Clinical trial NCT05993819: Impact of Adding Cognitive Behaviour Therapy to Supervised Pilates-based Core Stability Training in Patients With Multiple Sclerosis
Official title: Impact of Adding Cognitive Behaviour Therapy to Supervised Pilates-based Core Stability Training on Balance and Walking in Patients With Multiple Sclerosis
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Multiple Sclerosis
Keywords: cognitive behaviour therapy
Pilates exercise
palance
walking
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2023-08-15
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: pilates and cognitive behavioral therapy
Primary purpose: TREATMENT

Brief summary: To investigate the effect of adding cognitive behaviour therapy to supervised Pilates-based core stability training on balance, walking, fatigue and function in patients with multiple sclerosis

Detailed description: Multiple sclerosis (MS) is characterized by widespread demyelinating lesions and neurodegeneration in the central nervous system, leading to muscle weakness and compromised sensory-motor integration. Muscle weakness predominantly seen in lower extremities and decreased postural control deteriorate physical performance and gait function. Also , respiratory dysfunction and fatigue has been occurred. Optimal trunk control is provided by the somatosensory, motor, and musculoskeletal integrity, which is mostly damaged in MS. Core stability, is defined as the ability to control the position and movement of the trunk on the pelvis to allow optimum power and movement generation, transfer, and control in other segments. A decrease in core stability affects both trunk control and the quality of limb movements due to the kinetic chain in the body. Pilates-based core stability training (PBCST) is a controlled form of exercise used to improve the stabilization of the trunk muscles. The purpose of PBCST is to train the core muscles more effectively by using the basic principles of Pilates integrated into core stabilization exercises and the activation effect of breathing on deep muscles. Transversus abdominis (TrA) activation is crucial in this training. TrA is activated by a feed-forward mechanism of neuromuscular control before sudden spinal loads or limb movements and provides postural adaptation. Thus, effective TrA activation contributes to both distal mobility and postural control by increasing trunk stability (Freeman el al., 2012). We have recently developed a cognitive behavior therapy to explain MS fatigue that integrates the findings across biological and psychosocial research. This model proposes that primary disease factors trigger the initial symptom of fatigue in MS, and the fatigue is perpetuated or worsened depending . fifty patients with MS will be assigned randomly into two equal group; first one will receive cognitive behavioral therapy and pilates and the other will receive pilates only for eight weeks

Eligibility criteria: Inclusion Criteria:

* A score of 3.5 or less on the Expanded Disability Status Scale (EDSS) because individuals with an EDSS score greater than 3.5 need more assistance, being less independent.
* Age over 18 years
* All definite multiple sclerosis patients diagnosed as MS according to revised McDonald criteria 2017
* Both males and females were included

Exclusion Criteria:

-Individuals who had orthopedic, neurologic, and psychological problems that accompanied MS that might affect the treatment results-

* serious cognitive problems; performed regular exercise; were involved in another physiotherapy and rehabilitation program related to MS(Kurtzke, 1993)
* Pregnant were not included.
* Individuals who had an exacerbation during the treatment period

Primary outcomes:
measure: walking assessment
timeFrame: up to eight weeks
measure: balance
timeFrame: up to eight weeks
Secondary outcomes:
measure: fatigue
timeFrame: up to eight weeks
measure: life disability
timeFrame: up to eight weeks
Other outcomes:
Locations:
Study officials:
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