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Efficiency of Different Exercise Approaches in Individuals Providing Primary Care to MS

Primary Purpose

Back Pain

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Pilates Exercise
Mckenzie Exercise
Sponsored by
Istanbul Medipol University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Back Pain focused on measuring back pain, multiple sclerosis

Eligibility Criteria

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

Inclusion Criteria Chronic low back pain he is 18-60 years old No verbal communication barrier Complaining of pain for more than three months Volunteering of participants Exclusion Criteria Absence of cognitive impairment (delirium, dementia, amnesia) Exercise contraindications (uncontrolled medical conditions) Caring for individuals with an unclear diagnosis of MS Disagreeing with the measurements to be made or providing incomplete answers Previous spinal surgery Spinal and joint disorders other than lumbar disc herniation

Sites / Locations

  • HAZAL genç

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Pilates Exercise

Mckenzie Exercise

Arm Description

pilates exercise+ Mckenzie Exercise Six weeks, twice a week

Mckenzie Exercise Six weeks, twice a week

Outcomes

Primary Outcome Measures

Oswestry Low Back Pain Disability Questionnaire
It is a questionnaire to evaluate the disability levels and quality of life faced by patients due to low back pain. It was developed to evaluate pain-related limitation in people with acute, subacute, or chronic low back pain. It includes 1 item related to pain and 9 items related to activities of daily living (personal care, lifting, walking, sitting, sanding, sleep, sexual life, social life and travel). Each item is measured on a 6-point rank scale between 0 and 5 points according to the scenarios it contains. At the end of the survey, the scores are summed and the percentage value is calculated for the total score.
Beck Depression Scale
This scale has been shown to accurately measure the level of depression. The scale consists of 21 questions with 4 options, each corresponding to 0-3 points, and the patient is asked to choose the appropriate sentence according to his condition in the last week. mood, pessimism, sense of failure, dissatisfaction, sense of guilt, sense of punishment, self-hatred, self-blame, desire for self-punishment, crying spells, irritability, social introversion, indecisiveness, deterioration of body perception, determination of workability, sleep disorders, 21 symptoms and behaviors including fatigue, fatigue, decreased appetite, weight loss, somatic complaints and loss of libido are questioned.
Bakas Caregiver Impact Scale.
It evaluates the opportunity and power of caregiving for caregivers. The scale includes a total of 15 questions scored between +3 (best aspect) and -3 (worst aspect). It is a Likert-type scale with questions from 1 to 7 according to the answers that are affected by creation or negative effects. The worst affected person can get 15 points and the best affected person can get 105 points. As the score rises, it takes shape as "good influence", and as the score decreases, it takes shape as "bad influence".
Disability status assessment.
A single EDSS score between 0-10 is determined according to the scores obtained from the functional systems. While 0 points on the scale indicate normality, 10 points indicate the way of death when MS is sufficient. In the scale, the first score that can be obtained after 0 is 1. It is a beloved scale to see if there is an index in case of disability.
Multiple Sclerosis Quality of Life-54 (MSQOL-54)
It consists of 54 items, 2 main groups, 12 subgroups and 2 independent items: body organs health and places mental health (BMS). BFS units are in 8 subgroups: physical health, limitation due to physical devices, pain sensation, fatigue, social functionality, health perception, health distress, sexual functionality. BFS and BMS scores, which are the two main groups of the MSQOL-54 scale, are scored between 0-100. The high score obtained from the scale determines the goodness of life quality.
Algometer
An objective method, a manual algometer device, was used to assess pain sensitivity to pressure. In this study, "Baseline Dolorimeter" was preferred. The measurement was aimed at the unilateral iliocostalis lumborum muscle. Individuals were asked to say as soon as the feeling of pressure turned into a feeling of pain.

Secondary Outcome Measures

Full Information

First Posted
June 1, 2023
Last Updated
July 17, 2023
Sponsor
Istanbul Medipol University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05896995
Brief Title
Efficiency of Different Exercise Approaches in Individuals Providing Primary Care to MS
Official Title
Investigation of the Efficiency of Different Exercise Approaches in Individuals Providing Primary Care to Multiple Sclerosis Patients
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
May 1, 2023 (Actual)
Primary Completion Date
June 15, 2023 (Actual)
Study Completion Date
July 7, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul Medipol University Hospital

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
Multiple Sclerosis is known as an inflammatory central nervous system disease characterized by demyelination and axonal damage.
Detailed Description
Individuals with MS cannot perform self-care in many areas due to the problems they encounter during their daily life activities, and they need an individual who will take care of them and a lifelong care.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Back Pain
Keywords
back pain, multiple sclerosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
41 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pilates Exercise
Arm Type
Experimental
Arm Description
pilates exercise+ Mckenzie Exercise Six weeks, twice a week
Arm Title
Mckenzie Exercise
Arm Type
Active Comparator
Arm Description
Mckenzie Exercise Six weeks, twice a week
Intervention Type
Other
Intervention Name(s)
Pilates Exercise
Intervention Description
Pilates exercises target the deep muscles of the core, including the abdomen, lower back, hips, and glutes, while also engaging the whole body.
Intervention Type
Other
Intervention Name(s)
Mckenzie Exercise
Intervention Description
The McKenzie Method emphasizes self-treatment and active patient involvement in the management of their condition. It involves a systematic assessment process to determine the most appropriate exercises and interventions for an individual based on their specific symptoms and movement responses.
Primary Outcome Measure Information:
Title
Oswestry Low Back Pain Disability Questionnaire
Description
It is a questionnaire to evaluate the disability levels and quality of life faced by patients due to low back pain. It was developed to evaluate pain-related limitation in people with acute, subacute, or chronic low back pain. It includes 1 item related to pain and 9 items related to activities of daily living (personal care, lifting, walking, sitting, sanding, sleep, sexual life, social life and travel). Each item is measured on a 6-point rank scale between 0 and 5 points according to the scenarios it contains. At the end of the survey, the scores are summed and the percentage value is calculated for the total score.
Time Frame
6 weeks
Title
Beck Depression Scale
Description
This scale has been shown to accurately measure the level of depression. The scale consists of 21 questions with 4 options, each corresponding to 0-3 points, and the patient is asked to choose the appropriate sentence according to his condition in the last week. mood, pessimism, sense of failure, dissatisfaction, sense of guilt, sense of punishment, self-hatred, self-blame, desire for self-punishment, crying spells, irritability, social introversion, indecisiveness, deterioration of body perception, determination of workability, sleep disorders, 21 symptoms and behaviors including fatigue, fatigue, decreased appetite, weight loss, somatic complaints and loss of libido are questioned.
Time Frame
6 weeks
Title
Bakas Caregiver Impact Scale.
Description
It evaluates the opportunity and power of caregiving for caregivers. The scale includes a total of 15 questions scored between +3 (best aspect) and -3 (worst aspect). It is a Likert-type scale with questions from 1 to 7 according to the answers that are affected by creation or negative effects. The worst affected person can get 15 points and the best affected person can get 105 points. As the score rises, it takes shape as "good influence", and as the score decreases, it takes shape as "bad influence".
Time Frame
6 weeks
Title
Disability status assessment.
Description
A single EDSS score between 0-10 is determined according to the scores obtained from the functional systems. While 0 points on the scale indicate normality, 10 points indicate the way of death when MS is sufficient. In the scale, the first score that can be obtained after 0 is 1. It is a beloved scale to see if there is an index in case of disability.
Time Frame
6 weeks
Title
Multiple Sclerosis Quality of Life-54 (MSQOL-54)
Description
It consists of 54 items, 2 main groups, 12 subgroups and 2 independent items: body organs health and places mental health (BMS). BFS units are in 8 subgroups: physical health, limitation due to physical devices, pain sensation, fatigue, social functionality, health perception, health distress, sexual functionality. BFS and BMS scores, which are the two main groups of the MSQOL-54 scale, are scored between 0-100. The high score obtained from the scale determines the goodness of life quality.
Time Frame
6 weeks
Title
Algometer
Description
An objective method, a manual algometer device, was used to assess pain sensitivity to pressure. In this study, "Baseline Dolorimeter" was preferred. The measurement was aimed at the unilateral iliocostalis lumborum muscle. Individuals were asked to say as soon as the feeling of pressure turned into a feeling of pain.
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria Chronic low back pain he is 18-60 years old No verbal communication barrier Complaining of pain for more than three months Volunteering of participants Exclusion Criteria Absence of cognitive impairment (delirium, dementia, amnesia) Exercise contraindications (uncontrolled medical conditions) Caring for individuals with an unclear diagnosis of MS Disagreeing with the measurements to be made or providing incomplete answers Previous spinal surgery Spinal and joint disorders other than lumbar disc herniation
Facility Information:
Facility Name
HAZAL genç
City
Istanbul
ZIP/Postal Code
34070
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

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Efficiency of Different Exercise Approaches in Individuals Providing Primary Care to MS

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