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Efficacy of WB-EMS in Frail Older People

Primary Purpose

Frailty Syndrome

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
WB-EMS
social contact control group
Sponsored by
University of Erlangen-Nürnberg Medical School
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Frailty Syndrome

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • aged 65 years and older
  • frail according to Tilburg Frailty Indicator
  • residing in assisted living facility or nursing home
  • able to walk 4m w/o walking aid but without personal assistance
  • 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
  • Ventricular arrhythmias requiring therapy

Sites / Locations

  • Institute of Medical Physics, University of Erlangen-Nürnberg

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

WB-EMS

social contact control group

Arm Description

Outcomes

Primary Outcome Measures

Change in Lower Extremity Functioning
The Short Physical Performance Battery (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).

Secondary Outcome Measures

Change in Mobility measured by the Timed up & go test (TUG)
The TUG requires the participants to stand up from a chair, walk at usual pace to line at 3m, turn, walk back and sit down again. The time in seconds is recorded.
Change in leg strength
Maximal isometric knee extension strength will be assessed on the dominant leg with the participant seated. Three trials will be conducted.
Change in maximal hand grip strength
Grip strength will be assessed on the dominant hand using a digital dynamometer with the participant seated. Three trials will be conducted.
Change in gait speed
Gait speed will be assessed over 6 meters under 3 conditions, 1) walking at usual pace, 2) walking at usual pace while counting backwards by 3, 3) walking at fast pace
Change in Choice Stepping Reaction Time (CSRT) test
CSRT time will be measured as the total time to complete 12 steps onto four targets printed on a portable rubber mat following 8 practice trials.
Change in Body Sway
An instrumented test of postural sway (ISway) using a body-worn accelerometer will be used.
Change in Balance performance
The Berg Balance Scale (BBS) will be used to assess 14 balance tasks of static and dynamic stability. Each task is scored on a five-point scale according to quality or time ranging from "0" (lowest level of function) to "4" (highest level). The maximum score is 56.
Change in Functional Balance
The Alternate Step Test (AST) measures the time required to place the feet eight times in alternate order on a sturdy step (18 cm high) as fast as possible
Change in Frailty Status
Frailty will be assessed by the Fried Phenotype and the Tilburg Frailty Indicator (TFI). The Fried phenotype comprises of muscle weakness, fatigue, slowness, low physical activity levels, unintentional weight loss, each scored as 0 (criterion not fulfilled) or 1 (criterion fulfilled). A total sum score of 0 indicates a person is robust, a score of 1 or 2 indicates pre-frailty and a score of 3-5 indicates frailty. The TFI is a self-reported frailty scale consisting of 3 domains, physical (8 items), psychological (4 items) and social (3 items). A total sum score greater or equal to 5 indicates frailty.
Change in lean mass
Lean mass will be assessed using Bioelectrical Impedance Analysis (BIA).
Change in fat mass
Fat mass will be assessed using Bioelectrical Impedance Analysis (BIA).
Change in Physical Activity
Physical activities will be assessed using a 7-day accelerometry measurement. The device (ActivPAL 3 micro) will be attached to participants' thigh and worn over the complete 7-day/24-hour period.
Change in concentration of Triglycerides
Concentration of Triglycerides measured in mg/dl before first and last trainings
Change in concentration of total cholesterol
Concentration of Cholesterin measured in mg/dl before first and last trainings
Change in concentration of high-density lipoprotein (HDL)
Concentration of HDL measured in mg/dl before first and last trainings
Change in concentration of low-density lipoprotein (LDL)
Concentration of LDL measured in mg/dl before first and last trainings
Change in concentration of glucose
Concentration of Glucose measured in mg/dl before first and last trainings
Change in concentration of Creatinkinase (CK)
Concentration of CK measured in U/l before the first and after the last training
Change in concentration of Creatinine
Concentration of Creatinine measured in mg/dl before the first and after the last training
Change in estimated glomerular filtration rate (eGFR)
eGFR (creatinine clearance) measured in mL/min/1.73m² before the first and after the last training
Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Pain and function due to orthopedic problems will be assessed with the WOMAC questionnaire, comprising of 24 items each scored on a 5-point Likert scale.
Change in continence status
Continence status (frequency, severity, perceived burden, timing) will be assessed using the International Consultation on Incontinence Questionnaire (ICIQ, 5 items) and the short form of the Urogenital Distress Inventory (UDI-6, 6 items).
Change in depressive symptoms
Depressive symptoms will be assessed using the Iowa version of the Center for Epidemiologic Studies Depression Scale (CES-D), consisting of 11 items, each scored on a 3-point rating scale. The total sum score is calculated.
Change in concerns about falling
The Falls-efficacy Scale-International (FES-I) questionnaire will be used to assess the concerns about falling during 16 activities of daily living. Each item is scored on a 4-point rating scale and the total sum score is calculated.
Change in Quality of Life (QoL)
QoL will be assessed with 26-item WHOQOL-BREF covering physical health, psychological health, social relationships and environmental aspects. Each item is scored on a 5-point Likert scale.
Change in sarcopenia specific QoL
Sarcopenia specific QoL will be assessed with the SarQoL, comprising of 55 items in 22 questions rated on a 4-point Likert scale. Seven domains are specified: Physical and mental health, Locomotion, Body composition, Functionality, Activities of daily living, Leisure activities and Fear.
Change in Health-related Quality of Life (HrQoL)
HrQoL will be assessed using the 4-item HowRu scale comprising of 4 variables: pain or discomfort, feeling low or worried, limitation in activities and dependency on others. Each item is scored on a 4-point visual analogue scale.

Full Information

First Posted
July 15, 2021
Last Updated
July 18, 2022
Sponsor
University of Erlangen-Nürnberg Medical School
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1. Study Identification

Unique Protocol Identification Number
NCT04967534
Brief Title
Efficacy of WB-EMS in Frail Older People
Official Title
The Efficacy of Whole-Body Electromyostimulation (WB-EMS) in Frail Older People: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
July 21, 2021 (Actual)
Primary Completion Date
March 15, 2022 (Actual)
Study Completion Date
March 15, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Erlangen-Nürnberg Medical School

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 frailty outcomes, including physical functioning. However, frail older people with functional impairments are among the least physically active and have problems reaching high-intensity levels. Whole-body electromyostimulation (WB-EMS) allows the simultaneous innervation of all large muscle groups by external electrical stimulation, inducing a high-intensity RT at a low subjective effort level. The efficacy of WB-EMS in frail older people has yet to be determined. The primary objective of this study is to investigate the efficacy of WB-EMS in frail older people.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Frailty Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
parallel-group (1:1) randomized controlled trial
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
54 (Actual)

8. Arms, Groups, and Interventions

Arm Title
WB-EMS
Arm Type
Experimental
Arm Title
social contact control group
Arm Type
Sham Comparator
Intervention Type
Behavioral
Intervention Name(s)
WB-EMS
Intervention Description
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 12 weeks (total training duration 8 weeks). Easy to perform functional exercises focusing on balance, transfer ability, stepping, and lower extremity strength will be done during WB-EMS. Exercise intensity will be individually prescribed and adjusted by the rate of perceived exertion (RPE-Borg CR10 scale 4 (moderate) to 7 (hard)). WB-EMS will be fully supervised one-on-one.
Intervention Type
Behavioral
Intervention Name(s)
social contact control group
Intervention Description
Psycho-social intervention with participants randomized to the control group receiving (if wanted) the same social contact time (20-30 minutes/week) as the WB-EMS group. Depending on personal preferences and Covid-19 restrictions this will be done by phone or in-person one-on-one. Health-related topics and/or general chatting will be offered.
Primary Outcome Measure Information:
Title
Change in Lower Extremity Functioning
Description
The Short Physical Performance Battery (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
8 weeks, 16 weeks, 32 weeks
Secondary Outcome Measure Information:
Title
Change in Mobility measured by the Timed up & go test (TUG)
Description
The TUG requires the participants to stand up from a chair, walk at usual pace to line at 3m, turn, walk back and sit down again. The time in seconds is recorded.
Time Frame
8 weeks, 16 weeks, 32 weeks
Title
Change in leg strength
Description
Maximal isometric knee extension strength will be assessed on the dominant leg with the participant seated. Three trials will be conducted.
Time Frame
8 weeks, 16 weeks, 32 weeks
Title
Change in maximal hand grip strength
Description
Grip strength will be assessed on the dominant hand using a digital dynamometer with the participant seated. Three trials will be conducted.
Time Frame
8 weeks, 16 weeks, 32 weeks
Title
Change in gait speed
Description
Gait speed will be assessed over 6 meters under 3 conditions, 1) walking at usual pace, 2) walking at usual pace while counting backwards by 3, 3) walking at fast pace
Time Frame
16 weeks, 32 weeks
Title
Change in Choice Stepping Reaction Time (CSRT) test
Description
CSRT time will be measured as the total time to complete 12 steps onto four targets printed on a portable rubber mat following 8 practice trials.
Time Frame
16 weeks, 32 weeks
Title
Change in Body Sway
Description
An instrumented test of postural sway (ISway) using a body-worn accelerometer will be used.
Time Frame
8 weeks, 16 weeks, 32 weeks
Title
Change in Balance performance
Description
The Berg Balance Scale (BBS) will be used to assess 14 balance tasks of static and dynamic stability. Each task is scored on a five-point scale according to quality or time ranging from "0" (lowest level of function) to "4" (highest level). The maximum score is 56.
Time Frame
16 weeks, 32 weeks
Title
Change in Functional Balance
Description
The Alternate Step Test (AST) measures the time required to place the feet eight times in alternate order on a sturdy step (18 cm high) as fast as possible
Time Frame
16 weeks, 32 weeks
Title
Change in Frailty Status
Description
Frailty will be assessed by the Fried Phenotype and the Tilburg Frailty Indicator (TFI). The Fried phenotype comprises of muscle weakness, fatigue, slowness, low physical activity levels, unintentional weight loss, each scored as 0 (criterion not fulfilled) or 1 (criterion fulfilled). A total sum score of 0 indicates a person is robust, a score of 1 or 2 indicates pre-frailty and a score of 3-5 indicates frailty. The TFI is a self-reported frailty scale consisting of 3 domains, physical (8 items), psychological (4 items) and social (3 items). A total sum score greater or equal to 5 indicates frailty.
Time Frame
16 weeks, 32 weeks
Title
Change in lean mass
Description
Lean mass will be assessed using Bioelectrical Impedance Analysis (BIA).
Time Frame
16 weeks, 32 weeks
Title
Change in fat mass
Description
Fat mass will be assessed using Bioelectrical Impedance Analysis (BIA).
Time Frame
16 weeks, 32 weeks
Title
Change in Physical Activity
Description
Physical activities will be assessed using a 7-day accelerometry measurement. The device (ActivPAL 3 micro) will be attached to participants' thigh and worn over the complete 7-day/24-hour period.
Time Frame
16 weeks
Title
Change in concentration of Triglycerides
Description
Concentration of Triglycerides measured in mg/dl before first and last trainings
Time Frame
16 weeks
Title
Change in concentration of total cholesterol
Description
Concentration of Cholesterin measured in mg/dl before first and last trainings
Time Frame
16 weeks
Title
Change in concentration of high-density lipoprotein (HDL)
Description
Concentration of HDL measured in mg/dl before first and last trainings
Time Frame
16 weeks
Title
Change in concentration of low-density lipoprotein (LDL)
Description
Concentration of LDL measured in mg/dl before first and last trainings
Time Frame
16 weeks
Title
Change in concentration of glucose
Description
Concentration of Glucose measured in mg/dl before first and last trainings
Time Frame
16 weeks
Title
Change in concentration of Creatinkinase (CK)
Description
Concentration of CK measured in U/l before the first and after the last training
Time Frame
8 weeks, 16 weeks
Title
Change in concentration of Creatinine
Description
Concentration of Creatinine measured in mg/dl before the first and after the last training
Time Frame
8 weeks, 16 weeks
Title
Change in estimated glomerular filtration rate (eGFR)
Description
eGFR (creatinine clearance) measured in mL/min/1.73m² before the first and after the last training
Time Frame
8 weeks, 16 weeks
Title
Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Description
Pain and function due to orthopedic problems will be assessed with the WOMAC questionnaire, comprising of 24 items each scored on a 5-point Likert scale.
Time Frame
8 weeks, 16 weeks
Title
Change in continence status
Description
Continence status (frequency, severity, perceived burden, timing) will be assessed using the International Consultation on Incontinence Questionnaire (ICIQ, 5 items) and the short form of the Urogenital Distress Inventory (UDI-6, 6 items).
Time Frame
16 weeks, 32 weeks
Title
Change in depressive symptoms
Description
Depressive symptoms will be assessed using the Iowa version of the Center for Epidemiologic Studies Depression Scale (CES-D), consisting of 11 items, each scored on a 3-point rating scale. The total sum score is calculated.
Time Frame
16 weeks, 32 weeks
Title
Change in concerns about falling
Description
The Falls-efficacy Scale-International (FES-I) questionnaire will be used to assess the concerns about falling during 16 activities of daily living. Each item is scored on a 4-point rating scale and the total sum score is calculated.
Time Frame
16 weeks, 32 weeks
Title
Change in Quality of Life (QoL)
Description
QoL will be assessed with 26-item WHOQOL-BREF covering physical health, psychological health, social relationships and environmental aspects. Each item is scored on a 5-point Likert scale.
Time Frame
16 weeks
Title
Change in sarcopenia specific QoL
Description
Sarcopenia specific QoL will be assessed with the SarQoL, comprising of 55 items in 22 questions rated on a 4-point Likert scale. Seven domains are specified: Physical and mental health, Locomotion, Body composition, Functionality, Activities of daily living, Leisure activities and Fear.
Time Frame
16 weeks, 32 weeks
Title
Change in Health-related Quality of Life (HrQoL)
Description
HrQoL will be assessed using the 4-item HowRu scale comprising of 4 variables: pain or discomfort, feeling low or worried, limitation in activities and dependency on others. Each item is scored on a 4-point visual analogue scale.
Time Frame
8 weeks, 16 weeks, 32 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: aged 65 years and older frail according to Tilburg Frailty Indicator residing in assisted living facility or nursing home able to walk 4m w/o walking aid but without personal assistance 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 Ventricular arrhythmias requiring therapy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wolfgang Kemmler, PhD
Organizational Affiliation
University of Erlangen-Nürnberg Medical School
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institute of Medical Physics, University of Erlangen-Nürnberg
City
Erlangen
State/Province
Bavaria
ZIP/Postal Code
91052
Country
Germany

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
IPD will be shared upon reasonable request by the principal investigator. IPD relevant to a specific publication will be shared deidentified if it is the respective journal's requirement.
IPD Sharing Time Frame
Beginning 3 months and ending 5 years following article publication
IPD Sharing Access Criteria
Researchers who provide a methodologically sound proposal. Proposals should be directed to wolfgang.kemmler@imp.uni-erlangen.de

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Efficacy of WB-EMS in Frail Older People

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