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

Aristotle University Of Thessaloniki

Status: Completed

Conditions: Low Back Pain

Treatments: Other: Pilates exercise program

Study type: Interventional

Funder types: Other

Identifiers

NCT04752579

EC-48/2021

Details and patient eligibility

About

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.

Full 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.

Enrollment: 63 patients

Sex: Female

Ages: 65 to 85 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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63 participants in 2 patient groups, including a placebo group

Pilates exercise program

Experimental group

Description:

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

Treatment:

Other: Pilates exercise program

Control

Placebo Comparator group

Description:

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

Treatment:

Other: Pilates exercise program