NCT04815980

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2009

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 8, 2009

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 10, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 10, 2010

Completed
10.5 years until next milestone

First Submitted

Initial submission to the registry

March 22, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 25, 2021

Completed
Last Updated

March 25, 2021

Status Verified

March 1, 2021

Enrollment Period

1 year

First QC Date

March 22, 2021

Last Update Submit

March 22, 2021

Conditions

Keywords

PilatesRunningKnee

Outcome Measures

Primary Outcomes (1)

  • Knee Valgus

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

    12 weeks

Study Arms (2)

Control

NO INTERVENTION

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

Pilates

EXPERIMENTAL

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

Other: Exercise

Interventions

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

Pilates

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • over 18 years of age
  • generally healthy state

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of The Incarnate Word

San Antonio, Texas, 78209, United States

Location

MeSH Terms

Conditions

Motor ActivityKnee Injuries

Interventions

Exercise

Condition Hierarchy (Ancestors)

BehaviorLeg InjuriesWounds and Injuries

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Alexis Ortiz, PhD

    University of the Incarnate Word

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
PARALLEL
Model Details: Two groups randomized; no-exercise control vs. Pilates exercise group.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 22, 2021

First Posted

March 25, 2021

Study Start

September 8, 2009

Primary Completion

September 10, 2010

Study Completion

September 10, 2010

Last Updated

March 25, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

Locations