- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07596602
Machine-Based Pilates on Quality of Life and Low Back Pain in Older Adults (Pilates-LBP)
Feasibility and Preliminary Outcomes of a Machine-Based Pilates Program on Quality of Life and Low Back Pain in Aged Adults: A Mixed-Methods Approach
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The study is designed as an exploratory, quasi-experimental, single-arm pilot study. Participants presenting with moderate disability caused by low back pain (Oswestry Disability Index = 21% to 40%) will undergo a structured exercise protocol utilizing the Classical Pilates method on machines in a one-on-one setting. The intervention spans 12 weeks, consisting of two individual 50-minute sessions per week.
The pedagogical structure is divided into two distinct Classical approach components: the "Skeleton" (core base exercises on the Reformer and Mat) and the "System" (adaptations and specific exercises on auxiliary equipment like the Wunda Chair, Cadillac, and Barrels). Exercise progression is individualized based on biomechanical control, absence of pain, and ability to maintain a neutral lumbopelvic position. Resistance is modified primarily via adjustable springs on the equipment. Exercise intensity is strictly monitored using the Talk Test to ensure a light-to-moderate exertion level suitable for the geriatric demographic.
Assessments are conducted at baseline and post-intervention (12 weeks) using the WHOQOL-Bref for quality of life and the Oswestry Disability Index Version 2.0 for low back pain disability. Additionally, a qualitative focus group will be conducted post-intervention with a subsample of participants to capture contextual insights regarding mobility, psychosocial benefits, and daily habit integration.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Leiria District
-
Leiria, Leiria District, Portugal, 2411-901
- Instituto Politécnico de Leiria
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Aged between 55 and 75 years.
- Physically active in daily routines.
- No previous experience with machine-based Pilates.
- Presenting with moderate disability (Oswestry Disability Index = 21% to 40%) caused by low back pain.
Exclusion Criteria:
- Absolute contraindications to physical exercise.
- Severe spinal pathologies (e.g., hernias requiring surgery, severe osteoporosis, idiopathic scoliosis).
- Previous or scheduled spinal surgeries.
- Severe disability (Oswestry Disability Index > 41%).
- Chronic obstructive pulmonary disease.
- Recent stroke or myocardial infarction.
- Uncontrolled hypertension.
- Active oncological treatment.
- Physical therapy treatment for low back pain within the six months prior to the study.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Machine-Based Pilates Group
A 12-week program consisting of two individual 50-minute sessions per week.
The protocol integrates "Skeleton" exercises (Mat and Reformer) and "System" exercises (auxiliary equipment).
The periodization varies the positional stimulus (starting on Mat for the first 6 weeks, and starting on Reformer for the final 6 weeks).
Intensity is maintained at a light-to-moderate level, monitored continuously via the Talk Test.
|
A 12-week program consisting of two individual 50-minute sessions per week.
The protocol integrates "Skeleton" exercises (Mat and Reformer) and "System" exercises (auxiliary equipment).
The periodization varies the positional stimulus (starting on Mat for the first 6 weeks, and starting on Reformer for the final 6 weeks).
Intensity is maintained at a light-to-moderate level, monitored continuously via the Talk Test.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Quality of Life
Time Frame: Baseline (Week 0) and Post-Intervention (Week 13).
|
Assessed using the World Health Organization Quality of Life Brief (WHOQOL-Bref) questionnaire.
It evaluates four domains: physical, psychological, social relationships, and environment.
Responses for each item are recorded on a five-point scale ranging from 1 (minimum) to 5 (maximum), and the total domain scores are transformed to a 0 to 100 scale, where 0 is the minimum possible score and 100 is the maximum possible score.
Higher scores indicate a better perceived quality of life.
|
Baseline (Week 0) and Post-Intervention (Week 13).
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: José Carlos Laranjo Marques, ESECS
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CE/IPLEIRIA/62/2023
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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