<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/NCT04495647</url>
  </required_header>
  <id_info>
    <org_study_id>ETAPPEN_Pilot</org_study_id>
    <nct_id>NCT04495647</nct_id>
  </id_info>
  <brief_title>Feasibility of WB-EMS in Frail Older People</brief_title>
  <official_title>Feasibility and Safety of Whole-Body Electromyostimulation (WB-EMS) in Frail Older People: A Pilot Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Erlangen-Nürnberg Medical School</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Paracelsus Medical University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Erlangen-Nürnberg Medical School</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>
      Exercise in general and resistance training (RT) in particular have demonstrated positive&#xD;
      effects on physical functioning and frailty. However, frail older people with functional&#xD;
      impairments are among the least physically active and may have problems reaching high&#xD;
      intensity levels. The use of special vests with integrated electrodes allows the simultaneous&#xD;
      innervation of all large muscle groups by external electrical stimulation, inducing a&#xD;
      high-intensity RT at low subjective effort level. This whole-body electromyostimulation&#xD;
      (WB-EMS) may be a feasible option inducing training stimuli for functionally impaired frail&#xD;
      older people.&#xD;
&#xD;
      This study aims at investigating the feasibility and safety of WB-EMS in frail older people&#xD;
      with functional limitations. To explore the effects of age and functional status, young and&#xD;
      robust old reference groups will serve as comparators.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 22, 2020</start_date>
  <completion_date type="Actual">February 28, 2021</completion_date>
  <primary_completion_date type="Actual">December 31, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>frail older people (n=10) pre-post; robust older (n=10) and young (n=10) reference groups with identical intervention</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Recruitment rate</measure>
    <time_frame>8 weeks</time_frame>
    <description>measured by ratio of included/eligible participants</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Compliance</measure>
    <time_frame>from baseline to 8 weeks</time_frame>
    <description>measured by proportion of attended training sessions</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Retention rate</measure>
    <time_frame>at 8 weeks</time_frame>
    <description>measured by proportion of participants remaining in the study</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Dropout rate</measure>
    <time_frame>from baseline to 8 weeks</time_frame>
    <description>measured by the proportion of participants not completing the study</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Perceived enjoyment measured by the Physical Activity Enjoyment Scale for Older Adults (PACES-8)</measure>
    <time_frame>Change from baseline to 8 weeks</time_frame>
    <description>The PACES-8 comprises of 8 items on a 7-point bipolar rating scale. A sum score is calculated with higher PACES scores reflecting greater levels of enjoyment.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Intervention engagement measured by the Hopkins Rehabilitation Engagement Scale (HRERS)</measure>
    <time_frame>at 8 weeks</time_frame>
    <description>The HRERS, reported by instructors, comprises of 5 items on a verbal rating scale from 'Never' to 'Always'. Higher scores reflect greater levels of engagement.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Concentration of Myoglobin (MB)</measure>
    <time_frame>measured at baseline to week 1, week 3 and week 8</time_frame>
    <description>Concentration of MB measured in µg/l 3 hours after training</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Concentration of Creatinkinase (CK)</measure>
    <time_frame>measured at baseline to week 1, week 3 and week 8</time_frame>
    <description>Concentration of CK measured in U/l before, 48, 72 hours after training</description>
  </primary_outcome>
  <primary_outcome>
    <measure>estimated glomerular filtration rate (eGFR)</measure>
    <time_frame>measured at baseline to week 1, week 3 and week 8</time_frame>
    <description>eGFR (creatinine clearance) measured in mL/min/1.73m² before, 48, 72 hours after training</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Rhabdomyolysis surveillance measured by a self-developed questionnaire</measure>
    <time_frame>measured weekly</time_frame>
    <description>The questionnaire is to be filled out before, immediately after and 24 hours following training and containing information on specific (dark urine, muscle weakness, muscle pain) and unspecific (tachycardia, fever, general malaise, nausea, vomiting) symptoms and other adverse events (e.g. falls)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain assessed by the Brief Pain Inventory (BPI-SF)</measure>
    <time_frame>measured at baseline to week 1, week 3 and week 8</time_frame>
    <description>The BPI-SF comprises of 15 items asking questions on pain location, severity and interference and scored from 0 to 10 with higher scores indicating worse outcomes.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fatigue assessed by the Brief Fatigue Inventory (BFI)</measure>
    <time_frame>measured at baseline to week 1, week 3 and week 8</time_frame>
    <description>The BFI comprises of 10 items asking questions on fatigue severity and interference and scored from 0 to 10 with higher scores indicating worse outcomes.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>System usability measured by the System Usability Scale (SUS)</measure>
    <time_frame>once at 8 weeks</time_frame>
    <description>The SUS, reported by instructors, comprises of 10 items on a 5-point Likert scale from 1 ('strongly disagree') to 5 ('strongly agree'). Higher scores reflect greater levels of usability.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Lower extremity functioning measured by the Short Physical Performance Battery (SPPB)</measure>
    <time_frame>Change from baseline to 9 weeks</time_frame>
    <description>The SPPB comprises of three dimensions, balance (static - standing in 3 positions of increasing difficulty by reducing base of support for max. 10s), gait (usual pace - two walks of 4m lengths), functional strength (chair rise - five times sit-to-stand transfers as fast as possible). A sum score is calculated (0-12 points) with higher scores indicating better functional status and each dimension being equally weighed (0-4 points).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mobility measured by the Timed up &amp; go test (TUG)</measure>
    <time_frame>Change from baseline to 9 weeks</time_frame>
    <description>The TUG requires the participants to stand up from chair, walk at usual pace to line at 3m, turn, walk back and sit down again. The time in seconds is recorded.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maximum knee/hip extension strength</measure>
    <time_frame>Change from baseline to 9 weeks</time_frame>
    <description>Isokinetic leg press in Newton</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Skeletal muscle mass</measure>
    <time_frame>Change from baseline to 8 weeks</time_frame>
    <description>Bioelectrical impedance analysis (BIA)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of persons with Albuminuria</measure>
    <time_frame>measured at baseline to week 1, week 3 and week 8</time_frame>
    <description>Rate of persons with Albuminuria ≥ 2+ measured with a semi quantitative urine dipstick 24 hours after training</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of persons with Proteinuria</measure>
    <time_frame>measured at baseline to week 1, week 3 and week 8</time_frame>
    <description>Rate of persons with Proteinuria ≥ 3+ measured with a semi quantitative urine dipstick 24 hours after training</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Concentration of Urea</measure>
    <time_frame>measured at baseline to week 1, week 3 and week 8</time_frame>
    <description>Concentration of Urea measured in mg/dl before, 48, 72 hours after training</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Concentration of Cystatin C</measure>
    <time_frame>measured at baseline to week 1, week 3 and week 8</time_frame>
    <description>Concentration of Cystatin C measured in mg/l before, 48, 72 hours after training</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Concentration of Creatinine</measure>
    <time_frame>measured at baseline to week 1, week 3 and week 8</time_frame>
    <description>Concentration of Creatinine measured in mg/dl before, 48, 72 hours after training</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Concentration of Sodium</measure>
    <time_frame>measured at baseline to week 1, week 3 and week 8</time_frame>
    <description>Concentration of Sodium measured in mmol/l before, 48, 72 hours after training</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Concentration of Potassium</measure>
    <time_frame>measured at baseline to week 1, week 3 and week 8</time_frame>
    <description>Concentration of Potassium measured in mmol/l before, 48, 72 hours after training</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Concentration of Calcium</measure>
    <time_frame>measured at baseline to week 1, week 3 and week 8</time_frame>
    <description>Concentration of Calcium measured in mmol/l before, 48, 72 hours after training</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Concentration of Phosphate</measure>
    <time_frame>measured at baseline to week 1, week 3 and week 8</time_frame>
    <description>Concentration of Phosphate measured in mmol/l before, 48, 72 hours after training</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Health-related quality of life measured by the patient-reported Health Survey Short Form (SF-12)</measure>
    <time_frame>Change from baseline to 9 weeks</time_frame>
    <description>The SF-12 comprises of 12 items weighted and summed to provide physical and mental health scores (PCS and MCS), ranging from 0 to 100 with higher scores reflecting greater levels of the respective construct.</description>
  </other_outcome>
  <other_outcome>
    <measure>Concentration of Interleukin 6 (IL-6)</measure>
    <time_frame>measured at baseline to week 1, week 3 and week 8</time_frame>
    <description>Concentration of IL-6 measured in ng/l before, 3h, 48, 72 hours after training</description>
  </other_outcome>
  <other_outcome>
    <measure>Concentration of High-sensitivity C-reactive protein (hs CRP)</measure>
    <time_frame>measured at baseline to week 1, week 3 and week 8</time_frame>
    <description>Concentration of hs CRP measured in mg/l before, 48, 72 hours after training</description>
  </other_outcome>
  <other_outcome>
    <measure>Concentration of Cholesterin</measure>
    <time_frame>measured at baseline and week 8</time_frame>
    <description>Concentration of Cholesterin measured in mg/dl before first and last trainings</description>
  </other_outcome>
  <other_outcome>
    <measure>Concentration of low-density lipoprotein (LDL)</measure>
    <time_frame>measured at baseline and week 8</time_frame>
    <description>Concentration of LDL measured in mg/dl before first and last trainings</description>
  </other_outcome>
  <other_outcome>
    <measure>Concentration of high-density lipoprotein (HDL)</measure>
    <time_frame>measured at baseline and week 8</time_frame>
    <description>Concentration of HDL measured in mg/dl before first and last trainings</description>
  </other_outcome>
  <other_outcome>
    <measure>Concentration of Triglycerides</measure>
    <time_frame>measured at baseline and week 8</time_frame>
    <description>Concentration of Triglycerides measured in mg/dl before first and last trainings</description>
  </other_outcome>
  <other_outcome>
    <measure>Concentration of N-terminal pro b-type natriuretic peptide (NT-proBNP)</measure>
    <time_frame>measured at baseline to week 1, week 3 and week 8</time_frame>
    <description>Concentration of NT-proBNP measured in pg/ml before, 48, 72 hours after training</description>
  </other_outcome>
  <other_outcome>
    <measure>Concentration of Glucose</measure>
    <time_frame>measured at baseline and week 8</time_frame>
    <description>Concentration of Glucose measured in mg/dl before first and last trainings</description>
  </other_outcome>
  <other_outcome>
    <measure>Concentration of Creatinkinase Muscle/Brain (CK-MB (CK-2))</measure>
    <time_frame>measured at baseline to week 1, week 3 and week 8</time_frame>
    <description>Concentration of CK-MB (CK-2) measured in ng/ml before, 48, 72 hours after training</description>
  </other_outcome>
  <other_outcome>
    <measure>Concentration of high-sensitive cardiac troponin T (hs-cTnT)</measure>
    <time_frame>measured at baseline to week 1, week 3 and week 8</time_frame>
    <description>Concentration of hs-cTnT measured in ng/ml before, 48, 72 hours after training</description>
  </other_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Frailty</condition>
  <condition>Mobility Limitation</condition>
  <arm_group>
    <arm_group_label>WB-EMS_frail</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>WB-EMS_robust</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>WB-EMS_young</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Whole-Body Electromyostimulation</intervention_name>
    <description>Whole-Body Electromyostimulation (WB-EMS): Simultaneous, individually adjustable stimulation of 12 muscle groups using an interval approach with a duty cycle of 6s impulse/4s rest, bipolar electric current (impulse -frequency 85Hz, -width 350μs, rectangular pattern) will be applied.&#xD;
After a 4-week conditioning period, 1.5x 20 min/week WB-EMS will be conducted for 4 weeks (total training duration 8 weeks). Easy to perform functional exercises focusing on balance, transfer ability, stepping and lower extremity strength/power will be done during WB-EMS. Exercise intensity will be individually prescribed and adjusted by rate of perceived exertion (RPE-Borg CR10 scale 4 (moderate) to 7 (hard)).&#xD;
WB-EMS will be fully supervised one on one.&#xD;
All three arms will receive the same intervention.</description>
    <arm_group_label>WB-EMS_frail</arm_group_label>
    <arm_group_label>WB-EMS_robust</arm_group_label>
    <arm_group_label>WB-EMS_young</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Frail people&#xD;
&#xD;
        Inclusion Criteria:&#xD;
&#xD;
          -  75+ years&#xD;
&#xD;
          -  Frail&#xD;
&#xD;
          -  able to walk 4m w/o walking aid&#xD;
&#xD;
          -  no prior WB-EMS exposure&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  severe visual or hearing impairments&#xD;
&#xD;
          -  major cognitive impairment (MMSE &lt;10)&#xD;
&#xD;
          -  medications with muscle-anabolic effects&#xD;
&#xD;
          -  medical conditions affecting trainability of muscles (e.g. Myasthenia gravis, Cushing&#xD;
             syndrome, Morbus McArdle)&#xD;
&#xD;
          -  surgery within past two months&#xD;
&#xD;
          -  history of rhabdomyolysis&#xD;
&#xD;
          -  medical conditions affecting sensation of electrical stimuli (e.g. severe&#xD;
             polyneuropathy)&#xD;
&#xD;
          -  severe renal insufficiency (eGFR&lt;30 ml/min/1.73m²)&#xD;
&#xD;
          -  electronic implants&#xD;
&#xD;
          -  acute or untreated abdominal wall or inguinal hernia&#xD;
&#xD;
        Robust people&#xD;
&#xD;
        Inclusion Criteria:&#xD;
&#xD;
          -  75+ years&#xD;
&#xD;
          -  Robust&#xD;
&#xD;
          -  no prior WB-EMS exposure&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  severe visual or hearing impairments&#xD;
&#xD;
          -  major cognitive impairment (MMSE &lt;10)&#xD;
&#xD;
          -  medications with muscle-anabolic effects&#xD;
&#xD;
          -  medical conditions affecting trainability of muscles (e.g. Myasthenia gravis, Cushing&#xD;
             syndrome, Morbus McArdle)&#xD;
&#xD;
          -  surgery within past two months&#xD;
&#xD;
          -  history of rhabdomyolysis&#xD;
&#xD;
          -  medical conditions affecting sensation of electrical stimuli (e.g. severe&#xD;
             polyneuropathy)&#xD;
&#xD;
          -  severe renal insufficiency (eGFR&lt;30 ml/min/1.73m²)&#xD;
&#xD;
          -  electronic implants&#xD;
&#xD;
          -  acute or untreated abdominal wall or inguinal hernia&#xD;
&#xD;
        Younger people&#xD;
&#xD;
        Inclusion Criteria:&#xD;
&#xD;
          -  18-50 years&#xD;
&#xD;
          -  Healthy&#xD;
&#xD;
          -  no prior WB-EMS exposure&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  severe visual or hearing impairments&#xD;
&#xD;
          -  major cognitive impairment (MMSE &lt;10)&#xD;
&#xD;
          -  medications with muscle-anabolic effects&#xD;
&#xD;
          -  medical conditions affecting trainability of muscles (e.g. Myasthenia gravis, Cushing&#xD;
             syndrome, Morbus McArdle)&#xD;
&#xD;
          -  surgery within past two months&#xD;
&#xD;
          -  history of rhabdomyolysis&#xD;
&#xD;
          -  medical conditions affecting sensation of electrical stimuli (e.g. severe&#xD;
             polyneuropathy)&#xD;
&#xD;
          -  severe renal insufficiency (eGFR&lt;30 ml/min/1.73m²)&#xD;
&#xD;
          -  electronic implants&#xD;
&#xD;
          -  acute or untreated abdominal wall or inguinal hernia&#xD;
&#xD;
          -  pregnancy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>65 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Institute of Medical Physics, University of Erlangen-Nürnberg</name>
      <address>
        <city>Erlangen</city>
        <zip>91052</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>April 2021</verification_date>
  <study_first_submitted>July 10, 2020</study_first_submitted>
  <study_first_submitted_qc>July 28, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 3, 2020</study_first_posted>
  <last_update_submitted>April 27, 2021</last_update_submitted>
  <last_update_submitted_qc>April 27, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">April 28, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Frailty</mesh_term>
    <mesh_term>Mobility Limitation</mesh_term>
  </condition_browse>
  <!-- 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/NCT04495647
org study id: ETAPPEN_Pilot
nct id: NCT04495647
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Exercise in general and resistance training (RT) in particular have demonstrated positive
      effects on physical functioning and frailty. However, frail older people with functional
      impairments are among the least physically active and may have problems reaching high
      intensity levels. The use of special vests with integrated electrodes allows the simultaneous
      innervation of all large muscle groups by external electrical stimulation, inducing a
      high-intensity RT at low subjective effort level. This whole-body electromyostimulation
      (WB-EMS) may be a feasible option inducing training stimuli for functionally impaired frail
      older people.

      This study aims at investigating the feasibility and safety of WB-EMS in frail older people
      with functional limitations. To explore the effects of age and functional status, young and
      robust old reference groups will serve as comparators.
allocation: Non-Randomized
intervention model: Parallel Assignment
intervention model description: frail older people (n=10) pre-post; robust older (n=10) and young (n=10) reference groups with identical intervention
primary purpose: Treatment
masking: None (Open Label)
measure: Recruitment rate
time frame: 8 weeks
description: measured by ratio of included/eligible participants
measure: Compliance
time frame: from baseline to 8 weeks
description: measured by proportion of attended training sessions
measure: Retention rate
time frame: at 8 weeks
description: measured by proportion of participants remaining in the study
measure: Dropout rate
time frame: from baseline to 8 weeks
description: measured by the proportion of participants not completing the study
measure: Perceived enjoyment measured by the Physical Activity Enjoyment Scale for Older Adults (PACES-8)
time frame: Change from baseline to 8 weeks
description: The PACES-8 comprises of 8 items on a 7-point bipolar rating scale. A sum score is calculated with higher PACES scores reflecting greater levels of enjoyment.
measure: Intervention engagement measured by the Hopkins Rehabilitation Engagement Scale (HRERS)
time frame: at 8 weeks
description: The HRERS, reported by instructors, comprises of 5 items on a verbal rating scale from 'Never' to 'Always'. Higher scores reflect greater levels of engagement.
measure: Concentration of Myoglobin (MB)
time frame: measured at baseline to week 1, week 3 and week 8
description: Concentration of MB measured in µg/l 3 hours after training
measure: Concentration of Creatinkinase (CK)
time frame: measured at baseline to week 1, week 3 and week 8
description: Concentration of CK measured in U/l before, 48, 72 hours after training
measure: estimated glomerular filtration rate (eGFR)
time frame: measured at baseline to week 1, week 3 and week 8
description: eGFR (creatinine clearance) measured in mL/min/1.73m² before, 48, 72 hours after training
measure: Rhabdomyolysis surveillance measured by a self-developed questionnaire
time frame: measured weekly
description: The questionnaire is to be filled out before, immediately after and 24 hours following training and containing information on specific (dark urine, muscle weakness, muscle pain) and unspecific (tachycardia, fever, general malaise, nausea, vomiting) symptoms and other adverse events (e.g. falls)
measure: Pain assessed by the Brief Pain Inventory (BPI-SF)
time frame: measured at baseline to week 1, week 3 and week 8
description: The BPI-SF comprises of 15 items asking questions on pain location, severity and interference and scored from 0 to 10 with higher scores indicating worse outcomes.
measure: Fatigue assessed by the Brief Fatigue Inventory (BFI)
time frame: measured at baseline to week 1, week 3 and week 8
description: The BFI comprises of 10 items asking questions on fatigue severity and interference and scored from 0 to 10 with higher scores indicating worse outcomes.
measure: System usability measured by the System Usability Scale (SUS)
time frame: once at 8 weeks
description: The SUS, reported by instructors, comprises of 10 items on a 5-point Likert scale from 1 ('strongly disagree') to 5 ('strongly agree'). Higher scores reflect greater levels of usability.
measure: Lower extremity functioning measured by the Short Physical Performance Battery (SPPB)
time frame: Change from baseline to 9 weeks
description: The SPPB comprises of three dimensions, balance (static - standing in 3 positions of increasing difficulty by reducing base of support for max. 10s), gait (usual pace - two walks of 4m lengths), functional strength (chair rise - five times sit-to-stand transfers as fast as possible). A sum score is calculated (0-12 points) with higher scores indicating better functional status and each dimension being equally weighed (0-4 points).
measure: Mobility measured by the Timed up & go test (TUG)
time frame: Change from baseline to 9 weeks
description: The TUG requires the participants to stand up from chair, walk at usual pace to line at 3m, turn, walk back and sit down again. The time in seconds is recorded.
measure: Maximum knee/hip extension strength
time frame: Change from baseline to 9 weeks
description: Isokinetic leg press in Newton
measure: Skeletal muscle mass
time frame: Change from baseline to 8 weeks
description: Bioelectrical impedance analysis (BIA)
measure: Rate of persons with Albuminuria
time frame: measured at baseline to week 1, week 3 and week 8
description: Rate of persons with Albuminuria ≥ 2+ measured with a semi quantitative urine dipstick 24 hours after training
measure: Rate of persons with Proteinuria
time frame: measured at baseline to week 1, week 3 and week 8
description: Rate of persons with Proteinuria ≥ 3+ measured with a semi quantitative urine dipstick 24 hours after training
measure: Concentration of Urea
time frame: measured at baseline to week 1, week 3 and week 8
description: Concentration of Urea measured in mg/dl before, 48, 72 hours after training
measure: Concentration of Cystatin C
time frame: measured at baseline to week 1, week 3 and week 8
description: Concentration of Cystatin C measured in mg/l before, 48, 72 hours after training
measure: Concentration of Creatinine
time frame: measured at baseline to week 1, week 3 and week 8
description: Concentration of Creatinine measured in mg/dl before, 48, 72 hours after training
measure: Concentration of Sodium
time frame: measured at baseline to week 1, week 3 and week 8
description: Concentration of Sodium measured in mmol/l before, 48, 72 hours after training
measure: Concentration of Potassium
time frame: measured at baseline to week 1, week 3 and week 8
description: Concentration of Potassium measured in mmol/l before, 48, 72 hours after training
measure: Concentration of Calcium
time frame: measured at baseline to week 1, week 3 and week 8
description: Concentration of Calcium measured in mmol/l before, 48, 72 hours after training
measure: Concentration of Phosphate
time frame: measured at baseline to week 1, week 3 and week 8
description: Concentration of Phosphate measured in mmol/l before, 48, 72 hours after training
measure: Health-related quality of life measured by the patient-reported Health Survey Short Form (SF-12)
time frame: Change from baseline to 9 weeks
description: The SF-12 comprises of 12 items weighted and summed to provide physical and mental health scores (PCS and MCS), ranging from 0 to 100 with higher scores reflecting greater levels of the respective construct.
measure: Concentration of Interleukin 6 (IL-6)
time frame: measured at baseline to week 1, week 3 and week 8
description: Concentration of IL-6 measured in ng/l before, 3h, 48, 72 hours after training
measure: Concentration of High-sensitivity C-reactive protein (hs CRP)
time frame: measured at baseline to week 1, week 3 and week 8
description: Concentration of hs CRP measured in mg/l before, 48, 72 hours after training
measure: Concentration of Cholesterin
time frame: measured at baseline and week 8
description: Concentration of Cholesterin measured in mg/dl before first and last trainings
measure: Concentration of low-density lipoprotein (LDL)
time frame: measured at baseline and week 8
description: Concentration of LDL measured in mg/dl before first and last trainings
measure: Concentration of high-density lipoprotein (HDL)
time frame: measured at baseline and week 8
description: Concentration of HDL measured in mg/dl before first and last trainings
measure: Concentration of Triglycerides
time frame: measured at baseline and week 8
description: Concentration of Triglycerides measured in mg/dl before first and last trainings
measure: Concentration of N-terminal pro b-type natriuretic peptide (NT-proBNP)
time frame: measured at baseline to week 1, week 3 and week 8
description: Concentration of NT-proBNP measured in pg/ml before, 48, 72 hours after training
measure: Concentration of Glucose
time frame: measured at baseline and week 8
description: Concentration of Glucose measured in mg/dl before first and last trainings
measure: Concentration of Creatinkinase Muscle/Brain (CK-MB (CK-2))
time frame: measured at baseline to week 1, week 3 and week 8
description: Concentration of CK-MB (CK-2) measured in ng/ml before, 48, 72 hours after training
measure: Concentration of high-sensitive cardiac troponin T (hs-cTnT)
time frame: measured at baseline to week 1, week 3 and week 8
description: Concentration of hs-cTnT measured in ng/ml before, 48, 72 hours after training
arm group label: WB-EMS_frail
arm group type: Experimental
arm group label: WB-EMS_robust
arm group type: Active Comparator
arm group label: WB-EMS_young
arm group type: Active Comparator
intervention type: Other
intervention name: Whole-Body Electromyostimulation
description: Whole-Body Electromyostimulation (WB-EMS): Simultaneous, individually adjustable stimulation of 12 muscle groups using an interval approach with a duty cycle of 6s impulse/4s rest, bipolar electric current (impulse -frequency 85Hz, -width 350μs, rectangular pattern) will be applied.
After a 4-week conditioning period, 1.5x 20 min/week WB-EMS will be conducted for 4 weeks (total training duration 8 weeks). Easy to perform functional exercises focusing on balance, transfer ability, stepping and lower extremity strength/power will be done during WB-EMS. Exercise intensity will be individually prescribed and adjusted by rate of perceived exertion (RPE-Borg CR10 scale 4 (moderate) to 7 (hard)).
WB-EMS will be fully supervised one on one.
All three arms will receive the same intervention.
arm group label: WB-EMS_frail
arm group label: WB-EMS_robust
arm group label: WB-EMS_young
criteria: 
gender: All
minimum age: 65 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Germany
responsible party type: Sponsor
mesh term: Frailty
mesh term: Mobility Limitation