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Effectiveness of the Pilates Method Versus Aerobic Exercises in Elderly With Low Back Pain

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02729779
Recruitment Status : Active, not recruiting
First Posted : April 6, 2016
Last Update Posted : March 26, 2020
Sponsor:
Information provided by (Responsible Party):
Cristina Maria Nunes Cabral, Universidade Cidade de Sao Paulo

Brief 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. 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.

Condition or disease Intervention/treatment Phase
Low Back Pain Other: Pilates Group Other: Aerobic Group Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 74 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : April 1, 2017
Actual Primary Completion Date : July 31, 2018
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


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.
Other: 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.

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.
Other: Aerobic Group
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.




Primary Outcome Measures :
  1. Pain intensity [ Time Frame: Eight weeks after randomization ]
    Pain intensity will be measured by an 11-point Pain Numerical Rating Scale

  2. Disabitity [ Time Frame: Eight weeks after randomization ]
    Disability associated with low back pain will be measured using the 24-item Roland Morris Disability Questionnaire


Secondary Outcome Measures :
  1. Pain intensity [ Time Frame: Six months after randomization ]
    Pain intensity will be measured by an 11-point Pain Numerical Rating Scale

  2. Disability [ Time Frame: Six months after randomization ]
    Disability associated with low back pain will be measured using the 24-item Roland Morris Disability Questionnaire

  3. Global impression of improvement [ Time Frame: Eight weeks and six months after randomization ]
    Global impression of improvement will be measured by an 11-point Global Perceived Effect Scale

  4. Specific disability [ Time Frame: Eight weeks and six months after randomization ]
    Specific disability will be evaluated by an 11-point Patient-specific Functional Scale

  5. Dynamic balance [ Time Frame: Eight weeks and six months after randomization ]
    Dynamic balance will be evaluated by the 10-meter Walk Test (fast and normal speed)

  6. Dynamic Balance [ Time Frame: Eight weeks and six months after randomization ]
    Dynamic balance will be evaluated by the Sit-up Test

  7. Muscle strength of the gluteus maximus, gluteus medius and lateral hip rotators [ Time Frame: Eight weeks and six months after randomization ]
    Muscle strength will be evaluated by dynamometer

  8. Pressure pain threshold [ Time Frame: Eight weeks and six months after randomization ]
    Pressure pain threshold will be evaluated by digital pressure algometer



Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years to 85 Years   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02729779


Locations
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Brazil
Physical Therapy Outpatient Department
Sao Paulo, Brazil, 03071000
Sponsors and Collaborators
Universidade Cidade de Sao Paulo
Investigators
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Principal Investigator: Cristina MN Cabral, PhD Universidade Cidade de Sao Paulo
Publications:
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Responsible Party: Cristina Maria Nunes Cabral, PhD, Universidade Cidade de Sao Paulo
ClinicalTrials.gov Identifier: NCT02729779    
Other Study ID Numbers: 53162216.9.0000.0064
First Posted: April 6, 2016    Key Record Dates
Last Update Posted: March 26, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Back Pain
Low Back Pain
Pain
Neurologic Manifestations