Low Back PainNCT06943066
Pilates Exercises on Pain, Fatigue, Endurance, and Muscle Strength in Non-Specific Low Back Pain
A study testing Reformer Pilates and online pilates in people with Low Back Pain, run by Istanbul Medipol University Hospital at 1 site in Turkey (Türkiye).
Trial summary
Pilates exercises administered under the supervision of a physiotherapist on pain, endurance, and muscle strength in individuals with non-specific low back pain, and to determine which program is more beneficial and reliable. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Reformer Pilates and online pilates
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 6 Apr 2025to 7 Jul 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Aged between 18 and 60 years
- Non-specific low back pain for more than 12 weeks
- No clear pathological diagnosis
- Physically and cognitively capable of performing the exercises
- Pain level between 3 and 7 on the Visual Analog Scale (VAS) Exclusion Criteria
- Pregnancy
Show all 9Show fewer
- Spinal surgery in the last 6 months
- Neurological or chronic systemic diseases
- Movement restriction due to severe pain
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of Pilates Exercises on Pain, Fatigue, Endurance, and Muscle Strength in Individuals With Non-Specific Low Back Pain
Pilates exercises administered under the supervision of a physiotherapist on pain, endurance, and muscle strength in individuals with non-specific low back pain, and to determine which program is more beneficial and reliable.
Read the detailed description
The aim of this study is to compare the effects of different types of Pilates exercises administered under the supervision of a physiotherapist on pain, endurance, and muscle strength in individuals with non-specific low back pain, and to determine which program is more beneficial and reliable.
- Conditions
- Low Back Pain
- Being tested
- Reformer Pilates, Pilates control, online pilates
- Keywords
- exercise
- Medical subject headings
- Low Back Pain, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reformer PilatesOther
Reformer Pilates
Pilates controlOther
Pilates control
online pilatesOther
online pilates
| Study group | Role | What they receive |
|---|---|---|
| Reformer Pilates | Experimental | Not described Receives: Other: Reformer Pilates |
| Pilates control | Active comparator | Not described Receives: Other: Pilates control |
| online pilates | Active comparator | Not described Receives: Other: online pilates |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale
A 10-cm line where participants mark their pain intensity, ranging from 'no pain' to 'worst pain'.
Measured: 12 weeks
Oswestry Disability Index
A 10-section questionnaire evaluating the impact of back pain on daily activities. maximum point 56
Measured: 12 weeks
Fatigue Severity Scale
A 9-item self-report scale where participants rate how fatigue affects their daily life on a 1-7 scale.
Measured: 12 weeks
Heart Rate Variability
Measured using the Polar H10 sensor to evaluate autonomic nervous system activity during rest and activity.
Measured: 12 weeks
Trunk Flexor and Extensor Endurance Tests:
Time-based static hold tests assessing core stabilization ability in flexion and extension positions.
Measured: 12 weeks
Plank Test
Participant holds a forearm plank position, and the time until fatigue or form loss is recorded to assess core endurance.
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 posted24 Apr 2025
- Study start6 Apr 2025
- Primary completion6 Jun 2025
- Study completion7 Jul 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Medipol University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, hazal genc, Istanbul Medipol University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06943066
- Sponsor's protocol ID
- 2024-04-06
- Status last verified
- Aug 2025
- First submitted
- 17 Apr 2025
- Last updated
- 12 Aug 2025
- 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 12 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Pilates Exercises on Pain, Fatigue, Endurance, and Muscle Strength in Individuals With Non-Specific Low Back Pain
- ClinicalTrials.gov ID
- NCT06943066
- Acronym / sponsor ID
- 2024-04-06
- Conditions
- Low Back Pain
- Keywords
- exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Istanbul Medipol University HospitalUniversity, hospital or other
- Study start
- 6 Apr 2025 (actual)
- Primary completion
- 6 Jun 2025 (actual)
- Study completion
- 7 Jul 2025 (actual)
- First posted
- 24 Apr 2025 (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.
Pilates exercises administered under the supervision of a physiotherapist on pain, endurance, and muscle strength in individuals with non-specific low back pain, and to determine which program is more beneficial and reliable.
Detailed description
The aim of this study is to compare the effects of different types of Pilates exercises administered under the supervision of a physiotherapist on pain, endurance, and muscle strength in individuals with non-specific low back pain, and to determine which program is more beneficial and reliable.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Reformer Pilates | Experimental | Other: Reformer Pilates |
| Pilates control | Active comparator | Other: Pilates control |
| online pilates | Active comparator | Other: online pilates |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Aged between 18 and 60 years
- Non-specific low back pain for more than 12 weeks
- No clear pathological diagnosis
- Physically and cognitively capable of performing the exercises
- Pain level between 3 and 7 on the Visual Analog Scale (VAS) Exclusion Criteria
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Reformer PilatesReformer Pilates | Other | Reformer Pilates |
| Pilates controlPilates control | Other | Pilates control |
| online pilatesonline pilates | Other | online pilates |
Primary outcome
Visual Analog Scale
Time frame: 12 weeks
A 10-cm line where participants mark their pain intensity, ranging from 'no pain' to 'worst pain'.
Oswestry Disability Index
Time frame: 12 weeks
A 10-section questionnaire evaluating the impact of back pain on daily activities. maximum point 56
Fatigue Severity Scale
Time frame: 12 weeks
A 9-item self-report scale where participants rate how fatigue affects their daily life on a 1-7 scale.
Heart Rate Variability
Time frame: 12 weeks
Measured using the Polar H10 sensor to evaluate autonomic nervous system activity during rest and activity.
Trunk Flexor and Extensor Endurance Tests:
Time frame: 12 weeks
Time-based static hold tests assessing core stabilization ability in flexion and extension positions.
Plank Test
Time frame: 12 weeks
Participant holds a forearm plank position, and the time until fatigue or form loss is recorded to assess core endurance.
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 12 Aug 2025.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Reformer Pilates and online pilates in people with Low Back Pain, run by Istanbul Medipol University Hospital at 1 site in Turkey (Türkiye).
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 9 inclusion and 0 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 12 Aug 2025. 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 Turkey (Türkiye). 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?
Visual Analog Scale (time frame: 12 weeks). The study lists 6 primary outcomes in all. 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 12 Aug 2025.