Clinical trial NCT04495647: Feasibility of WB-EMS in Frail Older People
Official title: Feasibility and Safety of Whole-Body Electromyostimulation (WB-EMS) in Frail Older People: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Frailty
Mobility Limitation
Lead sponsor: University of Erlangen-Nürnberg Medical School
Sponsor class: OTHER
Collaborators: name: Paracelsus Medical University
First posted: 2020-08-03
Enrollment: 30
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
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

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Recruitment rate
timeFrame: 8 weeks
measure: Compliance
timeFrame: from baseline to 8 weeks
measure: Retention rate
timeFrame: at 8 weeks
measure: Dropout rate
timeFrame: from baseline to 8 weeks
measure: Perceived enjoyment measured by the Physical Activity Enjoyment Scale for Older Adults (PACES-8)
timeFrame: Change from baseline to 8 weeks
measure: Intervention engagement measured by the Hopkins Rehabilitation Engagement Scale (HRERS)
timeFrame: at 8 weeks
measure: Concentration of Myoglobin (MB)
timeFrame: measured at baseline to week 1, week 3 and week 8
measure: Concentration of Creatinkinase (CK)
timeFrame: measured at baseline to week 1, week 3 and week 8
measure: estimated glomerular filtration rate (eGFR)
timeFrame: measured at baseline to week 1, week 3 and week 8
Secondary outcomes:
measure: Rhabdomyolysis surveillance measured by a self-developed questionnaire
timeFrame: measured weekly
measure: Pain assessed by the Brief Pain Inventory (BPI-SF)
timeFrame: measured at baseline to week 1, week 3 and week 8
measure: Fatigue assessed by the Brief Fatigue Inventory (BFI)
timeFrame: measured at baseline to week 1, week 3 and week 8
measure: System usability measured by the System Usability Scale (SUS)
timeFrame: once at 8 weeks
measure: Lower extremity functioning measured by the Short Physical Performance Battery (SPPB)
timeFrame: Change from baseline to 9 weeks
measure: Mobility measured by the Timed up & go test (TUG)
timeFrame: Change from baseline to 9 weeks
measure: Maximum knee/hip extension strength
timeFrame: Change from baseline to 9 weeks
measure: Skeletal muscle mass
timeFrame: Change from baseline to 8 weeks
measure: Rate of persons with Albuminuria
timeFrame: measured at baseline to week 1, week 3 and week 8
measure: Rate of persons with Proteinuria
timeFrame: measured at baseline to week 1, week 3 and week 8
measure: Concentration of Urea
timeFrame: measured at baseline to week 1, week 3 and week 8
measure: Concentration of Cystatin C
timeFrame: measured at baseline to week 1, week 3 and week 8
measure: Concentration of Creatinine
timeFrame: measured at baseline to week 1, week 3 and week 8
measure: Concentration of Sodium
timeFrame: measured at baseline to week 1, week 3 and week 8
measure: Concentration of Potassium
timeFrame: measured at baseline to week 1, week 3 and week 8
measure: Concentration of Calcium
timeFrame: measured at baseline to week 1, week 3 and week 8
measure: Concentration of Phosphate
timeFrame: measured at baseline to week 1, week 3 and week 8
Other outcomes:
measure: Health-related quality of life measured by the patient-reported Health Survey Short Form (SF-12)
timeFrame: Change from baseline to 9 weeks
measure: Concentration of Interleukin 6 (IL-6)
timeFrame: measured at baseline to week 1, week 3 and week 8
measure: Concentration of High-sensitivity C-reactive protein (hs CRP)
timeFrame: measured at baseline to week 1, week 3 and week 8
measure: Concentration of Cholesterin
timeFrame: measured at baseline and week 8
measure: Concentration of low-density lipoprotein (LDL)
timeFrame: measured at baseline and week 8
measure: Concentration of high-density lipoprotein (HDL)
timeFrame: measured at baseline and week 8
measure: Concentration of Triglycerides
timeFrame: measured at baseline and week 8
measure: Concentration of N-terminal pro b-type natriuretic peptide (NT-proBNP)
timeFrame: measured at baseline to week 1, week 3 and week 8
measure: Concentration of Glucose
timeFrame: measured at baseline and week 8
measure: Concentration of Creatinkinase Muscle/Brain (CK-MB (CK-2))
timeFrame: measured at baseline to week 1, week 3 and week 8
measure: Concentration of high-sensitive cardiac troponin T (hs-cTnT)
timeFrame: measured at baseline to week 1, week 3 and week 8
Locations:
city: Erlangen
country: Germany
facility: Institute of Medical Physics, University of Erlangen-Nürnberg
Study officials:
References: