Pilot Randomized Controlled Trial Evaluating a Self-Determination Theory Tele-rehabilitation Physical Activity Intervention to Enhance Motivation, Physical Activity, and Quality of Life-related Outcomes Among Adults With SCI
Phase: NA
Conditions: Spinal Cord Injury
Sponsor: The Craig H. Neilsen Foundation

Version Date: 10/19/2017 
 
Project Title: A Telerehabilitation Approach to Enhance Quality of Life Through Exercise 
Among Adults With Paraplegia: Study Protocol. 
 
Principal Investigator 
Shane Sweet, Ph.D. 
Department of Kinesiology & Physical Education, Faculty of Education, McGill University 
Telephone: (514) 398-4184 ext. 09903 Email: shane.sweet@mcgill.ca 
 
 
Study Protocol 
 
 Interested participants will meet over the phone with a research assistant to assess their 
eligibility for the study, provide their informed consent, and confirm that they meet the 
requirements for installing the Remote Education, Augmented Communication, Training, and 
Supervision (REACTS) software (Innovative Imaging Technologies), which is the video-based 
telerehabilitation software and that they know how to use the software. REACTS is an 
interactive audio-video software that enables secure live communication and interaction between 
two or more individuals over an encrypted network. REACTS also allows for multi-feed 
streaming where multiple webcams can be connected and for multimedia sharing. All sessions 
can also be video recorded if the participant accepts the recording. In addition to using the video-
audio and secure features, the exercise counselor also enables the multimedia sharing platform 
where both she and the participants can edit a shared document (eg, action plans). Both the 
participant and the exercise counselor use a Windows-based computer meeting the software 
requirements. 
 
 Next, participants will be invited to complete the baseline questionnaire either verbally over the 
phone (with an emailed or mailed copy of the questionnaire to follow along with) or 
electronically using an online survey platform (SurveyGizmo). If the questionnaire package is 
mailed, a 1-day courier service will be used to minimize the delay. Once the baseline 
questionnaire is completed, the research assistant will randomly assign participants to the 
intervention or control group by opening a blinded, prelabeled (1-24), randomly ordered 
envelope to assign participants to one of two groups. The randomization is also stratified by 
gender (16 men, 8 women) in attempt to have a representative sample by gender [43]. The 
envelopes will be prepared by another member of the research team not directly involved in the 
data collection. The random allocation will be determined by a randomization tool 
(randomizer.org). Participants will be informed of their group assignment and told that another 
research assistant, blinded to their group allocation, will contact them to complete the same 
questionnaire at two other time points (6 weeks and 10 weeks from baseline). These follow-up 
data collection time points (6 weeks and 10 weeks) are set to represent the mid and end of the 8-
week intervention, which will start 2 weeks after baseline. Participants will receive up to Can 
$100 for completing the study. Specifically, they will receive $30, $35, and $35 if they complete 
the baseline, 6-week, and 10-week questionnaires, respectively.  
 
 
 
 

Version Date: 10/19/2017 
 
Intervention Group  
 
For participants assigned to the intervention group, the research assistant will schedule the 
participants’ first intervention session with the exercise counselor 2 weeks after their baseline 
assessment. The 2-week delay will allow us to send intervention-related materials (eg, webcams) 
and train participants on the REACTS software.  
 
Intervention Format  
 
The exercise intervention will be delivered by a kinesiologist trained in behavioral counseling 
and the adapted exercise in a Web based face-to-face format through the REACTS interactive 
audio-video software. Intervention participants will receive 1 weekly exercise session for 8 
weeks. An 8-week intervention was chosen (1) because the 8-week mark was associated with the 
greatest increases in Get in Motion clients’ exercise participation behavior [18] and represented 
the time point with the highest number of dropouts [21], and (2) to ensure feasibility for 
completion of the pilot RCT. The exercise counselor will receive behavior change skills training 
to ensure she is capable of fostering the psychological needs within SDT and apply behavior 
change techniques. The counselor will also participate in a motivational interviewing workshop 
to fine-tune her counseling skills. The use of motivational counseling intervention methods do 
not have any detrimental effects on exercise participation levels as motivationally focused 
interventions have been shown to be as effective as structured exercise interventions [44]. Across 
all of the eight intervention sessions, the counselor will create a social environment that is 
congruent with SDT.  
 
Intervention Components  
 
The exercise counselor will individually tailor her approach to each participant by understanding 
and taking into consideration the participant’s past and current exercise experiences (including a 
discussion of any prescribed exercise programs after completing an outpatient rehabilitation 
program), motives to be physically active (eg, improve functional ability, enhance participation 
in daily/social activities), salient concerns and barriers regarding exercise participation, and their 
physical home environment. Throughout the intervention, the exercise counselor and participants 
will co-construct and collaboratively adapt the participants’ exercise goals. SDT is at the core of 
this proposed intervention and a Theory Coding Scheme [38] will be used to evaluate the extent 
to which the theory is used, applied, and tested within the intervention. In line with the Theory 
Coding Scheme, we have linked each of our intervention components to either the three basic 
psychological needs, autonomous motivation, and/or exercise participation as illustrated in 
Figure 2. The specific weeks that each intervention component is planned to be implemented is 
shown in the first column of Figure 2 (Week #). Although the intervention components have 
been attributed to specific counseling sessions/weeks, the timing of the intervention components 
may differ between participants. The intervention is not standardized because, to be in line with 
SDT, the intervention will be tailored to the participants. As such, the participants’ interests and 
goals will be at the forefront of each session, and some components may be used earlier or later 
than outlined in Figure 2. Thus, the exercise counselor will be trained to use the model as a guide 
rather than a set protocol.  
 

Version Date: 10/19/2017 
 
Control Group 
 
 Participants assigned to the control group will be asked to continue with their regular routine for 
the next 2 months. We recognize that a compensatory rivalry bias [45] may occur as participants 
in the control group may seek out their own exercise program, which may then reduce the 
intervention’s effect. To help minimize this bias, the research assistant will remind control 
participants, after they complete the baseline questionnaire, of the importance of keeping their 
regular routine for the following 10 weeks. The control group will also be offered an exercise 
counseling session following the completion of the 10-week data collection time point.