Feasibility of WB-EMS in Frail Older People

Frailty Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04495647
• Other study ID #: ETAPPEN_Pilot
• Status: Completed
• Phase: N/A
• Start date: July 22, 2020
• Est. completion date: February 28, 2021

Study information

• Verified date: April 2021
• Source: University of Erlangen-Nürnberg Medical School
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: February 28, 2021
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Frailty
• Mobility Limitation

Intervention

Other:
• Whole-Body Electromyostimulation
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.

Locations

Country	Name	City	State
Germany	Institute of Medical Physics, University of Erlangen-Nürnberg	Erlangen

Sponsors (2)

Lead Sponsor	Collaborator
University of Erlangen-Nürnberg Medical School	Paracelsus Medical University

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Health-related quality of life measured by the patient-reported Health Survey Short Form (SF-12)	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.	Change from baseline to 9 weeks
Other	Concentration of Interleukin 6 (IL-6)	Concentration of IL-6 measured in ng/l before, 3h, 48, 72 hours after training	measured at baseline to week 1, week 3 and week 8
Other	Concentration of High-sensitivity C-reactive protein (hs CRP)	Concentration of hs CRP measured in mg/l before, 48, 72 hours after training	measured at baseline to week 1, week 3 and week 8
Other	Concentration of Cholesterin	Concentration of Cholesterin measured in mg/dl before first and last trainings	measured at baseline and week 8
Other	Concentration of low-density lipoprotein (LDL)	Concentration of LDL measured in mg/dl before first and last trainings	measured at baseline and week 8
Other	Concentration of high-density lipoprotein (HDL)	Concentration of HDL measured in mg/dl before first and last trainings	measured at baseline and week 8
Other	Concentration of Triglycerides	Concentration of Triglycerides measured in mg/dl before first and last trainings	measured at baseline and week 8
Other	Concentration of N-terminal pro b-type natriuretic peptide (NT-proBNP)	Concentration of NT-proBNP measured in pg/ml before, 48, 72 hours after training	measured at baseline to week 1, week 3 and week 8
Other	Concentration of Glucose	Concentration of Glucose measured in mg/dl before first and last trainings	measured at baseline and week 8
Other	Concentration of Creatinkinase Muscle/Brain (CK-MB (CK-2))	Concentration of CK-MB (CK-2) measured in ng/ml before, 48, 72 hours after training	measured at baseline to week 1, week 3 and week 8
Other	Concentration of high-sensitive cardiac troponin T (hs-cTnT)	Concentration of hs-cTnT measured in ng/ml before, 48, 72 hours after training	measured at baseline to week 1, week 3 and week 8
Primary	Recruitment rate	measured by ratio of included/eligible participants	8 weeks
Primary	Compliance	measured by proportion of attended training sessions	from baseline to 8 weeks
Primary	Retention rate	measured by proportion of participants remaining in the study	at 8 weeks
Primary	Dropout rate	measured by the proportion of participants not completing the study	from baseline to 8 weeks
Primary	Perceived enjoyment measured by the Physical Activity Enjoyment Scale for Older Adults (PACES-8)	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.	Change from baseline to 8 weeks
Primary	Intervention engagement measured by the Hopkins Rehabilitation Engagement Scale (HRERS)	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.	at 8 weeks
Primary	Concentration of Myoglobin (MB)	Concentration of MB measured in µg/l 3 hours after training	measured at baseline to week 1, week 3 and week 8
Primary	Concentration of Creatinkinase (CK)	Concentration of CK measured in U/l before, 48, 72 hours after training	measured at baseline to week 1, week 3 and week 8
Primary	estimated glomerular filtration rate (eGFR)	eGFR (creatinine clearance) measured in mL/min/1.73m² before, 48, 72 hours after training	measured at baseline to week 1, week 3 and week 8
Secondary	Rhabdomyolysis surveillance measured by a self-developed questionnaire	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)	measured weekly
Secondary	Pain assessed by the Brief Pain Inventory (BPI-SF)	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.	measured at baseline to week 1, week 3 and week 8
Secondary	Fatigue assessed by the Brief Fatigue Inventory (BFI)	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.	measured at baseline to week 1, week 3 and week 8
Secondary	System usability measured by the System Usability Scale (SUS)	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.	once at 8 weeks
Secondary	Lower extremity functioning measured by the Short Physical Performance Battery (SPPB)	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).	Change from baseline to 9 weeks
Secondary	Mobility measured by the Timed up & go test (TUG)	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.	Change from baseline to 9 weeks
Secondary	Maximum knee/hip extension strength	Isokinetic leg press in Newton	Change from baseline to 9 weeks
Secondary	Skeletal muscle mass	Bioelectrical impedance analysis (BIA)	Change from baseline to 8 weeks
Secondary	Rate of persons with Albuminuria	Rate of persons with Albuminuria = 2+ measured with a semi quantitative urine dipstick 24 hours after training	measured at baseline to week 1, week 3 and week 8
Secondary	Rate of persons with Proteinuria	Rate of persons with Proteinuria = 3+ measured with a semi quantitative urine dipstick 24 hours after training	measured at baseline to week 1, week 3 and week 8
Secondary	Concentration of Urea	Concentration of Urea measured in mg/dl before, 48, 72 hours after training	measured at baseline to week 1, week 3 and week 8
Secondary	Concentration of Cystatin C	Concentration of Cystatin C measured in mg/l before, 48, 72 hours after training	measured at baseline to week 1, week 3 and week 8
Secondary	Concentration of Creatinine	Concentration of Creatinine measured in mg/dl before, 48, 72 hours after training	measured at baseline to week 1, week 3 and week 8
Secondary	Concentration of Sodium	Concentration of Sodium measured in mmol/l before, 48, 72 hours after training	measured at baseline to week 1, week 3 and week 8
Secondary	Concentration of Potassium	Concentration of Potassium measured in mmol/l before, 48, 72 hours after training	measured at baseline to week 1, week 3 and week 8
Secondary	Concentration of Calcium	Concentration of Calcium measured in mmol/l before, 48, 72 hours after training	measured at baseline to week 1, week 3 and week 8
Secondary	Concentration of Phosphate	Concentration of Phosphate measured in mmol/l before, 48, 72 hours after training	measured at baseline to week 1, week 3 and week 8