<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/NCT04500223</url>
  </required_header>
  <id_info>
    <org_study_id>TYGH108045</org_study_id>
    <nct_id>NCT04500223</nct_id>
  </id_info>
  <brief_title>The Effect of Neck Stabilization Exercise Plus Cardiopulmonary Rehabilitation on Pulmonary Function of SCI</brief_title>
  <official_title>The Effect of Neck Stabilization Exercise Plus Cardiopulmonary Rehabilitation on Pulmonary Function of SCI</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Taoyuan General Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Taoyuan General Hospital</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>
      Cervicocranial flexion exercise (CCFE) and superficial neck flexor endurance training have&#xD;
      been widely implemented in clinical practice for curing chronic neck pain. By means of CCFE,&#xD;
      the muscle balance between deep neck flexor and superficial flexor would be optimal during&#xD;
      neck movement. In other words, the superficial neck flexor( scalenes, SCM, and trapezius)&#xD;
      would not overactive and the fatigue threshold might increase. Superficial neck flexor&#xD;
      endurance training is proved to be efficient in reducing superficial cervical flexor muscle&#xD;
      fatigue as well as increasing cervical flexion strength.&#xD;
&#xD;
      Reasonably, Cervicocranial flexion exercise (CCFE) and superficial neck flexor endurance&#xD;
      training are also beneficial to pulmonary function due to training the respiratory accessory&#xD;
      muscle (scalens and SCM). Hence this article hypothesizes that Cervicocranial flexion&#xD;
      exercise (CCFE) and superficial neck flexor endurance training combined with common pulmonary&#xD;
      rehabilitation will manifest better outcomes (pulmonary function, dyspnea situation, pain and&#xD;
      stiffness level of neck) than pulmonary rehabilitation only.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      2.1 subject 20 patients were recruited in this article during 2020/03 to 2021/02. The&#xD;
      inclusion criteria were 1.) SCI onset in a year; 2.) motor level above T12 and American&#xD;
      Spinal Injury Association Impairment Scale (AIS) grade A, B, C, or D; 3.) age from 20~70; 4.)&#xD;
      FEV1&lt; 80% prediction value. The exclusion criteria were 1.) ventilation dependence 2.)&#xD;
      Tracheostomy 3.) Psychiatric condition 4.) Progressive diseases 5.) infection 6.) cancer&#xD;
      7.)unable to speak Chinese or English. Patient who met the criteria would were asked to&#xD;
      provide written informed consent. The IRB were approved by Tao Yuan General Hospital,&#xD;
      Ministry of Health and Welfare, IRB committee.(TYGH108045 ) 2.2 procedure The subjects&#xD;
      included in this study were randomized assigned to experimental group and control group. The&#xD;
      randomization orders were decided by computer, and all the contents were concealed into a&#xD;
      dark color envelop. Before first treatment, the envelops were opened to determine which&#xD;
      treatment protocol were adopted. The treatment of experimental group was consist of&#xD;
      Cervicocranial flexion exercise (CCFE) and neck flexor endurance training plus normal&#xD;
      cardiopulmonary rehabilitation. The treatment of control group was composed of general neck&#xD;
      stretch exercise plus cardiopulmonary rehabilitation. Subsequently, initial measurement was&#xD;
      conducted including lung capacity test, dyspnea situation, pain and stiffness of neck.&#xD;
      Moreover, lung function such as FVC and FEV1, dyspnea situation, pain and stiffness of neck&#xD;
      were also recorded one time in a week as a short-term outcome. Then, the treatment protocols&#xD;
      were both executed for 30 minutes, ten times in a month. After completing the treatment&#xD;
      process, the final measurement were conducted as the initial treatment. All the outcome were&#xD;
      collected and analyzed by statistically method.&#xD;
&#xD;
      2.3 Outcome measurement Lung capacity was evaluated by in lung function examination center of&#xD;
      Taoyaun general hospital. The parameters revealed by this test. Before the examination,&#xD;
      bronchodilator should not be used to avoid interfering the outcome of examination. In&#xD;
      addition, portable lung capacity device(ezOxygen, Taipei, Taiwan) were adopted to record lung&#xD;
      function parameters such as FVC and FEV1. First, subjects were instructed to hold deep breath&#xD;
      and let his mouth firmly contact to the mouthpiece. Second, subjects were asked to exhale the&#xD;
      air into the mouth and the process was repeated three times, between each sessions, subjects&#xD;
      were allowed to rest at least thirty seconds. Three tests were recorded and the mean value&#xD;
      was calculated. The dyspnea situation was evaluated by the questionnaire Baseline Dyspnea&#xD;
      Index (BDI) and Transition Dyspnea Index (TDI). The BDI measured the severity of dyspnea at&#xD;
      the baseline and the TDI measured the change from baseline. Both questionnaires are composed&#xD;
      of three parts: functional impairment, magnitude of task, and magnitude of effort required to&#xD;
      evoke dyspnea. Each part in BDI is scored from 0(very severe) to 4(no impairment) and total&#xD;
      score from 0~12( the lower the score, the worse the severity of dyspnea) is also recorded.&#xD;
      Each component in TDI is rated by seven grades ranging from -3 (major deterioration) to +3&#xD;
      (major improvement). Total score ranged from - 9 to + 9. The lower the score is, the more&#xD;
      deterioration of the severity of dyspnea revealed. The minimal clinical important&#xD;
      difference(MCID) of TDI is ≥1 unit[31]. The number rating scale NRS is used to define the&#xD;
      level of neck pain and stiffness. The MCID of neck pain VAS is 1.5.&#xD;
&#xD;
      2.4 Treatment Experimental group is consist of CCFE and neck flexor endurance training plus&#xD;
      normal cardiopulmonary rehabilitation. Subjects were instructed to perform chin in without&#xD;
      excessive SCM contraction. CCFE was conducted in supine position. Subjects were asked to&#xD;
      maintain chin for 10 seconds each repetition, ten repetitions for a set, 3 sets in a&#xD;
      treatment session[30]. The physiotherapist with abundant experience related to CCFE&#xD;
      supervised all the treatment process to confirm the quality of execution. If no symptoms&#xD;
      revealed, the neck endurance exercise would involve into the treatment sessions. Neck&#xD;
      endurance exercise was also conducted in supine position. Subjects were taught to lift their&#xD;
      head with a neutral upper cervical spine first. Then, they gradually move the head and neck&#xD;
      through as full range as possible without induce discomfort or neck related symptom. This&#xD;
      exercise was performed 12~15 repetition depends on patient's condition[33]. If the subjects&#xD;
      were unable to achieve the training level, subject's bed were inclined up from horizontal.&#xD;
      Hence, the demand of lifting neck and head declined and subjects could perform aimed&#xD;
      repetitions. The cardiopulmonary rehabilitation protocol was based on Wu, Y.-T. et al[9], and&#xD;
      it was divide into three stages. In first stage, subjects lied in supine position, and they&#xD;
      were instructed to do diaphragm breath, pursed-lip breath, lateral coastal breath, cough&#xD;
      training, and rib mobilization. The dosage and type of therapy was decided depending on&#xD;
      subjects situation everyday. The total cardiopulmonary training was controlled in 20 minutes.&#xD;
      In second stage, the incentive spirometer (picture A) was integrated into the therapy.&#xD;
      Subjects were asked to inhale the air slowly with eye contact at the chamber of the&#xD;
      spirometer for controlling the air flow velocity. Subject were also asked to inhale as many&#xD;
      volumes as possible. Back support was inclined to hold subject in semi-sitting position. 15&#xD;
      repetitions was given to subjects and subjects received 20 second rest between each&#xD;
      repetition. In addition, some upper extremities training combined with breath exercise were&#xD;
      also involved in after incentive spirometer training. 15 repetitions, 3 sets was given to&#xD;
      subjects. In stage 3, the upper extremities exercise were combined with spirometer training.&#xD;
      15 repetitions, 3 sets was given to subjects. The experienced physiotherapist decided the&#xD;
      stages depends on patient's capability, that is, the stages were not the same for every&#xD;
      subject. The control group were composed of neck stretch exercise plus cardiopulmonary&#xD;
      rehabilitation. The neck stretch exercises were executed by physiotherapist before&#xD;
      cardiopulmonary training. Neck flexion, neck extension, neck right rotation, neck left&#xD;
      rotation, neck right side-bending, and neck left side-bending were applied to subjects 5&#xD;
      times for each direction, and neck maintained at end position for 30 seconds each time.&#xD;
&#xD;
      2.5 Statistical analysis The primary variable of the study were vital capacity, respiratory&#xD;
      complication ,and dyspnea. The secondary variable of the study were FEV1, pain and stiffness&#xD;
      of neck. Descriptive statistics for the categorical variable were documented as frequency&#xD;
      counts and percentages. The continuous variables were reported as mean + SD, if they were&#xD;
      normal distribution, or they were recorded as median and range.&#xD;
&#xD;
      The Wilcox signed test was adopted to analyze the treatment before and after the treatment&#xD;
      sessions (time effect). The Mann-Whitney U was applied for the difference before and after&#xD;
      treatment between two groups (group effect), and the baseline of two groups was also analyzed&#xD;
      by this method. The significant level was set as p value&lt; 0.05. All the statistical data&#xD;
      analysis were performed by SPSS version 22.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 1, 2020</start_date>
  <completion_date type="Actual">February 28, 2021</completion_date>
  <primary_completion_date type="Actual">February 1, 2021</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>FVC change</measure>
    <time_frame>initial points, first week, second week, final points.(total 3 week)</time_frame>
    <description>liter</description>
  </primary_outcome>
  <primary_outcome>
    <measure>FEV1/FVC change</measure>
    <time_frame>initial points, first week, second week, final points.(total 3 week)</time_frame>
    <description>percentage</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Baseline Dyspnea Index (BDI) and Transition Dyspnea Index (TDI) score change</measure>
    <time_frame>initial points, first week, second week, final points.(total 3 week)</time_frame>
    <description>points</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">13</enrollment>
  <condition>Spinal Cord Injury</condition>
  <arm_group>
    <arm_group_label>Cervical Cranioflexion exercise plus cardiopulmonary exercise</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>subjects who received Cervical Cranioflexion exercise plus cardiopulmonary exercise</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cervical stretch exercise plus cardiopulmonary rehabilitation</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>subjects who received Cervical stretch exercise plus cardiopulmonary rehabilitation</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Cervical Cranioflexion exercise plus cardiopulmonary exercise</intervention_name>
    <description>Intervention:Cervical Cranioflexion exercise plus cardiopulmonary exercise</description>
    <arm_group_label>Cervical Cranioflexion exercise plus cardiopulmonary exercise</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Cervical stretch exercise plus cardiopulmonary rehabilitation</intervention_name>
    <description>control:Cervical stretch exercise plus cardiopulmonary rehabilitation</description>
    <arm_group_label>Cervical stretch exercise plus cardiopulmonary rehabilitation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  SCI onset in a year.&#xD;
&#xD;
          -  Motor level above T12 and American Spinal Injury Association Impairment Scale (AIS)&#xD;
             grade A, B, C, or D.&#xD;
&#xD;
          -  Age from 20~70.&#xD;
&#xD;
          -  FEV1&lt; 80% prediction value.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Ventilation dependent&#xD;
&#xD;
          -  Tracheostomy&#xD;
&#xD;
          -  Psychiatric condition&#xD;
&#xD;
          -  Progressive diseases&#xD;
&#xD;
          -  infection&#xD;
&#xD;
          -  Cancer&#xD;
&#xD;
          -  Unable to speak Chinese or English.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Taoyaun General Hospital, Ministry of Wealth and Health</name>
      <address>
        <city>Taoyuan</city>
        <state>Taoyuan Dist.</state>
        <zip>330</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
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  <verification_date>July 2023</verification_date>
  <study_first_submitted>May 7, 2020</study_first_submitted>
  <study_first_submitted_qc>July 31, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 5, 2020</study_first_posted>
  <last_update_submitted>July 25, 2023</last_update_submitted>
  <last_update_submitted_qc>July 25, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 28, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Cervical exercise</keyword>
  <keyword>Cardiopulmonary rehabilitation</keyword>
  <keyword>Pulmonary function</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Spinal Cord Injuries</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


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/NCT04500223
org study id: TYGH108045
nct id: NCT04500223
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Cervicocranial flexion exercise (CCFE) and superficial neck flexor endurance training have
      been widely implemented in clinical practice for curing chronic neck pain. By means of CCFE,
      the muscle balance between deep neck flexor and superficial flexor would be optimal during
      neck movement. In other words, the superficial neck flexor( scalenes, SCM, and trapezius)
      would not overactive and the fatigue threshold might increase. Superficial neck flexor
      endurance training is proved to be efficient in reducing superficial cervical flexor muscle
      fatigue as well as increasing cervical flexion strength.

      Reasonably, Cervicocranial flexion exercise (CCFE) and superficial neck flexor endurance
      training are also beneficial to pulmonary function due to training the respiratory accessory
      muscle (scalens and SCM). Hence this article hypothesizes that Cervicocranial flexion
      exercise (CCFE) and superficial neck flexor endurance training combined with common pulmonary
      rehabilitation will manifest better outcomes (pulmonary function, dyspnea situation, pain and
      stiffness level of neck) than pulmonary rehabilitation only.
2.1 subject 20 patients were recruited in this article during 2020/03 to 2021/02. The
      inclusion criteria were 1.) SCI onset in a year; 2.) motor level above T12 and American
      Spinal Injury Association Impairment Scale (AIS) grade A, B, C, or D; 3.) age from 20~70; 4.)
      FEV1< 80% prediction value. The exclusion criteria were 1.) ventilation dependence 2.)
      Tracheostomy 3.) Psychiatric condition 4.) Progressive diseases 5.) infection 6.) cancer
      7.)unable to speak Chinese or English. Patient who met the criteria would were asked to
      provide written informed consent. The IRB were approved by Tao Yuan General Hospital,
      Ministry of Health and Welfare, IRB committee.(TYGH108045 ) 2.2 procedure The subjects
      included in this study were randomized assigned to experimental group and control group. The
      randomization orders were decided by computer, and all the contents were concealed into a
      dark color envelop. Before first treatment, the envelops were opened to determine which
      treatment protocol were adopted. The treatment of experimental group was consist of
      Cervicocranial flexion exercise (CCFE) and neck flexor endurance training plus normal
      cardiopulmonary rehabilitation. The treatment of control group was composed of general neck
      stretch exercise plus cardiopulmonary rehabilitation. Subsequently, initial measurement was
      conducted including lung capacity test, dyspnea situation, pain and stiffness of neck.
      Moreover, lung function such as FVC and FEV1, dyspnea situation, pain and stiffness of neck
      were also recorded one time in a week as a short-term outcome. Then, the treatment protocols
      were both executed for 30 minutes, ten times in a month. After completing the treatment
      process, the final measurement were conducted as the initial treatment. All the outcome were
      collected and analyzed by statistically method.

      2.3 Outcome measurement Lung capacity was evaluated by in lung function examination center of
      Taoyaun general hospital. The parameters revealed by this test. Before the examination,
      bronchodilator should not be used to avoid interfering the outcome of examination. In
      addition, portable lung capacity device(ezOxygen, Taipei, Taiwan) were adopted to record lung
      function parameters such as FVC and FEV1. First, subjects were instructed to hold deep breath
      and let his mouth firmly contact to the mouthpiece. Second, subjects were asked to exhale the
      air into the mouth and the process was repeated three times, between each sessions, subjects
      were allowed to rest at least thirty seconds. Three tests were recorded and the mean value
      was calculated. The dyspnea situation was evaluated by the questionnaire Baseline Dyspnea
      Index (BDI) and Transition Dyspnea Index (TDI). The BDI measured the severity of dyspnea at
      the baseline and the TDI measured the change from baseline. Both questionnaires are composed
      of three parts: functional impairment, magnitude of task, and magnitude of effort required to
      evoke dyspnea. Each part in BDI is scored from 0(very severe) to 4(no impairment) and total
      score from 0~12( the lower the score, the worse the severity of dyspnea) is also recorded.
      Each component in TDI is rated by seven grades ranging from -3 (major deterioration) to +3
      (major improvement). Total score ranged from - 9 to + 9. The lower the score is, the more
      deterioration of the severity of dyspnea revealed. The minimal clinical important
      difference(MCID) of TDI is ≥1 unit[31]. The number rating scale NRS is used to define the
      level of neck pain and stiffness. The MCID of neck pain VAS is 1.5.

      2.4 Treatment Experimental group is consist of CCFE and neck flexor endurance training plus
      normal cardiopulmonary rehabilitation. Subjects were instructed to perform chin in without
      excessive SCM contraction. CCFE was conducted in supine position. Subjects were asked to
      maintain chin for 10 seconds each repetition, ten repetitions for a set, 3 sets in a
      treatment session[30]. The physiotherapist with abundant experience related to CCFE
      supervised all the treatment process to confirm the quality of execution. If no symptoms
      revealed, the neck endurance exercise would involve into the treatment sessions. Neck
      endurance exercise was also conducted in supine position. Subjects were taught to lift their
      head with a neutral upper cervical spine first. Then, they gradually move the head and neck
      through as full range as possible without induce discomfort or neck related symptom. This
      exercise was performed 12~15 repetition depends on patient's condition[33]. If the subjects
      were unable to achieve the training level, subject's bed were inclined up from horizontal.
      Hence, the demand of lifting neck and head declined and subjects could perform aimed
      repetitions. The cardiopulmonary rehabilitation protocol was based on Wu, Y.-T. et al[9], and
      it was divide into three stages. In first stage, subjects lied in supine position, and they
      were instructed to do diaphragm breath, pursed-lip breath, lateral coastal breath, cough
      training, and rib mobilization. The dosage and type of therapy was decided depending on
      subjects situation everyday. The total cardiopulmonary training was controlled in 20 minutes.
      In second stage, the incentive spirometer (picture A) was integrated into the therapy.
      Subjects were asked to inhale the air slowly with eye contact at the chamber of the
      spirometer for controlling the air flow velocity. Subject were also asked to inhale as many
      volumes as possible. Back support was inclined to hold subject in semi-sitting position. 15
      repetitions was given to subjects and subjects received 20 second rest between each
      repetition. In addition, some upper extremities training combined with breath exercise were
      also involved in after incentive spirometer training. 15 repetitions, 3 sets was given to
      subjects. In stage 3, the upper extremities exercise were combined with spirometer training.
      15 repetitions, 3 sets was given to subjects. The experienced physiotherapist decided the
      stages depends on patient's capability, that is, the stages were not the same for every
      subject. The control group were composed of neck stretch exercise plus cardiopulmonary
      rehabilitation. The neck stretch exercises were executed by physiotherapist before
      cardiopulmonary training. Neck flexion, neck extension, neck right rotation, neck left
      rotation, neck right side-bending, and neck left side-bending were applied to subjects 5
      times for each direction, and neck maintained at end position for 30 seconds each time.

      2.5 Statistical analysis The primary variable of the study were vital capacity, respiratory
      complication ,and dyspnea. The secondary variable of the study were FEV1, pain and stiffness
      of neck. Descriptive statistics for the categorical variable were documented as frequency
      counts and percentages. The continuous variables were reported as mean + SD, if they were
      normal distribution, or they were recorded as median and range.

      The Wilcox signed test was adopted to analyze the treatment before and after the treatment
      sessions (time effect). The Mann-Whitney U was applied for the difference before and after
      treatment between two groups (group effect), and the baseline of two groups was also analyzed
      by this method. The significant level was set as p value< 0.05. All the statistical data
      analysis were performed by SPSS version 22.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: FVC change
time frame: initial points, first week, second week, final points.(total 3 week)
description: liter
measure: FEV1/FVC change
time frame: initial points, first week, second week, final points.(total 3 week)
description: percentage
measure: Baseline Dyspnea Index (BDI) and Transition Dyspnea Index (TDI) score change
time frame: initial points, first week, second week, final points.(total 3 week)
description: points
arm group label: Cervical Cranioflexion exercise plus cardiopulmonary exercise
arm group type: Experimental
description: subjects who received Cervical Cranioflexion exercise plus cardiopulmonary exercise
arm group label: Cervical stretch exercise plus cardiopulmonary rehabilitation
arm group type: Active Comparator
description: subjects who received Cervical stretch exercise plus cardiopulmonary rehabilitation
intervention type: Other
intervention name: Cervical Cranioflexion exercise plus cardiopulmonary exercise
description: Intervention:Cervical Cranioflexion exercise plus cardiopulmonary exercise
arm group label: Cervical Cranioflexion exercise plus cardiopulmonary exercise
intervention type: Other
intervention name: Cervical stretch exercise plus cardiopulmonary rehabilitation
description: control:Cervical stretch exercise plus cardiopulmonary rehabilitation
arm group label: Cervical stretch exercise plus cardiopulmonary rehabilitation
criteria: 
gender: All
minimum age: 20 Years
maximum age: 80 Years
healthy volunteers: No
facility: 
country: Taiwan
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responsible party type: Sponsor
mesh term: Spinal Cord Injuries
sharing ipd: No