- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06409858
Efficacy Testing of Les Mills Pilates
May 9, 2024 updated by: Gillian Hatfield, University of the Fraser Valley
Objectives: Determine the effect of an 8-week intervention of the new group fitness program Les Mills Pilates on balance, core stability, abdominal, back, and hip muscle endurance, flexibility, and mood.
Research questions: Does doing Les Mills Pilates twice per week for 8 weeks result in: 1) increased balance, 2) increased core stability, 3) increased abdominal, back, and hip muscle endurance, 4) increased flexibility, and 5) improved mood? Intended outcomes: this study will determine the efficacy of a new group fitness program developed by Les Mills International.
Results will be used to help refine the program, as well as in marketing of the program.
Study Overview
Study Type
Interventional
Enrollment (Estimated)
25
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Gillian L Hatfield, PhD
- Phone Number: 2217 604-504-7441
- Email: gillian.hatfield@ufv.ca
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Not participating in regular core training (no more than 10 minutes per session, twice per week)
- Active (150 minutes per week of moderate to vigorous physical activity)
Exclusion Criteria:
- any neurological, cardiovascular, or musculoskeletal conditions that would put them at risk while participating, or be made worse by exercise
- Participants with current lower back pain
- Pregnant participants
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intervention group
All participants will receive twice weekly Pilates classes for 8 weeks
|
Twice-weekly mat Pilates class for 8 weeks, either in person or online (depending on participant availability)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Core endurance (time to failure in seconds)
Time Frame: 8 weeks
|
Endurance of the core muscles- abdominals, back extensors, hip extensors, quadriceps- time to hold a plank (abdominals), biering-sorenson test (back extensors), unilateral hip bridge (hip extensors), wall sit (quadriceps) will be recorded.
Participants will hold each position until failure.
Higher times to reach failure indicate more endurance (better value).
|
8 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Balance (single leg reach distance in cm)
Time Frame: 8 weeks
|
Y-balance test- distance in cm.
Higher distances are better outcomes.
|
8 weeks
|
|
Core stability: Sahrmann trunk stability test
Time Frame: 8 weeks
|
Sahrmann trunk stability test- maximum level participants can perform with neutral lumbar spine.
Level 1 (minimum value) to Level 5 (maximum value).
Higher scores are better outcome.
|
8 weeks
|
|
Flexibility in cm
Time Frame: 8 weeks
|
Forward reach test.
Participants sit with legs extended and reach forward as far as they can.
Reach distance is measured.
Higher scores are better outcome (more flexibility).
|
8 weeks
|
|
Mood
Time Frame: Daily for 8 weeks
|
Perceived motivation, stress and fatigue on 0 (minimum value) -5 (maximum value) Likert scale, where higher numbers indicate more motivation (better outcome), stress (worst outcome), or fatigue (worse outcome)
|
Daily for 8 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Gillian L Hatfield, PhD, University of the Fraser Valley
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
May 1, 2024
Primary Completion (Estimated)
August 16, 2024
Study Completion (Estimated)
August 16, 2024
Study Registration Dates
First Submitted
May 3, 2024
First Submitted That Met QC Criteria
May 7, 2024
First Posted (Actual)
May 10, 2024
Study Record Updates
Last Update Posted (Actual)
May 13, 2024
Last Update Submitted That Met QC Criteria
May 9, 2024
Last Verified
May 1, 2024
More Information
Terms related to this study
Other Study ID Numbers
- 101548
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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