NCT07535866

Brief Summary

The goal of this clinical trial is to explore two remote running programs in runners with patellofemoral pain. One program asks runners to increase their step rate and reduce their training load, while the other asks runners to only reduce their training load. The study will compare these two programs with a control group who continue running as usual. It will also examine whether changes in running load and psychosocial factors are related to changes in pain and function. The main questions it aims to answer are:

  • Can these remote running programs reduce knee pain and improve function in runners with patellofemoral pain compared to the control group?
  • Is reducing training load plus increasing step rate more effective than reducing training load alone?
  • Are changes in running load, step rate, psychological and social factors related to improvements in pain and function? Researchers will compare a step rate increase plus load reduction group, a load reduction only group, and a control group to see which approach leads to the greatest improvements in pain and function. Participants will:
  • Complete online questionnaires about knee pain, knee function, and related psychosocial factors
  • Share running load data from their watch using an online platform
  • Follow 4 weeks of instructions based on their assigned group
  • Complete follow-up surveys 1, 2 and 6 months after the 4-week intervention period.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
52

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2025

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

March 3, 2025

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 21, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 21, 2026

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 1, 2026

Completed
16 days until next milestone

First Posted

Study publicly available on registry

April 17, 2026

Completed
Last Updated

April 17, 2026

Status Verified

April 1, 2026

Enrollment Period

12 months

First QC Date

April 1, 2026

Last Update Submit

April 10, 2026

Conditions

Keywords

Patellofemoral painRunningRetrainingStep RateKinesiophobiaPain CatastrophisingSocial SupportFunctionPain

Outcome Measures

Primary Outcomes (1)

  • Knee Pain

    Knee pain was assessed on a visual analogue scale of 0-100 with "0" corresponding to "no pain, and a "100" corresponding to "worst imaginable pain". Participants were asked to rate their knee pain from the previous week during running, usual and worst.

    This was measured at pre-intervention, after week 1, week 2, week 3, week 4 (immediately after the intervention) and at 1-, 2-, 6-months follow up.

Secondary Outcomes (6)

  • Knee Function

    This was measured at pre-intervention, after week 4 (immediately after the intervention) and at 1-, 2-, 6-months follow up.

  • Kinesiophobia

    This was measured at pre-intervention, after week 4 (immediately after the intervention) and at 1-, 2-, 6-months follow up.

  • Pain Catastrophising

    This was measured at pre-intervention, after week 4 (immediately after the intervention) and at 1-, 2-, 6-months follow up.

  • Social Support

    This was measured at pre-intervention, after week 4 (immediately after the intervention) and at 1-, 2-, 6-months follow up.

  • Running Load Metrics

    Running load data was collected throughout the study period. Summaries of 4-week periods were reported at pre-intervention, after week 4 (immediately after the intervention) and at 1-, 2-, 6-months follow up.

  • +1 more secondary outcomes

Study Arms (3)

Step Rate + Load Reduction Group

EXPERIMENTAL

This group received an intervention that aimed to increase their step rate by 5% and instructions on reducing their running load.

Behavioral: Step Rate Increase + Load Reduction

Load Reduction Group

EXPERIMENTAL

Runners allocated to this group received instructions on reducing their running load.

Behavioral: Load Reduction Group

Control Group

NO INTERVENTION

Runners assigned to this group were asked to continue their normal running routine for the duration of the intervention period.

Interventions

Runners in this group were advised on how to increase (5%) their step rate during running. During week 1 of the intervention runners in this group were advised to use a metronome while running to match their footfalls to the beat. The metronome was set at a rate of their baseline step rate plus 5% (e.g. a pre-intervention step rate of 160 would lead to the metronome being set at 168). During week 2 runners were advised to try running with the increased step rate without the metronome and just using their running device to monitor. They were advised to use the metronome if they felt it was necessary to maintain the step rate change. During week 3 participants were advised to monitor the step rate increase with the running device. Finally, during week 4 participants were asked to only monitor step rate post run. Runners in this group also received the same advice as the load reduction only group on reducing their training load.

Step Rate + Load Reduction Group

Runners allocated to the LR group were advised to reduce their weekly running load during the 4-week intervention period. They were asked to decrease their total running volume to reduce their knee pain to 20 out of 100 (by reducing duration and distance of runs). No specific quantity of volume reduction was imposed. They were asked to avoid running that involves inclines and declines. They were asked to avoid speed sessions in their weekly running. Runners were instructed to maintain a pain level at no more than 20 out of 100 VAS when running. If pain remained below this level, they were advised to gradually increase their running load the following week.

Load Reduction Group

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • currently running more than twice a week and ≥ 30 mins in total per week.
  • participants were required to have pain behind or adjacent to the patella (of at least 20 out of 100 pain on a 0-100 visual analogue scale from "no pain" to "worst imaginable pain") whilst running.
  • participants were required to experience low level pain (at least 20 out of 100 on a visual analogue) during one or more of the following activities: squatting, kneeling, prolonged sitting, walking up or downstairs.
  • duration of patellofemoral pain symptoms was required to be 3 months or greater prior to participation.
  • participants were required to have a compatible running watch that they were happy to onboard to DashLX to share their running load metrics
  • be willing to take part in a study that may ask them to alter their running load.

You may not qualify if:

  • currently suffering from any lower limb injuries (e.g. to hip, knee, calf, foot etc) or having sustained any such injury in the past 3 months
  • currently undergoing any other forms of treatment for the knee pain
  • having a neurological impediment affecting gait
  • currently pregnant or within 3 months of giving birth
  • suffer from any cardiovascular pathology

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cardiff Metropolitan University

Cardiff, United Kingdom

Location

MeSH Terms

Conditions

Patellofemoral Pain SyndromeKinesiophobiaPain

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal DiseasesPhobic DisordersAnxiety DisordersMental DisordersNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prinicipal Investigator

Study Record Dates

First Submitted

April 1, 2026

First Posted

April 17, 2026

Study Start

March 3, 2025

Primary Completion

February 21, 2026

Study Completion

February 21, 2026

Last Updated

April 17, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will share

All IPD that will be shared will be de-identified and for manuscript and publishing purposes only.

Locations