Main
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
|
ClinicalTrials.gov |
Last refreshed on:
|
12 December 2020 |
Main ID: |
NCT03082651 |
Date of registration:
|
13/03/2017 |
Prospective Registration:
|
No |
Primary sponsor: |
|
Public title:
|
Alternate Run Study
|
Scientific title:
|
Investigating the Effect of Alternating Training Load and Footwear Singly or in Combination in Runners: The Alternate Run Study |
Date of first enrolment:
|
August 1, 2016 |
Target sample size:
|
300 |
Recruitment status: |
Completed |
URL:
|
https://clinicaltrials.gov/show/NCT03082651 |
Study type:
|
Interventional |
Study design:
|
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: None (Open Label).
|
Phase:
|
N/A
|
|
Countries of recruitment
|
Canada
| | | | | | | |
Key inclusion & exclusion criteria
|
Inclusion Criteria:
- Subjects in this study will include adults (men and women) between the ages of 19 and
60, have been running on a regular basis (minimum once per week) over the past 6
months, are able to run for 60 minutes continuously, could tolerate 20-40km per week
in training, and have not experienced a running related injury requiring a stoppage of
2-weeks or more in the past 6 months. Only neutral and pronated foot postures (Foot
Posture Index between -2 and 8) will be recruited
Exclusion Criteria:
- have a history of surgery to their plantar fascia or Achilles tendon,
- have a diagnosis of osteoarthritis - or other degenerative musculoskeletal disorder -
affecting the lower extremity,
- take analgesic or anti-inflammatory medication 2 or more times per week over the past
4 weeks,
- take part in high impact activities 2 or more times per week during the study period
Age minimum:
19 Years
Age maximum:
60 Years
Gender:
All
|
Health Condition(s) or Problem(s) studied
|
Overuse Injury
|
Intervention(s)
|
Other: Constant training
|
Other: Alternating footwear
|
Other: Alternating run training load
|
Other: Constant footwear
|
Primary Outcome(s)
|
Running injuries
[Time Frame: 13-weeks]
|
Secondary Outcome(s)
|
Running-related pain
[Time Frame: 13-weeks]
|
Footwear comfort
[Time Frame: 13-weeks]
|
Region specific running-related pain
[Time Frame: 13-weeks]
|
Run Quality
[Time Frame: 13-weeks]
|
Secondary ID(s)
|
H16-00858
|
Source(s) of Monetary Support
|
Please refer to primary and secondary sponsors
|
Results
|
Results available:
|
|
Date Posted:
|
|
Date Completed:
|
|
URL:
|
|
|
|