Clinical trial NCT04752579: 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
Overall status: COMPLETED
Phase: NA
Conditions: Low Back Pain
Keywords: Mat-pilates exercises
elderly
chronic low back pain
physical therapy
rehabilitation
Lead sponsor: Aristotle University Of Thessaloniki
Sponsor class: OTHER
First posted: 2021-02-12
Enrollment: 63
Sex: FEMALE
Minimum age (years): 65
Maximum age (years): 85
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel Assignment
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Changes in Low back pain intensity with the Visual Analogue Scale (VAS)
timeFrame: pre-treatment, Week: 10, 6-month follow-up
measure: Changes in Roland Morris Disability Questionnaire
timeFrame: pre-treatment, Week: 10, 6-month follow-up
measure: Changes in Timed Up and Go (TUG) Test
timeFrame: pre-treatment, Week: 10, 6-month follow-up
measure: Changes in Berg Balance Scale
timeFrame: pre-treatment, Week: 10, 6-month follow-up
Secondary outcomes:
measure: Changes in the number of pills consumed via Pill Consumption Log
timeFrame: pre-treatment, Month: 1,3,6, post-intervention
measure: Changes in adherence to exercise via Exercise Diary keeping
timeFrame: Time Frame: pre-treatment, Month: 1,3,6, post-intervention
Other outcomes:
Locations:
city: Thessaloniki
country: Greece
facility: Department of Physical Education and Sports Sciences
state: Thermi
Study officials:
affiliation: Aristotle University Of Thessaloniki
name: Evaggelos Sykaras, PhD
role: STUDY_DIRECTOR
References: