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

Physical Activity Clinical Trial

— ALLWheel  

Official title:

Feasibility Evaluation of a Smartphone-delivered Peer-led Physical Activity Counselling Program for Improving Physical Activity in Manual Wheelchair Users

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02826707
• Other study ID #: SPPAC2016
• Status: Recruiting
• Phase: N/A
• Start date: February 7, 2019
• Est. completion date: December 2022

Study information

• Verified date: March 2022
• Source: Laval University
• Contact: Krista Best, PhD
• Phone: +1 778-846-8390
• Email: krista-lynn.best.1[@]ulaval.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 54
• Est. completion date: December 2022
• Est. primary completion date: September 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Physical Activity

Intervention

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.

Locations

Country	Name	City	State
Canada	Centre for Interdisciplinary Research in Rehabilitation and Social Integration	Quebec

Sponsors (2)

Lead Sponsor	Collaborator
Laval University	McGill University

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective physical activity	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.'	Change in physical activity from baseline to post-intervention (10 weeks post-baseline) and at follow-up (3 months post-intervention
Secondary	Subjective physical activity (Leisure-Time Physical Activity Questionnaire (LTPA))	Self-reported frequency (number of bouts) and duration (min per bout) of light, moderate and heavy intensity PA over the past 7 days.	Change in LTPA from baseline to post-intervention (10 weeks post-baseline) and at follow-up (3 months post-intervention
Secondary	Wheelchair skills capacity and performance (Wheelchair Skills Test- Questionnaire (WST-Q))	Subjective evaluation of the skills capacity and performance of 32 manual wheelchair skills.	Change in WST from baseline to post-intervention (10 weeks post-baseline) and at follow-up (3 months post-intervention
Secondary	Physical activity motivation (Behavioural Regulation in Exercise Questionnaire (BREQ-2))	Subjective evaluation of motivation for physical activity is measured using 5 subscales of regulation: external, introjected identified, intrinsic and amotivation.	Change in BREQ-2 from baseline to post-intervention (10 weeks post-baseline) and at follow-up (3 months post-intervention
Secondary	Perceived autonomy support (Health Care Climate Questionnaire (HCCQ))	Subjective evaluation of perceived autonomy support	Change in HCCQ from baseline to post-intervention (10 weeks post-baseline) and at follow-up (3 months post-intervention
Secondary	Satisfaction of psychological needs (Psychological Need Satisfaction in Exercise Scale (PNSES))	Subjective evaluation of satisfaction of psychological needs (i.e. autonomy, competence, relatedness) for physical activity will be measured only in the intervention group.	Change in PNSES from baseline to post-intervention (10 weeks post-baseline) and at follow-up (3 months post-intervention
Secondary	Self-efficacy to overcome barriers to leisure-time physical activity (Leisure-time Physical Activity Barrier Self-efficacy Scale)	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).	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
Secondary	Wheelchair use self-efficacy (Wheelchair Use Confidence Scale Short Form (WheelCon-SF))	Subjective evaluation of situations that challenge self-efficacy while using a manual wheelchair.	Change in WheelCon-SF from baseline to post-intervention (10 weeks post-baseline) and at follow-up (3 months post-intervention
Secondary	Satisfaction with participation in physical activity using a wheelchair (Wheelchair Outcome Measure (WhOM))	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.	Change in WhOM from baseline to post-intervention (10 weeks post-baseline) and at follow-up (3 months post-intervention
Secondary	Measure of self-efficacy in performing functional activities of daily living in individuals with Spinal Cord Injury (Moorong Self Efficacy Scale - MSES)	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.	Change in MSES from baseline to post-intervention (10 weeks post-baseline) and at follow-up (3 months post-intervention
Secondary	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)	Subjective evaluation of the reintegration to normal living activities	Change in RNLI from baseline to post-intervention (10 weeks post-baseline) and at follow-up (3 months post-intervention