N/A
N=28
ProACTIVE SCI Physical Activity Intervention
Spinal Cord Injuries
Bottom Line
View on ClinicalTrials.gov: NCT03111030 ↗Enrolled (actual)
28
Serious AEs
0.0%
Results posted
Mar 2022
Primary outcome: Primary: Change in Physical Activity: Leisure Time Physical Activity Questionnaire for People With SCI (LTPAQ) — 212; 274; 393; NA Total LTPA min/week
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- ProacTive SCI (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of British Columbia
- Primary completion
- Aug 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Physical Activity: Leisure Time Physical Activity Questionnaire for People With SCI (LTPAQ) |
212; 274; 393; NA; 370; NA | — |
| PRIMARY Change in Total Accelerometer Count as a Measure of Change in Physical Activity: 6-day Physical Activity Monitoring Period |
562000; 848000; 593000; NA; 659000; NA | — |
| SECONDARY Change in Health Action Process Approach Model Measure |
5.1; 5.7; 5.6; 5.4; 6.5; 6.5 | — |
| SECONDARY Number of Participants Participating in Qualitative Interviews |
14; 0 | — |
| SECONDARY Change in Pulse Wave Velocity |
10.6; 8.0; 9.7; 8.2 | — |
| SECONDARY Change in Arterial Structure: Wall Thickness |
0.62; 0.56; 0.61; 0.56 | — |
| SECONDARY Change in End Systolic Volume |
38; 36; 38; 35 | — |
| SECONDARY Change in End Diastolic Volume |
87; 84; 86; 82 | — |
| SECONDARY Change in Intraventricular Septum Diameter |
— | — |
| SECONDARY Change in Ventricular Internal Diameter |
42; 43; 43; 44 | — |
| SECONDARY Change in Systolic Function |
49; 48; 49; 47 | — |
| SECONDARY Change in Ejection Fraction |
57; 57; 56; 58 | — |
| SECONDARY Change in Cardiac Output |
3.22; 3.05; 3.13; 3.13 | — |
| SECONDARY Change in Fractional Shortening |
-19.0; -17.5; -19.2; -18.1 | — |
| SECONDARY Change in Diastolic Function |
0.99; 1.10; 1.02; 1.14 | — |
| SECONDARY Aerobic Fitness Evaluation: Peak Oxygen Uptake Test (VO2peak) |
1.16; 1.13; 1.30; 1.06 | — |
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. 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.
Eligibility Criteria
Inclusion Criteria
- Individuals must be competent to give informed consent,
- be able to propel an arm ergometer.
Exclusion Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT03111030). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.