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Completed

NCT Number: NCT07535866

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.

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Key information

Conditions

Patellofemoral Pain, PFP Anxiety Disorders Joint Diseases Kinesiophobia Mental Disorders Musculoskeletal Diseases Neurologic Manifestations Pain Patellofemoral Pain Syndrome Pathological Conditions, Signs and Symptoms Phobic Disorders Signs and Symptoms

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cardiff Metropolitan University

Cardiff, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Step Rate Increase + Load Reduction

Behavioral

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.

Load Reduction Group

Behavioral

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.

Primary outcomes

  1. Knee Pain

    Time frame: 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.

    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.

Secondary outcomes

  1. Knee Function

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

    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.

  2. Kinesiophobia

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

    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.

  3. Pain Catastrophising

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

    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.

  4. Social Support

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

    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.

  5. Running Load Metrics

    Time frame: 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.

    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.

  6. Step Rate

    Time frame: 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.

    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.

Sponsors and collaborators

Lead sponsor

Cardiff Metropolitan University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Apr 17, 2026
Registry last updated
Apr 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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