Clinical trial NCT02826707: Evaluation of a Smartphone-delivered Peer-led Physical Activity Counselling Program for Manual Wheelchair Users
Official title: Feasibility Evaluation of a Smartphone-delivered Peer-led Physical Activity Counselling Program for Improving Physical Activity in Manual Wheelchair Users
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Physical Activity
Lead sponsor: Laval University
Sponsor class: OTHER
Collaborators: name: McGill University
First posted: 2016-07-11
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Despite physical activity (PA) being a valuable modality for promoting health, the evidence for effective PA intervention strategies for manual wheelchair (MWC) users is underdeveloped. Community-based programs and telephone-counselling interventions to increase PA among MWC users have had some success, but the uptake and adherence to these interventions remains low within this population. Community-based programs may not reach MWC users who live in rural areas and have issues with transportation, while health professionals may not optimally relate with MWC when providing telephone counselling. Although the PA needs of MWCs are not fully understood, there is reason to believe that including peers into intervention delivery may have benefits.

A feasibility trial is critical and prudent prior to moving forwards with a large and expensive multi-site randomized controlled trial (RCT) to ensure that: the intervention meets the needs of the target population; the right outcomes are measured; and that the intervention is feasible to administer.

The objective of this study is to evaluate the feasibility of a Smartphone-delivered Peer-led Physical Activity Counselling (SPPAC) program for MWC users.


Eligibility criteria: Inclusion Criteria:

* live in the community
* have used a manual wheelchair for ≥ 1 year
* able to self-propel a manual wheelchair for at least 10m
* able to communicate in English or French
* have physical activity or mobility goals
* cognitively able to set goals (Mini-mental State Exam Score ≥ 25)

Exclusion Criteria:

* anticipate a health condition or procedure that contraindicates training (e.g., surgery scheduled which would impair physical activity)
* have a degenerative condition that is expected to progress quickly (e.g., Amyotrophic Lateral Sclerosis
* are concurrently or planning to receive manual wheelchair mobility training over the period of the study

Primary outcomes:
measure: Objective physical activity
timeFrame: Change in physical activity from baseline to post-intervention (10 weeks post-baseline) and at follow-up (3 months post-intervention
Secondary outcomes:
measure: Subjective physical activity (Leisure-Time Physical Activity Questionnaire (LTPA))
timeFrame: Change in LTPA from baseline to post-intervention (10 weeks post-baseline) and at follow-up (3 months post-intervention
measure: Wheelchair skills capacity and performance (Wheelchair Skills Test- Questionnaire (WST-Q))
timeFrame: Change in WST from baseline to post-intervention (10 weeks post-baseline) and at follow-up (3 months post-intervention
measure: Physical activity motivation (Behavioural Regulation in Exercise Questionnaire (BREQ-2))
timeFrame: Change in BREQ-2 from baseline to post-intervention (10 weeks post-baseline) and at follow-up (3 months post-intervention
measure: Perceived autonomy support (Health Care Climate Questionnaire (HCCQ))
timeFrame: Change in HCCQ from baseline to post-intervention (10 weeks post-baseline) and at follow-up (3 months post-intervention
measure: Satisfaction of psychological needs (Psychological Need Satisfaction in Exercise Scale (PNSES))
timeFrame: Change in PNSES from baseline to post-intervention (10 weeks post-baseline) and at follow-up (3 months post-intervention
measure: Self-efficacy to overcome barriers to leisure-time physical activity (Leisure-time Physical Activity Barrier Self-efficacy Scale)
timeFrame: Change in Self-efficacy to overcome barriers to leisure-time physical activity from baseline to post-intervention (10 weeks post-baseline) and at follow-up (3 months post-intervention
measure: Wheelchair use self-efficacy (Wheelchair Use Confidence Scale Short Form (WheelCon-SF))
timeFrame: Change in WheelCon-SF from baseline to post-intervention (10 weeks post-baseline) and at follow-up (3 months post-intervention
measure: Satisfaction with participation in physical activity using a wheelchair (Wheelchair Outcome Measure (WhOM))
timeFrame: Change in WhOM from baseline to post-intervention (10 weeks post-baseline) and at follow-up (3 months post-intervention
measure: Measure of self-efficacy in performing functional activities of daily living in individuals with Spinal Cord Injury (Moorong Self Efficacy Scale - MSES)
timeFrame: Change in MSES from baseline to post-intervention (10 weeks post-baseline) and at follow-up (3 months post-intervention
measure: Measure the degree to which individuals who have experienced traumatic or incapacitating illness achieve reintegration into normal social activities (Reintegration to Normal Living Index - RNLI)
timeFrame: Change in RNLI from baseline to post-intervention (10 weeks post-baseline) and at follow-up (3 months post-intervention
Other outcomes:
Locations:
city: Quebec
country: Canada
facility: Centre for Interdisciplinary Research in Rehabilitation and Social Integration
Study officials:
affiliation: Laval University
name: François Routhier, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Best KL, Routhier F, Sweet SN, Arbour-Nicitopoulos KP, Borisoff JF, Noreau L, Martin Ginis KA. The Smartphone Peer Physical Activity Counseling (SPPAC) Program for Manual Wheelchair Users: Protocol of a Pilot Randomized Controlled Trial. JMIR Res Protoc. 2017 Apr 26;6(4):e69. doi: 10.2196/resprot.7280.