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

Sponsor
Istanbul Medipol University Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05896995
Collaborator
(none)
42
2
2.5

Study Details

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
  • Other: Pilates Exercise
  • Other: Mckenzie Exercise
N/A

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
Anticipated Enrollment :
42 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
Anticipated Study Start Date :
Jun 1, 2023
Anticipated Primary Completion Date :
Jul 15, 2023
Anticipated Study Completion Date :
Aug 15, 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 [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 [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. [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. [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) [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 [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

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No

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

No locations specified.

Sponsors and Collaborators

  • Istanbul Medipol University Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
hazal genc, Principal Investigator, Istanbul Medipol University Hospital
ClinicalTrials.gov Identifier:
NCT05896995
Other Study ID Numbers:
  • 2023-07/02
First Posted:
Jun 9, 2023
Last Update Posted:
Jun 9, 2023
Last Verified:
Jun 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
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, Principal Investigator, Istanbul Medipol University Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 9, 2023