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Physical ActivityALLWheelNCT02826707

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

A study testing SPPAC intervention in people with Physical Activity, run by Laval University at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Physical Activity
What is being tested?
SPPAC intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteCanada
Study dates
7 Feb 2019to 31 Mar 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • Centre for Interdisciplinary Research in Rehabilitation and Social Integration

    Québec, G1M 2S8

Other trials in Canada

About this study

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

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.

Being tested
SPPAC intervention
Medical subject headings
Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SPPAC interventionBehavioural

    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.

Study groups in NCT02826707
Study groupRoleWhat they receive
SPPAC interventionExperimentalSmartphone-delivered peer-led physical activity counselling
Receives: Behavioral: SPPAC intervention
Control groupNo interventionPragmatic no-contact control group

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.'

    Measured: Change in physical activity from baseline to post-intervention (10 weeks post-baseline) and at follow-up (3 months post-intervention

Secondary outcomes (10)

  1. 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.

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

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

    Subjective evaluation of the skills capacity and performance of 32 manual wheelchair skills.

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

  3. 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.

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

  4. Perceived autonomy support (Health Care Climate Questionnaire (HCCQ))

    Subjective evaluation of perceived autonomy support

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

  5. 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.

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

  6. 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).

    Measured: 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

  7. 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.

    Measured: Change in WheelCon-SF from baseline to post-intervention (10 weeks post-baseline) and at follow-up (3 months post-intervention

  8. 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.

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

  9. 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.

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

  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)

    Subjective evaluation of the reintegration to normal living activities

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Jul 2016 (estimated)
  2. Study start7 Feb 2019
  3. Primary completion31 Mar 2023
  4. Study completion31 Mar 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02826707
Sponsor's protocol ID
SPPAC2016
Acronym
ALLWheel
Status last verified
Jul 2024
First submitted
31 May 2016
Last updated
19 Jul 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 28446419

Questions about this trial

What is this clinical trial studying?

A study testing SPPAC intervention in people with Physical Activity, run by Laval University at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02826707, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jul 2024.

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