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

• ClinicalTrials.gov Identifier: NCT05896995
• Recruitment Status: Completed
• First Posted: June 9, 2023
• Last Update Posted: July 19, 2023
• Sponsor: Istanbul Medipol University Hospital
• Information provided by (Responsible Party): hazal genc, Istanbul Medipol University Hospital

Study Description

Brief Summary:

Multiple Sclerosis is known as an inflammatory central nervous system disease characterized by demyelination and axonal damage.

Condition or disease	Intervention/treatment	Phase
Back Pain	Other: Pilates Exercise; Other: Mckenzie Exercise	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 41 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Investigator)
• Primary Purpose: Treatment
• Official Title: Investigation of the Efficiency of Different Exercise Approaches in Individuals Providing Primary Care to Multiple Sclerosis Patients
• Actual Study Start Date: May 1, 2023
• Actual Primary Completion Date: June 15, 2023
• Actual Study Completion Date: July 7, 2023

Arms and Interventions

Arm	Intervention/treatment
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.

Outcome Measures

Primary Outcome Measures :

1. 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.
2. 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.
3. 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".
4. 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.
5. 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. 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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

Turkey

HAZAL genç

Istanbul, Turkey, 34070

Sponsors and Collaborators

Istanbul Medipol University Hospital

More Information

• Responsible Party: hazal genc, Principal Investigator, Istanbul Medipol University Hospital
• ClinicalTrials.gov Identifier: NCT05896995
• Other Study ID Numbers: 2023-07/02
• First Posted: June 9, 2023
• Last Update Posted: July 19, 2023
• Last Verified: July 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by hazal genc, Istanbul Medipol University Hospital:

back pain; multiple sclerosis

Additional relevant MeSH terms:

Back Pain; Pain; Neurologic Manifestations