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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
41

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

  • Name: selin karakaya

Study Locations

  • Turkey
      • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Pilates Exercise
pilates exercise+ Mckenzie Exercise Six weeks, twice a week
Other: Pilates Exercise
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
Other: Mckenzie Exercise
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Istanbul Medipol University Hospital

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 15, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 7, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 1, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 1, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 9, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 19, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 17, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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