CClinicalTrials.gg
CompletedNCT04815980Updated Mar 25, 2021

Impact of Pilates on Running Mechanics

An interventional study of Exercise in Strength, Exercise and Knee Injuries, sponsored by University of the Incarnate Word. Completed at 1 site in United States. Open to participants aged 18 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-03-25.

Sponsored by University of the Incarnate Word · Not applicable, Interventional, and Screening

From the registry’s dates

  • Registered 11 years 6 months after the study started (first participant enrolled Sep 2009, registered Mar 2021).
Phase
Not applicable
Study type
Interventional
Enrollment
34
Allocation
Randomized
Ages
18 Years to 35 Years
Sex
All
01

Study summary

INTRODUCTION: Core strengthening, balance, and flexibility programs such as Pilates have been advocated to affect running mechanics and prevent lower extremity injuries positively. The purpose of this study was to assess the effects of a 12-week mat-based Pilates exercise program on dynamic knee valgus alignment in runners.

METHODS: Thirty-four young male and female adults performed a running protocol at baseline. The protocol consisted of the participants running on a treadmill at a constant five miles per hour (mph) for four minutes. Post-examination, participants were randomly assigned to a Pilates or control group (n=16 and n=18, respectively). A certified Pilates instructor gave the Pilates group a 12-week home-based program. To ensure participants in the Pilates group performed exercises correctly, the Pilates instructor conducted the first session, and provided feedback to each participant. Participants in both groups performed the same running testing protocol every four weeks. Knee valgus was measured as the medial displacement of the knee joint center during the running stance phase. Repeated measures Analysis of Variance (RepANOVA) was calculated at baseline and 4-, 8-, and 12-weeks post examinations to compare knee valgus during running.

Read the detailed description

Study Design and Participants A 12-week randomized controlled trial using a mat-based Pilates core-strengthening exercise program was conducted involving thirty-four young, healthy adults. Twenty men (mean ± SD; height: 171.77 ± 9.42 cm; weight: 72.59 ± 8.99 kg; BMI: 24.99 ± 2.10 kg/m2) and fourteen women (mean ± SD; height: 158.46 ± 2.96 cm; weight: 53.70 ± 2.45 kg; BMI: 21.81 ± 1.37 kg/m2) completed this study. All participants were over 18 and signed a written informed consent document approved by the Institutional Review Board. Inclusion criteria included no history of injury in the preceding six months, no history of lower extremity surgeries, and a generally healthy state. Before involvement in the main trials, each participant's height, body mass, leg length, pelvis, knee, and ankle width were measured according to the motion analysis software computerized model (Vicon Plugin Gait Model, Vicon Motion Inc., Denver, CO).

Procedures Participants reported to the laboratory having refrained from strenuous exercise during the preceding 48 hours. A running protocol was conducted four times during this study: at baseline, and at the fourth, eighth, and twelfth weeks. Participants underwent a standardized warm-up session running at four miles per hour (mph) on a treadmill for five minutes before progressively increasing the intensity to five mph without any inclination for another four minutes. To measure dynamic knee valgus during each session, a 3-dimensional high-speed (240 Hz) system (Vicon Motion Inc., Denver, CO) was used during the running protocol, emphasizing the running cycle's stance phase to measure medial knee displacement. For each participant, 3D kinematics were recorded for the dominant leg throughout the stance phase during the running protocol execution. The dominant leg was defined as the preferred leg to perform a single leg jump. Medial knee displacement was defined as the medial trajectory difference traveled by the knee joint center from initial contact to push-off, identified by two footswitches (500Hz; Delsys, Inc, Boston, MA) placed on the plantar aspect of the calcaneus and hallux. Three-dimensional data and pressure from the footswitches were real-timed synchronized in the motion analysis software (Vicon Nexus software, Vicon Motion Inc., Denver, CO).

Once baseline measurements were recorded, the participants were randomly assigned to either a home-based Pilates intervention or a control group. The Pilates intervention consisted of a warm-up, seven strengthening exercises, and a cool-down. The frequency of the program was three times a week, performing each exercise once for 15 repetitions. Participants in the Pilates group performed their first session with a certified Pilates instructor to ensure appropriate technique was performed. The control group was encouraged to continue their daily routine and not engage in additional physical activity or exercise. At the fourth and eighth weeks, the Pilates program's difficulty level increased by progressing to more challenging exercises.

Data Analysis T-tests were performed at baseline for anthropometrics and valgus variables to ensure both groups were homogenous. A 2 x 4 (group x time) repeated measures ANOVA (RepANOVA) was used to evaluate dynamic knee valgus changes. Group by time interaction and within and between main effects were separately assessed regardless of the interaction being significant based on recommendations by Wei et al. 2012 (Wei et al., 2012). Given the pilot nature of this investigation, an alpha level of p ≥ 0.05 was considered statistically significant for all analyses. SPSS version 26 (IBM SPSS, Armonk, New York) was used for statistical analyses.

02

Conditions studied

  • Strength
  • Exercise
  • Knee Injuries

Browse trials for

Keywords

  • Pilates
  • Running
  • Knee
03

In context

Knee Injuries

249 studies on the registry are indexed under Knee Injuries; 48 are open to participants now.

This study's enrollment of 34 is below the median of 50 across 160 interventional studies indexed under Knee Injuries.

Browse Knee Injuries studies →

Lead sponsor

University of the Incarnate Word is the lead sponsor of 15 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 35 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • over 18 years of age
  • generally healthy state

Exclusion criteria

Exclusion Criteria:

  • no history of injury in the preceding six months
  • no history of lower extremity surgeries
05

Study design

Phase
Not applicable
Primary purpose
Screening
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
34 participants (actual)

Study arms

  • No intervention
    Control

    The control group performed no Pilates intervention. They continued with their typical activities of daily living.

  • Experimental
    Pilates

    Participants in this group performed a 30 minute mat-based Pilates intervention 3 times/week for 12 weeks.

    Other: Exercise

Interventions

  • OtherExercise

    Home-based mat-based Pilates intervention 3 times a week for 12 weeks prepared by a certified Pilates instructor.

06

What researchers measure

Primary outcomes

  1. Knee Valgus

    Medial displacement of the knee from the moment of foot strike to push-off

    Time frame: 12 weeks

07

Study locations

1 site
  • University of The Incarnate Word
    San Antonio, Texas 78209, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 25, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04815980
Lead sponsor
University of the Incarnate Word
Responsible party
Alexis Ortiz (Professor, University of the Incarnate Word) — Principal investigator
First posted
Mar 25, 2021
Start date
Sep 8, 2009
Primary completion
Sep 10, 2010
Completion
Sep 10, 2010
Last update
Mar 25, 2021

Study contacts

Alexis Ortiz, PhD
principal investigator · University of the Incarnate Word

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion