Back to resultsFeasibility of WB-EMS in Frail Older People
Primary Purpose
Frailty, Mobility Limitation
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Whole-Body Electromyostimulation
Sponsored by
About this trial
This is an interventional treatment trial for Frailty
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
Sites / Locations
- Institute of Medical Physics, University of Erlangen-Nürnberg
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Active Comparator
Arm Label
WB-EMS_frail
WB-EMS_robust
WB-EMS_young
Arm Description
Outcomes
Primary Outcome Measures
Recruitment rate
measured by ratio of included/eligible participants
Compliance
measured by proportion of attended training sessions
Retention rate
measured by proportion of participants remaining in the study
Dropout rate
measured by the proportion of participants not completing the study
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.
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.
Concentration of Myoglobin (MB)
Concentration of MB measured in µg/l 3 hours after training
Concentration of Creatinkinase (CK)
Concentration of CK measured in U/l before, 48, 72 hours after training
estimated glomerular filtration rate (eGFR)
eGFR (creatinine clearance) measured in mL/min/1.73m² before, 48, 72 hours after training
Secondary Outcome Measures
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)
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.
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.
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.
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).
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.
Maximum knee/hip extension strength
Isokinetic leg press in Newton
Skeletal muscle mass
Bioelectrical impedance analysis (BIA)
Rate of persons with Albuminuria
Rate of persons with Albuminuria ≥ 2+ measured with a semi quantitative urine dipstick 24 hours after training
Rate of persons with Proteinuria
Rate of persons with Proteinuria ≥ 3+ measured with a semi quantitative urine dipstick 24 hours after training
Concentration of Urea
Concentration of Urea measured in mg/dl before, 48, 72 hours after training
Concentration of Cystatin C
Concentration of Cystatin C measured in mg/l before, 48, 72 hours after training
Concentration of Creatinine
Concentration of Creatinine measured in mg/dl before, 48, 72 hours after training
Concentration of Sodium
Concentration of Sodium measured in mmol/l before, 48, 72 hours after training
Concentration of Potassium
Concentration of Potassium measured in mmol/l before, 48, 72 hours after training
Concentration of Calcium
Concentration of Calcium measured in mmol/l before, 48, 72 hours after training
Concentration of Phosphate
Concentration of Phosphate measured in mmol/l before, 48, 72 hours after training
Full Information
NCT ID
NCT04495647
First Posted
July 10, 2020
Last Updated
April 27, 2021
Sponsor
University of Erlangen-Nürnberg Medical School
Collaborators
Paracelsus Medical University
1. Study Identification
Unique Protocol Identification Number
NCT04495647
Brief Title
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
2. Study Status
Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
July 22, 2020 (Actual)
Primary Completion Date
December 31, 2020 (Actual)
Study Completion Date
February 28, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Erlangen-Nürnberg Medical School
Collaborators
Paracelsus Medical University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Frailty, Mobility Limitation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
frail older people (n=10) pre-post; robust older (n=10) and young (n=10) reference groups with identical intervention
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
WB-EMS_frail
Arm Type
Experimental
Arm Title
WB-EMS_robust
Arm Type
Active Comparator
Arm Title
WB-EMS_young
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
Whole-Body Electromyostimulation
Intervention 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.
Primary Outcome Measure Information:
Title
Recruitment rate
Description
measured by ratio of included/eligible participants
Time Frame
8 weeks
Title
Compliance
Description
measured by proportion of attended training sessions
Time Frame
from baseline to 8 weeks
Title
Retention rate
Description
measured by proportion of participants remaining in the study
Time Frame
at 8 weeks
Title
Dropout rate
Description
measured by the proportion of participants not completing the study
Time Frame
from baseline to 8 weeks
Title
Perceived enjoyment measured by the Physical Activity Enjoyment Scale for Older Adults (PACES-8)
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.
Time Frame
Change from baseline to 8 weeks
Title
Intervention engagement measured by the Hopkins Rehabilitation Engagement Scale (HRERS)
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.
Time Frame
at 8 weeks
Title
Concentration of Myoglobin (MB)
Description
Concentration of MB measured in µg/l 3 hours after training
Time Frame
measured at baseline to week 1, week 3 and week 8
Title
Concentration of Creatinkinase (CK)
Description
Concentration of CK measured in U/l before, 48, 72 hours after training
Time Frame
measured at baseline to week 1, week 3 and week 8
Title
estimated glomerular filtration rate (eGFR)
Description
eGFR (creatinine clearance) measured in mL/min/1.73m² before, 48, 72 hours after training
Time Frame
measured at baseline to week 1, week 3 and week 8
Secondary Outcome Measure Information:
Title
Rhabdomyolysis surveillance measured by a self-developed questionnaire
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)
Time Frame
measured weekly
Title
Pain assessed by the Brief Pain Inventory (BPI-SF)
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.
Time Frame
measured at baseline to week 1, week 3 and week 8
Title
Fatigue assessed by the Brief Fatigue Inventory (BFI)
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.
Time Frame
measured at baseline to week 1, week 3 and week 8
Title
System usability measured by the System Usability Scale (SUS)
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.
Time Frame
once at 8 weeks
Title
Lower extremity functioning measured by the Short Physical Performance Battery (SPPB)
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).
Time Frame
Change from baseline to 9 weeks
Title
Mobility measured by the Timed up & go test (TUG)
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.
Time Frame
Change from baseline to 9 weeks
Title
Maximum knee/hip extension strength
Description
Isokinetic leg press in Newton
Time Frame
Change from baseline to 9 weeks
Title
Skeletal muscle mass
Description
Bioelectrical impedance analysis (BIA)
Time Frame
Change from baseline to 8 weeks
Title
Rate of persons with Albuminuria
Description
Rate of persons with Albuminuria ≥ 2+ measured with a semi quantitative urine dipstick 24 hours after training
Time Frame
measured at baseline to week 1, week 3 and week 8
Title
Rate of persons with Proteinuria
Description
Rate of persons with Proteinuria ≥ 3+ measured with a semi quantitative urine dipstick 24 hours after training
Time Frame
measured at baseline to week 1, week 3 and week 8
Title
Concentration of Urea
Description
Concentration of Urea measured in mg/dl before, 48, 72 hours after training
Time Frame
measured at baseline to week 1, week 3 and week 8
Title
Concentration of Cystatin C
Description
Concentration of Cystatin C measured in mg/l before, 48, 72 hours after training
Time Frame
measured at baseline to week 1, week 3 and week 8
Title
Concentration of Creatinine
Description
Concentration of Creatinine measured in mg/dl before, 48, 72 hours after training
Time Frame
measured at baseline to week 1, week 3 and week 8
Title
Concentration of Sodium
Description
Concentration of Sodium measured in mmol/l before, 48, 72 hours after training
Time Frame
measured at baseline to week 1, week 3 and week 8
Title
Concentration of Potassium
Description
Concentration of Potassium measured in mmol/l before, 48, 72 hours after training
Time Frame
measured at baseline to week 1, week 3 and week 8
Title
Concentration of Calcium
Description
Concentration of Calcium measured in mmol/l before, 48, 72 hours after training
Time Frame
measured at baseline to week 1, week 3 and week 8
Title
Concentration of Phosphate
Description
Concentration of Phosphate measured in mmol/l before, 48, 72 hours after training
Time Frame
measured at baseline to week 1, week 3 and week 8
Other Pre-specified Outcome Measures:
Title
Health-related quality of life measured by the patient-reported Health Survey Short Form (SF-12)
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.
Time Frame
Change from baseline to 9 weeks
Title
Concentration of Interleukin 6 (IL-6)
Description
Concentration of IL-6 measured in ng/l before, 3h, 48, 72 hours after training
Time Frame
measured at baseline to week 1, week 3 and week 8
Title
Concentration of High-sensitivity C-reactive protein (hs CRP)
Description
Concentration of hs CRP measured in mg/l before, 48, 72 hours after training
Time Frame
measured at baseline to week 1, week 3 and week 8
Title
Concentration of Cholesterin
Description
Concentration of Cholesterin measured in mg/dl before first and last trainings
Time Frame
measured at baseline and week 8
Title
Concentration of low-density lipoprotein (LDL)
Description
Concentration of LDL measured in mg/dl before first and last trainings
Time Frame
measured at baseline and week 8
Title
Concentration of high-density lipoprotein (HDL)
Description
Concentration of HDL measured in mg/dl before first and last trainings
Time Frame
measured at baseline and week 8
Title
Concentration of Triglycerides
Description
Concentration of Triglycerides measured in mg/dl before first and last trainings
Time Frame
measured at baseline and week 8
Title
Concentration of N-terminal pro b-type natriuretic peptide (NT-proBNP)
Description
Concentration of NT-proBNP measured in pg/ml before, 48, 72 hours after training
Time Frame
measured at baseline to week 1, week 3 and week 8
Title
Concentration of Glucose
Description
Concentration of Glucose measured in mg/dl before first and last trainings
Time Frame
measured at baseline and week 8
Title
Concentration of Creatinkinase Muscle/Brain (CK-MB (CK-2))
Description
Concentration of CK-MB (CK-2) measured in ng/ml before, 48, 72 hours after training
Time Frame
measured at baseline to week 1, week 3 and week 8
Title
Concentration of high-sensitive cardiac troponin T (hs-cTnT)
Description
Concentration of hs-cTnT measured in ng/ml before, 48, 72 hours after training
Time Frame
measured at baseline to week 1, week 3 and week 8
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
Institute of Medical Physics, University of Erlangen-Nürnberg
City
Erlangen
ZIP/Postal Code
91052
Country
Germany
12. IPD Sharing Statement
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Feasibility of WB-EMS in Frail Older People
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