Evaluation of a Smartphone-delivered Peer-led Physical Activity Counselling Program for Manual Wheelchair Users (ALLWheel)

• ClinicalTrials.gov Identifier: NCT02826707
• Recruitment Status: Recruiting
• First Posted: July 11, 2016
• Last Update Posted: March 23, 2022
• Sponsor: Laval University
• Collaborator: McGill University
• Information provided by (Responsible Party): Krista Best, Laval University

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Physical Activity	Behavioral: SPPAC intervention	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 54 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Feasibility Evaluation of a Smartphone-delivered Peer-led Physical Activity Counselling Program for Improving Physical Activity in Manual Wheelchair Users
• Actual Study Start Date: February 7, 2019
• Estimated Primary Completion Date: September 2022
• Estimated Study Completion Date: December 2022

Arms and Interventions

Arm	Intervention/treatment
Experimental: SPPAC intervention; Smartphone-delivered peer-led physical activity counselling	Behavioral: SPPAC intervention; A peer coach will deliver a physical activity counselling intervention using a Smartphone. Individualized programs will be based on participants physical activity/wheelchair mobility goals.
No Intervention: Control group; Pragmatic no-contact control group

Outcome Measures

Primary Outcome Measures :

1. Objective physical activity [ Time Frame: Change in physical activity from baseline to post-intervention (10 weeks post-baseline) and at follow-up (3 months post-intervention ]
   Physical activity will be measured objectively using Actigraphy, a small, lightweight accelerometry-based tri-axial activity monitor (Actigraph 3GTX) that is worn on the wrist and MWC without impeding bodily movements or PA. Information about motion direction and speed are integrated to produce an electrical current with variable magnitude and duration. The electrical current data are stored in the monitor as 'activity counts.'

Secondary Outcome Measures :

1. Subjective physical activity (Leisure-Time Physical Activity Questionnaire (LTPA)) [ Time Frame: Change in LTPA from baseline to post-intervention (10 weeks post-baseline) and at follow-up (3 months post-intervention ]
   Self-reported frequency (number of bouts) and duration (min per bout) of light, moderate and heavy intensity PA over the past 7 days.
2. Wheelchair skills capacity and performance (Wheelchair Skills Test- Questionnaire (WST-Q)) [ Time Frame: Change in WST from baseline to post-intervention (10 weeks post-baseline) and at follow-up (3 months post-intervention ]
   Subjective evaluation of the skills capacity and performance of 32 manual wheelchair skills.
3. Physical activity motivation (Behavioural Regulation in Exercise Questionnaire (BREQ-2)) [ Time Frame: Change in BREQ-2 from baseline to post-intervention (10 weeks post-baseline) and at follow-up (3 months post-intervention ]
   Subjective evaluation of motivation for physical activity is measured using 5 subscales of regulation: external, introjected identified, intrinsic and amotivation.
4. Perceived autonomy support (Health Care Climate Questionnaire (HCCQ)) [ Time Frame: Change in HCCQ from baseline to post-intervention (10 weeks post-baseline) and at follow-up (3 months post-intervention ]
   Subjective evaluation of perceived autonomy support
5. Satisfaction of psychological needs (Psychological Need Satisfaction in Exercise Scale (PNSES)) [ Time Frame: Change in PNSES from baseline to post-intervention (10 weeks post-baseline) and at follow-up (3 months post-intervention ]
   Subjective evaluation of satisfaction of psychological needs (i.e. autonomy, competence, relatedness) for physical activity will be measured only in the intervention group.
6. Self-efficacy to overcome barriers to leisure-time physical activity (Leisure-time Physical Activity Barrier Self-efficacy Scale) [ Time Frame: 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 ]
   Subjective evaluation of self-efficacy to overcome salient barriers to physical activity participation (e.g. when faced with transportation problems, bad weather, pain and fatigue).
7. Wheelchair use self-efficacy (Wheelchair Use Confidence Scale Short Form (WheelCon-SF)) [ Time Frame: Change in WheelCon-SF from baseline to post-intervention (10 weeks post-baseline) and at follow-up (3 months post-intervention ]
   Subjective evaluation of situations that challenge self-efficacy while using a manual wheelchair.
8. Satisfaction with participation in physical activity using a wheelchair (Wheelchair Outcome Measure (WhOM)) [ Time Frame: Change in WhOM from baseline to post-intervention (10 weeks post-baseline) and at follow-up (3 months post-intervention ]
   A semi-structured interview that allows participants to select important physical activity/wheelchair mobility participation goals. The importance and current level of satisfaction is evaluated.
9. Measure of self-efficacy in performing functional activities of daily living in individuals with Spinal Cord Injury (Moorong Self Efficacy Scale - MSES) [ Time Frame: Change in MSES from baseline to post-intervention (10 weeks post-baseline) and at follow-up (3 months post-intervention ]
   Subjective evaluation of self-efficacy in carrying out activities of daily living. Minimum value 1 and maximum value 7. A higher score indicates a higher perceived self efficacy.
10. 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) [ Time Frame: Change in RNLI from baseline to post-intervention (10 weeks post-baseline) and at follow-up (3 months post-intervention ]
    Subjective evaluation of the reintegration to normal living activities

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Contacts

Contact: Krista Best, PhD; +1 778-846-8390; krista-lynn.best.1@ulaval.ca

Locations

Canada

Centre for Interdisciplinary Research in Rehabilitation and Social Integration; Recruiting

Quebec, Canada, G1M 2S8

Contact: Krista L Best, PhD krista-lynn.best.1@ulaval.ca

Contact: Caroline Rahn, MSc caroline.rahn.ciussscn@ssss.gouv.qc.ca

Principal Investigator: Francois Routhier, PhD

Principal Investigator: Krista L Best, PhD

Sponsors and Collaborators

Laval University

McGill University

Investigators

• Principal Investigator: François Routhier, PhD; Laval University

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Krista Best, Assistant Professor/ Researcher, Laval University
• ClinicalTrials.gov Identifier: NCT02826707
• Other Study ID Numbers: SPPAC2016
• First Posted: July 11, 2016
• Last Update Posted: March 23, 2022
• Last Verified: March 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No