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

• ClinicalTrials.gov Identifier: NCT02729779
• Recruitment Status: Active, not recruiting
• First Posted: April 6, 2016
• Last Update Posted: March 26, 2020
• Sponsor: Universidade Cidade de Sao Paulo
• Information provided by (Responsible Party): Cristina Maria Nunes Cabral, Universidade Cidade de Sao Paulo

Study Description

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

Study Design

• 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

Arms and Interventions

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.

Outcome Measures

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

Eligibility Criteria

• 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.

Contacts and Locations

Locations

Brazil

Physical Therapy Outpatient Department

Sao Paulo, Brazil, 03071000

Sponsors and Collaborators

Universidade Cidade de Sao Paulo

Investigators

• Principal Investigator: Cristina MN Cabral, PhD; Universidade Cidade de Sao Paulo

More Information

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.

• 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
• Last Update Posted: March 26, 2020
• Last Verified: March 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Back Pain; Low Back Pain; Pain; Neurologic Manifestations