- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05896995
Efficiency of Different Exercise Approaches in Individuals Providing Primary Care to MS
July 17, 2023 updated by: hazal genc, Istanbul Medipol University Hospital
Investigation of the Efficiency of Different Exercise Approaches in Individuals Providing Primary Care to Multiple Sclerosis Patients
Multiple Sclerosis is known as an inflammatory central nervous system disease characterized by demyelination and axonal damage.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
41
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Istanbul, Turkey, 34070
- HAZAL genç
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Pilates Exercise
pilates exercise+ Mckenzie Exercise Six weeks, twice a week
|
Pilates exercises target the deep muscles of the core, including the abdomen, lower back, hips, and glutes, while also engaging the whole body.
|
Active Comparator: Mckenzie Exercise
Mckenzie Exercise Six weeks, twice a week
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Oswestry Low Back Pain Disability Questionnaire
Time Frame: 6 weeks
|
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.
|
6 weeks
|
Beck Depression Scale
Time Frame: 6 weeks
|
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.
|
6 weeks
|
Bakas Caregiver Impact Scale.
Time Frame: 6 weeks
|
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".
|
6 weeks
|
Disability status assessment.
Time Frame: 6 weeks
|
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.
|
6 weeks
|
Multiple Sclerosis Quality of Life-54 (MSQOL-54)
Time Frame: 6 weeks
|
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.
|
6 weeks
|
Algometer
Time Frame: 6 weeks
|
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.
|
6 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 1, 2023
Primary Completion (Actual)
June 15, 2023
Study Completion (Actual)
July 7, 2023
Study Registration Dates
First Submitted
June 1, 2023
First Submitted That Met QC Criteria
June 1, 2023
First Posted (Actual)
June 9, 2023
Study Record Updates
Last Update Posted (Actual)
July 19, 2023
Last Update Submitted That Met QC Criteria
July 17, 2023
Last Verified
July 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2023-07/02
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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