Clinical trial NCT03111030: ProACTIVE SCI Physical Activity Intervention
Official title: ProACTIVE SCI Physical Activity Coaching Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spinal Cord Injuries
Lead sponsor: University of British Columbia
Sponsor class: OTHER
Collaborators: name: Rick Hansen Institute
name: Ontario Neurotrauma Foundation
name: International Collaboration on Repair Discoveries
First posted: 2017-04-12
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

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.

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.

Primary outcomes:
measure: Change in Physical Activity: Leisure Time Physical Activity Questionnaire for People With SCI (LTPAQ)
timeFrame: Baseline, week 4, week 7, week 10, 6 month follow up
measure: Change in Total Accelerometer Count as a Measure of Change in Physical Activity: 6-day Physical Activity Monitoring Period
timeFrame: Baseline, week 4, week 7, week 10
Secondary outcomes:
measure: Change in Health Action Process Approach Model Measure
timeFrame: Baseline, 9 weeks from intervention start (week 10)
measure: Number of Participants Participating in Qualitative Interviews
timeFrame: 9 weeks from intervention start (week 10)
measure: Change in Pulse Wave Velocity
timeFrame: Baseline, 9 weeks from intervention start (week 10)
measure: Change in Arterial Structure: Wall Thickness
timeFrame: Baseline, 9 weeks from intervention start (week 10)
measure: Change in End Systolic Volume
timeFrame: Baseline, 9 weeks from intervention start (week 10)
measure: Change in End Diastolic Volume
timeFrame: Baseline, 9 weeks from intervention start (week 10)
measure: Change in Intraventricular Septum Diameter
timeFrame: Baseline, 9 weeks from intervention start (week 10)
measure: Change in Ventricular Internal Diameter
timeFrame: Baseline, 9 weeks from intervention start (week 10)
measure: Change in Systolic Function
timeFrame: Baseline, 9 weeks from intervention start (week 10)
measure: Change in Ejection Fraction
timeFrame: Baseline, 9 weeks from intervention start (week 10)
measure: Change in Cardiac Output
timeFrame: Baseline, 9 weeks from intervention start (week 10)
measure: Change in Fractional Shortening
timeFrame: Baseline, 9 weeks from intervention start (week 10)
measure: Change in Diastolic Function
timeFrame: Baseline, 9 weeks from intervention start (week 10)
measure: Aerobic Fitness Evaluation: Peak Oxygen Uptake Test (VO2peak)
timeFrame: Baseline, 9 weeks from intervention start (week 10)
Other outcomes:
Locations:
city: Kelowna
country: Canada
facility: University of British Columbia Okanagan
state: British Columbia
city: Vancouver
country: Canada
facility: International Collaboration on Repair Discoveries
state: British Columbia
Study officials:
affiliation: University of British Columbia- Okanagan
name: Kathleen Martin Ginis, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Dinwoodie 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.
citation: Hoekstra 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.
citation: Ma 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.