NCT03111030
- Acronym / sponsor ID
- H17-00559
- Conditions
- Spinal Cord Injuries
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Collaborators
- Rick Hansen Institute, Ontario Neurotrauma Foundation, International Collaboration on Repair Discoveries
- Study start
- 28 Apr 2017 (actual)
- Primary completion
- 1 Aug 2018 (actual)
- Study completion
- 1 Aug 2018 (actual)
- First posted
- 12 Apr 2017 (actual)
- Results
- Posted 9 Mar 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will employ a randomized, wait-list controlled trial. A total of 30 participants (15 experimental, 15 wait-list control) between 18-65 years of age who have chronic SCI ≥ 1 year prior will be recruited. Physical activity measures will be taken using wrist-based accelerometers and the Leisure Time Physical Activity Questionnaire for people with SCI (LTPAQ). Psychosocial factors will be evaluated through questionnaires. The primary health outcome measure (aPWV), and secondary cardiovascular parameters will be assessed using a combination of echocardiography and ultrasound. Fitness will be determined using a peak oxygen consumption test on an arm-cycle ergometer. All measurement will be taken at baseline and after 9 weeks following intervention commencement. Physical activity will also be sampled mid-intervention at 4 and 7 weeks. Training will involve weekly, 10-15 minute coaching sessions for 9 weeks. All pre- and post-assessments will take place at the Blusson Spinal Cord Centre at ICORD. Intervention content will be delivered in-person, over Skype or phone, and the wrist- worn accelerometers will be delivered and picked up from the participant's home during the intervention.
Detailed description
A randomized, wait-list controlled trial will be used to compare the effects of tailored PA coaching sessions versus no coaching on PA behaviour, psychosocial factors, and health outcomes. Eligible individuals will be randomly assigned (1:1) to either the experimental (PA coaching sessions) or wait-list control condition. Matched randomization based on baseline physical activity levels will be used. The randomization sequence will be generated by a research assistant independent of the trial.
Day 1 testing measures include vascular measures (arterial pulse wave velocity, arterial structure; 30 minutes), cardiac structure and function measures (30 minutes), a peak oxygen uptake test (60 minutes), for a total duration of 2 hours. Participants will be given an accelerometer to wear for the 6-day monitoring period (6.1.2) after which they will return for Day 2 testing.
Day 2 testing measures include administration of the LTPAQ (5 minutes), administration of the demographics and Health Action Process Approach model questionnaire (25 minutes), and a measurement of energy expenditure at different sub-maximal wheeling speeds to calibrate MVPA cut-points (30 minutes) and at baseline, the first PA coaching session will be administered (60 minutes) whereas at post-test a semi-structured interview will be administered (60 minutes). Total duration of day 2 testing will be 2 hours. The intervention protocol is described below. During the intervention, physical activity will be sampled at two time points; accelerometer and PARA SCI data will be taken during week 4 and week 7.
INTERVENTION
Intervention Protocol:
Experimental participants will receive weekly PA coaching sessions. Each session will be 10-15 minutes in duration and delivered either face to face, over Skype, or when the former modes are unavailable, over the phone. Additionally, supplemental resources may be emailed to the participants based on need throughout the intervention.
Participants' motivation to exercise will first be determined according to stages of the HAPA model. Those who identify as pre-intenders (no intention to exercise) will receive intervention strategies that focus on changing motivation to be physically active. Those identified as intenders (willing to exercise but have not started) will focus on providing resources and behavioural strategies to commence physical activity. Lastly, those identified as actors (already exercising) will receive intervention strategies that help participants maintain or improve PA behaviour.
For those in the intender or actor stage, the intervention aims to promote the international SCI PA guidelines to promote fitness (at least 20 minutes of moderate vigorous aerobic activity twice/week and strength training twice/week). For those exceeding the fitness guidelines, the international SCI PA guidelines to promote health are promoted (at least 30 minutes of moderate to vigorous aerobic activity three times/week and strength training twice/week). However, these aims will be modified based on the individual's baseline PA. During the first visit, participants' baseline PA levels will be reviewed and an appropriate PA goal to achieve in the following month will be formed. Ultimately, the goal is the decision of the participant.
Following goal setting, barriers to participating in PA will be identified. The interventionist will select intervention strategies based on the identified barriers. A pre-formed chart of corresponding intervention strategies (e.g. use of behaviour change techniques, referral to facilities or peers, suggesting at-home exercises) was developed to aid this pairing process (Appendix A). These intervention strategies are accompanied by a comprehensive toolkit based from the HAPA model (Appendix B). In brief, the toolkit advises on three key strategies for promoting PA to people with SCI: i) education, ii) referral, iii) tailored PA prescription.
Remaining weekly coaching sessions will review participants' progress and barriers to discuss new goals and strategies as outlined above.
Control Participants:
Control participants will complete baseline and post-testing only. Following completion of post-test measures they will be administered the same PA coaching session as the intervention group, with post-test measures being repeated upon intervention completion.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ProacTive SCI | Experimental | Behavioral: ProacTive SCIIndividualized physical activity coaching sessions |
| Wait-list control | No intervention | –Standard care, receiving physical activity coaching sessions after completing post-testing |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Individuals must be competent to give informed consent,
- be able to propel an arm ergometer.
Key exclusion criteria (8 listed)
- History and/or symptoms of CVD or cardiopulmonary problems/disease.
- Major trauma or surgery within the last 6 months.
- Active Stage 3 or 4 pressure ulcer (based on the National Pressure Ulcer Advisory Panel classification)
- Recent (within 1 year) history of lower-extremity or non-union fracture
- Any unstable medical/psychiatric condition or substance abuse disorder that is likely to affect their ability to complete this study.
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 |
|---|---|---|
| ProacTive SCIParticipants will receive weekly physical activity coaching sessions. Each session will be 10-15 minutes, delivered either face to face, over Skype, or over the phone. Additional resources may be emailed to participants based on need throughout the intervention (for example, a goal, list of places to exercise, contact information to reach mentoring services). A typical session may include: 1. An assessment of motivated the participant is to be physically active 2. A: If motivated, a physical activity goal will be set, strategies will be reviewed, and resources to accomplish that goal will be provided. B: If not motivated, questions will be asked to understand why the reasons for lack of motivation. If it is for any reasons including barriers, fear, confidence, or knowledge, the interventionist will discuss strategies to overcome these obstacles. 3. Progress and barriers will be reassessed and discussed. | Behavioural | ProacTive SCI |
Primary outcome
Change in Physical Activity: Leisure Time Physical Activity Questionnaire for People With SCI (LTPAQ)
Time frame: Baseline, week 4, week 7, week 10, 6 month follow up
Participants will be asked to complete a questionnaire, guided by the co-investigator (Jasmin Ma), that asks the participant to recall in the last 7 days how many days and for how long leisure time physical activity was performed. The recall assessment will take approximately 5 minutes to complete.
Change in Total Accelerometer Count as a Measure of Change in Physical Activity: 6-day Physical Activity Monitoring Period
Time frame: Baseline, week 4, week 7, week 10
Participants will be fitted with a wrist-based tri-axial accelerometer to be worn 24 hours a day for 6 days in order to determine intensity and amount of PA. They will keep a detailed PA diary recording all leisure time PA performed during the day. The primary outcome will be total vector magnitude (VM) accelerometer counts from a tri-axial wrist-worn accelerometer (GT9X, ActiGraph LLC, FL). During the intervention, the accelerometer will be picked up and dropped off to the participant's home to decrease burden. Text or email reminders (i.e. "Please don't forget to wear your accelerometer today") will be used to promote adherence to accelerometer wear.
14 secondary outcomes
Change in Health Action Process Approach Model Measure
Time frame: Baseline, 9 weeks from intervention start (week 10)
Number of Participants Participating in Qualitative Interviews
Time frame: 9 weeks from intervention start (week 10)
Change in Pulse Wave Velocity
Time frame: Baseline, 9 weeks from intervention start (week 10)
Change in Arterial Structure: Wall Thickness
Time frame: Baseline, 9 weeks from intervention start (week 10)
Change in End Systolic Volume
Time frame: Baseline, 9 weeks from intervention start (week 10)
Change in End Diastolic Volume
Time frame: Baseline, 9 weeks from intervention start (week 10)
Change in Intraventricular Septum Diameter
Time frame: Baseline, 9 weeks from intervention start (week 10)
Change in Ventricular Internal Diameter
Time frame: Baseline, 9 weeks from intervention start (week 10)
Change in Systolic Function
Time frame: Baseline, 9 weeks from intervention start (week 10)
Change in Ejection Fraction
Time frame: Baseline, 9 weeks from intervention start (week 10)
Change in Cardiac Output
Time frame: Baseline, 9 weeks from intervention start (week 10)
Change in Fractional Shortening
Time frame: Baseline, 9 weeks from intervention start (week 10)
Change in Diastolic Function
Time frame: Baseline, 9 weeks from intervention start (week 10)
Aerobic Fitness Evaluation: Peak Oxygen Uptake Test (VO2peak)
Time frame: Baseline, 9 weeks from intervention start (week 10)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37665832Hoekstra F, Martin Ginis KA, Collins D, Dinwoodie M, Ma JK, Gaudet S, Rakiecki D; SCI Exercise Counselling Panel; Gainforth HL. Applying state space grids methods to characterize counsellor-client interactions in a physical activity behavioural intervention for adults with disabilities. Psychol Sport Exerc. 2023 Mar;65:102350. doi: 10.1016/j.psychsport.2022.102350. Epub 2022 Dec 9.
- Derived from this study: PubMed 35351871Dinwoodie M, Hoekstra F, Stelzer S, Ma JK, Martin Ginis KA. A dynamic analysis of physical activity barriers experienced by adults with spinal cord injury. Spinal Cord Ser Cases. 2022 Mar 29;8(1):37. doi: 10.1038/s41394-022-00504-y.
- Derived from this study: PubMed 35298203Hoekstra F, Collins D, Dinwoodie M, Ma JK, Martin Ginis KA. Measuring behavior change technique delivery and receipt in physical activity behavioral interventions. Rehabil Psychol. 2022 May;67(2):128-138. doi: 10.1037/rep0000440. Epub 2022 Mar 17.
- Derived from this study: PubMed 31119717Ma JK, West CR, Martin Ginis KA. The Effects of a Patient and Provider Co-Developed, Behavioral Physical Activity Intervention on Physical Activity, Psychosocial Predictors, and Fitness in Individuals with Spinal Cord Injury: A Randomized Controlled Trial. Sports Med. 2019 Jul;49(7):1117-1131. doi: 10.1007/s40279-019-01118-5.
- Individual participant dataSharing planned: No
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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- Okanagan
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ProacTive SCI in people with Spinal Cord Injuries, run by University of British Columbia at 2 sites 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 2 inclusion and 8 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: finished, as of the sponsor's last update on 5 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Yes. Results are posted in the registry (first posted 9 Mar 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 in Physical Activity: Leisure Time Physical Activity Questionnaire for People With SCI (LTPAQ) (time frame: Baseline, week 4, week 7, week 10, 6 month follow up). The study lists 2 primary outcomes in all. 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 NCT03111030, which also lists 4 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 5 Dec 2024.