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Completed

NCT Number: NCT04495647

Feasibility of WB-EMS in Frail Older People

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.

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Key information

Conditions

Frailty Mobility Limitation Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institute of Medical Physics, University of Erlangen-Nürnberg

Erlangen, 91052, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Frail people

Inclusion criteria

  • 75+ years
  • Frail
  • able to walk 4m w/o walking aid
  • no prior WB-EMS exposure

Exclusion criteria

  • severe visual or hearing impairments
  • major cognitive impairment (MMSE <10)
  • medications with muscle-anabolic effects
  • medical conditions affecting trainability of muscles (e.g. Myasthenia gravis, Cushing syndrome, Morbus McArdle)
  • surgery within past two months
  • history of rhabdomyolysis
  • medical conditions affecting sensation of electrical stimuli (e.g. severe polyneuropathy)
  • severe renal insufficiency (eGFR<30 ml/min/1.73m²)
  • electronic implants
  • acute or untreated abdominal wall or inguinal hernia

Robust people

Inclusion criteria

  • 75+ years
  • Robust
  • no prior WB-EMS exposure

Exclusion criteria

  • severe visual or hearing impairments
  • major cognitive impairment (MMSE <10)
  • medications with muscle-anabolic effects
  • medical conditions affecting trainability of muscles (e.g. Myasthenia gravis, Cushing syndrome, Morbus McArdle)
  • surgery within past two months
  • history of rhabdomyolysis
  • medical conditions affecting sensation of electrical stimuli (e.g. severe polyneuropathy)
  • severe renal insufficiency (eGFR<30 ml/min/1.73m²)
  • electronic implants
  • acute or untreated abdominal wall or inguinal hernia

Younger people

Inclusion criteria

  • 18-50 years
  • Healthy
  • no prior WB-EMS exposure

Exclusion criteria

  • severe visual or hearing impairments
  • major cognitive impairment (MMSE <10)
  • medications with muscle-anabolic effects
  • medical conditions affecting trainability of muscles (e.g. Myasthenia gravis, Cushing syndrome, Morbus McArdle)
  • surgery within past two months
  • history of rhabdomyolysis
  • medical conditions affecting sensation of electrical stimuli (e.g. severe polyneuropathy)
  • severe renal insufficiency (eGFR<30 ml/min/1.73m²)
  • electronic implants
  • acute or untreated abdominal wall or inguinal hernia
  • pregnancy

Treatment and study plan

Whole-Body Electromyostimulation

Other

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.

Primary outcomes

  1. Recruitment rate

    Time frame: 8 weeks

    measured by ratio of included/eligible participants

  2. Compliance

    Time frame: from baseline to 8 weeks

    measured by proportion of attended training sessions

  3. Retention rate

    Time frame: at 8 weeks

    measured by proportion of participants remaining in the study

  4. Dropout rate

    Time frame: from baseline to 8 weeks

    measured by the proportion of participants not completing the study

  5. Perceived enjoyment measured by the Physical Activity Enjoyment Scale for Older Adults (PACES-8)

    Time frame: Change from baseline to 8 weeks

    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.

  6. Intervention engagement measured by the Hopkins Rehabilitation Engagement Scale (HRERS)

    Time frame: at 8 weeks

    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.

  7. Concentration of Myoglobin (MB)

    Time frame: measured at baseline to week 1, week 3 and week 8

    Concentration of MB measured in µg/l 3 hours after training

  8. Concentration of Creatinkinase (CK)

    Time frame: measured at baseline to week 1, week 3 and week 8

    Concentration of CK measured in U/l before, 48, 72 hours after training

  9. estimated glomerular filtration rate (eGFR)

    Time frame: measured at baseline to week 1, week 3 and week 8

    eGFR (creatinine clearance) measured in mL/min/1.73m² before, 48, 72 hours after training

Secondary outcomes

  1. Rhabdomyolysis surveillance measured by a self-developed questionnaire

    Time frame: measured weekly

    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)

  2. Pain assessed by the Brief Pain Inventory (BPI-SF)

    Time frame: measured at baseline to week 1, week 3 and week 8

    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.

  3. Fatigue assessed by the Brief Fatigue Inventory (BFI)

    Time frame: measured at baseline to week 1, week 3 and week 8

    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.

  4. System usability measured by the System Usability Scale (SUS)

    Time frame: once at 8 weeks

    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.

  5. Lower extremity functioning measured by the Short Physical Performance Battery (SPPB)

    Time frame: Change from baseline to 9 weeks

    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).

  6. Mobility measured by the Timed up & go test (TUG)

    Time frame: Change from baseline to 9 weeks

    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.

  7. Maximum knee/hip extension strength

    Time frame: Change from baseline to 9 weeks

    Isokinetic leg press in Newton

  8. Skeletal muscle mass

    Time frame: Change from baseline to 8 weeks

    Bioelectrical impedance analysis (BIA)

  9. Rate of persons with Albuminuria

    Time frame: measured at baseline to week 1, week 3 and week 8

    Rate of persons with Albuminuria ≥ 2+ measured with a semi quantitative urine dipstick 24 hours after training

  10. Rate of persons with Proteinuria

    Time frame: measured at baseline to week 1, week 3 and week 8

    Rate of persons with Proteinuria ≥ 3+ measured with a semi quantitative urine dipstick 24 hours after training

  11. Concentration of Urea

    Time frame: measured at baseline to week 1, week 3 and week 8

    Concentration of Urea measured in mg/dl before, 48, 72 hours after training

  12. Concentration of Cystatin C

    Time frame: measured at baseline to week 1, week 3 and week 8

    Concentration of Cystatin C measured in mg/l before, 48, 72 hours after training

  13. Concentration of Creatinine

    Time frame: measured at baseline to week 1, week 3 and week 8

    Concentration of Creatinine measured in mg/dl before, 48, 72 hours after training

  14. Concentration of Sodium

    Time frame: measured at baseline to week 1, week 3 and week 8

    Concentration of Sodium measured in mmol/l before, 48, 72 hours after training

  15. Concentration of Potassium

    Time frame: measured at baseline to week 1, week 3 and week 8

    Concentration of Potassium measured in mmol/l before, 48, 72 hours after training

  16. Concentration of Calcium

    Time frame: measured at baseline to week 1, week 3 and week 8

    Concentration of Calcium measured in mmol/l before, 48, 72 hours after training

  17. Concentration of Phosphate

    Time frame: measured at baseline to week 1, week 3 and week 8

    Concentration of Phosphate measured in mmol/l before, 48, 72 hours after training

Other outcomes

  1. Health-related quality of life measured by the patient-reported Health Survey Short Form (SF-12)

    Time frame: Change from baseline to 9 weeks

    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.

  2. Concentration of Interleukin 6 (IL-6)

    Time frame: measured at baseline to week 1, week 3 and week 8

    Concentration of IL-6 measured in ng/l before, 3h, 48, 72 hours after training

  3. Concentration of High-sensitivity C-reactive protein (hs CRP)

    Time frame: measured at baseline to week 1, week 3 and week 8

    Concentration of hs CRP measured in mg/l before, 48, 72 hours after training

  4. Concentration of Cholesterin

    Time frame: measured at baseline and week 8

    Concentration of Cholesterin measured in mg/dl before first and last trainings

  5. Concentration of low-density lipoprotein (LDL)

    Time frame: measured at baseline and week 8

    Concentration of LDL measured in mg/dl before first and last trainings

  6. Concentration of high-density lipoprotein (HDL)

    Time frame: measured at baseline and week 8

    Concentration of HDL measured in mg/dl before first and last trainings

  7. Concentration of Triglycerides

    Time frame: measured at baseline and week 8

    Concentration of Triglycerides measured in mg/dl before first and last trainings

  8. Concentration of N-terminal pro b-type natriuretic peptide (NT-proBNP)

    Time frame: measured at baseline to week 1, week 3 and week 8

    Concentration of NT-proBNP measured in pg/ml before, 48, 72 hours after training

  9. Concentration of Glucose

    Time frame: measured at baseline and week 8

    Concentration of Glucose measured in mg/dl before first and last trainings

  10. Concentration of Creatinkinase Muscle/Brain (CK-MB (CK-2))

    Time frame: measured at baseline to week 1, week 3 and week 8

    Concentration of CK-MB (CK-2) measured in ng/ml before, 48, 72 hours after training

  11. Concentration of high-sensitive cardiac troponin T (hs-cTnT)

    Time frame: measured at baseline to week 1, week 3 and week 8

    Concentration of hs-cTnT measured in ng/ml before, 48, 72 hours after training

Sponsors and collaborators

Lead sponsor

University of Erlangen-Nürnberg Medical School

Other

Collaborators

  • Paracelsus Medical University

Registry information

Official study title

Feasibility and Safety of Whole-Body Electromyostimulation (WB-EMS) in Frail Older People: A Pilot Study

Important dates

Study start
2020
Primary completion
2020
Study completion
2021
First posted
Aug 3, 2020
Registry last updated
Apr 28, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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