xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT05993819</url>
    </required_header>
    <id_info>
      <org_study_id>p.t.REC/012/004535</org_study_id>
      <nct_id>NCT05993819</nct_id>
    </id_info>
    <brief_title>Impact of Adding Cognitive Behaviour Therapy to Supervised Pilates-based Core Stability Training in Patients With Multiple Sclerosis</brief_title>
    <acronym>MS</acronym>
    <official_title>Impact of Adding Cognitive Behaviour Therapy to Supervised Pilates-based Core Stability Training on Balance and Walking in Patients With Multiple Sclerosis</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Cairo University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Cairo University</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        To investigate the effect of adding cognitive behaviour therapy to supervised Pilates-based&#xD;
        core stability training on balance, walking, fatigue and function in patients with multiple&#xD;
        sclerosis&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Multiple sclerosis (MS) is characterized by widespread demyelinating lesions and&#xD;
        neurodegeneration in the central nervous system, leading to muscle weakness and compromised&#xD;
        sensory-motor integration. Muscle weakness predominantly seen in lower extremities and&#xD;
        decreased postural control deteriorate physical performance and gait function. Also ,&#xD;
        respiratory dysfunction and fatigue has been occurred. Optimal trunk control is provided by&#xD;
        the somatosensory, motor, and musculoskeletal integrity, which is mostly damaged in MS. Core&#xD;
        stability, is defined as the ability to control the position and movement of the trunk on the&#xD;
        pelvis to allow optimum power and movement generation, transfer, and control in other&#xD;
        segments. A decrease in core stability affects both trunk control and the quality of limb&#xD;
        movements due to the kinetic chain in the body. Pilates-based core stability training (PBCST)&#xD;
        is a controlled form of exercise used to improve the stabilization of the trunk muscles. The&#xD;
        purpose of PBCST is to train the core muscles more effectively by using the basic principles&#xD;
        of Pilates integrated into core stabilization exercises and the activation effect of&#xD;
        breathing on deep muscles. Transversus abdominis (TrA) activation is crucial in this&#xD;
        training. TrA is activated by a feed-forward mechanism of neuromuscular control before sudden&#xD;
        spinal loads or limb movements and provides postural adaptation. Thus, effective TrA&#xD;
        activation contributes to both distal mobility and postural control by increasing trunk&#xD;
        stability (Freeman el al., 2012). We have recently developed a cognitive behavior therapy to&#xD;
        explain MS fatigue that integrates the findings across biological and psychosocial research.&#xD;
        This model proposes that primary disease factors trigger the initial symptom of fatigue in&#xD;
        MS, and the fatigue is perpetuated or worsened depending . fifty patients with MS will be&#xD;
        assigned randomly into two equal group; first one will receive cognitive behavioral therapy&#xD;
        and pilates and the other will receive pilates only for eight weeks&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 15, 2023</start_date>
    <completion_date type="Anticipated">December 30, 2023</completion_date>
    <primary_completion_date type="Anticipated">December 30, 2023</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <intervention_model_description>pilates and cognitive behavioral therapy</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Double (Investigator, Outcomes Assessor)</masking>
      <masking_description>opaque sealed envelope</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>walking assessment</measure>
      <time_frame>up to eight weeks</time_frame>
      <description>walking will be assessed by walkway device</description>
    </primary_outcome>
    <primary_outcome>
      <measure>balance</measure>
      <time_frame>up to eight weeks</time_frame>
      <description>balance will be assessed by biodex balance device</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>fatigue</measure>
      <time_frame>up to eight weeks</time_frame>
      <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).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>life disability</measure>
      <time_frame>up to eight weeks</time_frame>
      <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.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">50</enrollment>
    <condition>Multiple Sclerosis</condition>
    <arm_group>
      <arm_group_label>pilates based core stability training and congnitive therapy</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>the patients will receive pilates and cognitive therapy three times a week for eight weeks</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Pilates based core stability training</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>the patients will receive pilates three times a week for eight weeks</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>pilates based core stability training and congnitive therapy</intervention_name>
      <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.</description>
      <arm_group_label>pilates based core stability training and congnitive therapy</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Pilates based core stability training</intervention_name>
      <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.</description>
      <arm_group_label>Pilates based core stability training</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  A score of 3.5 or less on the Expanded Disability Status Scale (EDSS) because&#xD;
               individuals with an EDSS score greater than 3.5 need more assistance, being less&#xD;
               independent.&#xD;
  &#xD;
            -  Age over 18 years&#xD;
  &#xD;
            -  All definite multiple sclerosis patients diagnosed as MS according to revised McDonald&#xD;
               criteria 2017&#xD;
  &#xD;
            -  Both males and females were included&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          -Individuals who had orthopedic, neurologic, and psychological problems that accompanied MS&#xD;
          that might affect the treatment results-&#xD;
  &#xD;
            -  serious cognitive problems; performed regular exercise; were involved in another&#xD;
               physiotherapy and rehabilitation program related to MS(Kurtzke, 1993)&#xD;
  &#xD;
            -  Pregnant were not included.&#xD;
  &#xD;
            -  Individuals who had an exacerbation during the treatment period&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>70 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 7, 2023</study_first_submitted>
    <study_first_submitted_qc>August 7, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 15, 2023</study_first_posted>
    <last_update_submitted>August 7, 2023</last_update_submitted>
    <last_update_submitted_qc>August 7, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 15, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Cairo University</investigator_affiliation>
      <investigator_full_name>Al Shaymaa Shaaban Abd El Azeim</investigator_full_name>
      <investigator_title>principle investigator. alshaymaa shaaban abd el-azeim</investigator_title>
    </responsible_party>
    <keyword>cognitive behaviour therapy</keyword>
    <keyword>Pilates exercise</keyword>
    <keyword>palance</keyword>
    <keyword>walking</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Multiple Sclerosis</mesh_term>
      <mesh_term>Sclerosis</mesh_term>
    </condition_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT05993819
  org study id: p.t.REC/012/004535
  nct id: NCT05993819
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  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
  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
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: pilates and cognitive behavioral therapy
  primary purpose: Treatment
  masking: Double (Investigator, Outcomes Assessor)
  masking description: opaque sealed envelope
  measure: walking assessment
  time frame: up to eight weeks
  description: walking will be assessed by walkway device
  measure: balance
  time frame: up to eight weeks
  description: balance will be assessed by biodex balance device
  measure: fatigue
  time frame: up to eight weeks
  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).
  measure: life disability
  time frame: up to eight weeks
  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.
  arm group label: pilates based core stability training and congnitive therapy
  arm group type: Experimental
  description: the patients will receive pilates and cognitive therapy three times a week for eight weeks
  arm group label: Pilates based core stability training
  arm group type: Active Comparator
  description: the patients will receive pilates three times a week for eight weeks
  intervention type: Other
  intervention name: pilates based core stability training and congnitive therapy
  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.
  arm group label: pilates based core stability training and congnitive therapy
  intervention type: Other
  intervention name: Pilates based core stability training
  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.
  arm group label: Pilates based core stability training
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 70 Years
  healthy volunteers: No
  responsible party type: Principal Investigator
  investigator affiliation: Cairo University
  investigator full name: Al Shaymaa Shaaban Abd El Azeim
  investigator title: principle investigator. alshaymaa shaaban abd el-azeim
  mesh term: Multiple Sclerosis
  mesh term: Sclerosis