Low Back PainPilates-LBPNCT07596602
Machine-Based Pilates on Quality of Life and Low Back Pain in Older Adults
A study testing Machine-Based Classical Pilates Program in people with Low Back Pain and Aging, run by Instituto Politécnico de Leiria at 1 site in Portugal.
Trial summary
Chronic low back pain is one of the most prevalent and debilitating conditions among older adults, often compromising physical function and overall quality of life. Structured physical exercise, particularly the Pilates method, is widely recommended for managing this condition. Read more about this study
- Who is it for?
- Ages 55 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Low Back Pain, Aging, Quality of Life
- What is being tested?
- Machine-Based Classical Pilates Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 sitePortugal
- Study dates
- 21 Oct 2024to 30 Jan 2025
- 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 55 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- Uncontrolled hypertension.
- Active oncological treatment.
- Physical therapy treatment for low back pain within the six months prior to the study.
Trial locations and contacts
1 site in 1 country.
Portugal1 site
Instituto Politécnico de Leiria
Leiria, Leiria District, 2411-901
About this study
Official title: 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
Chronic low back pain is one of the most prevalent and debilitating conditions among older adults, often compromising physical function and overall quality of life. Structured physical exercise, particularly the Pilates method, is widely recommended for managing this condition. However, existing literature primarily focuses on younger populations using mat-based group classes. This pilot study utilizes an exploratory mixed-methods design to investigate the feasibility and preliminary outcomes of a 12-week individualized, machine-based Classical Pilates program on quality of life and low back pain in active older adults (aged 55 to 75 years). Participants will complete 24 individual sessions (twice a week). The aim is to assess changes in physical domains of quality of life and perceived low back pain intensity, while gathering qualitative contextual insights on body awareness and psychosocial well-being.
Read the 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.
- Conditions
- Low Back Pain, Aging, Quality of Life
- Being tested
- Machine-Based Classical Pilates Program
- Keywords
- Quality of Life, Low Back Pain, Pilates, Active Aging, Individualized Training
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Machine-Based Classical Pilates ProgramBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Machine-Based Pilates Group | Experimental | 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. Receives: Behavioral: Machine-Based Classical Pilates Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Quality of Life
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.
Measured: Baseline (Week 0) and Post-Intervention (Week 13).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2026
- Study start21 Oct 2024
- Primary completion30 Jan 2025
- Study completion30 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back PainStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All eligible participants are assigned to a single experimental arm to receive the 12-week machine-based Pilates intervention.
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto Politécnico de Leiria
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Filipe Fernandes Rodrigues, Instituto Politécnico de Leiria
- Investigators
- José Carlos Laranjo Marques, Study director, ESECS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07596602
- Sponsor's protocol ID
- CE/IPLEIRIA/62/2023
- Acronym
- Pilates-LBP
- Status last verified
- May 2026
- First submitted
- 13 May 2026
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be available on request from the corresponding author due to privacy and ethical restrictions.
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07596602
- Acronym / sponsor ID
- Pilates-LBP / CE/IPLEIRIA/62/2023
- Conditions
- Low Back Pain, Aging, Quality of Life
- Keywords
- Quality of Life, Low Back Pain, Pilates, Active Aging, Individualized Training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Instituto Politécnico de LeiriaUniversity, hospital or other
- Study start
- 21 Oct 2024 (actual)
- Primary completion
- 30 Jan 2025 (actual)
- Study completion
- 30 Jan 2025 (actual)
- First posted
- 19 May 2026 (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.
Chronic low back pain is one of the most prevalent and debilitating conditions among older adults, often compromising physical function and overall quality of life. Structured physical exercise, particularly the Pilates method, is widely recommended for managing this condition. However, existing literature primarily focuses on younger populations using mat-based group classes. This pilot study utilizes an exploratory mixed-methods design to investigate the feasibility and preliminary outcomes of a 12-week individualized, machine-based Classical Pilates program on quality of life and low back pain in active older adults (aged 55 to 75 years). Participants will complete 24 individual sessions (twice a week). The aim is to assess changes in physical domains of quality of life and perceived low back pain intensity, while gathering qualitative contextual insights on body awareness and psychosocial well-being.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All eligible participants are assigned to a single experimental arm to receive the 12-week machine-based Pilates intervention.
| Arm | Type | Receives |
|---|---|---|
| Machine-Based Pilates Group | Experimental | Behavioral: Machine-Based Classical Pilates ProgramA 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. |
Who may qualify
- Ages
- 55 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
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 |
|---|---|---|
| Machine-Based Classical Pilates ProgramA 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. | Behavioural | Machine-Based Pilates Group |
Primary outcome
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.
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 22 May 2026.
- Individual participant dataSharing planned: Yes. Data will be available on request from the corresponding author due to privacy and ethical restrictions.
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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.
José Carlos Laranjo Marques study director
ESECS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Machine-Based Classical Pilates Program in people with Low Back Pain and Aging, run by Instituto Politécnico de Leiria at 1 site in Portugal.
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 4 inclusion and 9 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 22 May 2026. 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 Portugal. 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?
Change in Quality of Life (time frame: Baseline (Week 0) and Post-Intervention (Week 13).). 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 22 May 2026.