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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:
Participants will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Load Reduction Group | Experimental | Runners allocated to this group received instructions on reducing their running load. |
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| Control Group | No Intervention | Runners assigned to this group were asked to continue their normal running routine for the duration of the intervention period. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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. |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cardiff Metropolitan University | Cardiff | United Kingdom |
All IPD that will be shared will be de-identified and for manuscript and publishing purposes only.
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| ID | Term |
|---|---|
| D046788 | Patellofemoral Pain Syndrome |
| D000092442 | Kinesiophobia |
| D010146 | Pain |
| ID | Term |
|---|---|
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D010698 | Phobic Disorders |
| D001008 | Anxiety Disorders |
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| 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. |
|
| 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. |
| D001523 |
| Mental Disorders |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |