StrengthNCT04815980
Impact of Pilates on Running Mechanics
A study testing Exercise in people with Strength and Exercise, run by University of the Incarnate Word at 1 site in United States.
Trial summary
INTRODUCTION: Core strengthening, balance, and flexibility programs such as Pilates have been advocated to affect running mechanics and prevent lower extremity injuries positively. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Strength, Exercise, Knee Injuries
- What is being tested?
- Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Sep 2009to 10 Sep 2010
- 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 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- over 18 years of age
- generally healthy state
Who cannot join
- no history of injury in the preceding six months
- no history of lower extremity surgeries
Trial locations and contacts
1 site in 1 country.
United States1 site
University of The Incarnate Word
San Antonio, Texas, 78209
About this study
Official title: Impact of Pilates Mat-Based Exercises on Knee Kinematics During Running
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.
- Conditions
- Strength, Exercise, Knee Injuries
- Being tested
- Exercise
- Keywords
- Pilates, Running, Knee
- Medical subject headings
- Motor Activity, Knee Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseOther
Home-based mat-based Pilates intervention 3 times a week for 12 weeks prepared by a certified Pilates instructor.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knee Valgus
Medial displacement of the knee from the moment of foot strike to push-off
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2021
- Study start8 Sep 2009
- Primary completion10 Sep 2010
- Study completion10 Sep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrengthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two groups randomized; no-exercise control vs. Pilates exercise group.
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of the Incarnate Word
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alexis Ortiz, University of the Incarnate Word
- Investigators
- Alexis Ortiz, PhD, Principal investigator, University of the Incarnate Word
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04815980
- Sponsor's protocol ID
- A4160108
- Status last verified
- Mar 2021
- First submitted
- 22 Mar 2021
- Last updated
- 25 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Pilates Mat-Based Exercises on Knee Kinematics During Running
- ClinicalTrials.gov ID
- NCT04815980
- Acronym / sponsor ID
- A4160108
- Conditions
- Strength, Exercise, Knee Injuries
- Keywords
- Pilates, Running, Knee
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- University of the Incarnate WordUniversity, hospital or other
- Study start
- 8 Sep 2009 (actual)
- Primary completion
- 10 Sep 2010 (actual)
- Study completion
- 10 Sep 2010 (actual)
- First posted
- 25 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Two groups randomized; no-exercise control vs. Pilates exercise group.
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –The control group performed no Pilates intervention. They continued with their typical activities of daily living. |
| Pilates | Experimental | Other: ExerciseParticipants in this group performed a 30 minute mat-based Pilates intervention 3 times/week for 12 weeks. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- over 18 years of age
- generally healthy state
Key exclusion criteria (2 listed)
- no history of injury in the preceding six months
- no history of lower extremity surgeries
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ExerciseHome-based mat-based Pilates intervention 3 times a week for 12 weeks prepared by a certified Pilates instructor. | Other | Pilates |
Primary outcome
Knee Valgus
Time frame: 12 weeks
Medial displacement of the knee from the moment of foot strike to push-off
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alexis Ortiz, PhD principal investigator
University of the Incarnate Word
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise in people with Strength and Exercise, run by University of the Incarnate Word at 1 site in United States.
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 2 inclusion and 2 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 25 Mar 2021. 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 States. 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 Valgus (time frame: 12 weeks). 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 25 Mar 2021.