NCT03111030

ProACTIVE SCI Physical Activity Intervention

Completed NA Results posted Last updated 5 December 2024

What this trial tests

NA trial testing ProacTive SCI in Spinal Cord Injuries in 28 participants. Completed in 1 August 2018.

Timeline

28 April 2017

Primary endpoint
1 August 2018

1 August 2018

Quick facts

Lead sponsor	University of British Columbia
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	supportive care
Enrollment	28
Start date	28 April 2017
Primary completion	1 August 2018
Estimated completion	1 August 2018
Sites	2 locations across Canada

Drugs / interventions tested

• ProacTive SCI

Conditions studied

• Spinal Cord Injuries — all drugs for Spinal Cord Injuries →

Sponsor

University of British Columbia

Who can join

Adults 18 to 65, any sex, with Spinal Cord Injuries. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change in Physical Activity: Leisure Time Physical Activity Questionnaire for People With SCI (LTPAQ) Primary · 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.

Baseline

Group	Value	95% CI
ProacTive SCI	212	± 195
Wait-list Control	274	± 300

Week 4

Group	Value	95% CI
ProacTive SCI	393	± 413
Wait-list Control	NA	± NA

Week 7

Group	Value	95% CI
ProacTive SCI	370	± 258
Wait-list Control	NA	± NA

Week 10

Group	Value	95% CI
ProacTive SCI	405	± 364
Wait-list Control	147	± 192

6 months FU

Group	Value	95% CI
ProacTive SCI	348	± 269
Wait-list Control	NA	± NA

Change in Total Accelerometer Count as a Measure of Change in Physical Activity: 6-day Physical Activity Monitoring Period Primary · 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 toda

Baseline

Group	Value	95% CI
ProacTive SCI	562000	± 188000
Wait-list Control	848000	± 759000

Week 4

Group	Value	95% CI
ProacTive SCI	593000	± 307000
Wait-list Control	NA	± NA

Week 7

Group	Value	95% CI
ProacTive SCI	659000	± 338000
Wait-list Control	NA	± NA

Week 10

Group	Value	95% CI
ProacTive SCI	702000	± 267000
Wait-list Control	598000	± 390000

Change in Health Action Process Approach Model Measure Secondary · Baseline, 9 weeks from intervention start (week 10)

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.

Affective outcome expectancies (Baseline)

Group	Value	95% CI
ProacTive SCI	5.1	± 1.3
Wait-list Control	5.7	± 0.9

Affective outcome expectancies (Week 10)

Group	Value	95% CI
ProacTive SCI	5.6	± 1.0
Wait-list Control	5.4	± 1.0

Instrumental outcome expectancies (Baseline)

Group	Value	95% CI
ProacTive SCI	6.5	± 0.6
Wait-list Control	6.5	± 0.9

Instrumental outcome expectancies (Week 10)

Group	Value	95% CI
ProacTive SCI	6.8	± 0.3
Wait-list Control	6.3	± 0.8

Risk perceptions (Baseline)

Group	Value	95% CI
ProacTive SCI	2.5	± 1.6
Wait-list Control	2.5	± 1.3

Risk perceptions (Week 10)

Group	Value	95% CI
ProacTive SCI	2.8	± 1.6
Wait-list Control	2.5	± 1.1

Aerobic exercise task self-efficacy (Baseline)

Group	Value	95% CI
ProacTive SCI	3.4	± 1.9
Wait-list Control	4.1	± 1.7

Aerobic exercise task self-efficacy (Week 10)

Group	Value	95% CI
ProacTive SCI	4.7	± 1.2
Wait-list Control	3.6	± 1.6

Number of Participants Participating in Qualitative Interviews Secondary · 9 weeks from intervention start (week 10)

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.

Group	Value	95% CI
ProacTive SCI	14
Wait-list Control	0

Change in Pulse Wave Velocity Secondary · Baseline, 9 weeks from intervention start (week 10)

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 s

Baseline

Group	Value	95% CI
ProacTive SCI	10.6	± 2.9
Wait-list Control	8.0	± 2.0

Week 10

Group	Value	95% CI
ProacTive SCI	9.7	± 2.5
Wait-list Control	8.2	± 1.9

Change in Arterial Structure: Wall Thickness Secondary · Baseline, 9 weeks from intervention start (week 10)

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.

Baseline

Group	Value	95% CI
ProacTive SCI	0.62	± 0.16
Wait-list Control	0.56	± 0.07

Week 10

Group	Value	95% CI
ProacTive SCI	0.61	± 0.15
Wait-list Control	0.56	± 0.07

Change in End Systolic Volume Secondary · Baseline, 9 weeks from intervention start (week 10)

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.

Baseline

Group	Value	95% CI
ProacTive SCI	38	± 9
Wait-list Control	36	± 9

Week 10

Group	Value	95% CI
ProacTive SCI	38	± 9
Wait-list Control	35	± 8

Change in End Diastolic Volume Secondary · Baseline, 9 weeks from intervention start (week 10)

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.

Baseline

Group	Value	95% CI
ProacTive SCI	87	± 18
Wait-list Control	84	± 20

Week 10

Group	Value	95% CI
ProacTive SCI	86	± 14
Wait-list Control	82	± 18

Change in Ventricular Internal Diameter Secondary · Baseline, 9 weeks from intervention start (week 10)

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.

Baseline

Group	Value	95% CI
ProacTive SCI	42	± 5
Wait-list Control	43	± 10

Week 10

Group	Value	95% CI
ProacTive SCI	43	± 4
Wait-list Control	44	± 4

Change in Systolic Function Secondary · Baseline, 9 weeks from intervention start (week 10)

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.

Baseline

Group	Value	95% CI
ProacTive SCI	49	± 9
Wait-list Control	48	± 11

Week 10

Group	Value	95% CI
ProacTive SCI	49	± 6
Wait-list Control	47	± 10

Change in Ejection Fraction Secondary · Baseline, 9 weeks from intervention start (week 10)

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.

Baseline

Group	Value	95% CI
ProacTive SCI	57	± 3
Wait-list Control	57	± 3

Week 10

Group	Value	95% CI
ProacTive SCI	56	± 3
Wait-list Control	58	± 3

Change in Cardiac Output Secondary · Baseline, 9 weeks from intervention start (week 10)

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.

Baseline

Group	Value	95% CI
ProacTive SCI	3.22	± 0.78
Wait-list Control	3.05	± 0.87

Week 10

Group	Value	95% CI
ProacTive SCI	3.13	± 0.63
Wait-list Control	3.13	± 0.96

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. 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.
   Ma JK, West CR, Martin Ginis KA. · · 2019 · cited 43× · PMID 31119717 · DOI 10.1007/s40279-019-01118-5
2. A dynamic analysis of physical activity barriers experienced by adults with spinal cord injury.
   Dinwoodie M, Hoekstra F, Stelzer S, Ma JK, et al · · 2022 · cited 9× · PMID 35351871 · DOI 10.1038/s41394-022-00504-y
3. Effects of a Tailored Physical Activity Intervention on Cardiovascular Structure and Function in Individuals With Spinal Cord Injury.
   Williams AM, Ma JK, Martin Ginis KA, West CR. · · 2021 · cited 8× · PMID 34027716 · DOI 10.1177/15459683211017504