Clinical trial NCT04838886: The Effect of Telerehabilitation Based Pilates Training in Multiple Sclerosis Patients
Official title: The Effect of Telerehabilitation Based Pilates Training on Physical Performance and Quality of Life in Multiple Sclerosis Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Sclerosis
Keywords: Multiple Sclerosis
Pilates
Exercise
Telerehabilitation
Physical performance
Balance
Gait
Fatigue
Lead sponsor: Gazi University
Sponsor class: OTHER
First posted: 2021-04-09
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Intervention and control groups
Primary purpose: TREATMENT

Brief summary: Multiple Sclerosis (MS) is a chronic inflammatory disease of the central nervous system characterized by myelin, oligodendrocyte, and axon damage. MS usually begins with attacks due to demyelination of axons in the brain, optic nerve, and spinal cord; over time it develops into a neurodegenerative disease associated with neurotrophic support deficiency and neuronal loss. In MS, various loss of strength, balance, fatigue, cognitive and gait disturbances arise in the central nervous system due to sensory and/or motor neuron degeneration. These disorders affect the quality of life by limiting the individual's activities and participation in their daily lives. Therefore, it is important to treat these disorders in the treatment of MS.

There are various pharmacological treatments and invasive procedures for the management of MS symptoms and one of the most commonly used treatment options is rehabilitation. Clinically-based exercise and rehabilitation are some of the most beneficial rehabilitation strategies in people with MS (PwMS). Clinically-based exercise and rehabilitation have been shown to stabilize or improve many physical symptoms of MS including loss of strength, balance dysfunction, impaired mobility, and fatigue. These benefits have led many practitioners to consider physical exercise as a nonpharmaceutical disease-modifying treatment. However, due to various factors such as mobility disorders, fatigue, and related problems, geographic location, time constraints, transportation difficulties, health insurance coverage, and financial burden, clinical-based exercise may be problematic in some pwMS. To overcome these challenges, approaches to rehabilitation have been developed such as telerehabilitation. The telerehabilitation system provides benefits such as continuity in patient education and rehabilitation, showing progress in rehabilitation, making changes in the treatment program, and saving individuals time and financial expenses. It is also an innovative and potential alternative to face-to-face interventions for treating disease-related disorders in pwMS. In literature, there are many studies examining the effectiveness of telerehabilitation in pwMS. According to these studies, ıt has been shown that telerehabilitation, with its technical facilities, had the potential to make clinical interventions widely accessible and effective for MS, however, telerehabilitation-based interventions could not replace traditional interventions but could perfectly complement. It has been found that telerehabilitation improved balance and postural control in MS patients and had no side effects. However, it was emphasized that the evidence levels of the studies were insufficient for methodological reasons. It has been determined additional studies are needed to investigate examining the effect on walking.

Another clinical-based exercise method is Pilates. Pilates is a "core" stability-based exercise method that includes endurance, flexibility, movement, posture, and respiratory control. Studies have shown that Pilates training can improve balance, mobility, and muscle strength, fatigue in pwMS due to its structure consisting of balance and strengthening exercises. When the literature is reviewed in terms of Telerehabilitation based on Pilates in pwMS, it is seen that there are only two studies. In both studies, pwMS were given 20 minutes of yoga, 20 minutes of Pilates, and 20 minutes of dual-task exercise. However, these studies were in the project phase and the results are still not reported. On the other hand, in both studies, Pilates is given as combined training.

As a result, telerehabilitation is an alternative method to MS treatment. In addition, while there are many clinical-based Pilates studies in the literature, telerehabilitation-based Pilates studies are insufficient. Telerehabilitation-based Pilates training studies are needed. Therefore, the investigators planned this study to investigate the effect of telerehabilitation-based pilates training on physical performance and quality of life in pwMS.

Detailed description: This study is planned as a randomized control trial. Patients will be randomly divided into two groups as intervention and control. The intervention group will be received telerehabilitation-based pilates training three times a week for six weeks. Telerehabilitation-based pilates will be provided via videoconferencing.

The first session will be the introduction session, patients will be informed about basic principles of Pilates and it will be included teaching inward movement of the lower abdominal wall and supine exercises of segmental movements involving trunk muscle recruitment to maintain a neutral posture. Afterward the session, a typical session will be included supine, side-lying, quadruped exercise, sitting on the exercise ball, and standing exercises. Exercises will be included thoracic extension, general abdominal strengthening, core stabilization exercises for the deep abdominal muscles. The difficulty of these exercises will be gradually increased and focused on keeping neutral positions of the spine in different gravity orientations. The control group will be a wait-list group without any additional specific treatment. All assessments will be done before and after the 6-week intervention program or waiting period. The demographic characteristics of the participants initially will be taken and the Expanded Disability Status Scale score of those of MS will be recorded. Primary outcomes are balance, gait, core endurance and power, and muscle strength; secondary outcomes are physical activity, fatigue, and quality of life

Eligibility criteria: Inclusion Criteria:

* 18-65 years of age
* Voluntarily participate in research to accept
* Having a diagnosis of "Multiple Sclerosis" by a specialist physician
* Relapse free in the last 3 mounts
* An Expanded Disability Status Scale (EDSS) score less than or equal to 4

Exclusion Criteria:

* Any cardiovascular, orthopedic, visual, hearing, and perception problems that may affect the results of the research.

Primary outcomes:
measure: Dynamic Balance- Baseline
timeFrame: Assessment will be conducted before the intervention
measure: Dynamic Balance-Post intervention
timeFrame: Assessment will be conducted immediately after the intervention.
measure: Static Balance- Baseline
timeFrame: Assessment will be conducted before the intervention.
measure: Static Balance- Post intervention
timeFrame: Assessment will be conducted immediately after the intervention.
measure: An individual's confidence in performing activities- Baseline
timeFrame: Assessment will be conducted before the intervention.
measure: An individual's confidence in performing activities- Post intervention
timeFrame: Assessment will be conducted immediately after the intervention.
measure: Exercise capacity- Baseline
timeFrame: Assessment will be conducted before the intervention.
measure: Exercise capacity- Post intervention
timeFrame: Assessment will be conducted immediately after the intervention.
measure: Gait parameters- Baseline
timeFrame: Assessment will be conducted before the intervention.
measure: Gait parameters- Post intervention
timeFrame: Assessment will be conducted immediately after the intervention.
measure: Functional mobility- Baseline
timeFrame: Assessment will be conducted before the intervention.
measure: Functional mobility- Post intervention
timeFrame: Assessment will be conducted immediately after the intervention.
measure: Core endurance- Baseline
timeFrame: Assessment will be conducted before the intervention.
measure: Core endurance- Post intervention
timeFrame: Assessment will be conducted immediately after the intervention.
measure: Core strength- Baseline
timeFrame: Assessment will be conducted before the intervention.
measure: Core strength-Post intervention
timeFrame: Assessment will be conducted immediately after the intervention.
measure: Muscle Strength outcomes- Baseline
timeFrame: Assessment will be conducted before the intervention.
measure: Muscle Strength outcomes- Post intervention
timeFrame: Assessment will be conducted immediately after the intervention.
Secondary outcomes:
measure: Physical activity level- Baseline
timeFrame: Assessment will be conducted before the intervention.
measure: Physical activity level- Post intervention
timeFrame: Assessment will be conducted immediately after the intervention.
measure: Fatigue severity- Baseline
timeFrame: Assessment will be conducted before the intervention.
measure: Fatigue severity- Post intervention
timeFrame: Assessment will be conducted immediately after the intervention.
measure: Impact of fatigue on activities- Baseline
timeFrame: Assessment will be conducted before the intervention.
measure: Impact of fatigue on activities- Post intervention
timeFrame: Assessment will be conducted immediately after the intervention.
measure: Health related quality of life- Baseline
timeFrame: Assessment will be conducted before the intervention.
measure: Health related quality of life- Post intervention- Post intervention
timeFrame: Assessment will be conducted immediately after the intervention.
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Gazi University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation
Study officials:
affiliation: Research Assistant
name: Kader Eldemir, PT, MSc.
role: STUDY_CHAIR
affiliation: Professor
name: Arzu Güçlü-Gündüz, PT, PhD
role: STUDY_DIRECTOR
References: