ProACTIVE SCI Physical Activity Intervention
Condition: Spinal Cord Injuries
MeSH terms: Spinal Cord Injuries
Study type: Interventional

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.
    

Intervention name(s): ProacTive SCI
Intervention type(s): Behavioral
Intervention description(s): 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care