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

NCT02729779 | Unknown DMC

• 1 other identifier: 53162216.9.0000.0064
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

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.

Conditions

Low Back Pain

Outcome Measures

Primary Outcomes (2)

• Pain intensity

  Pain intensity will be measured by an 11-point Pain Numerical Rating Scale

  Eight weeks after randomization

• Disabitity

  Disability associated with low back pain will be measured using the 24-item Roland Morris Disability Questionnaire

  Eight weeks after randomization

Secondary Outcomes (8)

• Pain intensity

  Six months after randomization

• Disability

  Six months after randomization

• Global impression of improvement

  Eight weeks and six months after randomization

• Specific disability

  Eight weeks and six months after randomization

• Dynamic balance

  Eight weeks and six months after randomization

Study Arms (2)

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.

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.

Other: Aerobic Group

Interventions

Pilates Group OTHER

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.

Pilates Group

Aerobic Group OTHER

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.

Aerobic Group

Eligibility Criteria

• Age: 65 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidade Cidade de Sao Paulo: lead

Study Sites (1)

Physical Therapy Outpatient Department

São Paulo, 03071000, Brazil

Location

Related Publications (1)

• 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.

  PMID: 31122227 BACKGROUND

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Cristina MN Cabral, PhD

  Universidade Cidade de Sao Paulo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: March 31, 2016
• First Posted: April 6, 2016
• Study Start: April 1, 2017
• Primary Completion: July 31, 2021
• Study Completion: December 1, 2021
• Last Updated: February 12, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)