Clinical trial NCT02833935: Enhancing Quality of Life Through Exercise: A Tele-Rehabilitation Approach
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spinal Cord Injury
Keywords: spinal cord injury
physical activity
self-determination theory
life satisfaction
Lead sponsor: The Craig H. Neilsen Foundation
Sponsor class: OTHER
Collaborators: name: McGill University
First posted: 2016-07-14
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Pilot randomized controlled trial evaluating a Self-Determination Theory (SDT) video-based tele-rehabilitation physical activity intervention aimed to enhance basic psychological needs, motivation, physical activity (PA), and quality of life- related outcomes of adults with spinal cord injury (SCI). It is anticipated that the individuals who receive the physical activity intervention (intervention group) will have moderate increases in their basic psychological needs, autonomous motivation, life satisfaction, and physical activity participation, and a moderate decrease in controlled motivation and depressive symptoms compared to the individuals who did not receive the intervention (control group).

Detailed description: Adults with spinal cord injury (SCI) report lower levels of quality of life (e.g., low life satisfaction; high depression) than the general population and have low rates of community participation. One health behavior that can improve these psychosocial outcomes is physical activity (PA). Unfortunately, PA rates are very low among adults with SCI. Novel interventions to increase PA are needed. One approach that has gained traction is video-based tele-rehabilitation, which has the benefit of reducing costs, increasing accessibility to services and delivering and adapting the intervention to the person's home environment.

Experts have strongly recommended that PA interventions be based in psychological theory to enhance their effectiveness. The intervention will be grounded in a strong psychological/motivational theory called self-determination theory (SDT). According to SDT, humans strive for growth and well-being by aiming to satisfy their three basic psychological needs of autonomy (sense of volition), competence (sense of capability) and relatedness (sense of connectedness). The investigators intervention will therefore be designed to foster these psychological needs in order to increase intrinsic/autonomous motivation for PA, promote higher PA levels and improve quality of life and participation.

To date, no study has either conducted a video-based tele-rehabilitation intervention to promote PA or has tested SDT among adults with SCI; thus providing the need for a pilot intervention. The purpose of this study is to pilot test an innovative, theory-informed, video-based tele-rehabilitation intervention aimed to enhance SDT-variables, PA and quality of life-related variables among adults with SCI. Effect sizes derived from this pilot intervention will be used to inform the sample size calculation of a subsequent larger randomized controlled trial. Given previous video-based PA tele-rehabilitation interventions do not exist, the hypotheses are derived from PA and general telephone-based counselling studies. Specifically, it is hypothesized that the video-based intervention will have moderate effects on SDT variables, PA, participation, life satisfaction and depression.

Eligibility criteria: Inclusion Criteria:

* Must have spinal cord injury (paraplegia)
* Must use a mobility device
* Must have sustained their injury at least 1 year prior
* Have a computer that matches requirements to use the online video-based software
* Speak and understand English or French
* Must have the intention to become physically active in the next two months or have been minimally active (\< 2 times a week) in the past two months

Exclusion Criteria:

* Receiving in-patient rehabilitation services
* Have been diagnosed with memory impairments
* Have severe communication difficulties and/or severe visual impairments
* Do not require a mobility device (e.g., wheelchair, cane)
* Have answered yes to one of the questions on the Physical Activity Readiness Questionnaire (PAR-Q+) and do not have a doctor's note saying it is safe for them to participate.

Primary outcomes:
measure: Treatment Self-Regulation for Exercise Scale
timeFrame: Baseline, Week 6, and Week 10
measure: Psychological Needs for Exercise Questionnaire
timeFrame: Baseline, Week 6, and Week 10
Secondary outcomes:
measure: Leisure Time Physical Activity Questionnaire for People With Spinal Cord Injury
timeFrame: Baseline, Week 6, and Week 10
measure: Person-Perceived Participation in Daily Activities Questionnaire
timeFrame: Baseline, Week 6, and Week 10
measure: Life Satisfaction Questionnaire
timeFrame: Baseline, Week 6, and Week 10
measure: Patient Health Questionnaire
timeFrame: Baseline, Week 6, and Week 10
measure: Health Care Climate Questionnaire
timeFrame: Baseline, Week 6, and Week 10
Other outcomes:
measure: Positive Affect and Negative Affect Schedule Questionnaire
timeFrame: Baseline, Week 6, and Week 10
measure: Meaning Questionnaire
timeFrame: Baseline, Week 6, and Week 10
measure: Social Cognitive Predictors of Leisure Time Physical Activity (LTPA) Among Adults With Spinal Cord Injury (e.g., Self-efficacy, Intentions, Action Planning)
timeFrame: Baseline, Week 6, and Week 10
measure: Behavioural Regulation in Exercise Questionnaire
timeFrame: Baseline, Week 6, and Week 10
Locations:
city: Montreal
country: Canada
facility: McGill University; Dept. of Kinesiology & Physical Education; Theories and Interventions in Exercise and Health Psychology Laboratory
state: Quebec
Study officials:
affiliation: McGill University
name: Shane Sweet, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sweet SN, Rocchi M, Arbour-Nicitopoulos K, Kairy D, Fillion B. A Telerehabilitation Approach to Enhance Quality of Life Through Exercise Among Adults With Paraplegia: Study Protocol. JMIR Res Protoc. 2017 Oct 19;6(10):e202. doi: 10.2196/resprot.8047.