<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/NCT03798418</url>
  </required_header>
  <id_info>
    <org_study_id>CCH-170208</org_study_id>
    <nct_id>NCT03798418</nct_id>
  </id_info>
  <brief_title>Sarcopenia and Risk of Falls in Patients With Major Chronic Diseases</brief_title>
  <official_title>Sarcopenia and Risk of Falls in Patients With Major Chronic Diseases - Effects of Therapeutic Exercise and Nutrition Intervention</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Changhua Christian Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Changhua Christian Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The objective of this study is to investigate the effects of therapeutic exercise and&#xD;
      nutrition intervention for sarcopenia and risk of falls in patients with major chronic&#xD;
      diseases. The outcomes will be analyzed regarding muscle strength, quality, and volume, etc.,&#xD;
      balance and gait, bone density, body composition, fall and quality of life after the&#xD;
      intervention.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The main common chronic diseases in the elderly such as stroke, osteoporosis, chronic kidney&#xD;
      disease and cancer, have been regarded as the fall high-risk patients. These patients are&#xD;
      considered to be at risk for sarcopenia due to decreased exercise, nutritional status, and&#xD;
      other reasons. Sarcopenia can be diagnosed and intervened effectively to delay the vicious&#xD;
      cycle of health. Past studies have pointed out that in addition to drug intervention,&#xD;
      treatment for sarcopenia must be accompanied by appropriate exercise and nutritional&#xD;
      intervention (such as protein supplements, vitamin D) in order to achieve the best prevention&#xD;
      and treatment.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 1, 2019</start_date>
  <completion_date type="Actual">September 30, 2022</completion_date>
  <primary_completion_date type="Actual">September 30, 2022</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>Prevention</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change of walking speed</measure>
    <time_frame>baseline: before intervention; follow-up: 3 months after intervention</time_frame>
    <description>distance: 6m, patients can walk with foor orthosis and assistive devices</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change of grip force</measure>
    <time_frame>before intervention; follow-up: 3 months after intervention</time_frame>
    <description>Use a grip force meter (kg) to test both hands for test 3 times</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change of postural sway displacement</measure>
    <time_frame>before intervention; follow-up: 3 months after intervention</time_frame>
    <description>Use computerized dynography to measure the postural sway displacement (mm)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change of postural sway velocity</measure>
    <time_frame>before intervention; follow-up: 3 months after intervention</time_frame>
    <description>Use computerized dynography to measure the postural sway velocity (mm/s)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change of postural sway area</measure>
    <time_frame>before intervention; follow-up: 3 months after intervention</time_frame>
    <description>Use computerized dynography to measure the postural sway area (mm^2)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change of step time</measure>
    <time_frame>before intervention; follow-up: 3 months after intervention</time_frame>
    <description>Use computerized dynography to measure spatial gait parameter: step time (ms)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change of stance time</measure>
    <time_frame>before intervention; follow-up: 3 months after intervention</time_frame>
    <description>Use computerized dynography to measure spatial gait parameter: stance time (ms)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change of swing time</measure>
    <time_frame>before intervention; follow-up: 3 months after intervention</time_frame>
    <description>Use computerized dynography to measure spatial gait parameter: swing time (ms)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change of single support time</measure>
    <time_frame>before intervention; follow-up: 3 months after intervention</time_frame>
    <description>Use computerized dynography to measure spatial gait parameter: single support time (ms)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change of double support time</measure>
    <time_frame>before intervention; follow-up: 3 months after intervention</time_frame>
    <description>Use computerized dynography to measure spatial gait parameter: double support time (ms)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change of step length</measure>
    <time_frame>before intervention; follow-up: 3 months after intervention</time_frame>
    <description>Use computerized dynography to measure spatial gait parameter: step distance (mm)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change of stance length</measure>
    <time_frame>before intervention; follow-up: 3 months after intervention</time_frame>
    <description>Use computerized dynography to measure spatial gait parameter: stance distance (mm)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change of muscle thickness</measure>
    <time_frame>before intervention; follow-up: 3 months after intervention</time_frame>
    <description>Use ultrasound to assess muscles morphological parameter: thickness (mm). Target muscles include quadriceps, hamstring, anterior tibialis, gastrocnemius.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change of muscle fiber length</measure>
    <time_frame>before intervention; follow-up: 3 months after intervention</time_frame>
    <description>Use ultrasound to assess muscles morphological parameter: fiber length (mm). Target muscles include quadriceps, hamstring, anterior tibialis, gastrocnemius.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change of muscle fiber orientation angle</measure>
    <time_frame>before intervention; follow-up: 3 months after intervention</time_frame>
    <description>Use ultrasound to assess muscles morphological parameter: fiber orientation angle (degrees). Target muscles include quadriceps, hamstring, anterior tibialis, gastrocnemius.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change of muscle cross section area</measure>
    <time_frame>before intervention; follow-up: 3 months after intervention</time_frame>
    <description>Use ultrasound to assess muscles morphological parameter: cross-sectional area (mm^2).&#xD;
Target muscles include quadriceps, hamstring, anterior tibialis, gastrocnemius.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change of physiological cost index (PCI)</measure>
    <time_frame>before intervention; follow-up: 3 months after intervention</time_frame>
    <description>Heart rate (HR: beats/min) and walking speed (m/s) have been previously shown to be linearly related to oxygen uptake at sub-maximal exercise levels. Combination of these two parameters yields a single value in beats per meter, the physiological cost index (PCI). This is calculated as Working HR - Resting HR (beats/min) / Walking speed (m/s)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change of international Quality of Life Assessment Short Form -36 (SF-36)</measure>
    <time_frame>before intervention; follow-up: 3 months after intervention</time_frame>
    <description>including 8 health concepts: (1) physical functioning, (2) role limitations because of physical health problems; (3) bodily pain, (4) social functioning, (5) general mental health (psychological distress and psychological wellbeing), (6) role limitations because of emotional problems, (7) vitality (energy/fatigue), (8) general health perceptions.&#xD;
Scoring: answers to each question are scored which are then summed and transformed to a 0 - 100 scale.&#xD;
The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change of amplitude of Muscle activity</measure>
    <time_frame>before intervention; follow-up: 3 months after intervention</time_frame>
    <description>use electromyography to measure the muscles activity in microvolts (uv) included quadriceps, hamstrings, tibialis anterior, gastrocnemius during subject walking in self-selected speed in 6 meters.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change of concentration of CRP (C-Reactive Protein)</measure>
    <time_frame>before intervention; follow-up: 3 months after intervention</time_frame>
    <description>The concentration of CRP in the blood test. CRP is used mainly as a marker of inflammation.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of concentration of ALB (Serum albumin)</measure>
    <time_frame>before intervention; follow-up: 3 months after intervention</time_frame>
    <description>The concentration of ALB in the blood test. Albumin is the most important contributor to the maintenance of plasma colloid oncotic pressure; deficiency results in edema.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of concentration of Glomerular Filtration Rate (GFR)</measure>
    <time_frame>before intervention; follow-up: 3 months after intervention</time_frame>
    <description>The concentration of GFR in the blood test. The glomerular filtration rate is the best test to measure the patient's level of kidney function and determine the stage of kidney disease. It can calculate it from the results of the blood creatinine test.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of concentration of Hemoglobin (Hb)</measure>
    <time_frame>Time Frame: before intervention; follow-up: 3 months after intervention</time_frame>
    <description>The concentration of Hb in the blood test.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of concentration of Glucose SPOT</measure>
    <time_frame>Time Frame: before intervention; follow-up: 3 months after intervention</time_frame>
    <description>The concentration of Glucose SPOT in the blood test. TheSpot glucose measurement in epidermal interstitial fluid appears to be a promising alternative to capillary blood glucose estimation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of concentration of Cholesterol</measure>
    <time_frame>before intervention; follow-up: 3 months after intervention</time_frame>
    <description>The concentration of Cholesterol in the blood test.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of concentration of Triglyceride</measure>
    <time_frame>before intervention; follow-up: 3 months after intervention</time_frame>
    <description>The concentration of Triglyceride in the blood test.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of concentration of Transferrin</measure>
    <time_frame>before intervention; follow-up: 3 months after intervention</time_frame>
    <description>The concentration of Transferrin in the blood test.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of Berg balance test (BBS)</measure>
    <time_frame>before intervention; follow-up: 3 months after intervention</time_frame>
    <description>including 14 items which are scored on a 5 points scale (0-4). The degree of success in achieving each task is given a score of zero (unable) to four (independent), and the final measure is the sum of all of the scores.&#xD;
The item scores are summed, minimum score =0, maximum score = 56</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of Fugl-Meyer Assessment (FMA)</measure>
    <time_frame>before intervention; follow-up: 3 months after intervention</time_frame>
    <description>Items are scored on a 3-point ordinal scale (0 = cannot perform; 1 = performs partially; 2 = performs fully) Maximum Score = 226 points The 5 domains assessed include, Motor function (UE maximum score = 66; LE maximum score = 34), Sensory function (maximum score = 24), Balance (maximum score = 14), Joint range of motion (maximum score = 44), Joint pain (maximum score = 44)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of Body Mass Index (BMI)</measure>
    <time_frame>before intervention; follow-up: 3 months after intervention</time_frame>
    <description>(body weight) kg/(height) m*(height)m</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of Mini-mental state examination (MMSE)</measure>
    <time_frame>before intervention; follow-up: 3 months after intervention</time_frame>
    <description>It is an 11-question measure that tests five areas of cognitive function:&#xD;
orientation, registration, attention and calculation, recall, and language. The maximum score is 30. A score of 23 or lower is indicative of cognitive impairment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of Modified Ashworth scale (MAS)</measure>
    <time_frame>before intervention; follow-up: 3 months after intervention</time_frame>
    <description>measures resistance during passive soft-tissue stretching, the score is ranged from 0-4 0: No increase in muscle tone&#xD;
Slight increase in muscle tone, manifested by a catch and release or by minimal resistance at the end of the range of motion when the affected part(s) is moved in flexion or extension 1+: Slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder (less than half) of the ROM&#xD;
More marked increase in muscle tone through most of the ROM, but affected part(s) easily moved&#xD;
Considerable increase in muscle tone, passive movement difficult&#xD;
Affected part(s) rigid in flexion or extension</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of Muscle tone</measure>
    <time_frame>before intervention; follow-up: 3 months after intervention</time_frame>
    <description>measure the muscle tone (kg/m) under muscle resting. Target muscles are quadricep, hamstring, anterior tibialis, gastrocnemius.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">186</enrollment>
  <condition>Stroke</condition>
  <condition>Osteoporosis</condition>
  <condition>Chronic Kidney Diseases</condition>
  <condition>Cancer</condition>
  <arm_group>
    <arm_group_label>exercise group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>elastic band strengthening exercise</description>
  </arm_group>
  <arm_group>
    <arm_group_label>exercise combine diet counseling group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>elastic band strengthening exercise combined diet counseling.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>elastic band strengthening exercise</intervention_name>
    <description>2-3days per week(150min per week)</description>
    <arm_group_label>exercise combine diet counseling group</arm_group_label>
    <arm_group_label>exercise group</arm_group_label>
    <other_name>thera-band strengthening exercise</other_name>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>diet counseling</intervention_name>
    <description>each patients in this group will receive4-5times diet counseling</description>
    <arm_group_label>exercise combine diet counseling group</arm_group_label>
    <other_name>nutrition counseling</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        -  Inclusion Criteria:&#xD;
&#xD;
               1. 55-85 years old&#xD;
&#xD;
               2. 3-6 months after onset&#xD;
&#xD;
               3. walk independently for at least 10m&#xD;
&#xD;
          -  Exclusion Criteria:&#xD;
&#xD;
               1. lower limb Brunnstrom stage &gt;5&#xD;
&#xD;
               2. combine other neuropathy diseases&#xD;
&#xD;
               3. significant deformity of lower limb include: Modified Ashworth scale(MAS) &gt;3;&#xD;
                  contracture, fracture, chronic joint pain.&#xD;
&#xD;
               4. joint arthroplasty&#xD;
&#xD;
               5. unstable vital sign&#xD;
&#xD;
               6. can not cooperate study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Tasen Wei, Doctor</last_name>
    <role>Study Director</role>
    <affiliation>Changhua Christian Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Changhua Christian Hospital</name>
      <address>
        <city>Changhua</city>
        <zip>500</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <reference>
    <citation>Biolo G, Cederholm T, Muscaritoli M. Muscle contractile and metabolic dysfunction is a common feature of sarcopenia of aging and chronic diseases: from sarcopenic obesity to cachexia. Clin Nutr. 2014 Oct;33(5):737-48. doi: 10.1016/j.clnu.2014.03.007. Epub 2014 Mar 29.</citation>
    <PMID>24785098</PMID>
  </reference>
  <reference>
    <citation>Stapleton T, Ashburn A, Stack E. A pilot study of attention deficits, balance control and falls in the subacute stage following stroke. Clin Rehabil. 2001 Aug;15(4):437-44. doi: 10.1191/026921501678310243.</citation>
    <PMID>11518445</PMID>
  </reference>
  <reference>
    <citation>Hyndman D, Ashburn A, Stack E. Fall events among people with stroke living in the community: circumstances of falls and characteristics of fallers. Arch Phys Med Rehabil. 2002 Feb;83(2):165-70. doi: 10.1053/apmr.2002.28030.</citation>
    <PMID>11833018</PMID>
  </reference>
  <reference>
    <citation>Kutner NG, Zhang R, Huang Y, Wasse H. Falls among hemodialysis patients: potential opportunities for prevention? Clin Kidney J. 2014 Jun;7(3):257-63. doi: 10.1093/ckj/sfu034. Epub 2014 Apr 15.</citation>
    <PMID>25852886</PMID>
  </reference>
  <reference>
    <citation>Cook WL, Tomlinson G, Donaldson M, Markowitz SN, Naglie G, Sobolev B, Jassal SV. Falls and fall-related injuries in older dialysis patients. Clin J Am Soc Nephrol. 2006 Nov;1(6):1197-204. doi: 10.2215/CJN.01650506. Epub 2006 Aug 30.</citation>
    <PMID>17699348</PMID>
  </reference>
  <reference>
    <citation>Couch ME, Dittus K, Toth MJ, Willis MS, Guttridge DC, George JR, Barnes CA, Gourin CG, Der-Torossian H. Cancer cachexia update in head and neck cancer: Definitions and diagnostic features. Head Neck. 2015 Apr;37(4):594-604. doi: 10.1002/hed.23599. Epub 2014 Mar 25.</citation>
    <PMID>24415363</PMID>
  </reference>
  <reference>
    <citation>Liu CJ, Latham NK. Progressive resistance strength training for improving physical function in older adults. Cochrane Database Syst Rev. 2009 Jul 8;2009(3):CD002759. doi: 10.1002/14651858.CD002759.pub2.</citation>
    <PMID>19588334</PMID>
  </reference>
  <verification_date>October 2022</verification_date>
  <study_first_submitted>December 28, 2018</study_first_submitted>
  <study_first_submitted_qc>January 9, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 10, 2019</study_first_posted>
  <last_update_submitted>October 30, 2022</last_update_submitted>
  <last_update_submitted_qc>October 30, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">November 1, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Changhua Christian Hospital</investigator_affiliation>
    <investigator_full_name>Ta-Sen Wei,MD</investigator_full_name>
    <investigator_title>Director, Physical Medical and Rehabilitation, Principal Investigator, Clinical Professor</investigator_title>
  </responsible_party>
  <keyword>Sarcopenia</keyword>
  <keyword>stroke</keyword>
  <keyword>osteoporosis</keyword>
  <keyword>chronic kidney disease</keyword>
  <keyword>cancer</keyword>
  <keyword>balance and gait</keyword>
  <keyword>fall</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Osteoporosis</mesh_term>
    <mesh_term>Sarcopenia</mesh_term>
    <mesh_term>Kidney Diseases</mesh_term>
    <mesh_term>Renal Insufficiency, Chronic</mesh_term>
    <mesh_term>Chronic Disease</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>only for research</ipd_description>
  </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/NCT03798418
org study id: CCH-170208
nct id: NCT03798418
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The objective of this study is to investigate the effects of therapeutic exercise and
      nutrition intervention for sarcopenia and risk of falls in patients with major chronic
      diseases. The outcomes will be analyzed regarding muscle strength, quality, and volume, etc.,
      balance and gait, bone density, body composition, fall and quality of life after the
      intervention.
The main common chronic diseases in the elderly such as stroke, osteoporosis, chronic kidney
      disease and cancer, have been regarded as the fall high-risk patients. These patients are
      considered to be at risk for sarcopenia due to decreased exercise, nutritional status, and
      other reasons. Sarcopenia can be diagnosed and intervened effectively to delay the vicious
      cycle of health. Past studies have pointed out that in addition to drug intervention,
      treatment for sarcopenia must be accompanied by appropriate exercise and nutritional
      intervention (such as protein supplements, vitamin D) in order to achieve the best prevention
      and treatment.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Double (Participant, Outcomes Assessor)
measure: Change of walking speed
time frame: baseline: before intervention; follow-up: 3 months after intervention
description: distance: 6m, patients can walk with foor orthosis and assistive devices
measure: Change of grip force
time frame: before intervention; follow-up: 3 months after intervention
description: Use a grip force meter (kg) to test both hands for test 3 times
measure: Change of postural sway displacement
time frame: before intervention; follow-up: 3 months after intervention
description: Use computerized dynography to measure the postural sway displacement (mm)
measure: Change of postural sway velocity
time frame: before intervention; follow-up: 3 months after intervention
description: Use computerized dynography to measure the postural sway velocity (mm/s)
measure: Change of postural sway area
time frame: before intervention; follow-up: 3 months after intervention
description: Use computerized dynography to measure the postural sway area (mm^2)
measure: Change of step time
time frame: before intervention; follow-up: 3 months after intervention
description: Use computerized dynography to measure spatial gait parameter: step time (ms)
measure: Change of stance time
time frame: before intervention; follow-up: 3 months after intervention
description: Use computerized dynography to measure spatial gait parameter: stance time (ms)
measure: Change of swing time
time frame: before intervention; follow-up: 3 months after intervention
description: Use computerized dynography to measure spatial gait parameter: swing time (ms)
measure: Change of single support time
time frame: before intervention; follow-up: 3 months after intervention
description: Use computerized dynography to measure spatial gait parameter: single support time (ms)
measure: Change of double support time
time frame: before intervention; follow-up: 3 months after intervention
description: Use computerized dynography to measure spatial gait parameter: double support time (ms)
measure: Change of step length
time frame: before intervention; follow-up: 3 months after intervention
description: Use computerized dynography to measure spatial gait parameter: step distance (mm)
measure: Change of stance length
time frame: before intervention; follow-up: 3 months after intervention
description: Use computerized dynography to measure spatial gait parameter: stance distance (mm)
measure: Change of muscle thickness
time frame: before intervention; follow-up: 3 months after intervention
description: Use ultrasound to assess muscles morphological parameter: thickness (mm). Target muscles include quadriceps, hamstring, anterior tibialis, gastrocnemius.
measure: Change of muscle fiber length
time frame: before intervention; follow-up: 3 months after intervention
description: Use ultrasound to assess muscles morphological parameter: fiber length (mm). Target muscles include quadriceps, hamstring, anterior tibialis, gastrocnemius.
measure: Change of muscle fiber orientation angle
time frame: before intervention; follow-up: 3 months after intervention
description: Use ultrasound to assess muscles morphological parameter: fiber orientation angle (degrees). Target muscles include quadriceps, hamstring, anterior tibialis, gastrocnemius.
measure: Change of muscle cross section area
time frame: before intervention; follow-up: 3 months after intervention
description: Use ultrasound to assess muscles morphological parameter: cross-sectional area (mm^2).
Target muscles include quadriceps, hamstring, anterior tibialis, gastrocnemius.
measure: Change of physiological cost index (PCI)
time frame: before intervention; follow-up: 3 months after intervention
description: Heart rate (HR: beats/min) and walking speed (m/s) have been previously shown to be linearly related to oxygen uptake at sub-maximal exercise levels. Combination of these two parameters yields a single value in beats per meter, the physiological cost index (PCI). This is calculated as Working HR - Resting HR (beats/min) / Walking speed (m/s)
measure: Change of international Quality of Life Assessment Short Form -36 (SF-36)
time frame: before intervention; follow-up: 3 months after intervention
description: including 8 health concepts: (1) physical functioning, (2) role limitations because of physical health problems; (3) bodily pain, (4) social functioning, (5) general mental health (psychological distress and psychological wellbeing), (6) role limitations because of emotional problems, (7) vitality (energy/fatigue), (8) general health perceptions.
Scoring: answers to each question are scored which are then summed and transformed to a 0 - 100 scale.
The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.
measure: Change of amplitude of Muscle activity
time frame: before intervention; follow-up: 3 months after intervention
description: use electromyography to measure the muscles activity in microvolts (uv) included quadriceps, hamstrings, tibialis anterior, gastrocnemius during subject walking in self-selected speed in 6 meters.
measure: Change of concentration of CRP (C-Reactive Protein)
time frame: before intervention; follow-up: 3 months after intervention
description: The concentration of CRP in the blood test. CRP is used mainly as a marker of inflammation.
measure: Change of concentration of ALB (Serum albumin)
time frame: before intervention; follow-up: 3 months after intervention
description: The concentration of ALB in the blood test. Albumin is the most important contributor to the maintenance of plasma colloid oncotic pressure; deficiency results in edema.
measure: Change of concentration of Glomerular Filtration Rate (GFR)
time frame: before intervention; follow-up: 3 months after intervention
description: The concentration of GFR in the blood test. The glomerular filtration rate is the best test to measure the patient's level of kidney function and determine the stage of kidney disease. It can calculate it from the results of the blood creatinine test.
measure: Change of concentration of Hemoglobin (Hb)
time frame: Time Frame: before intervention; follow-up: 3 months after intervention
description: The concentration of Hb in the blood test.
measure: Change of concentration of Glucose SPOT
time frame: Time Frame: before intervention; follow-up: 3 months after intervention
description: The concentration of Glucose SPOT in the blood test. TheSpot glucose measurement in epidermal interstitial fluid appears to be a promising alternative to capillary blood glucose estimation
measure: Change of concentration of Cholesterol
time frame: before intervention; follow-up: 3 months after intervention
description: The concentration of Cholesterol in the blood test.
measure: Change of concentration of Triglyceride
time frame: before intervention; follow-up: 3 months after intervention
description: The concentration of Triglyceride in the blood test.
measure: Change of concentration of Transferrin
time frame: before intervention; follow-up: 3 months after intervention
description: The concentration of Transferrin in the blood test.
measure: Change of Berg balance test (BBS)
time frame: before intervention; follow-up: 3 months after intervention
description: including 14 items which are scored on a 5 points scale (0-4). The degree of success in achieving each task is given a score of zero (unable) to four (independent), and the final measure is the sum of all of the scores.
The item scores are summed, minimum score =0, maximum score = 56
measure: Change of Fugl-Meyer Assessment (FMA)
time frame: before intervention; follow-up: 3 months after intervention
description: Items are scored on a 3-point ordinal scale (0 = cannot perform; 1 = performs partially; 2 = performs fully) Maximum Score = 226 points The 5 domains assessed include, Motor function (UE maximum score = 66; LE maximum score = 34), Sensory function (maximum score = 24), Balance (maximum score = 14), Joint range of motion (maximum score = 44), Joint pain (maximum score = 44)
measure: Change of Body Mass Index (BMI)
time frame: before intervention; follow-up: 3 months after intervention
description: (body weight) kg/(height) m*(height)m
measure: Change of Mini-mental state examination (MMSE)
time frame: before intervention; follow-up: 3 months after intervention
description: It is an 11-question measure that tests five areas of cognitive function:
orientation, registration, attention and calculation, recall, and language. The maximum score is 30. A score of 23 or lower is indicative of cognitive impairment.
measure: Change of Modified Ashworth scale (MAS)
time frame: before intervention; follow-up: 3 months after intervention
description: measures resistance during passive soft-tissue stretching, the score is ranged from 0-4 0: No increase in muscle tone
Slight increase in muscle tone, manifested by a catch and release or by minimal resistance at the end of the range of motion when the affected part(s) is moved in flexion or extension 1+: Slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder (less than half) of the ROM
More marked increase in muscle tone through most of the ROM, but affected part(s) easily moved
Considerable increase in muscle tone, passive movement difficult
Affected part(s) rigid in flexion or extension
measure: Change of Muscle tone
time frame: before intervention; follow-up: 3 months after intervention
description: measure the muscle tone (kg/m) under muscle resting. Target muscles are quadricep, hamstring, anterior tibialis, gastrocnemius.
arm group label: exercise group
arm group type: Active Comparator
description: elastic band strengthening exercise
arm group label: exercise combine diet counseling group
arm group type: Experimental
description: elastic band strengthening exercise combined diet counseling.
intervention type: Behavioral
intervention name: elastic band strengthening exercise
description: 2-3days per week(150min per week)
arm group label: exercise combine diet counseling group
arm group label: exercise group
other name: thera-band strengthening exercise
intervention type: Dietary Supplement
intervention name: diet counseling
description: each patients in this group will receive4-5times diet counseling
arm group label: exercise combine diet counseling group
other name: nutrition counseling
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Tasen Wei, Doctor
role: Study Director
affiliation: Changhua Christian Hospital
facility: 
country: Taiwan
citation: Biolo G, Cederholm T, Muscaritoli M. Muscle contractile and metabolic dysfunction is a common feature of sarcopenia of aging and chronic diseases: from sarcopenic obesity to cachexia. Clin Nutr. 2014 Oct;33(5):737-48. doi: 10.1016/j.clnu.2014.03.007. Epub 2014 Mar 29.
PMID: 24785098
citation: Stapleton T, Ashburn A, Stack E. A pilot study of attention deficits, balance control and falls in the subacute stage following stroke. Clin Rehabil. 2001 Aug;15(4):437-44. doi: 10.1191/026921501678310243.
PMID: 11518445
citation: Hyndman D, Ashburn A, Stack E. Fall events among people with stroke living in the community: circumstances of falls and characteristics of fallers. Arch Phys Med Rehabil. 2002 Feb;83(2):165-70. doi: 10.1053/apmr.2002.28030.
PMID: 11833018
citation: Kutner NG, Zhang R, Huang Y, Wasse H. Falls among hemodialysis patients: potential opportunities for prevention? Clin Kidney J. 2014 Jun;7(3):257-63. doi: 10.1093/ckj/sfu034. Epub 2014 Apr 15.
PMID: 25852886
citation: Cook WL, Tomlinson G, Donaldson M, Markowitz SN, Naglie G, Sobolev B, Jassal SV. Falls and fall-related injuries in older dialysis patients. Clin J Am Soc Nephrol. 2006 Nov;1(6):1197-204. doi: 10.2215/CJN.01650506. Epub 2006 Aug 30.
PMID: 17699348
citation: Couch ME, Dittus K, Toth MJ, Willis MS, Guttridge DC, George JR, Barnes CA, Gourin CG, Der-Torossian H. Cancer cachexia update in head and neck cancer: Definitions and diagnostic features. Head Neck. 2015 Apr;37(4):594-604. doi: 10.1002/hed.23599. Epub 2014 Mar 25.
PMID: 24415363
citation: Liu CJ, Latham NK. Progressive resistance strength training for improving physical function in older adults. Cochrane Database Syst Rev. 2009 Jul 8;2009(3):CD002759. doi: 10.1002/14651858.CD002759.pub2.
PMID: 19588334
responsible party type: Principal Investigator
investigator affiliation: Changhua Christian Hospital
investigator full name: Ta-Sen Wei,MD
investigator title: Director, Physical Medical and Rehabilitation, Principal Investigator, Clinical Professor
mesh term: Osteoporosis
mesh term: Sarcopenia
mesh term: Kidney Diseases
mesh term: Renal Insufficiency, Chronic
mesh term: Chronic Disease
sharing ipd: No
ipd description: only for research