Low Back PainNCT04752579
Effects of a Mat Pilates Exercise Program on Elderly Women With Chronic Nonspecific Low Back Pain
A study testing Pilates exercise program in people with Low Back Pain, run by Aristotle University Of Thessaloniki at 1 site in Greece.
Trial summary
The technique of Pilates exercises on a mat has proven to be effective and practically applicable to patients with chronic back pain. However, its application in women over 65 years has not been adequately studied. Read more about this study
- Who is it for?
- Ages 65 to 85 years, women only
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Pilates exercise program
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 63 participants
- Where
- 1 siteGreece
- Study dates
- 1 Jan 2021to 30 Dec 2021
- 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 65 to 85 years
- Women only
- No healthy volunteers
- Older adult
Who may be able to join
- Symptoms of chronic back pain lasting more than 12 weeks
- Score on the Visual Analog Scale for pain less than 70mm
- Timed Up and Go test score less than 15sec
Who cannot join
- Low back pain due to a serious pathology that refers to a red flag such as malignancy, vertebral fracture, osteomyelitis, rheumatoid arthritis, Cauda Equina Syndrome (CES)
- Participation in another exercise program in the last six months
- Diagnosed with neurodegenerative disease (e.g., Parkinson's disease)
- Recent stroke
- Senile dementia
Trial locations and contacts
1 site in 1 country.
Greece1 site
Department of Physical Education and Sports Sciences
Thessaloniki, Thermi, 57001
About this study
Official title: Effects of a Mat Pilates Exercise Program on Pain, Functional Ability and Balance in Elderly Women With Chronic Nonspecific Low Back Pain
The technique of Pilates exercises on a mat has proven to be effective and practically applicable to patients with chronic back pain. However, its application in women over 65 years has not been adequately studied.
Objective: This assessor-blind randomized clinical trial aims to study the effect of a mat Pilates exercise program on pain and functional ability of elderly women with chronic nonspecific low back pain.
Methods: 60 elderly women with chronic nonspecific low back pain (duration of symptoms more than 12 weeks) are expected to participate in this study. Participants will be divided into two groups of 30 people each; one being intervention and one control. The intervention group will follow a custom mat Pilates program (twice per week) for 10 weeks, while the control group will not follow any treatment. Pain, functionality, balance, the number of painkillers administered, and adherence to exercise will be assessed at the beginning and end of the study and will be re-examined six months later.
Read the detailed description
The technique of Pilates exercises on a mat has proven to be effective and practically applicable to patients with chronic back pain. However, its application in women over 65 years has not been adequately studied.
Objective: This assessor-blind randomized clinical trial aims to study the effect of a mat Pilates exercise program on pain and functional ability of elderly women with chronic nonspecific low back pain.
Methods: 60 non-active elderly women with chronic nonspecific low back pain (duration of symptoms more than 12 weeks) are expected to participate in this study. Participants will be divided into two groups of 30 people each; one being intervention and one control. The intervention group will follow a custom mat Pilates program (twice per week), while the control group will not follow any treatment. Primary outcomes will include pain with the visual analog scale for pain and functionality with the Roland-Morris Questionnaire (RMQ). Secondary outcomes will include the balance with the Berg balance scale and the Timed Up and Go test, the number of painkillers administered, and the adherence to the exercise that will be evaluated at the beginning and at the end of the study and re-evaluated six months after the end of the intervention. The treatment period will be 10 weeks.
- Conditions
- Low Back Pain
- Being tested
- Pilates exercise program
- Keywords
- Mat-pilates exercises, elderly, chronic low back pain, physical therapy, rehabilitation
- 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.
Pilates exercise programOther
The program will be individually supervised and will be conducted twice a week at the physiotherapy center.
- Slow execution of 7-10 repetitions of the following Pilates exercises: Pelvic Curl, Pilates Single Legs Lifts \& Leg Change, Twist Supine Pilates exercise, Chest Lifts Pilates Exercise, Chest Lift with Rotation Pilates exercise, 100's Prep Pilates Exercise, Single Leg Stretch Pilates Exercise, Front Support Pilates Exercise and Basic Back Extension Pilates Exercise. After the 6th week, while the person will be familiar with the basic exercises of the Pilates method the following exercises will be added: Leg Pull Front, Side Bend Pilates Exercise, Sphinx - Abdominal Lift Pilates Exercise, Shoulder Bridge Prep Pilates and Shoulder Bridge Pilates Exercise. Each session will be completed with breathing exercises and stretching exercises of the torso and lower limbs for 5 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Pilates exercise program | Experimental | Participants allocated to this group will receive a 10-week Pilates exercise program with each session having a duration of 45'. Receives: Other: Pilates exercise program |
| Control | Placebo comparator | Participants allocated to this group received general consulting instructions and a home-based general exercise sheet Receives: Other: Pilates exercise program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Low back pain intensity with the Visual Analogue Scale (VAS)
VAS is a card with an uncalibrated scale ranging from 0-100mm on the one side with each millimeter representing one pain level (0 representing no pain and 100 representing the worst pain in life). The patient subjectively estimated their pain level by marking a vertical line on the uncalibrated scale between 0 and 100.
Then the exact value of pain intensity could be obtained with a single ruler. Hence, the higher the value, the more intense the pain. VAS is widely used as it is easy to implement and is characterized by good psychometric propert
Measured: pre-treatment, Week: 10, 6-month follow-up
Changes in Roland Morris Disability Questionnaire
Disability associated with low back pain in the last 24 hours will be assessed using the Greek version of the Roland Morris Disability Questionnaire (Boscainos et al., 2003). This questionnaire has showed good test -retest reliability with intraclass correlation (ICC) ranging from 0.42 to 0.91 (Macedo et al., 2010), while Boscainos (2003), reports that the internal consistency reliability for the Greek version reached a Cronbach's alpha coefficient of 0.885. This questionnaire consists of 24 items that are related to daily activities which patients often report difficulty performing due to low back pain. Every positive answer earns a point and the final score is calculated by adding all the points. Thus, the higher the score is, the greater the limitation (Stratford, 1996).
Measured: pre-treatment, Week: 10, 6-month follow-up
Changes in Timed Up and Go (TUG) Test
The TUG test is a performance-based measure of functional mobility that was initially developed to identify mobility and dynamic balance impairments in older adults (Cameron and Monroe, 2007; Swearingen and Brach, 2001; Podsiadlo and Richardson, 1991). The TUG test has demonstrated high interrater and intrarater reliability when used to examine elderly adults (Cameron and Monroe, 2007; Swearingen and Brach, 2001). The test requires the subject to rise from a chair, walk three meters at a comfortable pace to a mark placed on the floor, turn around, walk back to the starting point, and return to sitting on the chair. The test's score is the time it takes the subject to complete the test.
Measured: pre-treatment, Week: 10, 6-month follow-up
Changes in Berg Balance Scale
The Berg balance scale is a tool suggested by Berg (Berg et al., 1989; Berg et al., 1992) to evaluate balance in the elderly. The test involves performing 14 tests of gradually increasing difficulty where in each one, the subject is asked to maintain a given position for a specific time or conduct specific tasks. Each of the 14 tests on the list is graded according to the balancing ability of the examinee from 0 to 4 points (with 0 indicating low balance ability while 4 high). Accord to Berg et al. (1992), a score of 56 indicates functional balance whereas a score lower than 45 indicates notable balance deficits, which have been related to increased fall risk.
Measured: pre-treatment, Week: 10, 6-month follow-up
Secondary outcomes (2)
Changes in the number of pills consumed via Pill Consumption Log
Participants will be asked to write down in a special diary the number of pills administered (anti-inflammatory and/or painkillers) during the follow-up period. The log will be kept kept on a weekly basis and the assessor will collect the data by phone 2-3 times a month.
Measured: pre-treatment, Month: 1,3,6, post-intervention
Changes in adherence to exercise via Exercise Diary keeping
After the ten weeks the participants of both groups will be asked to perform the specific exercise programs twice per week for a period of three months recording the adherence or not to the exercise programs in a weekly diary while the assessor will collect the data by phone 2-3 times a month.
Measured: Time Frame: pre-treatment, Month: 1,3,6, post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2021
- Study start1 Jan 2021
- Primary completion30 Dec 2021
- Study completion30 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Model description
- Parallel Assignment
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aristotle University Of Thessaloniki
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, LYTRAS DIMITRIOS, Aristotle University Of Thessaloniki
- Investigators
- Evaggelos Sykaras, PhD, Study director, Aristotle University Of Thessaloniki
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04752579
- Sponsor's protocol ID
- EC-48/2021
- Status last verified
- Jul 2023
- First submitted
- 9 Feb 2021
- Last updated
- 20 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lytras D, Iakovidis P, Sykaras E, Kottaras A, Kasimis K, Myrogiannis I, Barouxakis A, Tarfali G. Effects of a tailored mat-Pilates exercise program for older adults on pain, functioning, and balance in women with chronic non-specific low back pain: a randomized controlled trial. Aging Clin Exp Res. 2023 Dec;35(12):3059-3071. doi: 10.1007/s40520-023-02604-7. Epub 2023 Nov 7.
PubMed 37934400
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Mat Pilates Exercise Program on Pain, Functional Ability and Balance in Elderly Women With Chronic Nonspecific Low Back Pain
- ClinicalTrials.gov ID
- NCT04752579
- Acronym / sponsor ID
- EC-48/2021
- Conditions
- Low Back Pain
- Keywords
- Mat-pilates exercises, elderly, chronic low back pain, physical therapy, rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Aristotle University Of ThessalonikiUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 30 Dec 2021 (actual)
- Study completion
- 30 Dec 2021 (actual)
- First posted
- 12 Feb 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.
The technique of Pilates exercises on a mat has proven to be effective and practically applicable to patients with chronic back pain. However, its application in women over 65 years has not been adequately studied.
Objective: This assessor-blind randomized clinical trial aims to study the effect of a mat Pilates exercise program on pain and functional ability of elderly women with chronic nonspecific low back pain.
Methods: 60 elderly women with chronic nonspecific low back pain (duration of symptoms more than 12 weeks) are expected to participate in this study. Participants will be divided into two groups of 30 people each; one being intervention and one control. The intervention group will follow a custom mat Pilates program (twice per week) for 10 weeks, while the control group will not follow any treatment. Pain, functionality, balance, the number of painkillers administered, and adherence to exercise will be assessed at the beginning and end of the study and will be re-examined six months later.
Detailed description
The technique of Pilates exercises on a mat has proven to be effective and practically applicable to patients with chronic back pain. However, its application in women over 65 years has not been adequately studied.
Objective: This assessor-blind randomized clinical trial aims to study the effect of a mat Pilates exercise program on pain and functional ability of elderly women with chronic nonspecific low back pain.
Methods: 60 non-active elderly women with chronic nonspecific low back pain (duration of symptoms more than 12 weeks) are expected to participate in this study. Participants will be divided into two groups of 30 people each; one being intervention and one control. The intervention group will follow a custom mat Pilates program (twice per week), while the control group will not follow any treatment. Primary outcomes will include pain with the visual analog scale for pain and functionality with the Roland-Morris Questionnaire (RMQ). Secondary outcomes will include the balance with the Berg balance scale and the Timed Up and Go test, the number of painkillers administered, and the adherence to the exercise that will be evaluated at the beginning and at the end of the study and re-evaluated six months after the end of the intervention. The treatment period will be 10 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Parallel Assignment
| Arm | Type | Receives |
|---|---|---|
| Pilates exercise program | Experimental | Other: Pilates exercise programParticipants allocated to this group will receive a 10-week Pilates exercise program with each session having a duration of 45'. |
| Control | Placebo comparator | Other: Pilates exercise programParticipants allocated to this group received general consulting instructions and a home-based general exercise sheet |
Who may qualify
- Ages
- 65 to 85 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Symptoms of chronic back pain lasting more than 12 weeks
- Score on the Visual Analog Scale for pain less than 70mm
- Timed Up and Go test score less than 15sec
Key exclusion criteria (5 listed)
- Low back pain due to a serious pathology that refers to a red flag such as malignancy, vertebral fracture, osteomyelitis, rheumatoid arthritis, Cauda Equina Syndrome (CES)
- Participation in another exercise program in the last six months
- Diagnosed with neurodegenerative disease (e.g., Parkinson's disease)
- Recent stroke
- Senile dementia
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 |
|---|---|---|
| Pilates exercise programThe program will be individually supervised and will be conducted twice a week at the physiotherapy center. • Slow execution of 7-10 repetitions of the following Pilates exercises: Pelvic Curl, Pilates Single Legs Lifts \& Leg Change, Twist Supine Pilates exercise, Chest Lifts Pilates Exercise, Chest Lift with Rotation Pilates exercise, 100's Prep Pilates Exercise, Single Leg Stretch Pilates Exercise, Front Support Pilates Exercise and Basic Back Extension Pilates Exercise. After the 6th week, while the person will be familiar with the basic exercises of the Pilates method the following exercises will be added: Leg Pull Front, Side Bend Pilates Exercise, Sphinx - Abdominal Lift Pilates Exercise, Shoulder Bridge Prep Pilates and Shoulder Bridge Pilates Exercise. Each session will be completed with breathing exercises and stretching exercises of the torso and lower limbs for 5 minutes. | Other | Control, Pilates exercise program |
Primary outcome
Changes in Low back pain intensity with the Visual Analogue Scale (VAS)
Time frame: pre-treatment, Week: 10, 6-month follow-up
VAS is a card with an uncalibrated scale ranging from 0-100mm on the one side with each millimeter representing one pain level (0 representing no pain and 100 representing the worst pain in life). The patient subjectively estimated their pain level by marking a vertical line on the uncalibrated scale between 0 and 100. Then the exact value of pain intensity could be obtained with a single ruler. Hence, the higher the value, the more intense the pain. VAS is widely used as it is easy to implement and is characterized by good psychometric propert
Changes in Roland Morris Disability Questionnaire
Time frame: pre-treatment, Week: 10, 6-month follow-up
Disability associated with low back pain in the last 24 hours will be assessed using the Greek version of the Roland Morris Disability Questionnaire (Boscainos et al., 2003). This questionnaire has showed good test -retest reliability with intraclass correlation (ICC) ranging from 0.42 to 0.91 (Macedo et al., 2010), while Boscainos (2003), reports that the internal consistency reliability for the Greek version reached a Cronbach's alpha coefficient of 0.885. This questionnaire consists of 24 items that are related to daily activities which patients often report difficulty performing due to low back pain. Every positive answer earns a point and the final score is calculated by adding all the points. Thus, the higher the score is, the greater the limitation (Stratford, 1996).
Changes in Timed Up and Go (TUG) Test
Time frame: pre-treatment, Week: 10, 6-month follow-up
The TUG test is a performance-based measure of functional mobility that was initially developed to identify mobility and dynamic balance impairments in older adults (Cameron and Monroe, 2007; Swearingen and Brach, 2001; Podsiadlo and Richardson, 1991). The TUG test has demonstrated high interrater and intrarater reliability when used to examine elderly adults (Cameron and Monroe, 2007; Swearingen and Brach, 2001). The test requires the subject to rise from a chair, walk three meters at a comfortable pace to a mark placed on the floor, turn around, walk back to the starting point, and return to sitting on the chair. The test's score is the time it takes the subject to complete the test.
Changes in Berg Balance Scale
Time frame: pre-treatment, Week: 10, 6-month follow-up
The Berg balance scale is a tool suggested by Berg (Berg et al., 1989; Berg et al., 1992) to evaluate balance in the elderly. The test involves performing 14 tests of gradually increasing difficulty where in each one, the subject is asked to maintain a given position for a specific time or conduct specific tasks. Each of the 14 tests on the list is graded according to the balancing ability of the examinee from 0 to 4 points (with 0 indicating low balance ability while 4 high). Accord to Berg et al. (1992), a score of 56 indicates functional balance whereas a score lower than 45 indicates notable balance deficits, which have been related to increased fall risk.
2 secondary outcomes
Changes in the number of pills consumed via Pill Consumption Log
Time frame: pre-treatment, Month: 1,3,6, post-intervention
Changes in adherence to exercise via Exercise Diary keeping
Time frame: Time Frame: pre-treatment, Month: 1,3,6, post-intervention
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 20 Jul 2023.
- Derived from this study: PubMed 37934400Lytras D, Iakovidis P, Sykaras E, Kottaras A, Kasimis K, Myrogiannis I, Barouxakis A, Tarfali G. Effects of a tailored mat-Pilates exercise program for older adults on pain, functioning, and balance in women with chronic non-specific low back pain: a randomized controlled trial. Aging Clin Exp Res. 2023 Dec;35(12):3059-3071. doi: 10.1007/s40520-023-02604-7. Epub 2023 Nov 7.
- 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.
Evaggelos Sykaras, PhD study director
Aristotle University Of Thessaloniki
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pilates exercise program in people with Low Back Pain, run by Aristotle University Of Thessaloniki at 1 site in Greece.
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 3 inclusion and 5 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 20 Jul 2023. 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 Greece. 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. Some participants in this study may receive a placebo. 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?
Changes in Low back pain intensity with the Visual Analogue Scale (VAS) (time frame: pre-treatment, Week: 10, 6-month follow-up). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04752579, which also lists 1 linked publication.
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 20 Jul 2023.