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Effects of a Mat Pilates Exercise Program on Elderly Women With Chronic Nonspecific Low Back Pain

Primary Purpose

Low Back Pain

Status
Completed
Phase
Not Applicable
Locations
Greece
Study Type
Interventional
Intervention
Pilates exercise program
Sponsored by
Aristotle University Of Thessaloniki
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Low Back Pain focused on measuring Mat-pilates exercises, elderly, chronic low back pain, physical therapy, rehabilitation

Eligibility Criteria

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

Inclusion Criteria:

  • Symptoms of chronic back pain lasting more than 12 weeks
  • Score on the Visual Analog Scale for pain less than 70mm
  • Timed Up and Go test score less than 15sec

Exclusion Criteria:

  • Low back pain due to a serious pathology that refers to a red flag such as malignancy, vertebral fracture, osteomyelitis, rheumatoid arthritis, Cauda Equina Syndrome (CES)
  • Participation in another exercise program in the last six months
  • Diagnosed with neurodegenerative disease (e.g., Parkinson's disease)
  • Recent stroke
  • Senile dementia

Sites / Locations

  • Department of Physical Education and Sports Sciences

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Pilates exercise program

Control

Arm Description

Participants allocated to this group will receive a 10-week Pilates exercise program with each session having a duration of 45'.

Participants allocated to this group received general consulting instructions and a home-based general exercise sheet

Outcomes

Primary Outcome Measures

Changes in Low back pain intensity with the Visual Analogue Scale (VAS)
VAS is a card with an uncalibrated scale ranging from 0-100mm on the one side with each millimeter representing one pain level (0 representing no pain and 100 representing the worst pain in life). The patient subjectively estimated their pain level by marking a vertical line on the uncalibrated scale between 0 and 100. Then the exact value of pain intensity could be obtained with a single ruler. Hence, the higher the value, the more intense the pain. VAS is widely used as it is easy to implement and is characterized by good psychometric propert
Changes in Roland Morris Disability Questionnaire
Disability associated with low back pain in the last 24 hours will be assessed using the Greek version of the Roland Morris Disability Questionnaire (Boscainos et al., 2003). This questionnaire has showed good test -retest reliability with intraclass correlation (ICC) ranging from 0.42 to 0.91 (Macedo et al., 2010), while Boscainos (2003), reports that the internal consistency reliability for the Greek version reached a Cronbach's alpha coefficient of 0.885. This questionnaire consists of 24 items that are related to daily activities which patients often report difficulty performing due to low back pain. Every positive answer earns a point and the final score is calculated by adding all the points. Thus, the higher the score is, the greater the limitation (Stratford, 1996).
Changes in Timed Up and Go (TUG) Test
The TUG test is a performance-based measure of functional mobility that was initially developed to identify mobility and dynamic balance impairments in older adults (Cameron and Monroe, 2007; Swearingen and Brach, 2001; Podsiadlo and Richardson, 1991). The TUG test has demonstrated high interrater and intrarater reliability when used to examine elderly adults (Cameron and Monroe, 2007; Swearingen and Brach, 2001). The test requires the subject to rise from a chair, walk three meters at a comfortable pace to a mark placed on the floor, turn around, walk back to the starting point, and return to sitting on the chair. The test's score is the time it takes the subject to complete the test.
Changes in Berg Balance Scale
The Berg balance scale is a tool suggested by Berg (Berg et al., 1989; Berg et al., 1992) to evaluate balance in the elderly. The test involves performing 14 tests of gradually increasing difficulty where in each one, the subject is asked to maintain a given position for a specific time or conduct specific tasks. Each of the 14 tests on the list is graded according to the balancing ability of the examinee from 0 to 4 points (with 0 indicating low balance ability while 4 high). Accord to Berg et al. (1992), a score of 56 indicates functional balance whereas a score lower than 45 indicates notable balance deficits, which have been related to increased fall risk.

Secondary Outcome Measures

Changes in the number of pills consumed via Pill Consumption Log
Participants will be asked to write down in a special diary the number of pills administered (anti-inflammatory and/or painkillers) during the follow-up period. The log will be kept kept on a weekly basis and the assessor will collect the data by phone 2-3 times a month.
Changes in adherence to exercise via Exercise Diary keeping
After the ten weeks the participants of both groups will be asked to perform the specific exercise programs twice per week for a period of three months recording the adherence or not to the exercise programs in a weekly diary while the assessor will collect the data by phone 2-3 times a month.

Full Information

First Posted
February 9, 2021
Last Updated
July 18, 2023
Sponsor
Aristotle University Of Thessaloniki
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1. Study Identification

Unique Protocol Identification Number
NCT04752579
Brief Title
Effects of a Mat Pilates Exercise Program on Elderly Women With Chronic Nonspecific Low Back Pain
Official Title
Effects of a Mat Pilates Exercise Program on Pain, Functional Ability and Balance in Elderly Women With Chronic Nonspecific Low Back Pain
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
January 1, 2021 (Actual)
Primary Completion Date
December 30, 2021 (Actual)
Study Completion Date
December 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Aristotle University Of Thessaloniki

4. Oversight

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

5. Study Description

Brief Summary
The technique of Pilates exercises on a mat has proven to be effective and practically applicable to patients with chronic back pain. However, its application in women over 65 years has not been adequately studied. Objective: This assessor-blind randomized clinical trial aims to study the effect of a mat Pilates exercise program on pain and functional ability of elderly women with chronic nonspecific low back pain. Methods: 60 elderly women with chronic nonspecific low back pain (duration of symptoms more than 12 weeks) are expected to participate in this study. Participants will be divided into two groups of 30 people each; one being intervention and one control. The intervention group will follow a custom mat Pilates program (twice per week) for 10 weeks, while the control group will not follow any treatment. Pain, functionality, balance, the number of painkillers administered, and adherence to exercise will be assessed at the beginning and end of the study and will be re-examined six months later.
Detailed Description
The technique of Pilates exercises on a mat has proven to be effective and practically applicable to patients with chronic back pain. However, its application in women over 65 years has not been adequately studied. Objective: This assessor-blind randomized clinical trial aims to study the effect of a mat Pilates exercise program on pain and functional ability of elderly women with chronic nonspecific low back pain. Methods: 60 non-active elderly women with chronic nonspecific low back pain (duration of symptoms more than 12 weeks) are expected to participate in this study. Participants will be divided into two groups of 30 people each; one being intervention and one control. The intervention group will follow a custom mat Pilates program (twice per week), while the control group will not follow any treatment. Primary outcomes will include pain with the visual analog scale for pain and functionality with the Roland-Morris Questionnaire (RMQ). Secondary outcomes will include the balance with the Berg balance scale and the Timed Up and Go test, the number of painkillers administered, and the adherence to the exercise that will be evaluated at the beginning and at the end of the study and re-evaluated six months after the end of the intervention. The treatment period will be 10 weeks.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain
Keywords
Mat-pilates exercises, elderly, chronic low back pain, physical therapy, rehabilitation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
A masked assessor conducted the measurements.
Allocation
Randomized
Enrollment
63 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pilates exercise program
Arm Type
Experimental
Arm Description
Participants allocated to this group will receive a 10-week Pilates exercise program with each session having a duration of 45'.
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
Participants allocated to this group received general consulting instructions and a home-based general exercise sheet
Intervention Type
Other
Intervention Name(s)
Pilates exercise program
Intervention Description
The program will be individually supervised and will be conducted twice a week at the physiotherapy center. • Slow execution of 7-10 repetitions of the following Pilates exercises: Pelvic Curl, Pilates Single Legs Lifts & Leg Change, Twist Supine Pilates exercise, Chest Lifts Pilates Exercise, Chest Lift with Rotation Pilates exercise, 100's Prep Pilates Exercise, Single Leg Stretch Pilates Exercise, Front Support Pilates Exercise and Basic Back Extension Pilates Exercise. After the 6th week, while the person will be familiar with the basic exercises of the Pilates method the following exercises will be added: Leg Pull Front, Side Bend Pilates Exercise, Sphinx - Abdominal Lift Pilates Exercise, Shoulder Bridge Prep Pilates and Shoulder Bridge Pilates Exercise. Each session will be completed with breathing exercises and stretching exercises of the torso and lower limbs for 5 minutes.
Primary Outcome Measure Information:
Title
Changes in Low back pain intensity with the Visual Analogue Scale (VAS)
Description
VAS is a card with an uncalibrated scale ranging from 0-100mm on the one side with each millimeter representing one pain level (0 representing no pain and 100 representing the worst pain in life). The patient subjectively estimated their pain level by marking a vertical line on the uncalibrated scale between 0 and 100. Then the exact value of pain intensity could be obtained with a single ruler. Hence, the higher the value, the more intense the pain. VAS is widely used as it is easy to implement and is characterized by good psychometric propert
Time Frame
pre-treatment, Week: 10, 6-month follow-up
Title
Changes in Roland Morris Disability Questionnaire
Description
Disability associated with low back pain in the last 24 hours will be assessed using the Greek version of the Roland Morris Disability Questionnaire (Boscainos et al., 2003). This questionnaire has showed good test -retest reliability with intraclass correlation (ICC) ranging from 0.42 to 0.91 (Macedo et al., 2010), while Boscainos (2003), reports that the internal consistency reliability for the Greek version reached a Cronbach's alpha coefficient of 0.885. This questionnaire consists of 24 items that are related to daily activities which patients often report difficulty performing due to low back pain. Every positive answer earns a point and the final score is calculated by adding all the points. Thus, the higher the score is, the greater the limitation (Stratford, 1996).
Time Frame
pre-treatment, Week: 10, 6-month follow-up
Title
Changes in Timed Up and Go (TUG) Test
Description
The TUG test is a performance-based measure of functional mobility that was initially developed to identify mobility and dynamic balance impairments in older adults (Cameron and Monroe, 2007; Swearingen and Brach, 2001; Podsiadlo and Richardson, 1991). The TUG test has demonstrated high interrater and intrarater reliability when used to examine elderly adults (Cameron and Monroe, 2007; Swearingen and Brach, 2001). The test requires the subject to rise from a chair, walk three meters at a comfortable pace to a mark placed on the floor, turn around, walk back to the starting point, and return to sitting on the chair. The test's score is the time it takes the subject to complete the test.
Time Frame
pre-treatment, Week: 10, 6-month follow-up
Title
Changes in Berg Balance Scale
Description
The Berg balance scale is a tool suggested by Berg (Berg et al., 1989; Berg et al., 1992) to evaluate balance in the elderly. The test involves performing 14 tests of gradually increasing difficulty where in each one, the subject is asked to maintain a given position for a specific time or conduct specific tasks. Each of the 14 tests on the list is graded according to the balancing ability of the examinee from 0 to 4 points (with 0 indicating low balance ability while 4 high). Accord to Berg et al. (1992), a score of 56 indicates functional balance whereas a score lower than 45 indicates notable balance deficits, which have been related to increased fall risk.
Time Frame
pre-treatment, Week: 10, 6-month follow-up
Secondary Outcome Measure Information:
Title
Changes in the number of pills consumed via Pill Consumption Log
Description
Participants will be asked to write down in a special diary the number of pills administered (anti-inflammatory and/or painkillers) during the follow-up period. The log will be kept kept on a weekly basis and the assessor will collect the data by phone 2-3 times a month.
Time Frame
pre-treatment, Month: 1,3,6, post-intervention
Title
Changes in adherence to exercise via Exercise Diary keeping
Description
After the ten weeks the participants of both groups will be asked to perform the specific exercise programs twice per week for a period of three months recording the adherence or not to the exercise programs in a weekly diary while the assessor will collect the data by phone 2-3 times a month.
Time Frame
Time Frame: pre-treatment, Month: 1,3,6, post-intervention

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Female
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Symptoms of chronic back pain lasting more than 12 weeks Score on the Visual Analog Scale for pain less than 70mm Timed Up and Go test score less than 15sec Exclusion Criteria: Low back pain due to a serious pathology that refers to a red flag such as malignancy, vertebral fracture, osteomyelitis, rheumatoid arthritis, Cauda Equina Syndrome (CES) Participation in another exercise program in the last six months Diagnosed with neurodegenerative disease (e.g., Parkinson's disease) Recent stroke Senile dementia
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Evaggelos Sykaras, PhD
Organizational Affiliation
Aristotle University Of Thessaloniki
Official's Role
Study Director
Facility Information:
Facility Name
Department of Physical Education and Sports Sciences
City
Thessaloniki
State/Province
Thermi
ZIP/Postal Code
57001
Country
Greece

12. IPD Sharing Statement

Plan to Share IPD
No

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Effects of a Mat Pilates Exercise Program on Elderly Women With Chronic Nonspecific Low Back Pain

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