search
Back to results

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

Primary Purpose

Low Back Pain

Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Pilates Group
Aerobic Group
Sponsored by
Universidade Cidade de Sao Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Low Back Pain

Eligibility Criteria

65 Years - 85 Years (Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Physical Therapy Outpatient Department

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Pilates Group

Aerobic Group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Pain intensity
Pain intensity will be measured by an 11-point Pain Numerical Rating Scale
Disabitity
Disability associated with low back pain will be measured using the 24-item Roland Morris Disability Questionnaire

Secondary Outcome Measures

Pain intensity
Pain intensity will be measured by an 11-point Pain Numerical Rating Scale
Disability
Disability associated with low back pain will be measured using the 24-item Roland Morris Disability Questionnaire
Global impression of improvement
Global impression of improvement will be measured by an 11-point Global Perceived Effect Scale
Specific disability
Specific disability will be evaluated by an 11-point Patient-specific Functional Scale
Dynamic balance
Dynamic balance will be evaluated by the 10-meter Walk Test (fast and normal speed)
Dynamic Balance
Dynamic balance will be evaluated by the Sit-up Test
Muscle strength of the gluteus maximus, gluteus medius and lateral hip rotators
Muscle strength will be evaluated by dynamometer
Pressure pain threshold
Pressure pain threshold will be evaluated by digital pressure algometer

Full Information

First Posted
March 31, 2016
Last Updated
February 11, 2021
Sponsor
Universidade Cidade de Sao Paulo
search

1. Study Identification

Unique Protocol Identification Number
NCT02729779
Brief Title
Effectiveness of the Pilates Method Versus Aerobic Exercises in Elderly With Low Back Pain
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Unknown status
Study Start Date
April 1, 2017 (Actual)
Primary Completion Date
July 31, 2021 (Anticipated)
Study Completion Date
December 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidade Cidade de Sao Paulo

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
74 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Pilates Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Aerobic Group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Pilates Group
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Aerobic Group
Intervention Description
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 Measure Information:
Title
Pain intensity
Description
Pain intensity will be measured by an 11-point Pain Numerical Rating Scale
Time Frame
Eight weeks after randomization
Title
Disabitity
Description
Disability associated with low back pain will be measured using the 24-item Roland Morris Disability Questionnaire
Time Frame
Eight weeks after randomization
Secondary Outcome Measure Information:
Title
Pain intensity
Description
Pain intensity will be measured by an 11-point Pain Numerical Rating Scale
Time Frame
Six months after randomization
Title
Disability
Description
Disability associated with low back pain will be measured using the 24-item Roland Morris Disability Questionnaire
Time Frame
Six months after randomization
Title
Global impression of improvement
Description
Global impression of improvement will be measured by an 11-point Global Perceived Effect Scale
Time Frame
Eight weeks and six months after randomization
Title
Specific disability
Description
Specific disability will be evaluated by an 11-point Patient-specific Functional Scale
Time Frame
Eight weeks and six months after randomization
Title
Dynamic balance
Description
Dynamic balance will be evaluated by the 10-meter Walk Test (fast and normal speed)
Time Frame
Eight weeks and six months after randomization
Title
Dynamic Balance
Description
Dynamic balance will be evaluated by the Sit-up Test
Time Frame
Eight weeks and six months after randomization
Title
Muscle strength of the gluteus maximus, gluteus medius and lateral hip rotators
Description
Muscle strength will be evaluated by dynamometer
Time Frame
Eight weeks and six months after randomization
Title
Pressure pain threshold
Description
Pressure pain threshold will be evaluated by digital pressure algometer
Time Frame
Eight weeks and six months after randomization

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cristina MN Cabral, PhD
Organizational Affiliation
Universidade Cidade de Sao Paulo
Official's Role
Principal Investigator
Facility Information:
Facility Name
Physical Therapy Outpatient Department
City
Sao Paulo
ZIP/Postal Code
03071000
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
31122227
Citation
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.
Results Reference
background

Learn more about this trial

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

We'll reach out to this number within 24 hrs