NCT05713656

Brief Summary

Background Cycling is a very popular activity and has various health benefits. Knee pain is very common among recreational cyclists and often limits cyclists to perform their sport. Physiotherapy care including a bike fit is often a recommended treatment for cyclists with knee pain. Objective The aim of this proposal is to prospectively describe physiotherapy care (bike fit, education and exercises) and evaluate change in knee-related pain and disability among recreational cyclists with knee pain. Methods In this prospective observational study, 70 recreational cyclists consulting for knee pain at Physiovélo will be recruited. Physiovélo is a physiotherapy clinic specialized in bike fitting and in the assessment of cyclists with musculoskeletal disorders. Main findings from the bike fit assessment as well as interventions provided in terms of bike fit adjustment, education, advice and exercises will be collected. Various outcomes related to cycling such as cycling distance per week will also be collected. The primary outcome will knee pain during cycling measured with the numerical pain rating scale (NPRS, 0-10). Secondary outcomes will include disability measured with the Knee Outcome Survey of the Activities of Daily Living Scale (KOS-ADLS) and with a modified version of the Knee Outcome Survey Sports Activities Scale (KOS-SAS) for cyclist. Satisfaction with care will be measured with the visit-specific satisfaction questionnaire (VSQ-9). Adverse events related to the interventions will be collected. Outcomes will be collected on initial assessment and at 4 and 12 weeks after the consultation. Intention-to-treat analyses will be performed.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
76

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2023

Shorter than P25 for all trials

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

Study Start

First participant enrolled

January 4, 2023

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

January 26, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

February 6, 2023

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2024

Completed
Last Updated

September 19, 2024

Status Verified

September 1, 2024

Enrollment Period

12 months

First QC Date

January 26, 2023

Last Update Submit

September 10, 2024

Conditions

Outcome Measures

Primary Outcomes (2)

  • Knee pain during cycling numeric pain rating scale

    Worst, least \& average combined (0-10; 0=better)

    4 weeks (change from baseline)

  • Knee pain during cycling numeric pain rating scale

    Worst, least \& average combined (0-10; 0=better)

    12 weeks (change from baseline)

Secondary Outcomes (15)

  • Current knee pain numeric pain rating scale

    4 weeks (change from baseline)

  • Current knee pain numeric pain rating scale

    12 weeks (change from baseline)

  • Knee Outcome Survey of the Activities of Daily Living Scale

    4 weeks (change from baseline)

  • Knee Outcome Survey of the Activities of Daily Living Scale

    12 weeks (change from baseline)

  • Knee Outcome Survey Sports Activities Scale (adapted for cyclists)

    4 weeks (change from baseline)

  • +10 more secondary outcomes

Study Arms (1)

Physiotherapy and bikefit

Physiotherapy care including a bike fit, education and exercises provided by a physiotherapist with a BikePT bronze to gold certification.

Other: Physiotherapy care

Interventions

Physiotherapy care including a bike fit, education and exercises provided by a physiotherapist with a BikePT bronze to gold certification.

Physiotherapy and bikefit

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult cyclists with knee pain

You may qualify if:

  • cyclists with knee pain
  • consulting for a BikeFit at Physiovélo for the first time
  • at least 18 years old
  • legally able to consent
  • understand and speak French or English

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinique Physiovélo

Longueuil, Quebec, J4R 2T4, Canada

Location

MeSH Terms

Conditions

Knee Injuries

Condition Hierarchy (Ancestors)

Leg InjuriesWounds and Injuries

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 26, 2023

First Posted

February 6, 2023

Study Start

January 4, 2023

Primary Completion

January 1, 2024

Study Completion

January 1, 2024

Last Updated

September 19, 2024

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will not share

Data will be made available upon resonable request.

Locations