Low Back PainNCT02729779
Effectiveness of the Pilates Method Versus Aerobic Exercises in Elderly With Low Back Pain
A study testing Pilates Group and Aerobic Group in people with Low Back Pain, run by Universidade Cidade de Sao Paulo at 1 site in Brazil.
Trial summary
Chronic low back pain is potentially disabling for the elderly, and physical exercises are considered the best treatment for this problem. The Pilates method has been proven effective in the improvement of pain and function in patients with low back pain. Read more about this study
- Who is it for?
- Ages 65 to 85 years
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Pilates Group and Aerobic Group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Apr 2017to 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
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Elderly complaining of non-specific low back pain for more than three months
- Pain intensity equal to or more than 3 points evaluated by the Pain Numerical Rating Scale in the last seven days.
Who cannot join
- Contraindication to physical exercise;
- Back with severe disease (fractures, tumors, inflammatory diseases, ankylosing spondylitis and nerve root compromise confirmed by neurological tests);
- Previous or scheduled back surgery ;
- Severe cardiorespiratory disease;
- Cancer;
- Cognitive impairment;
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- Dependent gait;
- Patients who underwent physical therapy for low back pain in the last six months;
- Regular physical activity practitioners.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of the Pilates Method Versus Aerobic Exercises in the Treatment of Chronic Non-specific Low Back Pain in the Elderly: Randomized Controlled Trial
Chronic low back pain is potentially disabling for the elderly, and physical exercises are considered the best treatment for this problem. The Pilates method has been proven effective in the improvement of pain and function in patients with low back pain. However, the evidence about the effectiveness of Pilates method in the treatment of elderly patients with low back pain is scarce. Thus, the aim of this study is to investigate the effectiveness of the Pilates method compared to aerobic exercise in elderly with chronic non-specific low back pain. This randomized controlled trial with two arms and blinded assessor will include 74 patients aged between 65 and 85 years, of both sexes, complaining of chronic non-specific low back pain persisting for more than three months and pain intensity greater than 3 points in the Pain Numerical Rating Scale. The elderly will be randomized into two groups: Pilates Group (n = 37) with exercises based on Pilates method; and Aerobic Group (n = 37) with aerobic exercises, stretching and relaxation. Both groups will hold treatment twice a week with duration of 60 minutes for eight weeks. The primary outcomes will be: pain intensity and general disability assessed eight weeks after randomization. Secondary outcomes will be: pain intensity and general disability evaluated six months after randomization; global impression of improvement, specific disability and dynamic balance, muscle strength of the gluteus maximus, gluteus medius and lateral hip rotators and pressure pain threshold evaluated eight weeks and six months after randomization. We expect that the results of this study contribute to the clinical decision-making with respect to pain reduction and, consequently, improving balance and functionality of elderly with chronic low back pain.
- Conditions
- Low Back Pain
- Being tested
- Pilates Group, Aerobic Group
- 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 GroupOther
Elderly will be submitted to a specific exercise program of modified Pilates method performed in the mat and apparatus. In the first session, participants will receive basic guidance on the Pilates training and activation of the power house. The session will be divided in: global warming and stretching (5 minutes), Pilates exercises for upper and lower limbs, abdomen and spine (45 minutes), global stretching (5 minutes) and local relaxing massage (5 minutes).The session will consist of a minimum of 5 exercises and a maximum of 15 Pilates exercises. The elderly will receive 16 individual sessions with duration of 60 minutes, twice a week, with a total of eight weeks of treatment.
Aerobic GroupOther
Elderly will be submitted to an exercise program with global stretching (for lower and upper limbs and column with two repetitions and 30 seconds of maintenance in each segment) for 10 minutes, walking on a treadmill for 20 to 40 minutes, and relaxing massage for 5 minutes. The intensity of the effort during walking on a treadmill will be based on a combination of heart rate (based on the percentage of maximum heart rate: 208 - (0.7 x age)) and rate of perceived effort assessed by the Borg scale. Exercise will be performed respecting the fraction of 50-75% of maximum heart rate and levels between 12 to 13 (moderate intensity) of the Borg scale. The elderly will receive 16 individual sessions with duration of 60 minutes, twice a week, with a total of eight weeks of treatment.
| Study group | Role | What they receive |
|---|---|---|
| Pilates Group | Experimental | Elderly will be submitted to a specific exercise program of modified Pilates method performed in the mat and apparatus. In the first session, participants will receive basic guidance on the Pilates training and activation of the power house. The session will be divided in: global warming and stretching (5 minutes), Pilates exercises for upper and lower limbs, abdomen and spine (45 minutes), global stretching (5 minutes) and local relaxing massage (5 minutes).The session will consist of a minimum of 5 exercises and a maximum of 15 Pilates exercises. The elderly will receive 16 individual sessions with duration of 60 minutes, twice a week, with a total of eight weeks of treatment. Receives: Other: Pilates Group |
| Aerobic Group | Active comparator | The Aerobic Group will be submitted to an exercise program with global stretching (for lower and upper limbs and column with two repetitions and 30 seconds of maintenance in each segment) for 10 minutes, walking on a treadmill for 20 to 40 minutes and relaxing massage for 5 minutes. The intensity of the effort during walking on a treadmill will be based on a combination of heart rate (based on the percentage of maximum heart rate: 208 - (0.7 x age)) and rate of perceived effort assessed by the Borg scale. Exercise will be performed respecting the fraction of 50-75% of maximum heart rate and levels between 12 to 13 (moderate intensity) of the Borg scale. The elderly will receive 16 individual sessions with duration of 60 minutes, twice a week, with a total of eight weeks of treatment. Receives: Other: Aerobic Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity
Pain intensity will be measured by an 11-point Pain Numerical Rating Scale
Measured: Eight weeks after randomization
Disabitity
Disability associated with low back pain will be measured using the 24-item Roland Morris Disability Questionnaire
Measured: Eight weeks after randomization
Secondary outcomes (8)
Pain intensity
Pain intensity will be measured by an 11-point Pain Numerical Rating Scale
Measured: Six months after randomization
Disability
Disability associated with low back pain will be measured using the 24-item Roland Morris Disability Questionnaire
Measured: Six months after randomization
Global impression of improvement
Global impression of improvement will be measured by an 11-point Global Perceived Effect Scale
Measured: Eight weeks and six months after randomization
Specific disability
Specific disability will be evaluated by an 11-point Patient-specific Functional Scale
Measured: Eight weeks and six months after randomization
Dynamic balance
Dynamic balance will be evaluated by the 10-meter Walk Test (fast and normal speed)
Measured: Eight weeks and six months after randomization
Dynamic Balance
Dynamic balance will be evaluated by the Sit-up Test
Measured: Eight weeks and six months after randomization
Muscle strength of the gluteus maximus, gluteus medius and lateral hip rotators
Muscle strength will be evaluated by dynamometer
Measured: Eight weeks and six months after randomization
Pressure pain threshold
Pressure pain threshold will be evaluated by digital pressure algometer
Measured: Eight weeks and six months after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2016 (estimated)
- Study start1 Apr 2017
- Primary completion31 Jul 2021 (estimated)
- Study completionDec 2021 (estimated)
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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 74 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidade Cidade de Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cristina Maria Nunes Cabral, Universidade Cidade de Sao Paulo
- Investigators
- Cristina MN Cabral, PhD, Principal investigator, Universidade Cidade de Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02729779
- Sponsor's protocol ID
- 53162216.9.0000.0064
- Status last verified
- Feb 2021
- First submitted
- 31 Mar 2016
- Last updated
- 12 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
de Oliveira NTB, Ricci NA, Dos Santos Franco YR, Salvador EMES, Almeida ICB, Cabral CMN. Effectiveness of the Pilates method versus aerobic exercises in the treatment of older adults with chronic low back pain: a randomized controlled trial protocol. BMC Musculoskelet Disord. 2019 May 24;20(1):250. doi: 10.1186/s12891-019-2642-9.
PubMed 31122227
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of the Pilates Method Versus Aerobic Exercises in the Treatment of Chronic Non-specific Low Back Pain in the Elderly: Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02729779
- Acronym / sponsor ID
- 53162216.9.0000.0064
- Conditions
- Low Back Pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 74 participants (estimated)
- Lead sponsor
- Universidade Cidade de Sao PauloUniversity, hospital or other
- Study start
- 1 Apr 2017 (actual)
- Primary completion
- 31 Jul 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 6 Apr 2016 (estimated)
- 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 potentially disabling for the elderly, and physical exercises are considered the best treatment for this problem. The Pilates method has been proven effective in the improvement of pain and function in patients with low back pain. However, the evidence about the effectiveness of Pilates method in the treatment of elderly patients with low back pain is scarce. Thus, the aim of this study is to investigate the effectiveness of the Pilates method compared to aerobic exercise in elderly with chronic non-specific low back pain. This randomized controlled trial with two arms and blinded assessor will include 74 patients aged between 65 and 85 years, of both sexes, complaining of chronic non-specific low back pain persisting for more than three months and pain intensity greater than 3 points in the Pain Numerical Rating Scale. The elderly will be randomized into two groups: Pilates Group (n = 37) with exercises based on Pilates method; and Aerobic Group (n = 37) with aerobic exercises, stretching and relaxation. Both groups will hold treatment twice a week with duration of 60 minutes for eight weeks. The primary outcomes will be: pain intensity and general disability assessed eight weeks after randomization. Secondary outcomes will be: pain intensity and general disability evaluated six months after randomization; global impression of improvement, specific disability and dynamic balance, muscle strength of the gluteus maximus, gluteus medius and lateral hip rotators and pressure pain threshold evaluated eight weeks and six months after randomization. We expect that the results of this study contribute to the clinical decision-making with respect to pain reduction and, consequently, improving balance and functionality of elderly with chronic low back pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pilates Group | Experimental | Other: Pilates GroupElderly will be submitted to a specific exercise program of modified Pilates method performed in the mat and apparatus. In the first session, participants will receive basic guidance on the Pilates training and activation of the power house. The session will be divided in: global warming and stretching (5 minutes), Pilates exercises for upper and lower limbs, abdomen and spine (45 minutes), global stretching (5 minutes) and local relaxing massage (5 minutes).The session will consist of a minimum of 5 exercises and a maximum of 15 Pilates exercises. The elderly will receive 16 individual sessions with duration of 60 minutes, twice a week, with a total of eight weeks of treatment. |
| Aerobic Group | Active comparator | Other: Aerobic GroupThe Aerobic Group will be submitted to an exercise program with global stretching (for lower and upper limbs and column with two repetitions and 30 seconds of maintenance in each segment) for 10 minutes, walking on a treadmill for 20 to 40 minutes and relaxing massage for 5 minutes. The intensity of the effort during walking on a treadmill will be based on a combination of heart rate (based on the percentage of maximum heart rate: 208 - (0.7 x age)) and rate of perceived effort assessed by the Borg scale. Exercise will be performed respecting the fraction of 50-75% of maximum heart rate and levels between 12 to 13 (moderate intensity) of the Borg scale. The elderly will receive 16 individual sessions with duration of 60 minutes, twice a week, with a total of eight weeks of treatment. |
Who may qualify
- Ages
- 65 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- Elderly complaining of non-specific low back pain for more than three months
- Pain intensity equal to or more than 3 points evaluated by the Pain Numerical Rating Scale in the last seven days.
Key exclusion criteria (9 listed)
- Contraindication to physical exercise;
- Back with severe disease (fractures, tumors, inflammatory diseases, ankylosing spondylitis and nerve root compromise confirmed by neurological tests);
- Previous or scheduled back surgery ;
- Severe cardiorespiratory disease;
- Cancer;
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 GroupElderly will be submitted to a specific exercise program of modified Pilates method performed in the mat and apparatus. In the first session, participants will receive basic guidance on the Pilates training and activation of the power house. The session will be divided in: global warming and stretching (5 minutes), Pilates exercises for upper and lower limbs, abdomen and spine (45 minutes), global stretching (5 minutes) and local relaxing massage (5 minutes).The session will consist of a minimum of 5 exercises and a maximum of 15 Pilates exercises. The elderly will receive 16 individual sessions with duration of 60 minutes, twice a week, with a total of eight weeks of treatment. | Other | Pilates Group |
| Aerobic GroupElderly will be submitted to an exercise program with global stretching (for lower and upper limbs and column with two repetitions and 30 seconds of maintenance in each segment) for 10 minutes, walking on a treadmill for 20 to 40 minutes, and relaxing massage for 5 minutes. The intensity of the effort during walking on a treadmill will be based on a combination of heart rate (based on the percentage of maximum heart rate: 208 - (0.7 x age)) and rate of perceived effort assessed by the Borg scale. Exercise will be performed respecting the fraction of 50-75% of maximum heart rate and levels between 12 to 13 (moderate intensity) of the Borg scale. The elderly will receive 16 individual sessions with duration of 60 minutes, twice a week, with a total of eight weeks of treatment. | Other | Aerobic Group |
Primary outcome
Pain intensity
Time frame: Eight weeks after randomization
Pain intensity will be measured by an 11-point Pain Numerical Rating Scale
Disabitity
Time frame: Eight weeks after randomization
Disability associated with low back pain will be measured using the 24-item Roland Morris Disability Questionnaire
8 secondary outcomes
Pain intensity
Time frame: Six months after randomization
Disability
Time frame: Six months after randomization
Global impression of improvement
Time frame: Eight weeks and six months after randomization
Specific disability
Time frame: Eight weeks and six months after randomization
Dynamic balance
Time frame: Eight weeks and six months after randomization
Dynamic Balance
Time frame: Eight weeks and six months after randomization
Muscle strength of the gluteus maximus, gluteus medius and lateral hip rotators
Time frame: Eight weeks and six months after randomization
Pressure pain threshold
Time frame: Eight weeks and six months after randomization
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2021.
- Background: PubMed 31122227de Oliveira NTB, Ricci NA, Dos Santos Franco YR, Salvador EMES, Almeida ICB, Cabral CMN. Effectiveness of the Pilates method versus aerobic exercises in the treatment of older adults with chronic low back pain: a randomized controlled trial protocol. BMC Musculoskelet Disord. 2019 May 24;20(1):250. doi: 10.1186/s12891-019-2642-9.
- 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.
Cristina MN Cabral, PhD principal investigator
Universidade Cidade de Sao Paulo
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 Group and Aerobic Group in people with Low Back Pain, run by Universidade Cidade de Sao Paulo at 1 site in Brazil.
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 2 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: status not confirmed, as of the sponsor's last update on 12 Feb 2021. 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 Brazil. 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?
Results are not available in the source record.
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?
Pain intensity (time frame: Eight weeks after randomization). The study lists 2 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 NCT02729779, 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 12 Feb 2021.