Remote Step Rate and Load Based Interventions in Runners With Patellofemoral Pain

Randomised Control Trial of Remote Step Rate and Load Based Interventions in Runners With Patellofemoral Pain

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.

Study Overview

• Status: Completed
• Conditions: Patellofemoral Pain, PFP
• Intervention / Treatment: Behavioral: Step Rate Increase + Load Reduction; Behavioral: Load Reduction Group

• Study Type: Interventional
• Enrollment (Actual): 52
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Cardiff, United Kingdom
    • Cardiff Metropolitan University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Step Rate + Load Reduction Group; 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; 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.
Experimental: Load Reduction Group; Runners allocated to this group received instructions on reducing their running load.	Behavioral: 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.
No Intervention: Control Group; Runners assigned to this group were asked to continue their normal running routine for the duration of the intervention period.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Knee Function	Knee function was reported using the patellofemoral pain and osteoarthritis subscale of the knee injury and osteoarthritis outcome score (KOOS-PF; 11-item). Scores can range from 0-100, with higher scores indicating better function.	This was measured at pre-intervention, after week 4 (immediately after the intervention) and at 1-, 2-, 6-months follow up.
Kinesiophobia	The 11-item TAMPA scale of kinesiophobia was used to assess fear of movement. Each item is scored on a 4-point likert scale, with a higher score indicating greater kinesiophobia.	This was measured at pre-intervention, after week 4 (immediately after the intervention) and at 1-, 2-, 6-months follow up.
Pain Catastrophising	Pain catastrophising was measured using the 13-item pain catastrophising scale. It has 3 subdomains of rumination, magnification and helplessness. Scores can range from 0-52, with higher scores indicating higher amounts of 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	Received social support was measured using a 5-point likert scale for each of the 4 domains of social support (esteem, emotional, tangible, informational). Participants were asked to rate "the extent to which you have actually received the following types of support in relation to your knee pain during the previous 4 weeks". The minimum value was 0 and maximum was 4 for each domain. Higher scores indicated participants had received more 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	Participants were also required to sign their running watch up to the online platform DashLX to share running load metrics. A pre-study snapshot of the previous 12-weeks before starting was used to establish baseline running load. Then, all runs during the study period were shared in order to record running load metrics throughout participation in the study. To assess running load, cumulative 4-week running distance was calculated, which was the sum of the distance covered (km) during all runs in the four weeks prior to the data collection timepoint (pre-intervention, post-intervention and 1-month, 2-month and 6-month follow up). Weekly data was also reported.	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.
Step Rate	Participants were also required to sign their running watch up to the online platform DashLX to share running load metrics. A pre-study snapshot of the previous 12-weeks before starting was used to establish baseline step rate. Then, all runs during the study period were shared in order to record running step rate throughout participation in the study. To monitor step rate, the mean step rate from all runs during each period was computed. Weekly data was also reported.	Step rate 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.

Collaborators and Investigators

• Sponsor: Cardiff Metropolitan University

Study record dates

Study Major Dates

• Study Start (Actual): March 3, 2025
• Primary Completion (Actual): February 21, 2026
• Study Completion (Actual): February 21, 2026

Study Registration Dates

• First Submitted: April 1, 2026
• First Submitted That Met QC Criteria: April 10, 2026
• First Posted (Actual): April 17, 2026

Study Record Updates

• Last Update Posted (Actual): April 17, 2026
• Last Update Submitted That Met QC Criteria: April 10, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Pain; Function; Kinesiophobia; Social Support; Running; Retraining; Patellofemoral pain; Step Rate; Pain Catastrophising
• Additional Relevant MeSH Terms: Neurologic Manifestations; Musculoskeletal Diseases; Mental Disorders; Joint Diseases; Phobic Disorders; Anxiety Disorders; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Kinesiophobia; Pain; Patellofemoral Pain Syndrome
• Other Study ID Numbers: PGR-10673

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All IPD that will be shared will be de-identified and for manuscript and publishing purposes only.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No