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Patellofemoral Pain, PFPNCT07535866

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

A study testing Step Rate Increase + Load Reduction and Load Reduction Group in people with Patellofemoral Pain, PFP, run by Cardiff Metropolitan University at 1 site in United Kingdom.

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

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. Read more about this study

Who is it for?
Ages 18 to 45 years
Conditions the study is for
Patellofemoral Pain, PFP
What is being tested?
Step Rate Increase + Load Reduction and Load Reduction Group
Could I receive a placebo?
No, everyone receives an active treatment
How many people
52 participants
Where
1 siteUnited Kingdom
Study dates
3 Mar 2025to 21 Feb 2026
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 to 45 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site
  • Cardiff Metropolitan University

    Cardiff

Other trials in United Kingdom

About this study

Official title: 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:

Read more
  • 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.
Being tested
Step Rate Increase + Load Reduction, Load Reduction Group
Keywords
Patellofemoral pain, Running, Retraining, Step Rate, Kinesiophobia, Pain Catastrophising, Social Support, Function, Pain
Medical subject headings
Patellofemoral Pain Syndrome, Kinesiophobia, Pain

What participants receive

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

  • Step Rate Increase + Load ReductionBehavioural

    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 GroupBehavioural

    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.

Study groups in NCT07535866
Study groupRoleWhat they receive
Step Rate + Load Reduction GroupExperimentalThis group received an intervention that aimed to increase their step rate by 5% and instructions on reducing their running load.
Receives: Behavioral: Step Rate Increase + Load Reduction
Load Reduction GroupExperimentalRunners allocated to this group received instructions on reducing their running load.
Receives: Behavioral: Load Reduction Group
Control GroupNo interventionRunners assigned to this group were asked to continue their normal running routine for the duration of the intervention period.

What is being measured

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

  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.

    Measured: 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)
  1. 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.

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

  2. 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.

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

  3. 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.

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

  4. 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.

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

  5. 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.

    Measured: 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.

  6. 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.

    Measured: 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.

Timeline

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

  1. First posted17 Apr 2026
  2. Study start3 Mar 2025
  3. Primary completion21 Feb 2026
  4. Study completion21 Feb 2026

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
None (open label)
Enrolment
52 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07535866
Sponsor's protocol ID
PGR-10673
Status last verified
Apr 2026
First submitted
1 Apr 2026
Last updated
17 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: All IPD that will be shared will be de-identified and for manuscript and publishing purposes only.

Questions about this trial

What is this clinical trial studying?

A study testing Step Rate Increase + Load Reduction and Load Reduction Group in people with Patellofemoral Pain, PFP, run by Cardiff Metropolitan University at 1 site in United Kingdom.

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 5 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 17 Apr 2026. 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 United Kingdom. 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?

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

Where can I read the original study information?
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 17 Apr 2026.

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