- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02729779
Effectiveness of the Pilates Method Versus Aerobic Exercises in Elderly With Low Back Pain
February 11, 2021 updated by: Cristina Maria Nunes Cabral, Universidade Cidade de Sao Paulo
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.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
74
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Sao Paulo, Brazil, 03071000
- Physical Therapy Outpatient Department
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
65 years to 85 years (Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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;
- Dependent gait;
- Patients who underwent physical therapy for low back pain in the last six months;
- Regular physical activity practitioners.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Pilates Group
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.
|
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.
|
Active Comparator: Aerobic Group
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pain intensity
Time Frame: Eight weeks after randomization
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Pain intensity will be measured by an 11-point Pain Numerical Rating Scale
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Eight weeks after randomization
|
Disabitity
Time Frame: Eight weeks after randomization
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Disability associated with low back pain will be measured using the 24-item Roland Morris Disability Questionnaire
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Eight weeks after randomization
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pain intensity
Time Frame: Six months after randomization
|
Pain intensity will be measured by an 11-point Pain Numerical Rating Scale
|
Six months after randomization
|
Disability
Time Frame: Six months after randomization
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Disability associated with low back pain will be measured using the 24-item Roland Morris Disability Questionnaire
|
Six months after randomization
|
Global impression of improvement
Time Frame: Eight weeks and six months after randomization
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Global impression of improvement will be measured by an 11-point Global Perceived Effect Scale
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Eight weeks and six months after randomization
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Specific disability
Time Frame: Eight weeks and six months after randomization
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Specific disability will be evaluated by an 11-point Patient-specific Functional Scale
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Eight weeks and six months after randomization
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Dynamic balance
Time Frame: Eight weeks and six months after randomization
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Dynamic balance will be evaluated by the 10-meter Walk Test (fast and normal speed)
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Eight weeks and six months after randomization
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Dynamic Balance
Time Frame: Eight weeks and six months after randomization
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Dynamic balance will be evaluated by the Sit-up Test
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Eight weeks and six months after randomization
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Muscle strength of the gluteus maximus, gluteus medius and lateral hip rotators
Time Frame: Eight weeks and six months after randomization
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Muscle strength will be evaluated by dynamometer
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Eight weeks and six months after randomization
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Pressure pain threshold
Time Frame: Eight weeks and six months after randomization
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Pressure pain threshold will be evaluated by digital pressure algometer
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Eight weeks and six months after randomization
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Cristina MN Cabral, PhD, Universidade Cidade de Sao Paulo
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 1, 2017
Primary Completion (Anticipated)
July 31, 2021
Study Completion (Anticipated)
December 1, 2021
Study Registration Dates
First Submitted
March 31, 2016
First Submitted That Met QC Criteria
April 5, 2016
First Posted (Estimate)
April 6, 2016
Study Record Updates
Last Update Posted (Actual)
February 12, 2021
Last Update Submitted That Met QC Criteria
February 11, 2021
Last Verified
February 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 53162216.9.0000.0064
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
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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