search
Back to results

Impact of Adding Cognitive Behaviour Therapy to Supervised Pilates-based Core Stability Training in Patients With Multiple Sclerosis (MS)

Primary Purpose

Multiple Sclerosis

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
pilates based core stability training and congnitive therapy
Pilates based core stability training
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Sclerosis focused on measuring cognitive behaviour therapy, Pilates exercise, palance, walking

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    pilates based core stability training and congnitive therapy

    Pilates based core stability training

    Arm Description

    the patients will receive pilates and cognitive therapy three times a week for eight weeks

    the patients will receive pilates three times a week for eight weeks

    Outcomes

    Primary Outcome Measures

    walking assessment
    walking will be assessed by walkway device
    balance
    balance will be assessed by biodex balance device

    Secondary Outcome Measures

    fatigue
    fatigue severity scale will be used for assessment of fatigue. The FSS is a self-reported questionnaire that is simple and easy to use. It consists of 9 statements that rate the severity of the patient's fatigue symptoms in terms of how these symptoms affect motivation, exercise, physical function, and activities of daily living. Reflecting on their condition over the past week, patients score each item from 1 to 7, based on the extent, to which they agree or disagree with each statement (1 = strong disagreement, 7 = strong agreement).
    life disability
    short form 36 will be used for assessment the quality of life in eight domains. score the SF-36, scales are standardized with a scoring algorithm or by the SF-36v2 scoring software to obtain a score ranging from 0 to 100. Higher scores indicate better health status, and a mean score of 50 has been articulated as a normative value for all scales.

    Full Information

    First Posted
    August 7, 2023
    Last Updated
    August 7, 2023
    Sponsor
    Cairo University
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT05993819
    Brief Title
    Impact of Adding Cognitive Behaviour Therapy to Supervised Pilates-based Core Stability Training in Patients With Multiple Sclerosis
    Acronym
    MS
    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

    2. Study Status

    Record Verification Date
    August 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    August 15, 2023 (Anticipated)
    Primary Completion Date
    December 30, 2023 (Anticipated)
    Study Completion Date
    December 30, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Cairo University

    4. Oversight

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

    5. Study Description

    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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Multiple Sclerosis
    Keywords
    cognitive behaviour therapy, Pilates exercise, palance, walking

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    pilates and cognitive behavioral therapy
    Masking
    InvestigatorOutcomes Assessor
    Masking Description
    opaque sealed envelope
    Allocation
    Randomized
    Enrollment
    50 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    pilates based core stability training and congnitive therapy
    Arm Type
    Experimental
    Arm Description
    the patients will receive pilates and cognitive therapy three times a week for eight weeks
    Arm Title
    Pilates based core stability training
    Arm Type
    Active Comparator
    Arm Description
    the patients will receive pilates three times a week for eight weeks
    Intervention Type
    Other
    Intervention Name(s)
    pilates based core stability training and congnitive therapy
    Intervention Description
    Exercises were structured in different conditions such as supine, side-lying, prone, quadruped, sitting, and standing positions. The various variations of each exercise were created so that the easier or more difficult versions of the exercises were selected according to the level of the patients, basically in the same training plan for all.the patients also will receive cognitive behavioural therapy.The CBT manual was written specifically for this trial. The sessions were collaborative in style, and the therapist used Socratic questioning wherever possible. The main aim was to challenge any behavioral, cognitive, emotional and external factors that may be contributing to MS fatigue.
    Intervention Type
    Other
    Intervention Name(s)
    Pilates based core stability training
    Intervention Description
    Exercises were structured in different conditions such as supine, side-lying, prone, quadruped, sitting, and standing positions. The various variations of each exercise were created so that the easier or more difficult versions of the exercises were selected according to the level of the patients, basically in the same training plan for all. The exercises were gradually made more difficult to increase the stabilization of the trunk by gradually reducing the support surface, increasing the extremity loading, and adding various materials.Exercises were progressed every 2 weeks in both groups and were performed with 10 repetitions for the first 4 weeks and 15 repetitions for the next 4 weeks.
    Primary Outcome Measure Information:
    Title
    walking assessment
    Description
    walking will be assessed by walkway device
    Time Frame
    up to eight weeks
    Title
    balance
    Description
    balance will be assessed by biodex balance device
    Time Frame
    up to eight weeks
    Secondary Outcome Measure Information:
    Title
    fatigue
    Description
    fatigue severity scale will be used for assessment of fatigue. The FSS is a self-reported questionnaire that is simple and easy to use. It consists of 9 statements that rate the severity of the patient's fatigue symptoms in terms of how these symptoms affect motivation, exercise, physical function, and activities of daily living. Reflecting on their condition over the past week, patients score each item from 1 to 7, based on the extent, to which they agree or disagree with each statement (1 = strong disagreement, 7 = strong agreement).
    Time Frame
    up to eight weeks
    Title
    life disability
    Description
    short form 36 will be used for assessment the quality of life in eight domains. score the SF-36, scales are standardized with a scoring algorithm or by the SF-36v2 scoring software to obtain a score ranging from 0 to 100. Higher scores indicate better health status, and a mean score of 50 has been articulated as a normative value for all scales.
    Time Frame
    up to eight weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    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

    12. IPD Sharing Statement

    Learn more about this trial

    Impact of Adding Cognitive Behaviour Therapy to Supervised Pilates-based Core Stability Training in Patients With Multiple Sclerosis

    We'll reach out to this number within 24 hrs