NCT02826707

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 31, 2016

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 11, 2016

Completed
2.6 years until next milestone

Study Start

First participant enrolled

February 7, 2019

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2023

Completed
Last Updated

July 19, 2024

Status Verified

July 1, 2024

Enrollment Period

4.1 years

First QC Date

May 31, 2016

Last Update Submit

July 17, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (10)

  • Subjective physical activity (Leisure-Time Physical Activity Questionnaire (LTPA))

    Change in LTPA from baseline to post-intervention (10 weeks post-baseline) and at follow-up (3 months post-intervention

  • Wheelchair skills capacity and performance (Wheelchair Skills Test- Questionnaire (WST-Q))

    Change in WST from baseline to post-intervention (10 weeks post-baseline) and at follow-up (3 months post-intervention

  • Physical activity motivation (Behavioural Regulation in Exercise Questionnaire (BREQ-2))

    Change in BREQ-2 from baseline to post-intervention (10 weeks post-baseline) and at follow-up (3 months post-intervention

  • Perceived autonomy support (Health Care Climate Questionnaire (HCCQ))

    Change in HCCQ from baseline to post-intervention (10 weeks post-baseline) and at follow-up (3 months post-intervention

  • Satisfaction of psychological needs (Psychological Need Satisfaction in Exercise Scale (PNSES))

    Change in PNSES from baseline to post-intervention (10 weeks post-baseline) and at follow-up (3 months post-intervention

  • +5 more secondary outcomes

Study Arms (2)

SPPAC intervention

EXPERIMENTAL

Smartphone-delivered peer-led physical activity counselling

Behavioral: SPPAC intervention

Control group

NO INTERVENTION

Pragmatic no-contact control group

Interventions

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.

SPPAC intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre for Interdisciplinary Research in Rehabilitation and Social Integration

Québec, G1M 2S8, Canada

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • François Routhier, PhD

    Laval University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor/ Researcher

Study Record Dates

First Submitted

May 31, 2016

First Posted

July 11, 2016

Study Start

February 7, 2019

Primary Completion

March 31, 2023

Study Completion

March 31, 2023

Last Updated

July 19, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations